Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06334393
Study type Interventional
Source Valneva Austria GmbH
Contact VP Clinical Development
Phone +43 1 206200
Email info@valneva.com
Status Recruiting
Phase Phase 1
Start date March 25, 2024
Completion date December 28, 2025

See also
  Status Clinical Trial Phase
Completed NCT04697147 - Zika and Neurodevelopment Among Infants in Grenada N/A
Completed NCT03631719 - Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia
Completed NCT02952833 - ZIKA Vaccine in Naive Subjects Phase 1
Terminated NCT03055585 - Applying Wolbachia to Eliminate Dengue N/A
Not yet recruiting NCT05589012 - Evaluation of Viral Replication by Tonate Virus (TONV) and Zika Virus (ZIKV), Within an ex Vivo Trophoblast and Placental Model
Completed NCT02963909 - A Phase 1, First-in-human, Double-blinded, Randomized, Placebo-controlled Trial of a Zika Virus Purified Inactivated Vaccine (ZPIV) With Alum Adjuvant in Healthy Flavivirus-naive and Flavivirus-Primed Subjects. Phase 1
Completed NCT03110770 - VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents Phase 2
Terminated NCT03161444 - Estimated Cumulative Incidence of Zika Infection at the End of the First Epidemic in the French West Indies in a Sample of Patients Followed for HIV Infection. N/A
Completed NCT03008122 - Phase I, Randomized, Double-blinded, Placebo-Controlled Dose De-escalation Study to Evaluate Safety and Immunogenicity of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) in Adults in a Flavivirus Endemic Area Phase 1
Completed NCT04478656 - Safety and Immunogenicity of BBV121 Phase 1
Completed NCT03624946 - Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG) Phase 1
Completed NCT03330600 - Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome N/A
Completed NCT05041439 - Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico N/A
Recruiting NCT03255369 - Vertical Exposure to Zika Virus and Its Consequences for Child Neurodevelopment (ZIKVIRUSIFF)
Completed NCT03206541 - Neurologic Manifestations of the Arbovirus Infection in Colombia
Completed NCT03425149 - Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults Phase 1
Completed NCT04033068 - Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001) Phase 1
Completed NCT03679728 - Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection
Withdrawn NCT03204409 - ZIKAlliance Natural History Study
Completed NCT03776903 - Evaluation of the Clinical Performance of the ZIKV Detectâ„¢ 2.0 IgM Capture ELISA