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

Rheumatic Fever Clinical Trial

Official title:
Phase I Clinical Trial for Assessment of Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes in Healthy Volunteers

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Rheumatic Fever

Clinical Trial Details

NCT number	NCT03998592
Study type	Interventional
Source	Butantan Institute
Contact
Status	Withdrawn
Phase	Phase 1
Start date	May 2021
Completion date	October 2023

View Details

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