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

NCT06306196 | Recruiting Phase 2 DMC

• 1 other identifier: IVI Hecolin S001
• Study Type: interventional
• Target: 1,040
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Hepatitis E Virus Infection

Outcome Measures

Primary Outcomes (5)

• 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)

  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

  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

  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

  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

  Post dose 1 until 6 months post last dose

Secondary Outcomes (18)

• GMC of anti-HEV IgG

  4 weeks post third dose

• SR

  4 weeks post two doses of Hecolin®

• GMC of anti-HEV IgG

  4 weeks post two doses of Hecolin®

• SR and GMC of anti-HEV IgG

  4 weeks post third dose of Hecolin®

• SR

  24 weeks post two doses of Hecolin®

Other Outcomes (3)

• SR and GMC of anti-HEV IgG

  4 weeks post first, second and third dose of Hecolin® /Placebo

• Safety in all participants as per gender distribution and serostatus

  1. Within 30 minutes post each dose of vaccination. 2. Within 7 days post each dose of vaccination. 3. Within 28 days post each dose of vaccination. 4.Until 6 months post last dose of vaccination.

• Safety profile intra and inter age strata

  1. Within 30 minutes post each dose of vaccination. 2. Within 7 days post each dose of vaccination. 3. Within 28 days post each dose of vaccination. 4.Until 6 months post last dose of vaccination

Study Arms (17)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Biological: Isotonic Sodium Chloride injection

Interventions

Hecolin® Recombinant Hepatitis E Vaccine BIOLOGICAL

30㎍/dose, 0.5mL administered intramuscularly

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 injection BIOLOGICAL

0.5mL administered intramuscularly

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)

Eligibility Criteria

• Age: 2 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

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,

Sponsors & Collaborators

• International Vaccine Institute: lead
• Xiamen Innovax Biotech Co., Ltd: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (3)

MeCRU Clinical Research Unit

Ga-Rankuwa, South Africa

RECRUITING

Newtown Clinical Research Centre

Johannesburg, South Africa

RECRUITING

Be Part Research

Paarl, South Africa

RECRUITING

MeSH Terms

Conditions

Hepatitis E

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tarun Saluja

  International Vaccine Institute

  PRINCIPAL INVESTIGATOR

• Sanet Aspinall

  Ardent Consulting (Pty) Ltd

  PRINCIPAL INVESTIGATOR

• Elizabeth Hellström

  Be Part Research

  PRINCIPAL INVESTIGATOR

• Maphoshane Nchabeleng

  MeCRU Clinical Research Unit

  PRINCIPAL INVESTIGATOR

• Essack Mitha

  Newtown Clinical Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarun Saluja

CONTACT

+82-10-9736-2810; tarun.saluja@ivi.int

Sanet Aspinall

CONTACT

+27 21 569 0611; sanet.aspinall@ardent.consulting

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Adult participants will receive open-label IP and the PI, study staff and participants will not be blinded to Hecolin® administration. For children cohorts, the PI, study staff, and child participants will be blinded as to receipt of the study vaccine or placebo. The unblinded pharmacist preparing the IP as well as the unblinded vaccinator will not be involved in the safety assessment of participants and will be instructed not to comment on the experimental agent to study staff.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 12, 2024
• Study Start: April 4, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (3)