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NOT YET RECRUITING
NCT07078357
PHASE1/PHASE2

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

Sponsor: University of Sao Paulo General Hospital

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

StrepIncor

This arm will include 25/50/100/200 µg compared to placebo

OTHER

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