Hepatitis E Virus InfectionPhase 2NCT06306196
Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children
A Phase 2 study testing Hecolin® Recombinant Hepatitis E Vaccine and Isotonic Sodium Chloride injection in people with Hepatitis E Virus Infection, run by International Vaccine Institute at 3 sites in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis E Virus Infection
- What is being tested?
- Hecolin® Recombinant Hepatitis E Vaccine and Isotonic Sodium Chloride injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,040 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 4 Apr 2024to Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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,
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- 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.
- 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,
- Newly diagnosed HIV-positive (diagnosed on screening) on ARVs for 0-4 weeks (Note: These participants can be re-screened and enrolled once they have been on ARVs for 4 weeks),
- Febrile illness (body temperature ≥ 38°C) or acute illness within 3 days prior to the study vaccination,
- Serious adverse reaction to any vaccine, or any component of the investigational vaccine, including a history of anaphylaxis and symptoms of a severe allergic reaction and history of allergies in the past,
- Current hospitalization,
- History of inherited blood disorders, heparin-induced thrombocytopenia, or thromboembolic disorders,
- History of any blood product transfusion up to 6 months before enrolment,
- 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
- Currently taking anti-coagulation therapy, or chronic aspirin in the past 3 months,
- Pregnant or breastfeeding women throughout the study period,
- Extreme obesity (defined as BMI of 40 kg/m2 or higher),
- Chronic kidney disease requiring dialysis,
- Liver disease (Note mild chronic liver disease is not an exclusion criterion),
- Participants with acquired or hereditary immunodeficiencies other than HIV,
- History of hereditary, idiopathic, or acquired angioedema,
- No spleen or functional asplenia,
- Platelet disorder or other bleeding disorder that may cause injection contraindication,
- Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, or immunomodulators. The use of low dose topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted,
- According to the judgement of the investigator, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk due to participation in the study,
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa3 sites, 3 recruiting
- Recruiting
MeCRU Clinical Research Unit
Ga-Rankuwa
Maphoshane Nchabeleng, +27 125213032, maphoshane.nchabeleng@smu.ac.za
- Recruiting
Newtown Clinical Research Centre
Johannesburg
Essack Mitha, +27 114920336, emitha@newtowncrc.co.za
- Recruiting
Be Part Research
Paarl
Elizabeth Hellström, +27 218683990, pi@bepart.co.za
About this study
Official title: 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
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
Read the detailed description
The primary objective of the study is to demonstrate immune non-inferiority of 30 µg Hecolin® when given to healthy children (2-17 years) as compared to healthy adults (18-45 years) as measured by seroresponse rates (SR) of anti- HEV IgG ELISA antibody titers, 4 weeks after the 3 doses given at 0, 1- \& 6-months. Co-primary objective is to assess safety in each age cohort and descriptively compare lower age cohorts with higher age cohorts. Other immune parameters would be assessed as secondary objectives. Healthy children and adolescents collectively (2-17 years) will be compared for immune non-inferiority with healthy adults (18-45 years) as measured by geometric mean concentration (GMC) of anti-HEV IgG ELISA antibody titers, 4 weeks after the 3 doses given at 0, 1- \& 6-months. Among children (2-17 years) 3 doses of Hecolin® given at 0, 1 and 6 months will be compared with 2 doses of Hecolin® given at 1 and 6 months in terms of immune non-inferiority of SR and GMC of anti-HEV IgG ELISA antibody titers. The immune response will be compared between HIV positive and HIV negative adults in terms of SR and GMC as measured by anti-HEV IgG ELISA antibody titers at 4 weeks after completing 3 doses of Hecolin® (0, 1 and 6 months).
