Category: 8. Health

  • First report of Aedes albopictus in Saint Barthélemy (French West Indies) confirmed by morphological, molecular and MALDI-TOF mass spectrometry approaches | Parasites & Vectors

    First report of Aedes albopictus in Saint Barthélemy (French West Indies) confirmed by morphological, molecular and MALDI-TOF mass spectrometry approaches | Parasites & Vectors

    The French Territories of the Americas are regions frequently impacted by arthropod-borne viruses transmitted by Aedes aegypti mosquitoes, such as dengue, chikungunya, and Zika viruses [1]. However, the presence of Aedes albopictus, another important mosquito vector for arboviruses [2], had never been reported in any of these territories, despite the impressive spread of this mosquito in mainland France since 2004 [3]. In the Caribbean, Ae. albopictus was first reported in the Dominican Republic in 1993 [4].

    On 30 September 2024, two vector control agents collected mosquito larvae from a floor siphon (17°54′20″N, 62°49′28″W) near the Lorient post office on the island of Saint Barthélemy, as part of their routine entomological surveillance activities that include weekly larval prospections and ovitrapping. The larvae were brought to the Vector Control Agency office (Agence Régionale de Santé [ARS]) in Saint Barthélemy and reared until adulthood. After emergence, the agents noted the presence of adult mosquitoes that did not match morphological criteria for Ae. aegypti and photographed the mosquitoes. Entomologists from ARS Guadeloupe, ARS Martinique and from local research institutions examined the photographs and confirmed the agents’ suspicion that the mosquitoes were Ae. albopictus.

    Two weeks later, an exploration mission was organized, during which agents from ARS Guadeloupe, ARS Saint Barthélémy, and the Institut Pasteur of Guadeloupe (IPG) traveled to Saint Barthélémy to confirm the species’ identity and to inform about its distribution area on the island. Larval prospections conducted from 14 to 16 October identified five breeding sites within a 400-m radius of the initial detection site, all containing mosquitoes morphologically identified as Ae. albopictus (Table 1).

    Table 1 Aedes albopictus breeding sites identified in Saint Barthélemy (French West Indies) between 14 and 16 October 2024

    Morphological criteria described by Darsie [5] were initially used during the missions to identify Ae. albopictus at both the larval and adult stages (Fig. 1a–c). However, since Ae. albopictus shares morphological similarities with other members of the Scutellaris group, further identification steps were performed on two collected specimens using matrix-assisted laser desorption ionization—time-of-flight mass spectrometry (MALDI-TOF MS) and cytochrome c oxidase 1 (cox1) gene barcoding to confirm the species. Briefly, the two specimens were individually dissected to separate the head and thorax from the rest of the body, and then homogenized 3 × 1 min at 30 Hz in a tissue lyzer (Retsch GmbH, Haan Germany). Legs and/or thoraxes were separately treated for identification by MALDI-TOF MS as previously described [6]. Protein mass profiles were acquired using a Maldi Biotyper Sirius Mass Spectrometer (Bruker Daltonics, Bremen, Germany), operating in linear positive-ion mode, with detection at a laser frequency of 50 Hz within a mass range of 2–20 kDa. MALDI-TOF spectra databases shared between entomologists from the Institut Pasteur of New Caledonia and the IHU Méditerranée enabled almost instantaneously confirmation of the samples as Ae. albopictus species, with the relevant score for the two specimens (log-score identification value = 2.05, matching spectra of Ae. albopictus from Cameroon [using mosquito legs from specimen 1] and from Marseille [using mosquito thorax from specimen 2]). To evaluate spectral similarity between specimen 1, which was collected in Saint-Barthélemy, and those from other Ae. albopictus, we generated a clustering analysis via the MSP (main spectra library) dendrogram function in MALDI-Biotyper v3.0 software. (Bruker Daltonics) using MS spectra from Ae. albopictus and five other Aedes species from the Scutellaris group (Aedes scutellaris, Aedes pseudoscutellaris, Aedes futunae, Aedes malayensis and Aedes polynesiensis). The resulting MSP dendrogram showed that the spectrum of the Saint-Barthélemy specimen clustered together with those of other Ae. albopictus, ruling out the possibility of other species from the Scutellaris group (Fig. 1d). These results highlighted the high reproducibility and the specificity of protein profiles among Aedes species, allowing a rapid and relevant identification of the specimen.

    Fig. 1

    Identification of adult Aedes albopictus specimens found in Saint Barthélémy (French West Indies) according to morphological criteria (A, B, C), MALDI-TOF MS analysis (D) and cox1 gene barcoding (E). A Abdomen view: abdominal terga with complete basal white bands (red arrow), B thorax view: scutum with a medial-longitudinal white stripe (red arrow), C thorax view: mesepimeron with non-separated white scales, forming a V-shaped white spot (red arrow). D Main spectrum profile (MSP) dendrogram of Aedes Scutellaris Group. Spectrum from the mosquito specimen collected in Saint Barthélémy was obtained with a Maldi Biotyper Sirius mass spectrometer (Bruker Daltonics), and the dendrogram was generated by MALDI Biotyper Compas Explorer software. Distance units correspond to the relative similarity between spectra of Ae. albopictus from Saint Barthélémy and those from IHU Méditérranée and Institut Pasteur New Caledonia databases. E Molecular phylogenetic tree generated by the maximum likelihood method. The percentage bootstrap values shown at the nodes were calculated with 1000 replicates, and only bootstrap values > 70 are shown. Scale bar indicates nucleotide substitutions per site. Aedes albopictus sequences or spectra from Saint Barthelemy specimens are indicated in red and bold. cox1, Cytochrome c oxidase 1 gene; IHU, Institut hospitalo-universitaire; MALDI-TOF MS, matrix-assisted laser desorption ionization—time-of-flight mass spectrometry. Mosquito pictures were taken by Fabrice Sonor

