Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VLA1601 · 2 trials · 3 indications
frequency of solicited AEs (injection site and systemic reactions)
Geometric mean titer (GMT) for neutralizing antibodies against (ZIKV) determined by virus neutralization assay
| Arm | Type | Description |
|---|---|---|
| VLA1601 Low dose | EXPERIMENTAL | - |
| VLA1601 Low dose + CpG 1018® | EXPERIMENTAL | - |
| VLA1601 Low dose + 3M-052-AF | EXPERIMENTAL | - |
| VLA1601 Medium dose | EXPERIMENTAL | - |
| VLA1601 High dose | EXPERIMENTAL | - |
| Treatment Group I | EXPERIMENTAL | 0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.5 ml Placebo on Day 7 |
| Treatment Group II | EXPERIMENTAL | 0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.5 ml Placebo on Day 28 |
| Treatment Group III | EXPERIMENTAL | 0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.25 ml Placebo on Day 7 |
| Treatment Group IV | EXPERIMENTAL | 0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.25 ml Placebo on Day 28 |
| Treatment Group V | PLACEBO_COMPARATOR | 0.5 ml Placebo on Day 0, 7 and 28 |
| Name | Type | Description |
|---|---|---|
| VLA1601 | BIOLOGICAL | 0.45mL (milliliter), Day 1 and 29 |
| CpG 1018® | BIOLOGICAL | CpG 1018® will be investigated in combination with VLA1601 Low dose |
| 3M-052-AF | BIOLOGICAL | 3M-052-AF will be investigated in combination with VLA1601 Low dose |
| Placebo | BIOLOGICAL | Phosphate buffered saline (PBS) |
Key Inclusion Criteria: * 18 to 49 years of age * BMI of ≥18.5 and \<30 kg/m2 * generally healthy as determined by the investigator's clinical judgement based on medical history, physical examination, and screening laboratory tests. * If trial participant is of childbearing potential: negative preg...
VLA1601 is an investigational vaccine candidate being developed for the prevention of Zika virus infection. It is an inactivated, adjuvanted whole Zika virus vaccine designed to stimulate an immune response against the virus. Valneva SE is developing VLA1601, and it has been studied in Phase 1 clinical trials in healthy adult volunteers.
VLA1601 is being developed for the prevention of Zika virus infection and Zika virus disease. It is intended for use in healthy adults as a prophylactic vaccine. The candidate has been evaluated in Phase 1 trials to assess safety and immunogenicity in this population.
VLA1601 targets the Zika virus. As an inactivated, adjuvanted whole virus vaccine candidate, it presents the entire inactivated virus to the immune system with an adjuvant to enhance the response. The goal is to generate protective immunity against Zika virus infection.
VLA1601 is being developed by Valneva SE, a biopharmaceutical company whose ticker symbol is VALN. Valneva is the sponsor of the clinical program evaluating this Zika vaccine candidate.
VLA1601 is in Phase 1 clinical development. It has not been approved by the FDA and remains an investigational vaccine candidate. Two Phase 1 trials have been completed, and no active trials are currently listed for this candidate.
VLA1601 has been evaluated in two completed Phase 1 trials. NCT06334393 was a Phase 1 trial assessing safety and immunogenicity of the inactivated, adjuvanted whole Zika virus vaccine candidate in 150 healthy adults in the United States. NCT03425149 was a randomized, placebo-controlled, observer-blinded Phase 1 study in 67 healthy adults.