A total of 860 participants will be enrolled in the main study and will be divided into 4 age strata; 18-45 years (Cohort A), 12-17 years (Cohort B), 6-11 years (Cohort C) and 2-5 years (Cohort D) having 410, 175, 175 and 100 participants respectively. Cohort A will be further divided into Arm A1 and A2 having 232 HIV -ve and 178 HIV +ve participants respectively. All participants in cohort A will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Cohort B will be further divided into Arm B1, B2 and B3 having 70, 70 and 35 participants respectively. Arm B1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm B2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm B3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0, 1 and 6 months. Similarly, Cohort C will be further divided into Arm C1, C2 and C3 having 70, 70 and 35 participants respectively. Arm C1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm C2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm C3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0, 1 and 6 months. Cohort D will be further divided into Arm D1, D2 and D3 having 40, 40 and 20 participants respectively. Arm D1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm D2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm D3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0,1 and 6 months.
In the main study a total of 6 blood samples for immunogenicity will be collected from all participants at Day 0 (baseline), one month after first vaccination, one month after second vaccination, 6 months after first vaccination, one month after third vaccination, and at 6 months after third vaccination.
Blood samples will be collected at screening and one month after third vaccination from the HIV + arm to document CD4 T cells and HIV Viral load.
Out of the 860 participants enrolled in the main study, 2 additional blood samples after reconsent for the 2-year long term follow up period will be collected at V8 (12 months after 3rd dose) and V9 (24 months after 3rd dose) from any 100 HIV negative adults in Cohort A and from participants in Hecolin arms in Cohorts B, C and D (B1, B2, C1, C2, D1, and D2) for immunogenicity assessment. In the additional 0-1-month dose schedule component/arm, a total of 4 blood samples will be collected from all participants at V2 (Day 0), V3 (28 days after 1st dose), V4 (28 days after 2nd dose), V5 (6 months after 2nd dose), and 2 additional samples will be collected from participants in Hecolin arms in Cohorts B, C and D (B4, C4, and D4) at V6 (12months after 2nd dose), and V7 (24 months after 2nd dose) for immunogenicity assessment.
All participants will be observed at the study site for 30 minutes after each Investigational Product (IP) injection for any reactogenicity events. Local and systemic solicited adverse events will be recorded in a diary card during 7 days after each IP dose while unsolicited adverse events will be recorded during the 4 weeks after each IP injection. Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse of special interest (AESI) will be recorded during the entire study period i.e., until 6 months post last dose.
- Conditions
- Hepatitis E Virus Infection
- Being tested
- Hecolin® Recombinant Hepatitis E Vaccine, Isotonic Sodium Chloride injection
- Medical subject headings
- Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hecolin® Recombinant Hepatitis E VaccineBiological
30㎍/dose, 0.5mL administered intramuscularly
Isotonic Sodium Chloride injectionBiological
0.5mL administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Group A1 (Three doses of Hecolin®; HIV negative adults aged 18-45 years) | Experimental | Three doses of Hecolin® Recombinant Hepatitis E Vaccine administered at 0, 1 and 6 months to HIV negative participants, age 18-45 years old, 232 participants Receives: Biological: Hecolin® Recombinant Hepatitis E Vaccine |
| Group A2 (Three doses of Hecolin®; HIV positive adults aged 18-45 years) | Experimental | Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to HIV positive participants, age 18-45 years old, 178 participants Receives: Biological: Hecolin® Recombinant Hepatitis E Vaccine |
| Group B1 (Three doses of Hecolin®; healthy adolescents aged 12-17 years) | Experimental | Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 12-17 years old, 70 participants Receives: Biological: Hecolin® Recombinant Hepatitis E Vaccine |
