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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Hepatitis E Virus Infection

In brief

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

Key facts

Study ID: NCT06306196
Run by: International Vaccine Institute
People needed: 1040
Starts: 2024-04-04
Expected to finish: 2026-01-01
Last updated by the study team: 2025-04-29

Who can join

Age: 2 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

An individual who meets any of the following criteria will be excluded from participation in this study:
Has received any hepatitis E vaccine in the past,
Febrile illness (body temperature ≥ 38°C) or acute illness within 3 days prior to the study vaccination,
Known history or allergy to study vaccine components and/or excipients or other medications, or any other allergies or medical history deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial (e.g., Guillain-Barre Syndrome),
Major congenital abnormalities which in the opinion of the investigator may affect the participant's participation in the study,
Known history of immune function disorders including immunodeficiency diseases (known HIV infection or other immune function disorders) and lupus,
Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs within the past 6 weeks,
Any abnormality or chronic disease which in the opinion of the investigator might be detrimental to the safety of the participant and interfere with the assessment of the study objectives,
Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neural disorders, that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial,
History of splenectomy,
History of thrombocytopenia and/or thrombosis, myocarditis or pericarditis or any other significant cardiac condition,
With a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections/blood extractions.,
Receipt of blood or blood-derived products in the past 3 months,
Receipt of other vaccines from 4 weeks prior to test vaccination or planned to receive any vaccine within 4 weeks of last dose of study vaccine,
Concomitantly enrolled or scheduled to be enrolled in another trial,
Research staff involved with the clinical study or family/household members of research staff,
Body mass index (BMI) of ≥ 40 in adults and for children a BMI- index-for-age is ≥95th percentile, at the time of the screening visit, or
As per the Investigator's medical judgement, an individual could be excluded from the study despite meeting all inclusion/exclusion criteria mentioned above.
Inclusion criteria for HIV-positive arm:
Adults 18-45 years living with HIV on anti-retroviral (ARV) treatment and willing to have CD4 and viral load measured as per protocol,
Able to provide a voluntary signed informed consent,
Participants willing to follow the study procedures of the study and available for the entire duration of the study and agrees to the collection of all biospecimens,
Agreement to practice effective contraception for female participants of childbearing potential and non-sterile males until at least 3 months after the last vaccination.
Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the last dose of vaccine, and
Female participant is currently not breastfeeding.

Where it is running

MeCRU Clinical Research Unit — Ga-Rankuwa, South Africa (enrolling)
Newtown Clinical Research Centre — Johannesburg, South Africa (enrolling)
Be Part Research — Paarl, South Africa (enrolling)

Full record on ClinicalTrials.gov

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