Clinical Trial Phase I/IIa to Evaluate the Safety and Immunogenicity of StreptInCor

This is a Phase I/IIa, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to test the candidate vaccine StreptInCor. The study will include four different doses (25 µg, 50 µg, 100 µg, and 200 µg) of StreptInCor produced under Good Manufacturing Practices (GMP) and formulated with aluminum hydroxide as the vaccine adjuvant. The adjuvant alone will be used as a placebo in this trial. Five groups, each consisting of twelve healthy adult volunteers, will randomly receive two doses of the vaccine or placebo with a 28-day interval, along with a booster dose six months after the initial vaccination

NCT Number	NCT07078357
Lead Sponsor	University of Sao Paulo General Hospital
Conditions	Rheumatic Heart Disease, Rheumatic Heart Disease in Children, Vaccine Adverse Reaction, Rheumatic Diseases, Vaccine Acceptance, Vaccine
Enrollment	60 participants
Start Date	2025-10-01
Primary Completion	2027-10-01 (estimated)
Study Completion	2028-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-22