    We subsequently used the remaining body parts from the two specimens to conduct cox1 barcoding. Total DNA was extracted using the cetyltrimethylammonium bromide technique as previously described [7] and sequenced by Eurofins Genomics Europe (Sanger sequencing) using the primers HCO2198 and LCO1490 [6]. Sequences were analyzed, and multiple sequence alignment (Clustal W) was conducted using BioEdit version 7.0.5.3 software (BioEdit, Manchester, UK) [8, 9]. A molecular phylogenetic tree was generated by the maximum likelihood method based on the Timura 3-parameter model (best-fit nucleotide substitution pattern determined according to the corrected Akaike Information Criterion) using MEGA (http://www.megasoftware.net) with a bootstrap of 1000 replications [10]. Barcoding results indicated that the sequences from the mosquitoes collected in Saint Barthélemy (GenBank accession no. PQ644904 and PQ644905) shared 100% homology with sequences from Ae. albopictus collected in Europe and the Americas (Fig. 1e).

    In the following weeks, weekly entomological surveillance continued, and the number of Ae. albopictus-positive breeding sites on Lorient increased to 18 in a 665-m2 area. The species’ presence was also detected in five breeding sites within a 150-m2 area in Saint Jean (17°53′50″N, 62°50′14″W). The discovery of this second hotspot, located 1.6 km from Lorient and near the airport, suggests a broader distribution of the species on the island. The presence of this invasive mosquito species in Saint Barthélémy, an island with daily aerial or maritime connections to the French Departments of the Americas [11], raises concerns about the risk of its introduction into these territories, as well as into other Caribbean countries. After the first detection of Ae. albopictus in the Dominican Republic in 1993 [4], the species has been reported in an increasing number of Caribbean territories, including Cuba in 1995 [12], Cayman Islands in 1997 [13, 14], Trinidad in 2002 [15], Haiti in 2010 [16], and Jamaica in 2018 [17] (Fig. 2).

    Fig. 2
    figure 2

    Aedes albopictus distribution in the Caribbean. Countries or territories reporting the species have been marked with red location pins. Date of first detection is given in parentheses. Asterisks indicate the first detection in Saint Barthélemy. cox1, Cytochrome c oxidase 1 gene; IHU, Institut hospitalo-universitaire; MALDI-TOF MS, matrix-assisted laser desorption ionization—time-of-flight mass spectrometry. Created with BioRender.com

    It is noteworthy that in Cuba, from 1995 to 1999, Ae. albopictus was mainly distributed in peripheral municipalities with abundant vegetation rather that in more urbanized areas (i.e. city center). However, an increase in the species’ distribution in more urbanized areas, in association with Ae. aegypti, was observed from 2010 to 2018, highlighting the competitiveness of Ae. albopictus in the Caribbean context and an invasion process that can take several years [18]. In Saint Barthélemy, a 25-km2 island, Ae. albopictus is already present in artificial breeding sites from urban settings. In addition, half of these breeding sites contained the species in association with Ae. aegypti individuals (Table 1). In this context, the ecological plasticity of Ae. albopictus [19, 20] will likely facilitate its rapid invasion of Saint Barthélémy, emphasizing the urgent need to locally reinforce vector surveillance and control measures to prevent the further spread of this mosquito.

    This work also highlights the efficiency of MALDI-TOF MS for rapidly identifying mosquito specimens in a real-life surveillance situation. The value of this approach for entomological surveillance has been repeatedly shown [21, 22]. Although MALDI-TOF MS-based identification requires reference spectra databases to identify specimens, as well as standardized protocols for spectrum acquisition [23], the exchange of databases between regions and institutes with access to different mosquito species represents a key development perspective. This is particularly relevant in our increasingly globalized world, where the potential for transcontinental movements of viruses and vectors continues to grow.

    Continue Reading

  • ‘Very Healthy and Fit’ Mom, 39, Ignored Multiple Bowel Cancer Symptoms For Months

    ‘Very Healthy and Fit’ Mom, 39, Ignored Multiple Bowel Cancer Symptoms For Months

    NEED TO KNOW

    • Krystal Maeyke has been documenting her battle with bowel cancer on TikTok

    • In May 2023, Maeyke was diagnosed with stage 4 bowel cancer

    • She shared that she ignored her symptoms of night sweats and abdominal pain for months

    Krystal Maeyke believed the sharp stabbing pains in her stomach were a food allergy.

    Maeyke, 39, tried to ignore the uncomfortable sensations in her lower abdomen for three months until the pain became unbearable.

    The mom of one has been documenting her battle with cancer on her TikTok account. In a video, she describes her diagnosis and shares that “three months” before she got the news, “I was having sharp stabbing pains, very tired, unexplained night sweats, loss of appetite, irregular bowel movements, and feeling like s—.”

    She thought she was just “overworked, and being a busy mum.” She said that she was “very healthy and fit.”

    After her symptoms became unbearable, she was airlifted by the Royal Flying Doctors Service to the nearest hospital, which was 280 miles away.

