Phase I Clinical Trial for Assessment of Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rheumatic Fever
- Sponsor
- Butantan Institute
- Primary Endpoint
- Solicited and unsolicited adverse reactions
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
Investigators
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;
Outcomes
Primary Outcomes
Solicited and unsolicited adverse reactions
Time Frame: Six months after last dose
Frequency of solicited and unsolicited adverse reactions
Immune response to vaccine
Time Frame: Six months after last dose
Rate of seroconversion for vaccine epitopes