NCT04882514

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

A Randomized Double Blinded Within Dose, Controlled, Safety and Immunogenicity Study of GAS Vaccine Candidate in Healthy Individuals.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Group A streptococcus (GAS) is a bacteria that cause a number of different infections that range from mild illnesses to deadly diseases. It is estimated 500,000 deaths occur worldwide each year from GAS. To address these high rates of disease, the investigators want to test a new potential vaccine for safety and immune response in healthy participants. The investigators will verify the immediate safety of the J8-K4S2 and p\*17-K4S2 vaccines using a test dose in 10 volunteers. With respect to J8-K4S2 vaccine, safety of one of the peptide components (J8) has previously been established. Therefore, The investigators will begin with a test dose of J8-K4S2. The first IM injection of J8-K4S2 will be administered to the first participant. The investigators will wait two days, assess safety, then administer J8-K4S2 to a second participant. The investigators will wait two days, assess safety, then administer J8-K4S2 to a third participant. This process will continue until 5 participants have received a test dose of J8- K4S2. If there are no safety concerns with the first 5 participants, the investigators will have shown the preliminary safety of the K4S2 component. If the J8-K4S2 vaccine is well-tolerated, second and third doses of J8-K4S2 will be administered at 3 and 6 weeks, testing the safety of repeated dosing. The investigators will next administer p\*17-K4S2 to a sixth participant, wait two days, assess safety, and administer p\*17-K4S2 to a seventh participant. The investigators will wait two days, assess safety, then administer p\*17-K4S2 to an eighth participant. This process will continue until 5 participants have received a test dose of p\*17-K4S2. If there are no safety concerns, the investigators will have shown the preliminary safety of the p\*17 component. If the p\*17-K4S2 peptide vaccine is well-tolerated, second and third doses of p\*17-K4S2 will be administered at 3 and 6 weeks, testing the safety of repeated dosing. Following this stage 1 challenge, if no safety concerns arise, the study will proceed to stage 2, with randomized allocation to each arm for 20 more participants who will receive J8-K4S2 vaccine (n=5), p\*17-K4S2 vaccine (n=5), and 10 who receive comparator (rabies) vaccine.

Conditions

• Group A Streptococcal Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-07
• Primary completion: 2025-05-12
• Completion: 2025-05-12
• First posted: 2021-05-12
• Last updated: 2025-05-28

Locations

1 site across 1 country: Canada