Actively Recruiting
Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children
Led by International Vaccine Institute · Updated on 2025-04-29
1040
Participants Needed
3
Research Sites
91 weeks
Total Duration
On this page
Sponsors
I
International Vaccine Institute
Lead Sponsor
X
Xiamen Innovax Biotech Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants aged 2 to 45 years at enrollment
- Participants or their parent/legal representative have given voluntary informed consent or assent
- Willingness to follow study procedures, be available for the entire study duration, and agree to biospecimen collection
- HIV negative status
- Not pregnant
- Agreement to use effective contraception for females of childbearing potential and non-sterile males until at least 8 months after first vaccination
- Practiced adequate contraception or abstained from activities that could cause pregnancy for at least 28 days before first vaccine dose
- Female participants not currently breastfeeding
You will not qualify if you...
- Received any hepatitis E vaccine previously
- Febrile illness (temperature 60 386C) or acute illness within 3 days before vaccination
- Known allergy to vaccine components or other medications increasing risk of adverse events
- Major congenital abnormalities affecting study participation
- Known immune disorders including HIV or lupus
- Chronic use of systemic steroids, cytotoxic or immunosuppressive drugs within past 6 weeks
- Any abnormality or chronic disease that may affect safety or study assessments
- Behavioral, cognitive, substance abuse, psychiatric, or neural disorders interfering with participation
- History of splenectomy
- History of thrombocytopenia, thrombosis, myocarditis, pericarditis, or significant cardiac conditions
- Bleeding disorders contraindicating injections or blood draws
- Receipt of blood products in past 3 months
- Receipt of other vaccines within 4 weeks before or after study vaccination
- Enrollment in another clinical trial
- Research staff or family members of research staff
- BMI 60 40 in adults or BMI-index-for-age 60 95th percentile in children at screening
- Any other investigator-judged reason for exclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
MeCRU Clinical Research Unit
Ga-Rankuwa, South Africa
Actively Recruiting
2
Newtown Clinical Research Centre
Johannesburg, South Africa
Actively Recruiting
3
Be Part Research
Paarl, South Africa
Actively Recruiting
Research Team
T
Tarun Saluja
CONTACT
S
Sanet Aspinall
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
17
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