| Group B2 (Two doses of Hecolin®; healthy adolescents aged 12-17 years) | Experimental | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months) and one dose of Placebo, administered at 1-month timepoint, to age 12-17 years old, 70 participants Receives: Biological: Hecolin® Recombinant Hepatitis E Vaccine; Biological: Isotonic Sodium Chloride injection |
| Group B3 (Placebo; healthy adolescents aged 12-17 years) | Placebo comparator | Three doses of Placebo, administered at 0, 1 and 6 months, to age 12-17 years old, 35 participants Receives: Biological: Isotonic Sodium Chloride injection |
| Group C1 (Three doses of Hecolin®; healthy children aged 6-11 years) | Experimental | Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 6-11 years old, 70 participants Receives: Biological: Hecolin® Recombinant Hepatitis E Vaccine |
| Group C2 (Two doses of Hecolin®; healthy children aged 6-11 years) | Experimental | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0 and 6 months and one dose of Placebo, administered at 1-month timepoint, to age 6-11 years old, 70 participants Receives: Biological: Hecolin® Recombinant Hepatitis E Vaccine; Biological: Isotonic Sodium Chloride injection |
| Group C3 (Placebo; healthy children aged 6-11 years) | Placebo comparator | Three doses of Placebo, administered at 0, 1 and 6 months, to age 6-11 years old, 35 participants Receives: Biological: Isotonic Sodium Chloride injection |
| Group D1 (Three doses of Hecolin®; healthy children aged 2-5 years) | Experimental | Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 2-5 years old, 40 participants Receives: Biological: Hecolin® Recombinant Hepatitis E Vaccine |
| Group D2 (Two doses of Hecolin®; healthy children aged 2-5 years) | Experimental | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0 and 6 months and of Placebo, administered at 1-month timepoint, to age 2-5 years old, 40 participants Receives: Biological: Hecolin® Recombinant Hepatitis E Vaccine; Biological: Isotonic Sodium Chloride injection |
| Group D3 (Placebo; healthy children aged 2-5 years) | Placebo comparator | Three doses of Placebo, administered at 0, 1 and 6 months, to age 2-5 years old, 40 participants Receives: Biological: Isotonic Sodium Chloride injection |
| Group B4 (Two doses of Hecolin®; healthy children aged 12-17 years) | Experimental | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 12-17 years old, 50 participants Receives: Biological: Hecolin® Recombinant Hepatitis E Vaccine |
| Group B5 (Placebo; healthy children aged 12-17 years) | Experimental | Two doses of Placebo, administered at 0, and 1 month, to age 12-17 years old, 10 participants Receives: Biological: Isotonic Sodium Chloride injection |
| Group C4 (Two doses of Hecolin®; healthy children aged 6-11 years) | Experimental | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 6-11 years old, 50 participants Receives: Biological: Hecolin® Recombinant Hepatitis E Vaccine |
| Group C5 (Placebo; healthy children aged 6-11 years) | Experimental | Two doses of Placebo, administered at 0, and 1 month, to age 6-11 years old, 10 participants Receives: Biological: Isotonic Sodium Chloride injection |
| Group D4 (Two doses of Hecolin®; healthy children aged 2-5 years) | Experimental | Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 2-5 years old, 50 participants Receives: Biological: Hecolin® Recombinant Hepatitis E Vaccine |
| Group D5 (Placebo; healthy children aged 2-5 years) | Experimental | Two doses of Placebo, administered at 0, and 1 month, to age 2-5 years old, 10 participants Receives: Biological: Isotonic Sodium Chloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroresponse rate
Seroresponse rate (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years) as compared to healthy adults (18-45 years)
Measured: 4 weeks post third dose of Hecolin®
Proportion of immediate adverse events
Proportion of immediate adverse events within 30 minutes post each dose of vaccination in all study participants
Measured: Within 30 minutes post each dose of vaccination
Proportion of solicited local and systemic adverse events
Proportion of solicited local and systemic adverse events within 7 days post each dose of vaccination in all study participants
Measured: Within 7 days post each dose
Proportion of unsolicited adverse events
Proportion of unsolicited adverse events within 28 days post each dose of vaccination in all study participants
Measured: Within 28 days post each dose
Proportion of SAEs, MAAEs and AESIs
