A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.
Condition: Hepatitis
MeSH terms: Hepatitis A; Hepatitis E; Hepatitis
Intervention: Hepatitis E vaccine, recombinant (Sar 56 kDa); Placebo
Intervention description: 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose); PBS buffer placebo containing alum
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2000.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis E; clinical hepatitis; vaccine; efficacy; Nepal

Summary:

      The purpose of this study is to determine if a hepatitis E vaccine is safe and able to
      prevent symptomatic liver disease due to the hepatitis E virus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female 18 years of age or older at the time of the first vaccination.

          -  Written or oral witnessed (if the subject was illiterate) informed consent obtained
             from the subject

          -  Free of obvious health problems as established by medical history before entering into
             the study

          -  If the subject was female, she must have a negative serum pregnancy test within 48
             hours prior to each vaccination and must agree to avoid becoming pregnant during the
             course of vaccination and until 30 days after the last dose of vaccine.

        Exclusion Criteria:

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Administration of chronic (defined as more than 14 days) immunosuppressants or other
             immune modifying drugs within six months of vaccination. For corticosteroids, this
             will mean prednisone, or equivalent, * 0.5 mg/kg/day. Inhaled and topical steroids are
             allowed.

          -  Any chronic drug therapy to be continued during the study period with the exception of
             contraceptive agents, homeopathic remedies, vitamins, minerals and any other dietary
             supplements or other drug therapy at the discretion of the investigator.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days of the first dose of study vaccine, excluding tetanus toxoid or rabies
             vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection, as reported by the volunteer (testing
             for HIV will not be performed).

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrollment. Acute disease was defined as the presence of
             a moderate or severe illness with or without fever. All vaccines could be administered
             to persons with a minor illness such as diarrhea, mild upper respiratory infection
             with or without low-grade febrile illness, i.e., oral temperature < 38.0°C (100.4°F).

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by history.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Pregnant female.

          -  History of chronic alcohol consumption (defined as the consumption of the equivalent
             of 4 or more 12 ounce beers 4 or more times a week) and/or intravenous drug abuse.

          -  Antibodies to rHEV (* 20 WR U/mL).