Smallpox

Researchers are evaluating the protective efficacy and safety of a recombinant herpes zoster vaccine called LZ901 in healthy adults aged 40 years and older. This phase 3, randomized, double-blind, placebo-controlled trial aims to protect participants against shingles caused by the varicella zoster virus. The vaccine contains a tetramer of VZV glycoprotein E combined with an aluminum hydroxide adjuvant known to enhance immune response and widely used in vaccines worldwide. Participants will receive two doses of either the LZ901 vaccine or a placebo (aluminum hydroxide adjuvant) injected into the upper arm on day 0 and day 29. Around 26,000 participants will be enrolled, including a subgroup of about 3,000 to assess the consistency of immune response across three vaccine batches and monitor persistence of immunity up to 36 months. The study includes four groups: treatment main, placebo main, treatment immunization, and placebo immunization groups. Participants will undergo up to 24 visits depending on their group, including on-site and in-person visits for screening, vaccination, and follow-up assessments. Researchers will monitor vaccine efficacy 30 days after full immunization, track adverse events from immediate to 12 months post-vaccination, and evaluate immune response through antibody tests at multiple time points. The study also explores the vaccine's impact on reducing the severity and occurrence of postherpetic neuralgia in adults 40 years and older.

Researchers are conducting a randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety and immune response of two doses of the MVA strain monkeypox attenuated live vaccine in adults aged 18 years and older. The study aims to assess how well this vaccine works and its safety in different groups, including healthy individuals, men who have sex with men, and people living with HIV. Participants are also categorized based on whether they have previously received a smallpox vaccine. Participants will be randomly assigned to one of three groups: low-dose vaccine, high-dose vaccine, or placebo, with equal distribution among these groups. Each participant will receive two doses, one on day 0 and another on day 28. The study includes groups with and without prior smallpox vaccination history. The trial is designed to carefully compare responses and side effects across these groups. During the study, participants will be monitored closely for immediate and delayed adverse events after each vaccination. Safety assessments include tracking any serious or special interest adverse events for up to 12 months after the last dose. Participants will attend follow-up visits, complete diaries or contact cards, and undergo physical exams and laboratory tests to evaluate vaccine safety and immune response over time. The total study duration includes the vaccination phase and long-term safety monitoring.

This observational study aims to understand the immune responses triggered by vaccination against monkeypox in both HIV positive and HIV negative individuals who are at high risk of monkeypox infection. The study is motivated by the recent monkeypox outbreak, with a significant number of cases reported in Spain, where nearly 40% of diagnosed individuals are living with HIV. Researchers want to gather data on how the vaccine works, especially in people with HIV, due to limited information on vaccine effectiveness and immune response in this group. Participants receive the monkeypox vaccine as a preventive measure before exposure. The vaccine is given as a single intradermal dose, which may cause more reactions than the traditional subcutaneous injection. The study compares immune responses between HIV positive and HIV negative groups and tracks antibody levels and their ability to neutralize the virus over time, including after one or two doses if applicable. During the study, participants will have blood samples taken to measure antibody presence and quantity between 29 and 90 days after vaccination, with additional assessments between 150 and 180 days. Researchers will evaluate changes in immunity and compare responses between the two groups. The study includes follow-up over several months to monitor immune response, with all study-related care provided under medical supervision. Participant involvement includes agreeing to follow-up visits and blood tests as scheduled.

Researchers are studying how monkeypox (mpox) spreads in the Democratic Republic of Congo (DRC), how it affects different groups of people, and how well vaccines protect against it. This observational study uses a cross-sectional survey design, collecting data from patients diagnosed with mpox at one point in time, and a case-control approach comparing those who test positive to those who test negative to find risk factors and vaccine effectiveness. The study is conducted by the Institut National de Recherche Biomédicale and international partners, focusing on provinces heavily affected by mpox outbreaks. Participants with suspected mpox who visit hospitals or health centers for testing will be invited to join the study. They will answer questions about symptoms, medical history, exposure to the virus, and vaccination status. Biological samples such as blood, throat swabs, and skin lesion swabs will be collected to test for mpox and other infections like measles or chickenpox. Hospitalized patients will have additional data recorded about their recovery. During the study, researchers will collect clinical and sociodemographic information, exposure factors, and transmission modes of mpox. They will compare infection rates between vaccinated and unvaccinated people and examine differences between two virus types. The study also tracks co-infections and risk factors for severe disease or death. Data will help train healthcare workers and improve real-time sharing on an online platform. The study will run for two years, assessing many health and transmission outcomes related to mpox.

Researchers are evaluating the drug tecovirimat in adults with mpox infection, also known as monkeypox, in this randomized controlled double-blind clinical trial. The study aims to determine if tecovirimat is effective and safe for treating mpox. Participants must have confirmed mpox infection with active skin or mucosal lesions to join the trial. Participants will be randomly assigned to receive either oral tecovirimat capsules or a matching placebo. The tecovirimat group will take 600 mg twice daily (three 200 mg capsules each dose) for 14 days, totaling 28 doses. The placebo group will follow the same schedule with identical capsules but without the active drug. During the study, researchers will closely monitor participants' mpox lesions, symptoms, and overall condition. They will assess the time it takes for lesions to fully heal within 28 days, symptom resolution up to 90 days, and any side effects or complications. Other outcomes include quality of life changes, virus clearance from skin or mucosal swabs, and hospital admissions. Safety will be evaluated throughout the trial, which lasts up to 90 days after treatment starts.

