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

Status: Recruiting

Location: See all (3) locations...

Intervention Type: Biological

Study Type: Interventional

Study Phase: Phase 2

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

Eligibility

Participation Requirements

Sex: All

Minimum Age: 2

Maximum Age: 45

Healthy Volunteers: t

View:

• 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.

• 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.

Locations

Other Locations

South Africa

MeCRU Clinical Research Unit

RECRUITING

Ga-rankuwa

Newtown Clinical Research Centre

RECRUITING

Johannesburg

Be Part Research

RECRUITING

Paarl

Contact Information

Primary

Tarun Saluja

tarun.saluja@ivi.int

+82-10-9736-2810

Backup

Sanet Aspinall

sanet.aspinall@ardent.consulting

+27 21 569 0611

Time Frame

Start Date: 2024-04-04

Estimated Completion Date: 2026-01

Participants

Target number of participants: 1040

Treatments

Experimental: Group A1 (Three doses of Hecolin®; HIV negative adults aged 18-45 years)

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

Experimental: Group A2 (Three doses of Hecolin®; HIV positive adults aged 18-45 years)

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

Experimental: Group B1 (Three doses of Hecolin®; healthy adolescents aged 12-17 years)

Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 12-17 years old, 70 participants

Experimental: Group B2 (Two doses of Hecolin®; healthy adolescents aged 12-17 years)

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

Placebo_comparator: Group B3 (Placebo; healthy adolescents aged 12-17 years)

Three doses of Placebo, administered at 0, 1 and 6 months, to age 12-17 years old, 35 participants

Experimental: Group C1 (Three doses of Hecolin®; healthy children aged 6-11 years)

Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 6-11 years old, 70 participants

Experimental: Group C2 (Two doses of Hecolin®; healthy children aged 6-11 years)

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

Placebo_comparator: Group C3 (Placebo; healthy children aged 6-11 years)

Three doses of Placebo, administered at 0, 1 and 6 months, to age 6-11 years old, 35 participants

Experimental: Group D1 (Three doses of Hecolin®; healthy children aged 2-5 years)

Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 2-5 years old, 40 participants

Experimental: Group D2 (Two doses of Hecolin®; healthy children aged 2-5 years)

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

Placebo_comparator: Group D3 (Placebo; healthy children aged 2-5 years)

Three doses of Placebo, administered at 0, 1 and 6 months, to age 2-5 years old, 40 participants

Experimental: Group B4 (Two doses of Hecolin®; healthy children aged 12-17 years)

Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 12-17 years old, 50 participants

Experimental: Group B5 (Placebo; healthy children aged 12-17 years)

Two doses of Placebo, administered at 0, and 1 month, to age 12-17 years old, 10 participants

Experimental: Group C4 (Two doses of Hecolin®; healthy children aged 6-11 years)

Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 6-11 years old, 50 participants

Experimental: Group C5 (Placebo; healthy children aged 6-11 years)

Two doses of Placebo, administered at 0, and 1 month, to age 6-11 years old, 10 participants

Experimental: Group D4 (Two doses of Hecolin®; healthy children aged 2-5 years)

Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 2-5 years old, 50 participants

Experimental: Group D5 (Placebo; healthy children aged 2-5 years)

Two doses of Placebo, administered at 0, and 1 month, to age 2-5 years old, 10 participants

Related Therapeutic Areas

HIV/AIDS

Hepatitis

Hepatitis E

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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

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