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

NCT07078357 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-22

No results posted yet for this study

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

Conditions

  • Rheumatic Heart Disease
  • Rheumatic Heart Disease in Children
  • Vaccine Adverse Reaction
  • Rheumatic Diseases
  • Vaccine Acceptance
  • Vaccine

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

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Jorge E Kalil Filho, Full Professor, MD, PhD · Heart Institute - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-10-01
Completion
2028-12-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07078357 on ClinicalTrials.gov