What is VAX-A1 studying for Group A Streptococcal Infection?

VAX-A1 is being studied to evaluate its safety, tolerability, and ability to trigger an immune response in healthy adults. This trial aims to understand how the vaccine interacts with the immune system and what side effects may occur. The study is sponsored by Vaxcyte, Inc.

Who may be eligible for this Group A Streptococcal Infection clinical trial?

Adults aged 18 to 40 years who are healthy and able to complete all study visits may be eligible. Women must not be pregnant or breastfeeding and need to use contraception if sexually active. Participants must be willing to provide blood samples and use an electronic diary. Please review eligibility criteria for more details.

Is there any cost to participate in this Group A Streptococcal Infection clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years - 40Years

All Genders

Healthy Volunteers

ID07616934

Phase 1 Clinical Trial Evaluating Safety, Tolerability, and Immune Response of VAX-A1 Vaccine in Healthy Adults Aged 18 to 40

Led by Vaxcyte, Inc. · Updated on 2026-06-16

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a phase 1, first-in-human, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and immune response of the VAX-A1 vaccine in healthy adults aged 18 to 40 years. The study aims to understand how the vaccine affects the immune system and monitor any side effects in this healthy young adult population. Participants are assigned to one of four groups receiving either low, mid, or high doses of VAX-A1 or placebo. Each participant receives two intramuscular injections, one on Day 1 and another at Month 2. The study follows a dose-escalation design to carefully evaluate different vaccine doses compared to placebo. Throughout the study, participants will be closely monitored for local and systemic reactions up to 7 days after each vaccination, as well as any adverse events for up to 8 months after the first dose. Blood samples will be collected at multiple time points to evaluate immune responses and safety laboratory tests. Participants will also complete an electronic diary to help track symptoms and reactions, with follow-up visits continuing through the study duration until 6 months after the second dose.

CONDITIONS

Brief Title

A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults

Who Can Participate

Age: 18Years - 40Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Individuals 18-40 years of age (inclusive) at the time of randomization
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, stored indefinitely, and used for research
Able to provide proof of identity as required for enrollment
Healthy with no significant acute or chronic medical conditions as determined by medical history, vital signs, physical exam, lab tests, TTE, ECG, and investigator assessment
Postmenopausal for at least 1 year or surgically sterile for at least 6 months if applicable
Women of childbearing potential must not be pregnant or lactating, have negative pregnancy tests, and agree to use contraception if sexually active
Able to use a smartphone, tablet, computer, or other device with internet access for eDiary completion

You will not qualify if you...

History of significant cardiac, rheumatologic, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other diseases
History of invasive GAS infection or poststreptococcal immune mediated disease
Known or suspected autoimmune or immunodeficiency disorders
Diagnosis or positive test for HIV, Hepatitis B, or Hepatitis C
History of malignancy except treated basal cell, squamous cell skin cancer, or in situ cervical cancer
Bleeding disorders causing significant difficulties with injections or blood draws
Severe allergic reactions to previous vaccinations
Fever over 38.0°C or acute illness within 3 days prior to vaccination
Elevated blood pressure (systolic ≥140 mmHg or diastolic ≥90 mmHg) confirmed at screening
Clinically significant medical conditions found on physical exam or inadequate venous access
Grade 2 or higher abnormal safety lab tests
Abnormal ESR, CRP, or C3 levels
Confirmed microscopic hematuria on urinalysis
Evidence of recent or active GAS infection
Abnormal findings on echocardiogram or ECG indicating possible cardiac pathology
Recent or planned receipt of investigational products or licensed vaccines near study dosing
Blood or blood product transfusion within 6 months
Use of immunosuppressive therapy or corticosteroids within specified time frames
Body mass index ≥32 kg/m2 or ≤18 kg/m2
History of alcohol or drug abuse in past 5 years
Any medical, psychiatric, or social condition that may interfere with study participation
Employment or first-degree relative employment with Sponsor, CRO, Investigator, or study personnel

Research Team

Clinical Development

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