Actively Recruiting
Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women
Led by International Vaccine Institute · Updated on 2024-09-27
2358
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
I
International Vaccine Institute
Lead Sponsor
O
Open Philanthropy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 16-45 years between 14 0/7 and 34 6/7 weeks gestation with uncomplicated, singleton pregnancies and no known increased risk for complications.
- Non-pregnant women aged 16-45 years in good health with negative pregnancy test if of childbearing potential.
- Willingness to provide written informed consent for self and infant participation.
- Ability to comply with study visits, treatment plan, laboratory tests, and other procedures.
- Good health confirmed by medical history, physical exam, vital signs, prenatal assessments, and laboratory evaluations.
- Females of childbearing potential using effective birth control for at least 4 weeks before screening and until 4 weeks after last vaccination (non-pregnant women only).
You will not qualify if you...
- Previous receipt of any hepatitis E vaccine.
- Fever (axillary temperature ≥ 38.5°C) or acute illness within 3 days before vaccination.
- Known allergy to vaccine components or any medical history increasing risk of adverse events.
- Major congenital abnormalities affecting participation.
- Known immune disorders including HIV or lupus.
- Recent use of systemic steroids, cytotoxic or immunosuppressive drugs within past 6 weeks.
- Any chronic disease or abnormality considered unsafe or interfering with study objectives.
- Behavioral, cognitive, psychiatric, or substance abuse conditions interfering with participation.
- History of splenectomy, thrombocytopenia, thrombosis, myocarditis, pericarditis, or significant cardiac conditions.
- Known bleeding disorders contraindicating injections or blood draws (except low dose aspirin use).
- Blood or blood product transfusion within past 3 months.
- Receipt or planned receipt of other vaccines within 4 weeks before or after study vaccination.
- Participation in another clinical trial or being research staff/family of research staff.
- Body mass index (BMI) ≥ 40 at screening.
- Pregnancy complications, plans to terminate pregnancy, prior stillbirth or neonatal death, multiple spontaneous abortions, prior preterm delivery ≤ 34 weeks, prior infant with genetic or major congenital disorders, major gynecologic or abdominal surgery (except Caesarean section), pregnancy from IVF, pregnancy from rape or incest, plans to release neonate for adoption or ward of state, or more than 5 prior deliveries (pregnant women only).
- Pregnancy or plans to become pregnant during study (non-pregnant women only).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Aga Khan University
Karachi, Sindh, Pakistan, 74800
Actively Recruiting
Research Team
K
Katerina Rok Song, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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