Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children (NCT06306196) | Clinical Trial Compass
RecruitingPhase 2
Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children
South Africa1,040 participantsStarted 2024-04-04
Plain-language 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
Who can participate
Age range2 Years – 45 Years
SexALL
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Inclusion criteria
✓. Healthy participants 2 to 45 years of age at enrollment,
✓. Participants/Parent(s)/LAR who have voluntarily given informed consent/assent,
✓. Participants/Parent(s)/LAR willing to follow the study procedures and available for the entire duration of the study and agrees to the collection of all biospecimens,
✓. HIV negative,
✓. Not pregnant,
✓. Agreement to practice effective contraception for female participants of childbearing potential and non-sterile males until at least 8 months after the first vaccination.
✓. Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose of vaccine, and
✓. Female participant not currently breastfeeding.
Exclusion criteria
✕. Has received any hepatitis E vaccine in the past,
What they're measuring
1
Seroresponse rate
Timeframe: 4 weeks post third dose of Hecolin®
2
Proportion of immediate adverse events
Timeframe: Within 30 minutes post each dose of vaccination
3
Proportion of solicited local and systemic adverse events
Timeframe: Within 7 days post each dose
4
Proportion of unsolicited adverse events
Timeframe: Within 28 days post each dose
5
Proportion of SAEs, MAAEs and AESIs
Timeframe: Post dose 1 until 6 months post last dose
. 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,