Researchers are studying the long-term immune response to a booster dose of the MVA-BN vaccine, which is designed to prevent mpox, a viral disease caused by the MPXV virus. This research focuses on men who have sex with men (MSM) using HIV pre-exposure prophylaxis (PrEP), a key group at risk. The study is observational and aims to provide more information on how durable the vaccine's protection is after a booster dose, following recommendations due to recent outbreaks and public health concerns worldwide. Participants in this study have previously received two doses of the MVA-BN vaccine and are eligible for a booster dose as per health guidelines. The study will observe these individuals over time without assigning treatments, monitoring their immune responses after the booster dose. The trial will track immune system markers and any mpox infections to understand the vaccine's long-term effects. During the study, participants will be followed for up to 24 months, with evaluations of their immune response and safety after receiving the booster dose. Researchers will collect data on antibody levels at 12 and 24 months, observe the pattern of immune response, and document any cases of mpox infection. The study involves regular medical monitoring and aims to gather detailed information about how the booster dose supports immunity in this population.

This research aims to learn about how well patients hospitalized at Melun Hospital know their own vaccination status and their attitudes towards vaccination. It focuses on understanding the rate of vaccination knowledge among these patients, their willingness to update vaccinations, and how factors like gender, job, having a regular doctor, or chronic illness may influence vaccination status. This is an observational study conducted during the national European Vaccination Week in France. Participants are randomly selected from ten different hospital departments, including internal medicine, infectious diseases, surgery, cardiology, and geriatrics, among others. During hospitalization, patients complete a questionnaire designed by the hospital's Public Health Unit and Hygiene Operational Team. The study does not involve any treatments but gathers information about patients' vaccination knowledge and attitudes. Participants will complete the questionnaire during their hospital stay. Researchers will measure how many patients know their vaccination status and how many want to update it. They will also assess the impact of gender, occupation, having a treating physician, and chronic illness on vaccination knowledge. The study's main evaluation happens on the first day of questionnaire completion. The total participation involves only this one-time questionnaire during hospitalization.

Researchers are investigating the effects of measles vaccine (MV) and Bacille Calmette-Guérin vaccine (BCG) given to women of fertile age before pregnancy, and the impact of providing early measles vaccination to their children. The study aims to understand both measles-specific and general immune benefits in mothers and children, focusing on antibody responses, viral loads after yellow fever vaccination, and overall health outcomes. This is a phase 4 randomized, triple-blind trial conducted in Guinea-Bissau, exploring the novel concept that vaccinating mothers with live vaccines may enhance protection for their children. In this trial, 2400 non-pregnant, HIV-negative women aged 15 to 35 will be randomly assigned to receive either the measles vaccine, BCG vaccine, or a saline placebo. Their children, all receiving BCG at birth as per local recommendations, will be further randomized at 20 weeks of age to receive either an early measles vaccine or placebo. All children will then receive the standard measles and yellow fever vaccines at 9 months. The study will create six groups combining maternal and child vaccination schedules to compare outcomes. Participants will be followed through regular home visits and health center monitoring. Women will have blood samples taken before and after vaccination to measure antibody levels. Children will be closely monitored monthly and have blood samples taken at specified ages to assess immune responses and viral loads. The study tracks morbidity and mortality data for both mothers and children over time, using interviews, hospital records, and vaccination documentation. The trial will continue until 2027, assessing which vaccination schedules best support health and immunity.

This research aims to assess the immune responses in people vaccinated against mpox with either the MVA-BN or LC16m8 vaccine during a routine vaccination campaign in Kinshasa, Democratic Republic of the Congo. About 150 participants vaccinated with MVA-BN and 150 vaccinated with LC16m8 will be included. The study focuses on understanding how the immune response develops and lasts over time. Participants will have blood samples collected at six visits over a 24-month period: on the day of vaccination (day 0), 28 days later, 59 days later, and then at 8, 16, and 24 months. At each visit, 10 mL of blood will be taken, with an additional 20 mL collected from a subgroup of participants. The study evaluates the presence and levels of neutralizing and binding antibodies against the mpox virus. During the study, participants will be monitored through scheduled visits to collect blood samples and assess immune responses. The main outcome measured is the rate of seroconversion for neutralizing antibodies 28 days after vaccination. Other measures include antibody levels at various time points up to 24 months and vaccine tolerability. The study also tracks any mpox infections after vaccination and factors influencing immune response strength.

Researchers are investigating Mpox, a disease with rising cases in Central and East Africa, caused by two virus strains with different characteristics and spread patterns. The study aims to develop new immune tests to estimate how many people have been exposed to Mpox or vaccinated, helping to prioritize vaccine use in affected communities. This outbreak is considered a public health emergency due to increasing cases and deaths, especially with limited testing in some regions. Participants are grouped by their exposure status: those at risk but without symptoms, those recovered from Mpox or vaccinated, and those with no known exposure. The study uses diagnostic tests including an Mpox-specific antibody ELISA and a dried blood spot lateral flow assay to detect immune responses. All participants undergo the same testing procedures to assess their exposure or immunity status. During the study visit, participants provide biological samples for testing and complete surveys about their views on outbreak studies, immune diagnostic tools, and vaccine logistics. Researchers will measure Mpox-specific antibodies and evaluate rapid test accuracy. The study will also gather perspectives from healthcare workers and the public to support future vaccine strategies. The total participation involves sampling and questionnaires conducted on the first day.