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Also known as VAX-A1 Low, VAX-A1 Mid
VAX-A1 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| VAX-A1 Low | EXPERIMENTAL | Participants will receive 2 doses of VAX-A1 administered via intramuscular injection at Day 1 and Month 2 |
| VAX-A1 Mid | EXPERIMENTAL | Participants will receive 2 doses of VAX-A1 administered via intramuscular injection at Day 1 and Month 2 |
| VAX-A1 High | EXPERIMENTAL | Participants will receive 2 doses of VAX-A1 administered via intramuscular injection at Day 1 and Month 2 |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 2 doses of placebo administered via intramuscular injection at Day 1 and Month 2 |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | 0.5mL of placebo (normal saline) will be administered into the deltoid muscle |
| VAX-A1 Low | BIOLOGICAL | 0.5mL of the low dose VAX-A1 will be administered into the deltoid muscle |
| VAX-A1 Mid | BIOLOGICAL | 0.5mL of the mid dose VAX-A1 will be administered into the deltoid muscle |
| VAX-A1 High | BIOLOGICAL | 0.5mL of the high dose VAX-A1 will be administered into the deltoid muscle |
Inclusion Criteria: * Individuals 18-40 years of age (inclusive) at the time of randomization into the study * Able and willing to complete the informed consent process * Available for clinical follow-up through the last study visit at 6 months post-Dose 2 * Willing to have blood samples collected,...
VAX-A1 is an investigational monoclonal antibody being developed by Vaxcyte, Inc. for the prevention of Group A Streptococcal infection. It is in Phase 1 clinical development and is designed to be given to healthy young adults. VAX-A1 has not been approved by any regulatory agency.
VAX-A1 is being studied for the prevention of Group A Streptococcal infection in healthy adults. It is an investigational monoclonal antibody and has not been approved for any indication. The Phase 1 trial is evaluating its safety, tolerability, and immunogenicity in healthy young adults.
VAX-A1 targets multiple Streptococcus pyogenes antigens: ScpA, SpyAD, SLO, and GAC. By binding these targets, the monoclonal antibody is designed to interfere with Group A Streptococcus infection. This multi-antigen approach is intended to provide broad coverage against the pathogen.
VAX-A1 is being developed by Vaxcyte, Inc., which trades on the Nasdaq under the ticker PCVX. Vaxcyte is the sponsor of the Phase 1 clinical trial evaluating VAX-A1 in healthy young adults.
VAX-A1 is in Phase 1 clinical development. The only trial is currently recruiting participants. VAX-A1 is investigational and has not been approved by the FDA or any other regulatory authority for any indication.
VAX-A1 is being evaluated in a single Phase 1 trial, NCT07616934, titled A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults. The trial is randomized, double-blind, placebo-controlled, and plans to enroll 80 participants in Australia.
Yes, VAX-A1 Low and VAX-A1 Mid are alternative names for VAX-A1. These names may refer to different dose levels or formulations of the same investigational monoclonal antibody being developed by Vaxcyte, Inc. for Group A Streptococcal infection.