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

NCT07078357 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 37164814.4.0000.0068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute rheumatic fever; Rheumatic heart disease; Vaccine development program; Group A streptococcus (GAS); Streptococcus pyogenes

Outcome Measures

Primary Outcomes (2)

• Safety outcome

  • Safety outcome: The primary safety objective will be the absence of serious adverse events following immunization that have a reasonable causal relationship with the studied product in the StreptInCor and placebo groups;

  From enrollment to the end of treatment at six months

• Immunogenicity outcome

  Immunogenicity outcome: The primary immunogenicity outcome will be an increase of at least 4 times in IgG antibody levels against the StreptInCor peptide, 6 months after the last immunization.

  From enrollment to the end of treatment at six months

Study Arms (2)

Low dose Synthetic Vaccine Against Streptococcus Pyogenes- First arm

EXPERIMENTAL

25 mcg / 50 mcg / 100 mcg / 200mcg of the experimental vaccine will be administered.

Other: Placebo

Aluminum hydroxide (a vaccine adjuvant) - fifth arm

PLACEBO COMPARATOR

Aluminum hydroxide (a vaccine adjuvant) will be administered as a placebo

Biological: StrepIncor; Other: Placebo

Interventions

StrepIncor BIOLOGICAL

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

Aluminum hydroxide (a vaccine adjuvant) - fifth arm

Placebo OTHER

A placebo (aluminum adjuvant) will be administered and compared to the other study arms

Aluminum hydroxide (a vaccine adjuvant) - fifth arm; Low dose Synthetic Vaccine Against Streptococcus Pyogenes- First arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Heart Institute - Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de São Paulo

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Rheumatic Heart Disease; Rheumatic Diseases; Rheumatic Fever

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Arthritis; Joint Diseases

Study Officials

• Jorge E Kalil Filho, Full Professor, MD, PhD

  Heart Institute - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

  STUDY DIRECTOR

Central Study Contacts

RONEY O SAMPAIO, MD, PhD

CONTACT

+ 55-11- 2661-5056; roney.sampaio@hc.fm.usp.br

SELMA PALACIOS, PhD

CONTACT

+55-11-2661-5901; selmapalacios@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

BR (1)