Proportion of Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse events of special interest (AESIs) post dose 1 until 6 months post last dose of vaccination
Measured: Post dose 1 until 6 months post last dose
Secondary outcomes (18)
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years) as compared to healthy adults (18-45 years)
Measured: 4 weeks post third dose
SR
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) 4 weeks post two doses of Hecolin® administered at 0, and 6 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years)
Measured: 4 weeks post two doses of Hecolin®
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 4 weeks post two doses of Hecolin® administered at 0, and 6 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years)
Measured: 4 weeks post two doses of Hecolin®
SR and GMC of anti-HEV IgG
SR and GMC of anti-HEV IgG at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months in healthy older children (6-17 years) and healthy adults (18-45 years)
Measured: 4 weeks post third dose of Hecolin®
SR
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 24 weeks post two doses of Hecolin® administered at 0, and 6 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy child
Measured: 24 weeks post two doses of Hecolin®
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 24 weeks post two doses of Hecolin® administered at 0, and 6 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years)
Measured: 24 weeks post two doses of Hecolin®
SR
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to HIV-positive adults as compared to HIV-negative healthy adults (18-45 years)
Measured: 4 weeks post third dose of Hecolin®
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to HIV-positive adults as compared to HIV-negative healthy adults (18-45 years)
Measured: 4 weeks post third dose of Hecolin®
SR
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to virally suppressed (CD4 count < 350) and virally unsuppressed (CD4 count ≥ 350) HIV-positive adults (18-45 years)
Measured: 4 weeks post third dose of Hecolin®
GMC of anti-HEV IgG
MC of anti-HEV IgG at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to virally suppressed (CD4 count < 350) and virally unsuppressed (CD4 count ≥ 350) HIV-positive adults (18-45 years)
Measured: 4 weeks post third dose of Hecolin®
SR
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 4 weeks post first, second and third dose of Hecolin® /Placebo administered at 0, 1 and 6 months in healthy children (12-17 years), (6-11 years), (2-5 years) and adults (18-45 years) individually
Measured: 4 weeks post first, second and third dose of Hecolin® /Placebo
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 4 weeks post first, second and third dose of Hecolin® /Placebo administered at 0, 1 and 6 months in healthy children (12-17 years), (6-11 years), (2-5 years) and adults (18-45 years) individually
Measured: 4 weeks post first, second and third dose of Hecolin® /Placebo
SR and GMC of anti-HEV IgG
SR and GMC of anti-HEV IgG at 4 weeks post first, second and third dose of Hecolin® /Placebo administered at 0, 1 and 6 months in healthy children (12-17 years), (6-11 years), (2-5 years) and adults (18-45 years) collectively and individually as per sero- status at baseline.
Measured: 4 weeks post first, second and third dose of Hecolin® /Placebo
GMC of anti-HEV IgG for additional 0-1 dose schedule
GMC of anti-HEV IgG at 4 weeks post two doses of Hecolin® administered at 0 and 1 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years)
Measured: 4 weeks post first, second of Hecolin
GMC of anti-HEV IgG for additional 0-1 dose schedule
SR and GMC of anti-HEV IgG in paired sera at 4 weeks post each dose of Hecolin® /Placebo when administered two doses at 0 and 1 months or at 0 and 6 months or three doses at 0, 1 and 6 months in individual age groups in healthy children (12 - 17 years, 6 - 11 years, and 2 - 5 years) or three doses at 0, 1 and 6 months in adults (18 - 45 years).
Measured: 4 weeks post first, second and third dose of Hecolin® /Placebo
SR and GMC of anti-HEV IgG for additional 0-1 dose schedule
SR and GMC of anti-HEV IgG in paired sera at 4 weeks post each dose of Hecolin® /Placebo when administered two doses at 0 and 1 months or at 0 and 6 months or three doses at 0, 1 and 6 months in individual age groups in healthy children (12 - 17 years, 6 - 11 years, and 2 - 5 years) or three doses at 0, 1 and 6 months in adults (18 - 45 years).
