J&J’s Ebola Vaccine Candidate AdvancesBy
Janssen Vaccines & Prevention B.V., part of Johnson & Johnson, has completed a submission to the World Health Organization (WHO) for Emergency Use Assessment and Listing (EUAL) for its investigational preventive Ebola prime-boost vaccine regimen. The EUAL is a special procedure that can be implemented when there is an outbreak of a disease with high rates of morbidity or mortality and a lack of treatment or prevention options.
The EUAL assists United Nations member states and procurement agencies determine the acceptability for use of a specific vaccine in a public health emergency. The decision to grant EUAL to the investigational preventative vaccine regimen will be based on an evaluation of available data, including quality, safety, and immunogenicity as well as a risk/benefit analysis.While the EUAL potentially allows for deployment of a vaccine in an emergency, the vaccine remains investigational pending formal regulatory agency review and approval.
Prime-boost vaccination is an established prevention approach for several infectious diseases. It involves giving an initial dose to prime the immune system, followed by a booster dose at a later date with the goal of potentially strengthening and optimizing the duration of immunity. Janssen’s heterologous prime-boost vaccine regimen contains two components based on AdVac technology from Janssen, and MVA-BN technology from Bavarian Nordic A/S.
Janssen reported positive Phase I results of the vaccine. Janssen is also preparing to initiate a first-in-human Phase 1 clinical study to test a second-generation, multivalent version of the AdVac/MVA-BN vaccine regimen. The multivalent heterologous prime-boost regimen is intended to protect against multiple filoviruses that cause disease in humans, including the Ebola, Sudan, and Marburg viruses. The US. study will test the safety, tolerability, and immunogenicity of this vaccine regimen in varying dosing schedules among healthy volunteers. The National Institute of Allergy and Infectious Diseases, part of the US.National Institutes of Health, is funding this study.
Source: Johnson & Johnson