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Tests treatment safety and results for Hepatitis E Infection
Official title Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women
ClinicalTrials.gov ID: NCT05808166
What this study is testing
What is Hecolin® (Recombinant Hepatitis E Vaccine (Escherichia coli)).?
Hecolin® (Recombinant Hepatitis E Vaccine (Escherichia coli)). is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hepatitis e infection.
Also referred to as 26 kDa protein (239 amino acids, aa368 to aa606) encoded by ORF2 of the HEV1 (Chinese HEV strain, genotype 1) and is expressed in Escherichia coli as a non-fusion protein..
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- In order to be eligible to participate in this study, a pregnant/non-pregnant woman must meet all of the following criteria: Pregnant women only:
- 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...
- 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...
You likely can't join if
- A pregnant/non-pregnant woman who meets any of the following criteria will be excluded from participation in this study:
- 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...
- Major congenital abnormalities which in the opinion of investigator may affect the participant's participation in the study.
- Known history of immune function disorders including immunodeficiency diseases (known HIV infection or other immune function disorders) and lupus.
See the full eligibility criteria
- In order to be eligible to participate in this study, a pregnant/non-pregnant woman must meet all of the following criteria: Pregnant women only:
- 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...
- 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...
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Non-pregnant women only:
- Healthy women 16-45 years of age.
- Individual willing to provide written informed consent to participate in the study.
- Individual who can be followed up during the study period and can comply with the study requirements.
- Individual in good health as determined by the outcome of medical history, physical examination, vital signs, laboratory evaluations at screening and the clinical judgment of the investigator.
- Individuals who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Females of childbearing potential with negative urinary pregnancy test on the day of screening.
- Females of childbearing potential who are using an effective birth control method2 for at least 4 weeks before the screening and up to 4 weeks after the last vaccination.
- A pregnant/non-pregnant woman who meets any of the following criteria will be excluded from participation in this study:
- 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...
- Major congenital abnormalities which in the opinion of investigator may affect the participant's participation in the study.
- Known history of immune function disorders including immunodeficiency diseases (known HIV infection or other immune function disorders) and lupus.
- Chronic use of systemic steroids (\>2 mg/kg/day or \>20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs within past 6 weeks.
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives.
- Behavioral or cognitive impairment, or chronic substance abuse, or psychiatric disease or neural disorders, that, in the opinion of the investigator, could interfere with the participant's ability to participate in the...
- History of splenectomy.
- Past history of thrombocytopenia and/or thrombosis, myocarditis or pericarditis or any other significant cardiac condition.
- With a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections/blood extractions. (Those who receive low dose aspirin (less than...
- Receipt of blood or blood-derived products in the past 3 months.
- Receipt of other vaccines from 4 weeks prior to test vaccination or planned to receive any vaccine within 4 weeks of last dose of study vaccine
- As per Investigator's medical judgement, an individual could be excluded from the study in spite of meeting all inclusion/exclusion criteria mentioned above.
- Concomitantly enrolled or scheduled to be enrolled in another trial.
- Research staff involved with the clinical study or family/household members of research staff.
- Body mass index (BMI) of ≥ 40, at the time of the screening visit. Pregnant women only: 1\. Plans to terminate her pregnancy. Pregnancy complications (in the current pregnancy) such as preterm labor, gestational...
The study team makes the final eligibility decision.
Where it's taking place
- Karachi, Sindh, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 16 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Karachi, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.