Peptide-based GAS Vaccine for Streptococcal Infections

Recruiting in Palo Alto (17 mi)

Overseen by Michael Hawkes, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Alberta

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Vanessa Meier-Stephenson, MD, PhD

Principal Investigator

University of Alberta

Michael Good, MD, PhD

Principal Investigator

Griffith University

Michael Houghton, PhD

Principal Investigator

University of Alberta

Lorne Tyrrell, MD PhD

Principal Investigator

University of Alberta

Michael Hawkes, MD, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

Healthy adults aged 18-45, non-smokers with good health as confirmed by medical screening. Participants must not be pregnant or breastfeeding, agree to use effective birth control, and have up-to-date vaccinations for influenza and COVID-19. They should not have a recent history of streptococcal infection or immunosuppressive therapy, nor plan to travel overseas soon after vaccination.

Inclusion Criteria

Agree not to donate blood for the duration of the trial

I am up to date with my flu and COVID-19 vaccines.

Women must agree not to become pregnant during the trial. If they are sexually active, they must use an effective method of birth control, e.g. insertable, injectable, transdermal, or combination oral contraceptive approved by Health Canada combined with a barrier contraceptive and have negative results on a serum or urine pregnancy test done before administration of study medication

Exclusion Criteria

You have been diagnosed with severe mental health conditions like schizophrenia or bipolar disorder that significantly affect your daily life.

I have previously used appetite suppressants like phentermine or Fen-Phen.

I haven't needed antibiotics for a serious infection in the last 14 days.

Treatment Details

Interventions

• J8-K4S2 (Peptide-based Vaccine)
• p*17-K4S2 (Peptide-based Vaccine)
• Rabavert vaccine (Vaccine)

Trial Overview The trial is testing the safety and immune response of two experimental vaccines (p*17-K4S2, J8-K4S2) against Group A Streptococcus compared to an existing Rabavert vaccine. Healthy participants will receive injections in their arm and their antibody levels will be monitored.

Participant Groups

Group I: Vaccine p*17-K4S2 (50 µg/mL) Vaccine Experimental Treatment 1 Intervention

To evaluate the safety and immunogenicity of p\*17-CRM197 (25µg) + K4S2-CRM197 (6.25µg): TOTAL 31.25 µg

Group II: J8-K4S2 (100 µg/mL ) Vaccine Experimental Treatment 1 Intervention

To evaluate the safety and immunogenicity J8-CRM197 (50µg) + K4S2-CRM197 (6.25µg): TOTAL 56.25 µg

Group III: Rabavert Vaccine Placebo Group 1 Intervention

Comparator vaccine (RABAVERT)

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

Griffith University

Collaborator

Trials

18

Recruited

22,900+