Phase 1 testing of a vaccine for the Zika virus showed a favorable safety profile in all doses and schedules tested, Emergent BioSolutions announced.
The vaccine, VLA1601, is being developed by Emergent BioSolutions and Valneva SE. Zika is a mosquito-borne virus that has been detected in Africa, Southeast Asia, the Pacific Islands, and the Americas.
VLA1601 is a highly purified inactivated vaccine candidate using the same manufacturing platform as Valneva’s IXIARO – a vaccine for Japanese Encephalitis (JE). In pre-clinical development, VLA1601 demonstrated excellent purity and had an overall biological, chemical and physical profile comparable to the commercially produced JE vaccine.
Further, VLA1601 showed to be immunogenic in all treatment groups and induced both dose- and schedule-dependent neutralizing antibodies against the Zika virus. Seroconversion Rates (SCR) reached up to 85.7 percent on Day 35.
The vaccine is being co-financed by Emergent and Valneva.
“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, chief medical officer of Valneva, said.
The Phase 1 test is assessing the safety and immunogenicity of two different dose levels of the Zika virus vaccine candidate in 67 healthy adults aged 18-49 years. It is being conducted in Knoxville, Tenn.
“Emergent’s continued focus on the development of prevention and treatment strategies for emerging infectious diseases is part of its broader mission – to protect and enhance life. Through our work, we are committed to making a positive impact on public health across the globe,” Kelly Lyn Warfield, vice president of Vaccines and Anti-Infectives Research and Development at Emergent BioSolutions, said.
The final analysis is expected in the first quarter of 2019.