Clinical trial NCT03998592: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Rheumatic Fever
Keywords: vaccine
peptide
Streptococcus pyogenes
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
Collaborators: name: InCor - Instituto do Coração - HCFMUSP.
First posted: 2019-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Solicited and unsolicited adverse reactions
timeFrame: Six months after last dose
measure: Immune response to vaccine
timeFrame: Six months after last dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: InCor Heart Institute
name: Luiza Guilherme, PhD
role: STUDY_CHAIR
affiliation: InCor Heart Institute
name: Roney O Sampaio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: