Emergent BioSolutions Inc. and Valneva SE announced that a phase 1 study of their purified inactivated Zika virus vaccine candidate showed that it has a favorable safety profile in all tested doses and schedules.
According to a news release, the study was a first-in-human, randomized, placebo-controlled and observer-blinded study of two different dose levels of the alum-adjuvanted, inactivated whole virus vaccine candidate, VLA1601, in 67 healthy, flavivirus-naive participants aged 18 to 49 years.
The final analysis is expected in the first quarter of 2019 and will include additional immunology data based on a final analysis at day 208 after the first vaccination.
“We are pleased to see progress of this promising vaccine candidate for the prevention of infections caused by the Zika virus and their serious implications during pregnancy. The excellent safety profile supports further optimization of the elicited immune response to cover an unmet medical need in the most vulnerable populations,” Wolfgang Bender, MD, PhD, Valneva chief medical officer, said in the release.
The first recorded outbreak of Zika in humans occurred in 2007 — 60 years after the flavivirus was first detected in Uganda’s Zika Forest. Starting in 2015, the virus caused an epidemic in the Americas centered in Brazil that has been associated with birth defects in children born to infected mothers. Around 80% of those infected with Zika do not have symptoms and experience only asymptomatic seroconversion.
Other trials to evaluate Zika vaccine candidates are underway, including a phase 1 trial being conducted by the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research and the Vaccine Testing Center at the University of Vermont’s Larner College of Medicine to evaluate a vaccine developed by the NIH.
The FDA in January granted Takeda’s Zika vaccine candidate fast-track status while it was in phase 1 development. – by Erin Michael
News release. Emergent BioSolutions and Valneva report positive phase 1 results for their vaccine candidate against the Zika virus. https://globenewswire.com/news-release/2018/11/19/1654097/0/en/Emergent-BioSolutions-and-Valneva-Report-Positive-Phase-1-Results-for-Their-Vaccine-Candidate-Against-the-Zika-Virus.html. Accessed November 21, 2018.