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Clinical Trial Phase I/IIa to Evaluate the Safety and Immunogenicity of StreptInCor
Sponsor: University of Sao Paulo General Hospital
Summary
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
Official title: Phase I/IIa Clinical Trial to Evaluate the Safety and Immunogenicity of StreptInCor, a Synthetic Vaccine Against Streptococcus Pyogenes, in Healthy Adult Volunteers.
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-10-01
Completion Date
2028-12-01
Last Updated
2025-07-22
Healthy Volunteers
Yes
Conditions
Interventions
StrepIncor
This arm will include 25/50/100/200 µg compared to placebo
Placebo
A placebo (aluminum adjuvant) will be administered and compared to the other study arms
Locations (1)
Heart Institute - Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de São Paulo
São Paulo, São Paulo, Brazil