Towards Zika preparedness: immunogenicity insights from vaccine research TheLancetInfDis zika zikavirus vaccine zikavaccine zikavirusvaccine
By Neha MathurJun 30 2023Reviewed by Lily Ramsey, LLM In a recent article published in the Lancet Infectious Diseases, researchers performed a phase I randomized clinical trial between November 7, 2016, and October 30, 2018, in the United States of America to assess the safety and immunogenicity of an inactivated Zika virus vaccine candidate.
The Zika virus was endemic in sub-Saharan Africa and the Indian Ocean basin for decades. Much later, scientists discovered that it was a pathogen of public health importance because it caused severe congenital defects and neurological disorders. About the study For this phase I, double-blind, placebo-controlled trial, researchers recruited 18 to 49-year-old adults with no previous flavivirus exposure , confirmed by a microneutralization assay. The study cohort did not have pregnant females and individuals with serological evidence of human immunodeficiency virus , hepatitis B, or hepatitis C infections.
The team analyzed primary study outcomes, i.e., systemic, local adverse events, serious adverse events , and adverse events of special interest , in recipients of at least one ZPIV or placebo dose. They assessed solicited adverse events up to seven days post-vaccination and unsolicited adverse events up to day 28 after vaccination.
A microneutralization titer of 1:10 or more indicated seropositivity, i.e., Zika virus-specific nAbs and nAbs against yellow fever and Japanese encephalitis viruses, before and after ZPIV vaccination. flavivirus naive, IXIARO-primed, and YFVAX-primed groups. Based on one-year follow-up data, it also posed no significant safety issues.
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