This is a Phase I/IIa, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to test the candidate vaccine StreptInCor. The study will include four different doses (25 µg, 50 µg, 100 µg, and 200 µg) of StreptInCor produced under Good Manufacturing Practices (GMP) and formulated with aluminum hydroxide as the vaccine adjuvant. The adjuvant alone will be used as a placebo in this trial. Five groups, each consisting of twelve healthy adult volunteers, will randomly receive two doses of the vaccine or placebo with a 28-day interval, along with a booster dose six months after the initial vaccination
• Healthy male or female volunteers, aged between 18 and 45 years;
Availability to undergo all procedures throughout the study period;
Provide free and informed consent to participate in the study.
Participation in clinical trials within the last year
Participation in cohort studies
Diagnosis of concomitant infections or diseases that may affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasms, and autoimmune diseases;
Current or previous diagnosis or family history of ARF, chorea, obsessive-compulsive disorder, or glomerulonephritis;
Parallel
StrepIncor
Biological/VaccineThis arm will include 25/50/100/200 µg compared to placebo
Placebo
Other interventionA placebo (aluminum adjuvant) will be administered and compared to the other study arms
Safety outcome
• Safety outcome: The primary safety objective will be the absence of serious adverse events following immunization that have a reasonable causal relationship with the studied product in the StreptInCor and placebo groups;
Immunogenicity outcome
Immunogenicity outcome: The primary immunogenicity outcome will be an increase of at least 4 times in IgG antibody levels against the StreptInCor peptide, 6 months after the last immunization.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
