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 designed to generate an immune response against the Zika virus in healthy adults. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
VLA1601 is being developed by Valneva SE, a biopharmaceutical company. Valneva is publicly traded on the stock exchange under the ticker symbol VALN. The company is conducting clinical trials to evaluate the safety and immunogenicity of this vaccine candidate.
VLA1601 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both of which were randomized, placebo-controlled, and observer-blinded studies. The vaccine remains investigational and has not received regulatory approval for use outside of clinical trials.
VLA1601 has been studied in two completed Phase 1 clinical trials. The first trial, NCT03425149, enrolled 67 healthy adults in the United States. The second trial, NCT06334393, enrolled 150 healthy adults. Both trials assessed the safety and immunogenicity of the vaccine candidate.
VLA1601 is an inactivated whole Zika virus vaccine. It contains a whole Zika virus that has been inactivated, meaning it cannot cause disease. When administered, it is designed to stimulate the immune system to produce antibodies against the Zika virus, potentially providing protection against infection.
Yes, VLA1601 is an inactivated, adjuvanted whole Zika virus vaccine candidate. The vaccine contains an inactivated form of the Zika virus, which is combined with an adjuvant to enhance the immune response. It is being evaluated for its ability to prevent Zika virus infection.