Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women

PHASE2RecruitingINTERVENTIONAL
Enrollment

2,358

Participants

Timeline

Start Date

May 2, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

April 30, 2026

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)

Trial Locations (1)

74800

RECRUITING

The Aga Khan University, Karachi

All Listed Sponsors
collaborator

Open Philanthropy

OTHER

collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Thrasher Research Fund

OTHER

lead

International Vaccine Institute

OTHER