Measured: 4 weeks post first, second and third dose of Hecolin® /Placebo
SR and GMC of anti-HEV IgG for additional 0-1 dose schedule
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 24 weeks post two doses of Hecolin® administered at 0-, and 1- month in healthy children (2-17 years).
Measured: 24 weeks post two doses of Hecolin®
SR and GMC of anti-HEV IgG for additional long-term follow up component
SR and GMC (defined as the percentage of participants with anti-HEV IgG antibodies above the detection limit, assessed at 1 year and 2 years post two doses of Hecolin® administered in healthy children (2-17 years) at 0- \& 6-months or at 0- \& 1-month or post 3 doses (0, 1 \& 6 month) in healthy children (2-17 years) and healthy adults (18-45 years)
Measured: 1 and 2 years post two doses of Hecolin®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start4 Apr 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis E Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Tarun Saluja, Principal investigator, International Vaccine InstituteSanet Aspinall, Principal investigator, Ardent Consulting (Pty) LtdElizabeth Hellström, Principal investigator, Be Part ResearchMaphoshane Nchabeleng, Principal investigator, MeCRU Clinical Research UnitEssack Mitha, Principal investigator, Newtown Clinical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306196
- Sponsor's protocol ID
- IVI Hecolin S001
- Status last verified
- Apr 2025
- First submitted
- 18 Feb 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saluja T, Telele N, Hellstrom E, Mitha E, Nchabeleng M, Baiden R, D'Cor NA, Vemula S, Park JY, Yang L, Lee J, Kim DR, Park S, Aspinall S, Pan H, Shih JW, Lynch JA. Hepatitis E virus seroprevalence in South Africa: a multi-site study among HIV-negative and HIV-positive adults and age-stratified children (2-17 Years). BMC Infect Dis. 2026 Jul 7;26(1):1272. doi: 10.1186/s12879-026-13905-3.
PubMed 42414915
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06306196
- Acronym / sponsor ID
- IVI Hecolin S001
- Conditions
- Hepatitis E Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Bill and Melinda Gates Foundation
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The primary objective of the study is to demonstrate immune non-inferiority of 30 µg Hecolin® when given to healthy children (2-17 years) as compared to healthy adults (18-45 years) as measured by seroresponse rates (SR) of anti- HEV IgG ELISA antibody titers, 4 weeks after the 3 doses given at 0, 1- \& 6-months. Co-primary objective is to assess safety in each age cohort and descriptively compare lower age cohorts with higher age cohorts. Other immune parameters would be assessed as secondary objectives. Healthy children and adolescents collectively (2-17 years) will be compared for immune non-inferiority with healthy adults (18-45 years) as measured by geometric mean concentration (GMC) of anti-HEV IgG ELISA antibody titers, 4 weeks after the 3 doses given at 0, 1- \& 6-months. Among children (2-17 years) 3 doses of Hecolin® given at 0, 1 and 6 months will be compared with 2 doses of Hecolin® given at 1 and 6 months in terms of immune non-inferiority of SR and GMC of anti-HEV IgG ELISA antibody titers. The immune response will be compared between HIV positive and HIV negative adults in terms of SR and GMC as measured by anti-HEV IgG ELISA antibody titers at 4 weeks after completing 3 doses of Hecolin® (0, 1 and 6 months).
A total of 860 participants will be enrolled in the main study and will be divided into 4 age strata; 18-45 years (Cohort A), 12-17 years (Cohort B), 6-11 years (Cohort C) and 2-5 years (Cohort D) having 410, 175, 175 and 100 participants respectively. Cohort A will be further divided into Arm A1 and A2 having 232 HIV -ve and 178 HIV +ve participants respectively. All participants in cohort A will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Cohort B will be further divided into Arm B1, B2 and B3 having 70, 70 and 35 participants respectively. Arm B1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm B2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm B3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0, 1 and 6 months. Similarly, Cohort C will be further divided into Arm C1, C2 and C3 having 70, 70 and 35 participants respectively. Arm C1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm C2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm C3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0, 1 and 6 months. Cohort D will be further divided into Arm D1, D2 and D3 having 40, 40 and 20 participants respectively. Arm D1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm D2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm D3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0,1 and 6 months.
