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

Brief Title

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

Official Title

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

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Solicited and unsolicited adverse reactions


Condition

Rheumatic Fever

Intervention

Streptococcus pyogenes vaccine (50 µg)

Study Arms / Comparison Groups

 Low-dose vaccine
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

0

Start Date

May 2021

Completion Date

October 2023

Primary Completion Date

March 2022

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.
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Luiza Guilherme, PhD, , 



Administrative Informations


NCT ID

NCT03998592

Organization ID

EGA-01-IB


Responsible Party

Sponsor

Study Sponsor

Butantan Institute

Collaborators

 InCor - Instituto do Coração - HCFMUSP.

Study Sponsor

Luiza Guilherme, PhD, Study Chair, InCor Heart Institute


Verification Date

February 2021