RecruitingPhase 2NCT05808166

Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women

A Phase II, Randomized, Observer-blinded, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women Between Gestational Age 14-34 Weeks and Non-Pregnant Women of 16-45 Years Old.

Sponsor

International Vaccine Institute

Enrollment

2,358 participants

Start Date

May 2, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatitis E Infection

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.

Eligibility

Sex: FEMALEMin Age: 16 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Hecolin® (Recombinant Hepatitis E Vaccine (Escherichia coli)). and Isotonic Sodium Chloride injection for people with hepatitis e infection. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 16 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHecolin® (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).

OTHERIsotonic 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)

Locations(1)

The Aga Khan University

Karachi, Sindh, Pakistan

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NCT05808166