WithdrawnPhase 1

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

Stopped: Agreement between interested partied ended

0Started 2021-05

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 infec…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Solicited and unsolicited adverse reactions

Timeframe: Six months after last dose

Immune response to vaccine

Timeframe: Six months after last dose

Trial details

NCT IDNCT03998592

SponsorButantan Institute

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-03

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