    At Alice Springs Hospital, she was given a series of tests. On May 30, 2023, Krystal Maeyke was diagnosed with metastatic bowel cancer.

    gofundme Krystal Maeyke

    In the same video, Maeyke shared, “I underwent a series of tests. That’s when I knew it was something serious. I was woken up later that night by a doctor whose words I will never forget.”

    ” ‘Krystal, I’ve got bad news…. You have cancer,’ ” she recalled the doctor telling her. “The weight of those words, accompanied by my question of ‘How do you know?’ and the doctor’s response, ‘It’s everywhere,’ shook me to my core.”

    According to the Cleveland Clinic, stage 4 is characterized by the cancer having spread to other “distant” parts of the body than where it originated. In this stage, it is considered metastatic or advanced cancer.

    Maeyke also said that before her diagnosis, she had months of night sweats, which she “ignored.”

    “I was experiencing persistent night sweats a few months before I was diagnosed. I would wake up during the night drenched in sweat, enough so I had to change clothes and sheets.” She described that “some nights it would happen a few times.”

    “It was summertime, and I slept with the air [conditioner] on and a fan, so I just thought it was my air [conditioner] not keeping up with the summer heat. So I ignored this sign,” the mom shared.

    Never miss a story — sign up for PEOPLE’s free daily newsletter to stay up-to-date on the best of what PEOPLE has to offer, from celebrity news to compelling human interest stories.  

    Maeyke continues to share her ongoing battle against cancer on her TikTok account, sharing with almost 50,000 people the key signs of bowel cancer and the treatment that she is undergoing, including multiple rounds of chemotherapy.

    Maeyke has been transparent in her struggle with cancer and candidly shared that one of the most complex parts is planning for the future of her son, Maison.

    Maeyke set up a GoFundMe to develop a financial cushion for her family during her illness. In the post, she wrote, “The true weight of my struggle lies not in my own pain, but the potential loss for my 12-year-old son, Maison.”

    According to Cancer Research UK, some symptoms of bowel cancer can be bleeding from the rectum or blood in your poop, a change in bowel habits, a lump in your abdomen, tiredness and breathlessness. It can also feel like cramping pains in the abdomen, feeling bloated, constipation and being sick.

    Read the original article on People


    Continue Reading

  • 7 Rheumatology Updates to Know

    7 Rheumatology Updates to Know

    The second quarter of 2025 brought critical developments in rheumatology and autoimmune disease, as the FDA advanced several high-impact therapies and new data emerged to support innovative treatments. Regulatory milestones included the first-ever approval of inebilizumab for immunoglobulin G4-related disease, a landmark for this underserved patient population, and expanded indications for upadacitinib in giant cell arteritis, offering clinicians new tools for managing complex inflammatory conditions. Meanwhile, late-stage trial successes for TNX-102 SL in fibromyalgia and deucravacitinib in psoriatic arthritis hinted at promising future options for patients facing chronic pain and joint disease.

    Alongside these approvals and data readouts, advances in gout and lupus therapies underscored the ongoing evolution of targeted treatment strategies, with monthly pegloticase regimens showing feasibility for uncontrolled gout and belimumab reaffirming its role in systemic lupus erythematosus. However, an expansive analysis of rheumatoid arthritis trends painted a sobering picture of rising disease burden despite progress in treatment, highlighting the need for renewed global efforts in prevention and early intervention.

    Check out this Q2 2025 rheumatology month in review for a recap of HCPLive’s coverage of the top rheumatology news and research from the past few months:

    New Therapies Address Unmet Needs

    FDA Approves Inebilizumab (Uplizna) as First IgG4-RD Therapy for Adults
    The FDA has approved inebilizumab-cdon (Uplizna) as the first treatment for adults with immunoglobulin G4-related disease (IgG4-RD), addressing a significant unmet need in this rare autoimmune condition. This approval offers a new therapeutic option for patients previously reliant on less targeted treatments.​

    FDA Approves Upadacitinib, Expanding Treatment for Adults With Giant Cell Arteritis
    Upadacitinib has received FDA approval for treating adults with giant cell arteritis, providing a new option for managing this inflammatory vascular disease. This expands the therapeutic arsenal for clinicians dealing with this challenging condition.​

    New Data Support TNX-102 SL Efficacy Ahead of PDUFA

    TNX-102 SL, a sublingual cyclobenzaprine formulation, showed significant efficacy in reducing pain and improving sleep disturbance in fibromyalgia patients in the phase 3 RESILIENT study, with benefits sustained over 14 weeks. The phase 1 PK study demonstrated that TNX-102 SL achieves higher dynamic peak cyclobenzaprine levels with reduced exposure to its active metabolite norcyclobenzaprine, which may contribute to more durable effects compared to oral formulations. If approved by its August 15, 2025 PDUFA date, TNX-102 SL could become the first new FDA-approved fibromyalgia therapy in over 15 years and a novel non-opioid analgesic option for this challenging chronic pain condition.

    EULAR Data Readouts

    Phase 3 Deucravacitinib Trial Meets ACR20 End Point in PsA

    The phase 3 POETYK PsA-1 trial demonstrated that deucravacitinib significantly improved joint and skin symptoms in adults with active psoriatic arthritis, meeting its primary endpoint with 54.2% of treated patients achieving ACR20 response at week 16 versus 34.1% on placebo. Key secondary endpoints were also met, including significant improvements in skin clearance, physical function, and quality of life measures, alongside evidence of inhibited radiographic progression. The safety profile of deucravacitinib was consistent with previous studies, with no new safety signals identified, supporting its potential as an oral, first-in-class TYK2 inhibitor for psoriatic arthritis management.

