Peptide-based GAS Vaccine for Streptococcal Infections

Overseen By Avi Seth

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Alberta

Must not be taking: Fen-Phen, Immunosuppressants, others

Disqualifiers: Cardiac disease, Autoimmune disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on psychiatric drugs, your condition must be stable for at least 3 months before joining the study.

What data supports the effectiveness of the treatment J8-K4S2, p*17-K4S2, Rabavert vaccine for streptococcal infections?

Research shows that the J8 peptide, a component of the treatment, has been effective in generating immune responses in mice and non-human primates, providing protection against lethal streptococcal infections. This suggests that the treatment could potentially be effective in preventing streptococcal infections in humans. ^{1 2 3 4 5}

Is the peptide-based GAS vaccine safe for humans?

Research on the peptide-based GAS vaccine, including versions like J8-K4S2 and p*17-K4S2, has shown it to be safe in animal studies, with no significant adverse effects observed in mice, non-human primates, and rats. These studies suggest the vaccine is generally safe, but human trials are needed to confirm this. ^{1 2 3 6 7}

What makes the J8-K4S2, p*17-K4S2 treatment unique for streptococcal infections?

The J8-K4S2, p*17-K4S2 treatment is unique because it is a peptide-based vaccine targeting the conserved regions of the M protein in Group A Streptococcus (GAS), which is a novel approach compared to traditional treatments. This vaccine aims to provide broad protection against multiple GAS serotypes by inducing an immune response that can recognize and neutralize the bacteria. ^{1 2 3 8 9}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Safety Assessment

Initial safety of J8-K4S2 and p*17-K4S2 vaccines is assessed with test doses in small groups of participants

6 weeks

Multiple visits for each participant

Treatment

Participants receive repeated doses of J8-K4S2 or p*17-K4S2 vaccines, or a comparator rabies vaccine

6 weeks

3 visits (in-person) for each participant

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular visits for safety and immunogenicity assessments

Treatment Details

Interventions

• J8-K4S2
• p*17-K4S2
• Rabavert 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+

Griffith University

Collaborator

Trials

18

Recruited

22,900+

References

1. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity in mice and non-human primates of the Group A Streptococcal J8 peptide vaccine candidate conjugated to CRM197. [2021]

2. Egypt pubmed.ncbi.nlm.nih.gov

Immunogenicity and Safety of a Chemically Synthesized Divalent Group A Streptococcal Vaccine. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Toward the development of an antidisease, transmission-blocking intranasal vaccine for group a streptococcus. [2008]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Identification and assessment of new vaccine candidates for group A streptococcal infections. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term antibody memory induced by synthetic peptide vaccination is protective against Streptococcus pyogenes infection and is independent of memory T cell help. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Prime-Pull Immunization with a Bivalent M-Protein and Spy-CEP Peptide Vaccine Adjuvanted with CAF®01 Liposomes Induces Both Mucosal and Peripheral Protection from covR/S Mutant Streptococcus pyogenes. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Protection of mice from group A streptococcal infection by intranasal immunisation with a peptide vaccine that contains a conserved M protein B cell epitope and lacks a T cell autoepitope. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of safety and immunogenicity of a group A streptococcus vaccine candidate (MJ8VAX) in a randomized clinical trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Toward the development of a synthetic group a streptococcal vaccine of high purity and broad protective coverage. [2006]