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Testing begins for inactivated Zika vaccine
With the support of the National Institute of Allergy and Infectious Diseases, the Walter Reed Army Institute of Research began the first of five early stage clinical trials to test the safety and efficacy of an investigational Zika vaccine, according to a recent press release.
“We urgently need a safe and effective vaccine to protect people from Zika virus infection as the virus continues to spread and cause serious public health consequences, particularly for pregnant women and their babies,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in the release. “We are pleased to be part of the collaborative effort to advance this promising candidate vaccine into clinical trials.”
Expected to be completed by fall 2018, the study uses the same technology the Walter Reed Army Institute of Research (WRAIR) used to successfully develop a vaccine for another flavivirus called Japanese encephalitis. The experimental Zika Purified Inactivated Virus (ZPIV) vaccine contains whole Zika virus particles that have been inactivated. Safety testing and animal studies showed that the vaccine generated antibodies that neutralized the virus.
WRAIR aims to enroll 75 people aged 18 to 49 years with no previous flavivirus infection. Each participant will receive the same ZPIV 5 µg dose. Dividing them randomly into 3 groups, 25 participants will receive 2 intramuscular injections of the vaccine or a placebo 28 days apart while the other groups (25 participants each) will receive a two-dose regimen of Japanese encephalitis virus vaccine or one dose of a yellow fever vaccine before starting the two-dose ZPIV vaccine regimen.
After 1 year, 30 of the participants who received the two-dose ZPIV regimen will receive a third dose.
Four other phase 1 studies investigating the ZPIV vaccine will follow in the coming months.
WRAIR, NIAID, and Biomedical Advanced Research and Development Authority (BARDA) established a joint Research Collaboration Agreement to support the development of the ZPIV vaccine. NIAID, the regulatory sponsor, will ensure the trials follow protocols and inform the FDA if risks or adverse events occur. Two independent, objective parties will monitor the trial and report any safety issues to the WRAIR Institutional Review Board. — by Savannah Demko
Disclosures: BARDA is funding the advanced development of the ZPIV vaccine candidate through a six-year contract with Sanofi Pasteur.