    Higher Dose Pegloticase Q4W Feasible for Uncontrolled Gout

    The phase 4 FORWARD trial suggests that once-monthly (Q4W) dosing of pegloticase at 16 mg or 30 mg, combined with methotrexate, can maintain serum urate control in most patients with uncontrolled gout, with 68-73% achieving sustained sUA responses through month 6. These findings indicate that less frequent pegloticase infusions could improve treatment logistics and adherence while maintaining comparable safety and efficacy to the established Q2W regimen. Importantly, infusion reaction rates were low and consistent with prior studies, supporting monthly pegloticase as a feasible alternative for patients struggling with the burden of biweekly therapy.

    Belimumab Superior to Placebo in Yielding Systemic Lupus Erythematosus Responses

    A meta-analysis of five Phase 3 trials has confirmed the efficacy of belimumab in systemic lupus erythematosus (SLE) using the BICLA responder index. The pooled analysis of over 3000 patients showed significantly higher BICLA response rates with belimumab versus placebo, particularly in those with high disease activity or serologic markers. The therapy was also more effective when combined with antimalarials, reinforcing its clinical utility in SLE management.

    Arthritis Burden Soars Globally

    Rheumatoid Arthritis Burden Has Surged Over Last 30 Years

    A large AI-driven analysis of rheumatoid arthritis (RA) trends across 953 global locations revealed a 13.2% rise in RA incidence since 1990, affecting 17.9 million people in 2021, with a shift toward younger populations. While age-standardized RA mortality dropped by 32.7% since 1980, global RA-related DALYs nearly doubled, highlighting an expanding burden despite medical advances. The study also pinpointed local hotspots—like West Berkshire, UK, with the highest incidence—and demonstrated that targeted interventions, such as smoking reduction, could substantially lower RA burden, emphasizing the importance of localized strategies beyond socioeconomic status alone.

    Continue Reading

  • Novel brain scan may predict age-related disease

    Novel brain scan may predict age-related disease

    Share on Pinterest
    An experimental brain scan may be able to accurately predict a person’s risk of age-related disorders. Image credit: Rafe Swan/Getty Images.
    • People age at different rates, partly due to genetics but largely because of lifestyle.
    • A person’s rate of aging can indicate how likely they are to develop age-related disorders, such as dementia.
    • Now, researchers have developed a method based on a single brain scan in middle age that could predict how fast a person is likely to age.
    • They suggest that their method, which can predict the aging rate of both brain and body, may detect who should implement lifestyle changes to reduce their risk of age-related illness.

    Some people appear to age more slowly than others. This is partly due to genetics, which studies suggest accounts for around 25% of the variation in longevity but is largely due to lifestyle and the environment.

    Modifications in lifestyle, such as following a healthy diet, exercising regularly, getting adequate sleep, not smoking, and not drinking alcohol to excess, can help slow a person’s rate of aging and delay or prevent age-related disorders.

    A person’s rate of aging is often referred to as their biological age — how old their cells are — which can vary greatly from their chronological age, or the number of years since their birth. Measuring this can be tricky.

    Now, a group of researchers from Duke, Harvard, and the University of Otago, New Zealand, have developed a method of predicting how fast a person will age, based on a single brain scan performed around the age of 45.

    In their study, which is published in Nature Aging, the researchers suggest that the Dunedin Pace of Aging Calculated from NeuroImaging (DunedinPACNI) could help researchers determine how aging affects health, and help them evaluate the effectiveness of anti-aging strategies.

    “The study developed and validated a new MRI-based biomarker called DunedinPACNI which shows not only a score for brain age, i.e. how old the brain looks, but also shows connections to cognitive decline and other health measures, allowing to perhaps predict how quickly a person ages and how their health will evolve later in life,” Madalina Tivarus, PhD, associate professor of Imaging Sciences and Neuroscience at the Del Monte Institute for Neuroscience at the University of Rochester, not involved in the study, told Medical News Today.

    “The idea of using a routine MRI brain scan to do a ‘aging check-up’ is very interesting and exciting,” Tivarus told us.

    This study builds on the Dunedin Study, previous research conducted in the same cohort of participants. This study, which followed a group of 1,037 people born in Dunedin, New Zealand in 1972–’73, looked at age-related changes in gene methylation to create an epigenetic clock.

    In the Dunedin Study, researchers regularly tested participants’ blood pressure, body mass index (BMI), glucose (blood sugar) and cholesterol levels, lung and kidney function, and even gum recession and tooth decay.

    Over almost 20 years, they used the overall pattern of change across these health markers to generate a score for how fast each person was aging.

    In the latest study, researchers used a single MRI scan of the brain performed when participants were aged 45, which they correlated with the Dunedin Study aging data. They then developed their DunedinPACNI to estimate rate of aging using only information from the MRI scan.

    They found that their prediction accuracy was in line with more established epigenetic methods.

    People with faster DunedinPACNI scores had several indicators of more rapid aging, including:

    • worse balance, slower gait, weaker lower and upper body strength, and poorer coordination
    • self-reported worse health and more physical limitations
    • poorer performance on cognitive function tests
    • greater childhood-to-adulthood cognitive decline
    • older physical appearance.

    Emer MacSweeney, MD, CEO and consultant Neuroradiologist at Re:Cognition Health, who was not involved in this research, highlighted how important brain imaging could be, telling MNT that:

    “The researchers observed that individuals with higher DunedinPACNI scores, indicating faster brain aging, were also more likely to experience health deterioration in other organ systems, such as cardiovascular and respiratory health. The fact that brain imaging can reflect systemic aging suggests the brain may serve as a biomarker for overall biological age, offering a non-invasive, accessible measure of aging processes throughout the body.”

