The randomised, placebo-controlled trial will evaluate the safety and immunogenicity of various doses of Valneva’s Zika vaccine. Credit: Valneva SE.

Valneva has commenced the Phase I VLA1601-102 clinical trial of its second-generation adjuvanted inactivated vaccine candidate, VLA1601, against the Zika virus (ZIKV).

The randomised, placebo-controlled trial will evaluate the safety and immunogenicity of various dose levels of VLA1601.

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It will involve approximately 150 participants aged 18 to 49 years in the US, who will receive low, medium, or high doses of VLA1601.

Subjects who receive the low-dose vaccine will also be given an additional adjuvant, either Dynavax Technologies’ CpG 1018 adjuvant or Access to Advanced Health Institute’s 3M-052-AF adjuvant.

The company anticipates reporting the topline findings from the trial in the first half of next year.

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VLA1601 is a highly purified inactivated vaccine that is being developed on the manufacturing platform of Valneva’s licensed Japanese encephalitis vaccine, IXIARO.

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This platform was also optimised to create the company’s Covid-19 vaccine VLA2001, the first to obtain standard marketing authorisation in Europe.

Valneva’s first-generation Zika vaccine candidate demonstrated a favourable safety profile and immunogenicity at all tested doses and schedules in a Phase I trial conducted in 2018.

The latest development comes after the company received approval in the US for its chikungunya vaccine, IXCHIQ, in November last year.

Valneva chief medical officer Juan Carlos Jaramillo said: “Valneva’s commitment to our vision, to live in a world in which no one dies or suffers from a vaccine-preventable disease, fuels our pursuit for preparedness solutions against the Zika virus.

“As global temperatures rise and rainfall increases, the habitat for disease-carrying mosquitoes expands, presenting an ongoing public health challenge.”