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

No results posted yet for this study

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

Placebo

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

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07616934 on ClinicalTrials.gov