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

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new vaccine called StreptInCor, which aims to help prevent rheumatic heart disease—a condition that can affect the heart after certain infections. The study will look at how safe the vaccine is and whether it helps the body build protection against the disease. Volunteers will receive different doses of the vaccine or a placebo (a harmless substance without the active vaccine) to compare the effects. The vaccine is given in two shots one month apart, with an additional booster shot six months later.

If you are healthy, between 18 and 45 years old, and able to attend all the study visits, you might be eligible to join. People with certain health conditions, recent infections, or who are pregnant will not be able to participate. Those who join will be randomly assigned to receive either the vaccine or placebo without knowing which one, and the researchers will closely monitor their health throughout the study. This trial has not yet started recruiting volunteers but aims to find out if this vaccine can be a safe and effective way to protect against rheumatic heart disease in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Healthy male or female volunteers, aged between 18 and 45 years;
• • Availability to undergo all procedures throughout the study period;
• • Provide free and informed consent to participate in the study.
• Exclusion Criteria:
• • Participation in clinical trials within the last year
• • Participation in cohort studies
• • Diagnosis of concomitant infections or diseases that may affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasms, and autoimmune diseases;
• • Current or previous diagnosis or family history of ARF, chorea, obsessive-compulsive disorder, or glomerulonephritis;
• • Current or previous diagnosis of heart diseases;
• • Severe asthma or chronic obstructive pulmonary disease (COPD);
• • Abnormal neurological clinical assessment, especially chorea;
• • Use of treatments that may affect immunity in the last four weeks, including immunomodulators, corticosteroids (only systemic use for two weeks or more), or antineoplastic agents;
• • Use of treatments that may affect heart valves in the last four weeks or planned during the study period, including fenfluramine and dexfenfluramine;
• • Renal insufficiency determined by estimated creatinine clearance below 45 ml/min/1.73m²;
• • History of intolerance or allergy to any component of the study product, including antigen or adjuvant;
• • Presence of valve abnormalities or alterations in cardiac anatomy as defined by echocardiogram;
• • Altered electrocardiogram;
• • Evidence or suspicion of recent S. pyogenes infection based on clinical symptoms in the last four weeks;
• • Pregnancy, breastfeeding mother, or intention to become pregnant during the study period (only female participants);
• • Any other condition that may interfere with the study process as assessed by the researchers, including sample size and statistical power.