    “This study is exciting because it shows that MRI scans might be used not just to detect disease, but also to track how the brain is aging long before problems begin. However, it’s still early days. While promising, DunedinPACNI still needs to be tested more widely in larger and more diverse populations across different ages, ethnicities, and health backgrounds. It did perform well across multiple large datasets, but more global validation is needed.”

    The researchers compared the DunedinPACNI with measures of hippocampal and ventricular volume, which are commonly used MRI-based measures of brain aging, using UK Biobank and ADNI participants.

    They found that faster DunedinPACNI was more consistently and strongly associated with poor cognition, poor health, frailty, and risk of dementia, disease and mortality than either of these measures.

    Tivarus was impressed by the study structure.

    “The study methodology has some important strengths such as it is using a robust, decades-long longitudinal dataset, uses sound statistical methods, and has been validated extensively using imaging data from other large studies,” she explained.

    However, she also pointed out that there were “some limitations, such as the specific population data used to train the model (mostly European ancestry, from a specific geographical location), its performance in younger or pediatric populations is untested, [and] it infers dynamic processes from one static image (one MRI snapshot).”

    “While I don’t think it is ready for clinical use, DunedinPACNI appears to be a promising imaging biomarker of biological aging,” Tivarus told us.

    Continue Reading

  • First large-scale stem cell bank created to investigate Alzheimer’s genetic risk factors

    First large-scale stem cell bank created to investigate Alzheimer’s genetic risk factors

    Alzheimer’s disease (AD) is a common, debilitating neurodegenerative disease affecting about 10 percent of people over the age of 65 and one third of people aged 85 and above. Besides environmental factors, the genes have a strong influence on whether or not a person develops AD during their lifetime. Through genome sequencing of DNA from large groups of healthy people and people with AD, some naturally occurring small changes in the DNA, known as genetic variants, were found to be more frequent in AD patients than in healthy people. As more and more of these AD-associated genetic “risk” variants are discovered, it is now possible to calculate a person’s individual polygenic risk score (PRS), meaning the likelihood of the person to develop AD, with high accuracy. Despite this progress, it is still largely unknown how genetic risk variants, or combinations thereof, cause AD in individual patients and more specifically, how risk variants impact the health and function of brain cells.

    To address this, researchers in the UK Dementia Research Institute at Cardiff University, UK, have now generated the first large-scale stem cell bank from over 100 individuals selected for extremes of AD PRS, which had previously been determined by genome sequencing. The results of the work are published today in Stem Cell Reports. About two thirds of the donors had been diagnosed with AD and had a relatively high PRS while one third were cognitively healthy, age-matched individuals with a low PRS. Blood cells from these individuals were genetically engineered to turn them into induced pluripotent stem cells (iPSCs), which are immature cells capable of generating all cell types of the body. The new “iPSC Platform to Model Alzheimer’s disease Risk” (IPMAR) resource will be made available to researchers worldwide to facilitate studies on the impact of risk variants in iPSC-based cellular models of AD in the lab. Ultimately, the resource can be used to increase our understanding of genetic risk factors linked to AD, and may inform the design of new, individualized treatments or prevention strategies.

    Source:

    International Society for Stem Cell Research

    Journal reference:

    Maguire, E., et al. (2025). Modeling common Alzheimer’s disease with high and low polygenic risk in human iPSC: A large-scale research resource. Stem Cell Reports. doi.org/10.1016/j.stemcr.2025.102570.

    Continue Reading

  • Nasal COVID Vax Shows Promise in Phase 1 Clinical Trial

    Nasal COVID Vax Shows Promise in Phase 1 Clinical Trial

    CINCINNATI, July 4, 2025 /PRNewswire/ — During the COVID-19 pandemic, scientists learned that the critical path to infection started with the SARS-CoV-2 virus invading the nasal tissues of its victims, then causing millions of deaths by spreading through the body and robbing the sickest people of their ability to breathe.

    While the traditional way to administer protection has been to inject vaccines into the bloodstream, many experts called for developing a nasally delivered vaccine as a potentially more-effective approach. Now, encouraging results are in from the first human clinical trial to be conducted in the United States of a nasal COVID vaccine. Findings from the study led by an expert at Cincinnati Children’s were published July 4, 2025, in Science Advances.

    “A single dose of this vaccine (CVXGA) was well tolerated. It generated a wide spectrum of specific immune responses including mucosal and systemic immune responses. Those who received the highest dose of the vaccine showed significantly lower rates of symptomatic COVID-19 infection,” says the study’s lead author, Paul Spearman, MD, a long-time leader in vaccine research and vice chair for clinical and translational research and education at Cincinnati Children’s.

    The vaccine is made by the Georgia-based company CyanVac LLC, which also funded the clinical trial. Based on the promising data generated from this phase 1 trial, two larger clinical studies involving more people are underway (NCT05736835 and NCT06742281).

    If these trials also prove successful, the CVXGA vaccine could join four other nasal COVID vaccines approved in other countries: two in China, one in Russia, and another in India.

    Why is a nasal vaccine needed?

    While the total number of deaths from COVID has declined far from the peak pandemic years, the virus has not disappeared. In fact, 663 Americans died of COVID in the 28 days ended June 15, 2025. Those deaths (which in one month exceeded the combined deaths of the three deadliest plane crashes since 2022) accounted for 67% of the 987 total deaths worldwide reported to the World Health Organization.