In the main study a total of 6 blood samples for immunogenicity will be collected from all participants at Day 0 (baseline), one month after first vaccination, one month after second vaccination, 6 months after first vaccination, one month after third vaccination, and at 6 months after third vaccination.
Blood samples will be collected at screening and one month after third vaccination from the HIV + arm to document CD4 T cells and HIV Viral load.
Out of the 860 participants enrolled in the main study, 2 additional blood samples after reconsent for the 2-year long term follow up period will be collected at V8 (12 months after 3rd dose) and V9 (24 months after 3rd dose) from any 100 HIV negative adults in Cohort A and from participants in Hecolin arms in Cohorts B, C and D (B1, B2, C1, C2, D1, and D2) for immunogenicity assessment. In the additional 0-1-month dose schedule component/arm, a total of 4 blood samples will be collected from all participants at V2 (Day 0), V3 (28 days after 1st dose), V4 (28 days after 2nd dose), V5 (6 months after 2nd dose), and 2 additional samples will be collected from participants in Hecolin arms in Cohorts B, C and D (B4, C4, and D4) at V6 (12months after 2nd dose), and V7 (24 months after 2nd dose) for immunogenicity assessment.
All participants will be observed at the study site for 30 minutes after each Investigational Product (IP) injection for any reactogenicity events. Local and systemic solicited adverse events will be recorded in a diary card during 7 days after each IP dose while unsolicited adverse events will be recorded during the 4 weeks after each IP injection. Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse of special interest (AESI) will be recorded during the entire study period i.e., until 6 months post last dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Group A1 (Three doses of Hecolin®; HIV negative adults aged 18-45 years) | Experimental | Biological: Hecolin® Recombinant Hepatitis E VaccineThree doses of Hecolin® Recombinant Hepatitis E Vaccine administered at 0, 1 and 6 months to HIV negative participants, age 18-45 years old, 232 participants |
| Group A2 (Three doses of Hecolin®; HIV positive adults aged 18-45 years) | Experimental | Biological: Hecolin® Recombinant Hepatitis E VaccineThree doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to HIV positive participants, age 18-45 years old, 178 participants |
| Group B1 (Three doses of Hecolin®; healthy adolescents aged 12-17 years) | Experimental | Biological: Hecolin® Recombinant Hepatitis E VaccineThree doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 12-17 years old, 70 participants |
| Group B2 (Two doses of Hecolin®; healthy adolescents aged 12-17 years) | Experimental | Biological: Hecolin® Recombinant Hepatitis E Vaccine, Biological: Isotonic Sodium Chloride injectionTwo doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months) and one dose of Placebo, administered at 1-month timepoint, to age 12-17 years old, 70 participants |
| Group B3 (Placebo; healthy adolescents aged 12-17 years) | Placebo comparator | Biological: Isotonic Sodium Chloride injectionThree doses of Placebo, administered at 0, 1 and 6 months, to age 12-17 years old, 35 participants |
| Group C1 (Three doses of Hecolin®; healthy children aged 6-11 years) | Experimental | Biological: Hecolin® Recombinant Hepatitis E VaccineThree doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 6-11 years old, 70 participants |
| Group C2 (Two doses of Hecolin®; healthy children aged 6-11 years) | Experimental | Biological: Hecolin® Recombinant Hepatitis E Vaccine, Biological: Isotonic Sodium Chloride injectionTwo doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0 and 6 months and one dose of Placebo, administered at 1-month timepoint, to age 6-11 years old, 70 participants |
