NOT YET RECRUITING
NCT07078357
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
Gender: All
Ages: 18 Years - 45 Years
Rheumatic Heart Disease
Rheumatic Heart Disease in Children
Vaccine Adverse Reaction
+3