    India (101 deaths) was the only other nation reporting more than 100 COVID deaths in this timeframe, and its population is more than four times larger than the US. The wealthy Western nation Sweden reported 22 deaths. 

    Since the pandemic began, the virus has mutated several times. This has required adjusting the vaccine and suggests that annual re-vaccination may be needed to prevent another pandemic. A nasal vaccine could prove both more effective medically and more tolerable for young children and adults who may fear needles.

    “There is a need for improved COVID vaccines that offer more complete and durable protection,” Spearman says. “A nasal vaccine has the potential to block SARS-CoV-2 at its mucosal entry site and to reduce transmission of the virus to others.”

    How effective was the nasal vaccine?

    The clinical trial included 72 people who received vaccinations, with ages ranging from 12 to 53. A total of 61 participants completed the entire trial. During the period of the trial from September 2021 to May 2023, various waves of SARS-CoV-2 variant infections emerged in the US.

    Participants were divided among four groups. One group received a low dose of the vaccine, which served as a control group. The other three higher dose groups included one group of adults that had never been infected or had not been vaccinated recently; a group of adults that had been recently vaccinated with a previous mRNA vaccine; and a group of teens that also had been vaccinated.

    Overall, about 25% of recipients reported having a runny nose after the vaccine; 8% reported nausea. None had a fever.

    The researchers found evidence that the vaccine was absorbed in the nasal tissues, and that it generated statistically significant antibody responses, as intended.

    CVXGA1 produced a combined 51.9% mucosal antibody response rate across the three higher dose groups, compared to just 21.4% in the lower dose group.

    The low-dose group (Group 1, enrolled from September 2021 to February 2022) had the highest overall COVID-19 infection rate: 73.3%. The other three groups had infection rates ranging from 11.1% to 22.2%. None of those found to be infected required hospital care.

    The results suggest that the vaccine reduced the risk of infection by at least 67% compared to never being vaccinated before. However, definitive proof of efficacy will require larger trials designed specifically for this purpose.

    What’s next?

    By design, a phase 1 clinical trial involves low numbers of participants. However, the results were encouraging enough to recommend moving ahead with larger clinical trials.

    The largest of the two ongoing trials (NCT06742281) seeks to enroll up to 10,016 participants by mid-2026 with the study completed by mid-2027.

    SOURCE Cincinnati Children’s Hospital Medical Center

    Continue Reading

  • Research highlights an increase in informal use of doxyPEP/PrEP among key populations in the Netherlands

    Research highlights an increase in informal use of doxyPEP/PrEP among key populations in the Netherlands

    New research analyzing an online survey of 1,633 respondents found 15% recent use of doxycycline post- and pre-exposure prophylaxis (doxyPEP/PrEP) among men who have sex with men (MSM), transgender and gender diverse people in the Netherlands according to a recent study published by Eurosurveillance. These data highlight an increase in the informal use of doxyPEP/PrEP, with 65% of the participants intending to use it in the future. Currently, doxyPEP/PrEP is not recommended or actively promoted by healthcare professionals in the Netherlands. Informal use i.e. without a prescription by a healthcare professional, could contribute to antimicrobial resistance (AMR) and changes in the microbiome.

    The use of doxyPEP has been shown to be an effective method in the prevention against sexually transmitted infections (STIs) in MSM, transgender and gender diverse persons. Clinical trials of doxyPEP have shown significant reductions in syphilis and chlamydia, with additional potential to reduce incidence of other bacterial STIs such as chlamydia and gonorrhea

    However, the public health implications of the widespread use of doxyPEP are subject to current debate. The administration of doxyPEP to specific individuals could prevent a substantial number of STIs and lower antibiotic use, particularly among those who repeatedly have STIs.

    Informal doxyPEP/PrEP use associated with HIV PrEP use, sexualized drug use and perception of safety

    As highlighted by this paper and an accompanying editorial by Lyons et al., the prescription of doxyPEP to many sexually active individuals poses the risk of a substantial population-level increase in overall antibiotic consumption and an increase in AMR.

    Teker et al. reviewed data from a cross-sectional study gathered from an online survey among MSM, transgender and gender diverse persons of 18 years of age or older. The survey focused on previous use of doxyPEP or doxyPrEP awareness and intention to use it. Participants were recruited through advertisements at the Centre for Sexual Health in Amsterdam, the Netherlands, as well as dating apps (Grindr), Instagram, Facebook, Facebook Messenger and targeted Instagram accounts.

    In the study, 23% of participants reported having ever used doxyPEP/PrEP and 15% reported having used doxyPEP/PrEP in the six months prior to the survey. Respondents informing about recent use were more likely to report living with HIV or frequently using oral HIV PrEP in the six months before taking the survey. They were also more likely to report a history of bacterial STIs, having a higher number of sexual partners, and a higher frequency of engaging in chemsex and in group sex during that period.

    Doxycycline was the most used antibiotic reported in this study, with 46% of the participants reporting using it recently as PEP, 29% of recent PEP users using it as PrEP and 25% using it as a combination of both. 

    Overall, the intention to use doxyPEP/PrEP was very high among the study population, with more than half of the participants (65%) expressing intention to use. More than two thirds of respondents (72%) were willing to pay for doxyPEP/PrEP if it became formally available, indicating a potential demand for the drug among the study population and beyond. 