| Group C3 (Placebo; healthy children aged 6-11 years) | Placebo comparator | Biological: Isotonic Sodium Chloride injectionThree doses of Placebo, administered at 0, 1 and 6 months, to age 6-11 years old, 35 participants |
| Group D1 (Three doses of Hecolin®; healthy children aged 2-5 years) | Experimental | Biological: Hecolin® Recombinant Hepatitis E VaccineThree doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 2-5 years old, 40 participants |
| Group D2 (Two doses of Hecolin®; healthy children aged 2-5 years) | Experimental | Biological: Hecolin® Recombinant Hepatitis E Vaccine, Biological: Isotonic Sodium Chloride injectionTwo doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0 and 6 months and of Placebo, administered at 1-month timepoint, to age 2-5 years old, 40 participants |
| Group D3 (Placebo; healthy children aged 2-5 years) | Placebo comparator | Biological: Isotonic Sodium Chloride injectionThree doses of Placebo, administered at 0, 1 and 6 months, to age 2-5 years old, 40 participants |
| Group B4 (Two doses of Hecolin®; healthy children aged 12-17 years) | Experimental | Biological: Hecolin® Recombinant Hepatitis E VaccineTwo doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 12-17 years old, 50 participants |
| Group B5 (Placebo; healthy children aged 12-17 years) | Experimental | Biological: Isotonic Sodium Chloride injectionTwo doses of Placebo, administered at 0, and 1 month, to age 12-17 years old, 10 participants |
| Group C4 (Two doses of Hecolin®; healthy children aged 6-11 years) | Experimental | Biological: Hecolin® Recombinant Hepatitis E VaccineTwo doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 6-11 years old, 50 participants |
| Group C5 (Placebo; healthy children aged 6-11 years) | Experimental | Biological: Isotonic Sodium Chloride injectionTwo doses of Placebo, administered at 0, and 1 month, to age 6-11 years old, 10 participants |
| Group D4 (Two doses of Hecolin®; healthy children aged 2-5 years) | Experimental | Biological: Hecolin® Recombinant Hepatitis E VaccineTwo doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 2-5 years old, 50 participants |
| Group D5 (Placebo; healthy children aged 2-5 years) | Experimental | Biological: Isotonic Sodium Chloride injectionTwo doses of Placebo, administered at 0, and 1 month, to age 2-5 years old, 10 participants |
Who may qualify
- Ages
- 2 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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,
Key exclusion criteria (39 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hecolin® Recombinant Hepatitis E Vaccine30㎍/dose, 0.5mL administered intramuscularly | Biological | Group A1 (Three doses of Hecolin®; HIV negative adults aged 18-45 years), Group A2 (Three doses of Hecolin®; HIV positive adults aged 18-45 years), Group B1 (Three doses of Hecolin®; healthy adolescents aged 12-17 years), Group B2 (Two doses of Hecolin®; healthy adolescents aged 12-17 years), Group B4 (Two doses of Hecolin®; healthy children aged 12-17 years), Group C1 (Three doses of Hecolin®; healthy children aged 6-11 years), Group C2 (Two doses of Hecolin®; healthy children aged 6-11 years), Group C4 (Two doses of Hecolin®; healthy children aged 6-11 years), Group D1 (Three doses of Hecolin®; healthy children aged 2-5 years), Group D2 (Two doses of Hecolin®; healthy children aged 2-5 years), Group D4 (Two doses of Hecolin®; healthy children aged 2-5 years) |
| Isotonic Sodium Chloride injection0.5mL administered intramuscularly | Biological | Group B2 (Two doses of Hecolin®; healthy adolescents aged 12-17 years), Group B3 (Placebo; healthy adolescents aged 12-17 years), Group B5 (Placebo; healthy children aged 12-17 years), Group C2 (Two doses of Hecolin®; healthy children aged 6-11 years), Group C3 (Placebo; healthy children aged 6-11 years), Group C5 (Placebo; healthy children aged 6-11 years), Group D2 (Two doses of Hecolin®; healthy children aged 2-5 years), Group D3 (Placebo; healthy children aged 2-5 years), Group D5 (Placebo; healthy children aged 2-5 years) |
