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A Trial of a Peptide-based Group A Streptococcal (GAS) Vaccine Candidate in Healthy Individuals.

NCT04882514 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-28

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety and antibody (germ fighters) response of experimental (investigational) vaccine candidates against the germ group A streptococcus when injected into the arm of healthy adults.

Conditions

  • Group A Streptococcal Infection

Interventions

BIOLOGICAL

p*17-K4S2

Administer p\*17-K4S2 25 μg vaccine at 0, 3, and 6 weeks and evaluate the safety and antibody levels for a total of 6 months after the last injection. All vaccines will be administered intramuscularly

BIOLOGICAL

J8-K4S2

Administer a vaccination schedule of J8-K4S2 50μg vaccine at 0, 3, and 6 weeks and evaluate the safety and antibody levels for a total of 6 months after the last injection. All vaccines will be administered intramuscularly

BIOLOGICAL

Rabavert vaccine

Administer the standard Rabavert vaccine at 0, 3, and 6 weeks and evaluate the safety and antibody levels for a total of 6 months after the last injection. All vaccines will be administered intramuscularly. The Rabavert vaccine will be used as a control comparator as it has a similar approved dosing schedule to the investigational vaccines.

Sponsors & Collaborators

  • Griffith University

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Vanessa Meier-Stephenson, MD, PhD · University of Alberta

  • Michael Good, MD, PhD · Griffith University

  • Michael Houghton, PhD · University of Alberta

  • Lorne Tyrrell, MD PhD · University of Alberta

  • Michael Hawkes, MD, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-07
Primary Completion
2025-05-12
Completion
2025-05-12

Countries

  • Canada

Study Locations

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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 NCT04882514 on ClinicalTrials.gov