    It was also found that doxyPEP/PrEP was primarily obtained from countries outside of the Netherlands or through prescriptions, with participants paying on average €30 for the drug.

    Additional determinants for both informal use of doxyPEP/PrEP and high intention to use included using oral HIV PrEP or living with HIV, receiving advice from others to use doxyPEP/PrEP and perceiving doxyPEP/PrEP as an effective and safe method of STI prevention.

    Potential antimicrobial resistance risks from lack of monitoring

    The impact of prophylactic antibiotic use on AMR was highlighted in the study as there are uncertainties regarding the long-term adverse effects of doxyPEP/PrEP use. Teker et al. emphasize the potential harms of doxycycline effectiveness and AMR risks, as summarised in previous studies including in the United States. 

    They also cite its potential effects on the gut microbiome, which need to be studied further. If doxyPEP is implemented in country-wide clinical guidance, it would be vital to monitor both individual and population-level resistance to doxycycline.

    Lack of awareness on the extent of informal use of doxyPEP/PrEP makes it difficult to monitor and implement appropriate public health stewardship. This leads to difficulties in detecting overuse, misuseand adverse effects including AMR development and effects on microbiome composition.

    Source:

    European Centre for Disease Prevention and Control (ECDC)

    Journal reference:

    Buhari, T., et al. (2025). Emergent informal use of doxycycline post- and pre-exposure prophylaxis among men who have sex with men and transgender and gender diverse people, the Netherlands, 2024. Eurosurveillance. doi.org/10.2807/1560-7917.ES.2025.30.26.2400707

    Continue Reading

  • Human brain cells continue to form into late adulthood, study finds

    Human brain cells continue to form into late adulthood, study finds

    A study has shown that neurons or nerve cells continue to form well into late adulthood in the brain’s hippocampus, which manages memory—a finding that presents compelling new evidence about the human brain’s adaptability.

    Advertisement

    Neurogenesis—a process whereby new neurons are created—is said to continue throughout one’s life, even as the rate is considered to slow down with age.

    However, researchers from Karonlinska Institutet in Sweden said the extent and significance of neurogenesis is still debated with no clear evidence of cells that precede new neurons—or ‘neural progenitor cells’—actually existing and dividing in adults.

    “We have now been able to identify these cells of origin, which confirms that there is an ongoing formation of neurons in the hippocampus of the adult brain,” Jonas Frisen, professor of stem cell research, Karolinska Institutet, who led the research published in the journal Science.

    The team used carbon dating methods to analyse DNA from brain tissue, which made it possible to determine when the cells were formed. Tissue samples of people aged 0 to 78 were obtained from international biobanks, they said.

    The results showed that cells that precede the forming of new neurons in adults are similar to those mice, pigs and monkeys, with differences in genes which are active.

    The researchers also found large differences between individuals—some adult humans had many neural progenitor cells, others hardly any at all.

    Frisen added that the study is an “important piece of the puzzle in understanding how the human brain works and changes during life”, with implications for developing regenerative treatments in neurodegenerative and psychiatric disorders.

    A steady loss of neurons resulting in an impaired functioning and eventually cell death is said to drive neurodegenerative disorders, which affects the hippocampus, among other brain regions. Risks of the disorders are known to heighten with age.

    For the study, the researchers used a method called ‘single-nucleus RNA sequencing’, which looks at activity of a gene in a cell’s nucleus.

    This was combined with machine learning (a type of AI) to discern varied stages of how neurons develop, from stem cells to immature neurons, many of which were in the division phase, the team said.

    “We analysed the human hippocampus from birth through adulthood by single-nucleus RNA sequencing. We identified all neural progenitor cell stages in early childhood,” they wrote.

    “In adults, using antibodies against the proliferation marker Ki67 and machine learning algorithms, we found proliferating neural progenitor cells,” the authors wrote.

    “The results support the idea that adult neurogenesis occurs in the human hippocampus and add valuable insights of scientific and medical interest,” the study said.


    Continue Reading

  • Restoring neuron balance in the amygdala reverses anxiety in mice

    Restoring neuron balance in the amygdala reverses anxiety in mice

    The Synaptic Physiology laboratory, led by Juan Lerma at the Institute for Neurosciences (IN), a joint center of the Spanish National Research Council (CSIC) and Miguel Hernández University (UMH) of Elche, has discovered that a specific group of neurons in the amygdala, a brain region involved in emotion regulation, plays a key role in the emergence of conditions such as anxiety, depression, and altered social behavior. This study, published in iScience, shows that restoring the neuronal excitability balance in a specific area of the amygdala is enough to reverse these behaviors in mice.

    We already knew the amygdala was involved in anxiety and fear, but now we’ve identified a specific population of neurons whose imbalanced activity alone is sufficient to trigger pathological behaviors.”

    Juan Lerma, Institute for Neurosciences (IN), a joint center of the Spanish National Research Council (CSIC)

    His team utilized a genetically modified mouse model to overexpress the Grik4 gene, thereby increasing the number of GluK4-type glutamate receptors and raising neuronal excitability. These animals, developed by the same lab in 2015, show anxiety and social withdrawal behaviors very similar to those observed in individuals with disorders such as autism or schizophrenia.

    The researchers normalized the gene’s expression specifically in neurons of the basolateral amygdala, which restored communication with another group of inhibitory neurons in the centrolateral amygdala known as ‘regular firing neurons’. “That simple adjustment was enough to reverse anxiety-related and social deficit behaviors, which is remarkable”, says Álvaro García, first author of the study.

