Nipah virus vaccine trial
A first-in-human Nipah virus vaccine trial was launched over the last week, according to University of Oxford.
The first clinical trial participants received doses of the ChAdOx1 NipahB vaccine.
Fifty-one people aged 18 to 55 will participate in the trial, which will be led by the Oxford Vaccine Group and is funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
Professor Brian Angus, the trial’s Principal Investigator and Professor and Reader in Infectious Diseases at the Centre for Clinical Tropical Medicine and Global Health in the University of Oxford’s Nuffield Department of Medicine said: “Nipah virus was first identified in 1998, and yet 25 years on the global health community still has no approved vaccines or treatments for this devastating disease.
“Due to the high mortality rate and the nature of Nipah virus transmission, the disease is identified as a priority pandemic pathogen. This vaccine trial is an important milestone in identifying a solution that could prevent local outbreaks occurring, while also helping the world prepare for a future global pandemic.”
The milestone clinical trial comes as the global health community marks the 25th anniversary of the first Nipah virus outbreaks.
JYNNEOS smallpox vaccine induces an efficient immune response against mpox in people with HIV
An observational study conducted by researchers from Pompeu Fabra University and Hospital del Mar determines that the intradermal administration of the JYNNEOS vaccine against smallpox induces an efficient immune response that should protect people living with HIV from contracting the monkeypox virus.
This vaccine administration method requires less material to inject into each patient, multiplying the available vaccine doses by 5. This observational study also indicates that individuals with a low level of CD4 T cells - a type of white blood cell essential for effectively combating new infections - need a booster dose 28 days after the first dose to compensate for their immunosuppressed state.
The study was published in the Journal of Medical Virology.
"Our results clearly support the proposed dose-sparing vaccination route also for the protection of immunocompromised individuals who need the vaccine the most", adds Andreas Meyerhans, an ICREA researcher and UPF full professor, who coordinated the experimental part of the study.
This study provides an early indication of how best to proceed with preventive vaccination against monkeypox in a group of individuals at high risk of infection. However, further studies should confirm and expand on the observations derived from a small number of vaccinated individuals.
Anthrax vaccine, BioThrax, big contract
Emergent BioSolutions Inc. announced that it has secured an indefinite-delivery, indefinite-quantity (IDIQ) procurement contract with a maximum value up to $235.8 million to supply BioThrax® (Anthrax Vaccine Adsorbed) for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease.
“As a part of our mission to protect and enhance lives, Emergent is proud to continue supporting and preparing our nation’s service members who have a high risk of exposure to anthrax bacteria by supplying BioThrax vaccine,” said Paul Williams, senior vice president, products head at Emergent.
BioThrax vaccine is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age. BioThrax is approved for pre-exposure prophylaxis of disease in persons at high risk of exposure. BioThrax is approved for post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.
The efficacy of BioThrax for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.
Chikungunya vaccine trial in children
Valneva SE announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva’s single-shot chikungunya vaccine.
There is currently no approved chikungunya vaccine for children. Valneva’s vaccine IXCHIQ® is currently the only licensed chikungunya vaccine to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the virus.
Once available, the Phase 2 pediatric data are intended to support a Phase 3 pivotal study in children with the objective to extend the label in this age group following initial regulatory approvals in adults and possibly in adolescents.
The multicenter, prospective, randomized, observer-blinded, Phase 2 clinical trial is planned to enroll approximately 300 healthy children one to eleven years of age at three trial sites in the Dominican Republic and Honduras. Following a safety run-in phase, participants will be randomized to receive either a full dose formulation of the vaccine (120 participants), a half dose formulation (120 participants) or a control vaccine (60 participants).
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “This pediatric trial is extremely important. Given the significant threat that chikungunya poses to individuals living in or traveling to endemic areas, it is crucial to make the vaccine accessible to all age groups. By doing so, we can broaden the protection against and reduce the impact of this debilitating disease.”