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VAX-A1 Low

Phase 1

Group A Streptococcal Infection | Monoclonal antibody | Other |Vaxcyte, Inc.|Last Updated: Jun 1, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07616934A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young AdultsPHASE1 NOT YET_RECRUITING 80 — — Jun 1, 2026Dec 1, 2027Jun 1, 20261 Australia
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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 — 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 2, 2026NCT07616934NEW_TRIAL: changed
LOWJun 2, 2026NCT07616934NEW_TRIAL: changed
LOWJun 2, 2026NCT07616934NEW_TRIAL: changed