Project Details

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

Brittany Kmush, PhD

Summary

BACKGROUND: Hepatitis E virus (HEV) is the leading cause of acute viral hepatitis in the world, with a disproportionately high burden of disease and death among pregnant women and their unborn children in developing regions. There is a safe and effective vaccine licensed in China and Pakistan to prevent HEV, but it has not yet prequalified by WHO nor has it been tested during pregnancy. GAP: This study aims to evaluate the safety and immunogenicity of the HEV vaccine, Hecolin®, for pregnant mothers and their infants. HYPOTHESIS: We hypothesize that Hecolin® will be safe and immunogenic in both the mothers and their infants. METHODS: This is a phase II randomized, observer-blinded, placebo-controlled study with 3 arms enrolling a total of 2,358 participants from Pakistan. 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. RESULTS: Pending. IMPACT: The results of this trial will help pave the way for pre-qualification and policy recommendations for use of this very promising and effective vaccine by WHO and its subsequent availability to prevent the unacceptable high maternal and infant mortality from HEV in Asia and Africa. Optional/Additional Comments: This trial is being jointly funded by the Thrasher Research Fund, the Bill and Melinda Gates Foundation, and Open Philanthropy. The Thrasher Research Fund is providing support for infant follow-up and HEV antibody testing in the infants and breast milk.