A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults
NCT07616934 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-06-01
Summary
This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of VAX-A1 in healthy adults 18-40 years of age.
Conditions
- Group A Streptococcal Infection
Interventions
- BIOLOGICAL
-
0.5mL of placebo (normal saline) will be administered into the deltoid muscle
- BIOLOGICAL
-
VAX-A1 Low
0.5mL of the low dose VAX-A1 will be administered into the deltoid muscle
- BIOLOGICAL
-
VAX-A1 Mid
0.5mL of the mid dose VAX-A1 will be administered into the deltoid muscle
- BIOLOGICAL
-
VAX-A1 High
0.5mL of the high dose VAX-A1 will be administered into the deltoid muscle
Sponsors & Collaborators
-
Vaxcyte, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- Australia
Study Locations
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