Clinical Trial to Assess Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes

NCT ID: NCT03998592

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2023-10-31

Brief Summary

This is a double-blind, randomized, placebo-controlled phase I clinical trial with dose-escalation of a synthetic vaccine against Streptococcus pyogenes. The active component of this vaccine candidate is a synthetic polypeptide named StreptInCor designed to elicit humoral and cell-mediated immune responses. The vaccine will be formulated with Aluminium hydroxide in three different doses of StreptInCor (50 µg, 100µg, 200 µg). The proposed vaccination schedule is three doses (0, 1, 6 months). The doses will be escalated for the next group after safety review.

Conditions

Rheumatic Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Low-dose vaccine

Group Type: EXPERIMENTAL

Streptococcus pyogenes vaccine (50 µg)

Intervention Type: BIOLOGICAL

Vaccine containing 50 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant

Mid-dose vaccine

Group Type: EXPERIMENTAL

Streptococcus pyogenes vaccine (100 µg)

Intervention Type: BIOLOGICAL

Vaccine containing 100 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant

High-dose vaccine

Group Type: EXPERIMENTAL

Streptococcus pyogenes vaccine (200 µg)

Intervention Type: BIOLOGICAL

Vaccine containing 200 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo without active component

Interventions

Streptococcus pyogenes vaccine (50 µg)

Vaccine containing 50 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant

Intervention Type: BIOLOGICAL

Streptococcus pyogenes vaccine (100 µg)

Vaccine containing 100 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant

Intervention Type: BIOLOGICAL

Streptococcus pyogenes vaccine (200 µg)

Vaccine containing 200 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant

Intervention Type: BIOLOGICAL

Placebo

Placebo without active component

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers, both sex, aging 18 to 45 years;
• Availability for all procedures during the study period;
• Provide free informed consent to join the study

Exclusion Criteria

• Diagnosis of concomitant infections or diseases that might affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasias, and autoimmune diseases;
• Previous or current diagnosis or family antecedent of rheumatic fever, chorea, obsessive-compulsive disorder or glomerulonephritis;
• Previous or current diagnosis of cardiac disease;
• Severe asma or Chronic obstructive pulmonary disease (COPD);
• Abnormal neurological clinical assessment, particularly chorea;
• Use of treatments that might affect the immunity in the last four weeks, including immunomodulators, corticosteroids (only systemic use equal or longer than two weeks), or antineoplastic agents;
• Use of treatments that might affect heart valves in the latest four weeks, including fenfluramine e dexfenfluramine;
• Kidney failure determined by creatinine clearance lower than 45 ml/min/1,73m²;
• History of intolerance or allergy to any component of investigational products, including antigen or adjuvant;
• Presence of abnormalities in heart valves or heart anatomy defined by echocardiogram;
• Electrocardiogram disturbances;
• Presence of cross-reactive antibodies against human tissues (heart, kidney, cartilage, brain) in screening tests;
• Evidence or suspicion of recent infection due to S. pyogenes assessed by clinical symptoms and negative rapid test for Streptococcus;
• Pregnancy, breastfeeding mother or intention to became pregnant during the study period;
• Any other condition that might affect the study process according to the investigators.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InCor - Instituto do Coração - HCFMUSP.

UNKNOWN

Sponsor Role: collaborator

Butantan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luiza Guilherme, PhD

Role: STUDY_CHAIR

InCor Heart Institute

Roney O Sampaio, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

InCor Heart Institute

Other Identifiers

EGA-01-IB

Identifier Type: -

Identifier Source: org_study_id