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Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women

NCT05808166 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2358

Last updated 2024-09-27

No results posted yet for this study

Summary

This is a phase II randomized, observer-blinded, placebo-controlled study with 3 arms enrolling a total of 2,358 participants. The arms are composed of Arm 1, pregnant participants receiving Hecolin® (N=1,104) with immunogenicity subset (n=150), Arm 2, pregnant participants receiving placebo (N=1,104) with immunogenicity subset (n=150), and Arm 3, non-pregnant participants receiving Hecolin® (N=150) of which all participants in this arm will be included in the immunogenicity subset.

Conditions

  • Hepatitis E Infection

Interventions

BIOLOGICAL

Hecolin® (Recombinant Hepatitis E Vaccine (Escherichia coli)).

Hecolin® will be administered 2 doses administered 4 weeks apart during pregnancy and 1 dose administered after delivery at least 20 weeks following the second dose for the pregnant participants (arm 1), and 0, 1 and 6 months for the non-pregnant participant (arm 3).

OTHER

Isotonic Sodium Chloride injection

Placebo will be administered 2 doses administered 4 weeks apart during pregnancy and 1 dose administered after delivery at least 20 weeks following the second dose for the pregnant participants (arm 2)

Sponsors & Collaborators

  • Open Philanthropy

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Thrasher Research Fund

    collaborator OTHER

  • International Vaccine Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-02
Primary Completion
2025-11-30
Completion
2026-04-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05808166 on ClinicalTrials.gov