Rheumatic Fever
Conditions
Keywords
vaccine, peptide, Streptococcus pyogenes
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.
Interventions
BIOLOGICALStreptococcus pyogenes vaccine (50 µg)
Vaccine containing 50 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
BIOLOGICALStreptococcus pyogenes vaccine (100 µg)
Vaccine containing 100 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
BIOLOGICALStreptococcus pyogenes vaccine (200 µg)
Vaccine containing 200 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
OTHERPlacebo
Placebo without active component
Sponsors
InCor - Instituto do Coração - HCFMUSP.
Butantan Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune response to vaccine | Six months after last dose | Rate of seroconversion for vaccine epitopes |
| Solicited and unsolicited adverse reactions | Six months after last dose | Frequency of solicited and unsolicited adverse reactions |
Outcome results
None listed