RecruitingPhase 2NCT06306196

Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children

A Phase 2b, Open-label Study to Evaluate the Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adult Participants Followed by a Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Immunogenicity and Safety of Hecolin® in Children

Sponsor

International Vaccine Institute

Enrollment

1,040 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatitis E Virus Infection

Summary

The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals

Eligibility

Min Age: 2 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and immune response (immunogenicity) to a hepatitis E vaccine called Hecolin in HIV-positive and HIV-negative adults, as well as in children, to understand how well it works across different populations. **You may be eligible if (healthy participants)...** - You are between 2 and 45 years old - You are HIV-negative - You are not pregnant or breastfeeding - You are willing to use effective contraception for at least 8 months after the first vaccination - You are willing to follow all study procedures for the full duration **You may NOT be eligible if...** - You are HIV-positive (for the healthy arm) - You are pregnant or breastfeeding - You are unwilling or unable to use contraception - You do not meet the study's health requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHecolin® Recombinant Hepatitis E Vaccine

30㎍/dose, 0.5mL administered intramuscularly

BIOLOGICALIsotonic Sodium Chloride injection

0.5mL administered intramuscularly

Locations(3)

MeCRU Clinical Research Unit

Ga-Rankuwa, South Africa

Newtown Clinical Research Centre

Johannesburg, South Africa

Be Part Research

Paarl, South Africa

View Full Details on ClinicalTrials.gov

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NCT06306196