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VAX-A1 Low

Phase 1

Group A Streptococcal Infection | Monoclonal antibody | Other |Vaxcyte, Inc.|Last Updated: Jun 16, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

VAX-A1 Low · 1 trial · 1 indication

Phase 1 1
NCT07616934A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young AdultsGroup A Streptococcal Infection
RECRUITING80 Analytics
PHASE1RECRUITING
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults
Group A Streptococcal Infection
NCT0761693480
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Study Endpoints

Primary Endpoints

Frequency of solicited local reactions (redness, swelling, and pain at injection site)
up to 7 days after each vaccination
Frequency of solicited systemic adverse events (AE) (fever, headache, fatigue, muscle pain, rash, joint pain, nausea/vomiting, diarrhea)
up to 7 days after each vaccination
Frequency of laboratory abnormalities identified from protocol-scheduled safety laboratory assessments at 7 days after each vaccination and reported as AE
7 days after each vaccination
Frequency of unsolicited AE
up to 30 days after each vaccination
Frequency of medically attended AE (MAAE)
Up to 8 months after first vaccination
Frequency of new onset chronic illness (NOCI)
up to 8 months after the first vaccination
Frequency of serious adverse events (SAE)
from screening through up to 8 months after first vaccination
Occurrence of AE of special interest (AESI) (acute rheumatic fever [ARF], acute carditis [AC], and acute glomerulonephritis [AGN])
up to 8 months after the first vaccination

Secondary Endpoints

Median value of each safety laboratory parameter assessed 7 days after each vaccination
7 days after each vaccination
Median change from baseline to 7 days after each vaccination for each safety laboratory parameter
7 days after each vaccination
Serum IgG geometric mean titer (GMT) at each scheduled immunogenicity sample collection visit for each vaccine antigen (SLO, C5a pep, SpyAD, GAC)
Prior to each vaccination, 1 month after each vaccination and Month 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VAX-A1 LowEXPERIMENTALParticipants will receive 2 doses of VAX-A1 administered via intramuscular injection at Day 1 and Month 2
VAX-A1 MidEXPERIMENTALParticipants will receive 2 doses of VAX-A1 administered via intramuscular injection at Day 1 and Month 2
VAX-A1 HighEXPERIMENTALParticipants will receive 2 doses of VAX-A1 administered via intramuscular injection at Day 1 and Month 2
PlaceboPLACEBO_COMPARATORParticipants will receive 2 doses of placebo administered via intramuscular injection at Day 1 and Month 2

Interventions

NameTypeDescription
PlaceboBIOLOGICAL0.5mL of placebo (normal saline) will be administered into the deltoid muscle
VAX-A1 LowBIOLOGICAL0.5mL of the low dose VAX-A1 will be administered into the deltoid muscle
VAX-A1 MidBIOLOGICAL0.5mL of the mid dose VAX-A1 will be administered into the deltoid muscle
VAX-A1 HighBIOLOGICAL0.5mL of the high dose VAX-A1 will be administered into the deltoid muscle
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

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,...

Countries:Australia
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Recent Changes (Last 90 Days)

LOWJun 16, 2026NCT07616934Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT07616934Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT07616934Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about VAX-A1 Low

What is VAX-A1 Low used for?

VAX-A1 Low is an investigational vaccine being developed for the prevention of Group A Streptococcal Infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The vaccine is being studied for its safety, tolerability, and immunogenicity in healthy young adults.

Who makes VAX-A1 Low?

VAX-A1 Low is being developed by Vaxcyte, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol PCVX. The company is conducting a Phase 1 clinical trial to evaluate the vaccine's safety, tolerability, and immunogenicity in healthy young adults.

What phase is VAX-A1 Low in?

VAX-A1 Low is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is recruiting participants to evaluate the vaccine's safety, tolerability, and immunogenicity.

What clinical trials is VAX-A1 Low in?

VAX-A1 Low is being evaluated in a Phase 1 clinical trial with the identifier NCT07616934. This randomized, double-blind, placebo-controlled study is recruiting 80 healthy young adults in Australia to assess the safety, tolerability, and immunogenicity of the vaccine.

Is VAX-A1 Low the same as VAX-A1?

VAX-A1 Low is a formulation of the investigational vaccine VAX-A1, developed by Vaxcyte, Inc. The Phase 1 trial NCT07616934 evaluates VAX-A1 in healthy young adults for the prevention of Group A Streptococcal Infection. The specific 'Low' designation refers to a dose level being tested.