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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Hecolin® (Recombinant Hepatitis E Vaccine (Escherichia coli)).
Biological/Vaccine
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).
Isotonic Sodium Chloride injection
Other intervention
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)

Treatment groups

2,358 Participants

are divided into 3 treatment groups

Group A: Pregnant participant receiving Hecolin®Experimental treatment 1 intervention

Group B: Pregnant participants receiving placeboPlacebo comparator 1 intervention

Group C: Non-Pregnant participants receiving Hecolin®Active comparator 1 intervention

Trial outcomes

Primary outcomes

Proportion of pregnancy-related AESI and SAE from vaccination in pregnant participant.

* Proportion of pregnancy-related AESI from the vaccination throughout the entire study in pregnant participants. * Proportion of SAE from the vaccination throughout the entire study in pregnant participants.

Time frame

Throughout the study period, approximately 24 months.

Immunogenicity in pregnant and non-pregnant participants

GMC of anti-HEV IgG at 4 weeks post second dose of Hecolin® administered 4 weeks apart in pregnant women and non-pregnant women.

Time frame

4 weeks post second dose of Hecolin®

Secondary outcomes

Proportion of AESIs and SAE in neonate/infant participants.

* Proportion of neonatal/infant AESIs. * Proportion of SAE through the 6 months of life in neonate/infant.

Time frame

6 months of life in neonate/infant

Proportion of immediate adverse events in pregnant and non-pregnant participants

Proportion of immediate adverse events within 30 minutes post each dose of vaccination in pregnant and non-pregnant participants.

Time frame

Within 30 minutes post each dose of vaccination.

Proportion of Solicited local and system adverse events in pregnant and non-pregnant participants

Proportion of solicited local and systemic adverse events within 7 days post each dose of vaccination in pregnant and non-pregnant participants.

Time frame

Within 7 days post each dose of vaccination.

Proportion of unsolicited adverse events in pregnant and non-pregnant participants

Proportion of unsolicited adverse events within 28 days post each dose of vaccination in pregnant and non-pregnant participants.

Time frame

Within 28 days post each dose of vaccination.

Other outcomes

Proportion of vaginal delivery, elective cesarian section and emergency cesarian section in pregnant participants.

Time frame

throughout the study

Immunogenicity in neonate/infant participants

* GMC of anti-HEV IgG in neonates/infants at delivery and age of 6 weeks and 6 months. * Anti-HEV IgG Subclass

Time frame

at delivery, infant age of 6 weeks and 6 months

Immunogenicity in maternal blood and umbilical cord at delivery

* GMC of anti-HEV IgG in maternal blood and umbilical cord at the time of delivery * Anti-HEV IgG Subclass

Time frame

at time of delivery

Immunogenicity in breastmilk

* GMC of anti-HEV IgG in breastmilk at delivery and postpartum 6 weeks and 6 months. * Anti-HEV IgG Subclass

Time frame

at delivery, 6 weeks and 6 months post partum

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International Vaccine Institute

Lead sponsor

Open Philanthropy

Collaborator

Bill and Melinda Gates Foundation

Collaborator

Thrasher Research Fund

Collaborator

Source ClinicalTrials.gov

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