    The animals were evaluated using electrophysiological techniques and behavioral tests that measure anxiety, depression, and social interaction in rodents, based on their preference for exploring open spaces or their interest in unfamiliar mice. Then, using genetic engineering and modified viruses, the scientists selectively corrected the alteration in the basolateral amygdala and observed changes in both neuronal activity and the animals’ behavior.

    They also applied the same procedure to wild-type mice that displayed intrinsic anxiety, and it was also effective in reducing their anxiety. “This validates our findings and gives us confidence that the mechanism we identified is not exclusive to a specific genetic model, but may represent a general principle for how these emotions are regulated in the brain”, Lerma adds.

    Some behavioral deficits, such as object recognition memory, were not resolved, suggesting that other brain areas, such as the hippocampus, may also be involved in these disorders and remain uncorrected. The study opens the door to new therapeutic possibilities: “Targeting these specific neural circuits could become an effective and more localized strategy to treat affective disorders”, the researcher concludes.

    This work was possible thanks to funding from the Spanish State Research Agency (AEI) – Spanish Ministry of Science, Innovation and Universities, the Severo Ochoa Excellence Program for Research Centers at the Institute for Neurosciences CSIC-UMH, the European Regional Development Fund (ERDF), and the Generalitat Valenciana through the PROMETEO and CIPROM programs.

    Source:

    Miguel Hernández University (UMH) of Elche

    Journal reference:

    García, A., et al. (2025). Central role of regular firing neurons of centrolateral amygdala in affective behaviors. iScience. doi.org/10.1016/j.isci.2025.112649.

    Continue Reading

  • Mortality from Chronic Heart Disease Increases as Heart Attack Mortality Falls

    Mortality from Chronic Heart Disease Increases as Heart Attack Mortality Falls

    Sara King, MD | Image Credit: heart.org

    Although the last 50 years have seen a decrease in heart disease deaths, chronic disease mortality has concurrently risen in a trade-off from more patients surviving events such as heart attacks.

    According to a recent study, heart disease accounted for 41% of all deaths in the US in 1970; by 2022, it accounted for 24% of all deaths. The proportion of deaths caused by acute myocardial infarctions (AMI) dropped by almost 90% during this period. However, chronic heart diseases, such as heart failure, hypertensive heart disease, and arrhythmias, are rising substantially in the American population.1

    “People are now surviving these acute events, so they have the opportunity to develop these other heart conditions,” said Sara King, MD, a medical resident of Stanford University of Medicine and lead author of the study.1

    Investigators collected data from the National Vital Statistics System Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research database, examining adults ≥ 25 years of age in the US from 1970 to 2022. Investigated outcomes included absolute number and age-adjusted mortality of total heart disease, ischemic heart disease, and other subtypes.2

    During the indicated time, the US population > 25 years of age increased from 108.9 million to 229 million. Life expectancy likewise increased from 70.9 years to 77.5 years. The National Vital Statistics System recorded a total of 119,152,492 deaths, with 37,276,835 (31%) attributed to heart disease. In 1970, 733,273 heart disease deaths were recorded, of which 666,257 (91%) were ischemic and 67,016 (9%) were from other diseases. In 2022, investigators found 701,443 heart disease deaths, of which 371,360 (53%) were ischemic and 330,083 (47%) were from other heart diseases.2

    Age-adjusted mortality for AMI also decreased by 89%, from 354 per 100,000 in 1970 to 40 per 100,000 in 2022. Average annual percentage change (AAPC) for AMI was -4.2% (95% CI, -4.3 to -4.1) from 1970 to 2022. Age-adjusted mortality for chronic ischemic heart disease fell by 71%, from 343 per 100,000 to 98 per 100,000. AAPC for chronic ischemic heart disease was -2.5% (95% CI, -2.6 to -2.4).2

    Notably, investigators also saw age-adjusted mortality for other heart disease subtypes increase by 81%, from 68 per 100,000 to 123 per 100,000. AAPC for other heart disease subtypes was 1.2% (95% CI, 1.1 to 1.2). Heart failure, hypertensive heart disease, and arrhythmia had the greatest mortality increases, with age-adjusted mortality rising from 13 to 32 per 100,000 (146% increase), 16 to 33 per 100,000 (106% increase), and 2 to 11 per 100,000 (450% increase).2

    Additionally, the rise in non-ischemic heart disease deaths reflects a rise in risk factors including obesity, diabetes, hypertension, and physical inactivity, according to King and colleagues. Roughly 50% of adults have diabetes or pre-diabetes, and 40% have obesity.1

    While investigators noted the reduction in heart disease mortality over the last 50 years may be indicative of success in medical and public health interventions, they also indicated the emerging challenges presented by chronic ischemic heart disease and similar conditions. They suggest several possible explanations for the shift; interventional methods to reduce mortality from AMI, improvement in cardiac imaging, and the development of beta blockers, renal-angiotensin-aldosterone system inhibitors, and others.2

    “We have so many tools in our toolbox now, but still, there’s a lot more that can be developed and improved,” King said. “I hope the numbers just keep getting better.”1

    References
    1. Standford Medicine. As fewer Americans die from heart attacks, more succumb to chronic heart disease. Eurekalert! June 25, 2025. Accessed July 2, 2025. https://www.eurekalert.org/news-releases/1088540
    2. King SJ, Wangdak Yuthok TY, Bacong AM, et al. Heart disease mortality in the United States, 1970 to 2022. Journal of the American Heart Association. 2025;14(13). doi:10.1161/jaha.124.038644

    Continue Reading