Primary outcome
Seroresponse rate
Time frame: 4 weeks post third dose of Hecolin®
Seroresponse rate (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years) as compared to healthy adults (18-45 years)
Proportion of immediate adverse events
Time frame: Within 30 minutes post each dose of vaccination
Proportion of immediate adverse events within 30 minutes post each dose of vaccination in all study participants
Proportion of solicited local and systemic adverse events
Time frame: Within 7 days post each dose
Proportion of solicited local and systemic adverse events within 7 days post each dose of vaccination in all study participants
Proportion of unsolicited adverse events
Time frame: Within 28 days post each dose
Proportion of unsolicited adverse events within 28 days post each dose of vaccination in all study participants
Proportion of SAEs, MAAEs and AESIs
Time frame: Post dose 1 until 6 months post last dose
Proportion of Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse events of special interest (AESIs) post dose 1 until 6 months post last dose of vaccination
18 secondary outcomes
GMC of anti-HEV IgG
Time frame: 4 weeks post third dose
SR
Time frame: 4 weeks post two doses of Hecolin®
GMC of anti-HEV IgG
Time frame: 4 weeks post two doses of Hecolin®
SR and GMC of anti-HEV IgG
Time frame: 4 weeks post third dose of Hecolin®
SR
Time frame: 24 weeks post two doses of Hecolin®
GMC of anti-HEV IgG
Time frame: 24 weeks post two doses of Hecolin®
SR
Time frame: 4 weeks post third dose of Hecolin®
GMC of anti-HEV IgG
Time frame: 4 weeks post third dose of Hecolin®
SR
Time frame: 4 weeks post third dose of Hecolin®
GMC of anti-HEV IgG
Time frame: 4 weeks post third dose of Hecolin®
SR
Time frame: 4 weeks post first, second and third dose of Hecolin® /Placebo
GMC of anti-HEV IgG
Time frame: 4 weeks post first, second and third dose of Hecolin® /Placebo
SR and GMC of anti-HEV IgG
Time frame: 4 weeks post first, second and third dose of Hecolin® /Placebo
GMC of anti-HEV IgG for additional 0-1 dose schedule
Time frame: 4 weeks post first, second of Hecolin
GMC of anti-HEV IgG for additional 0-1 dose schedule
Time frame: 4 weeks post first, second and third dose of Hecolin® /Placebo
SR and GMC of anti-HEV IgG for additional 0-1 dose schedule
Time frame: 4 weeks post first, second and third dose of Hecolin® /Placebo
SR and GMC of anti-HEV IgG for additional 0-1 dose schedule
Time frame: 24 weeks post two doses of Hecolin®
SR and GMC of anti-HEV IgG for additional long-term follow up component
Time frame: 1 and 2 years post two doses of Hecolin®
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 42414915Saluja T, Telele N, Hellstrom E, Mitha E, Nchabeleng M, Baiden R, D'Cor NA, Vemula S, Park JY, Yang L, Lee J, Kim DR, Park S, Aspinall S, Pan H, Shih JW, Lynch JA. Hepatitis E virus seroprevalence in South Africa: a multi-site study among HIV-negative and HIV-positive adults and age-stratified children (2-17 Years). BMC Infect Dis. 2026 Jul 7;26(1):1272. doi: 10.1186/s12879-026-13905-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tarun Saluja principal investigator
International Vaccine Institute
Sanet Aspinall principal investigator
Ardent Consulting (Pty) Ltd
Elizabeth Hellström principal investigator
Be Part Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hecolin® Recombinant Hepatitis E Vaccine and Isotonic Sodium Chloride injection in people with Hepatitis E Virus Infection, run by International Vaccine Institute at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarun Saluja (+82-10-9736-2810, tarun.saluja@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroresponse rate (time frame: 4 weeks post third dose of Hecolin®). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06306196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.