Zika Virus Infection Clinical Trial
Official title:
A Phase 1 Double-blind, Randomized, Dose Finding Clinical Trial With an Open-label run-in Part to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Flavivirus-naïve Adults Aged 18 to 49 Years
This phase 1 clinical trial consists of an initial open-label sentinel run-in (n=25) and a randomized, double-blind, dose-finding (n=125) investigating three antigen dose levels (low, medium and high) of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants (CpG1018®, 3M-052-AF/AP 60-702). VLA1601 will be administered according to a two-dose regimen (i.e., on Day 1 and Day 29). The primary objective of this trial is to assess the safety and tolerability of the vaccine candidate up to 7 days after each vaccination; and to assess the immune response induced by the vaccine candidate 28 days after the second vaccination. Additionally, safety and immune response of the vaccine candidate will be monitored throughout the trial.
VLA1601 is a second generation, highly purified, inactivated, whole ZIKV vaccine candidate (adsorbed on aluminum hydroxide) designed for active immunization for the prevention of disease caused by the flavivirus ZIKV. This phase 1 clinical trial consists of an initial open-label sentinel run-in (n=25) and a randomized, double-blind, dose-finding (n=125), investigating three antigen dose levels (low, medium and high) of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants (CpG1018®, 3M-052-AF/AP 60-702). VLA1601 will be administered according to a two-dose regimen (i.e., on Day 1 and Day 29). The screening period can last up to 21 days. The trial will begin with the enrolment of 25 sentinel participants (5 participants in each of the 5 treatment arms) in a sequential open-label, staggered dose-escalation. The sentinel safety data will be closely monitored by the sponsor's Safety Review Committee (SRC). The SRC will decide on the start of the next treatment arm(s) during the run-in open-label part of the trial. An independent Data and Safety Monitoring Board (DSMB) will review safety data of all sentinels; upon favorable recommendation from the DSMB and sponsor decision, the trial will continue with the randomized part. Approximately 125 participants will be randomized 1:1:1:1:1 into 5 treatment arms. Primary objects include the assessment of safety and tolerability of VLA1601 up to 7 days following each vaccination and assessment of immunogenicity at 28 days post second vaccination. Following a sponsor review of available safety and immunogenicity data up to 6 months after the second vaccination, the most favorable treatment arm(s) will be selected for an on-site visit at Day 395 for long-term safety and immunogenicity assessment. All other treatment arms will be followed only by phone-call for the Day 395 assessment of long-term safety. ;
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