Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women
ConditionHepatitis E Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age16-45
SponsorInternational Vaccine Institute
About this trial
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 criteria
Qualifiers
Healthy women 16-45 years of age who are between 14 0/7 and 34 6/7 weeks gestation1 on the day of planned vaccination with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications for herself and her infant.
Individual willing to provide written informed consent for herself and her infant to participate in the study.
Individual who can be followed up during the study period and can comply with the study requirements.
Individual and fetus in good health as determined by the outcome of medical history, physical examination, obstetric history, prenatal care (by ultrasound and other prenatal assessment subject to gestational age), vital signs, laboratory evaluations at screening and the clinical judgment of the investigator.
Disqualifiers
Has received any hepatitis E vaccine in the past.
Febrile illness (axillary temperature ≥ 38.5°C) or acute illness within 3 days prior to the study vaccination.
Known history or allergy to study vaccine components and/or excipients or other medications, or any other allergies or medical history deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial (e.g., Guillain-Barre Syndrome).
Major congenital abnormalities which in the opinion of investigator may affect the participant's participation in the study.
Trial design
Treatments tested in this trial
- Hecolin® (Recombinant Hepatitis E Vaccine (Escherichia coli)).
- Isotonic Sodium Chloride injection
Treatment groups
2,358 Participants
are divided into 3 treatment groupsSponsors and collaborators
International Vaccine Institute
Lead sponsor
Open Philanthropy
Collaborator
Bill and Melinda Gates Foundation
Collaborator
Thrasher Research Fund
Collaborator
Source ClinicalTrials.gov