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A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00287469
First received: February 2, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hepatitis
Biological: Hepatitis E vaccine, recombinant (Sar 56 kDa)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase II, Prospective, Randomized, Double-Blind, Placebo Controlled, Field Efficacy Trial of a Candidate Hepatitis E Vaccine in Nepal.

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:
  • definite hepatitis E disease with onset at least two weeks after vaccine/placebo dose 3.

Secondary Outcome Measures:
  • definite and probable hepatitis E disease with onset at least two weeks post vaccine/placebo dose 3
  • definite hepatitis E disease with onset at least two weeks post vaccine/placebo dose and before two weeks after vaccine/placebo dose 3.
  • hepatitis E disease severity.
  • vaccine safety
  • level of total immunoglobulin to HEV capsid

Estimated Enrollment: 2000
Study Start Date: February 2000
Estimated Study Completion Date: January 2004
Detailed Description:

This is a prospective, randomized, double-blind, placebo-controlled with 2 study groups (vaccine and placebo). Three doses of the study vaccine are given according to a 0, 1, 6 month schedule. Vaccine efficacy will be assessed by maintaining active surveillance for clinical hepatitis every 2 weeks and hospital based surveillance for the full duration of the trial. Total planned study population is 2000 eligible subjects (1000 in the vaccine group and 1000 in the placebo group). Total vaccinated cohort for the analysis of reactogenicity is 200 (100 in the vaccine group and 100 in the placebo group).

Volunteers who enroll will be followed for evidence of symptomatic liver disease for approximately 2 years, and those who become ill will be admitted to hospital for care.

To evaluate safety, a randomly designated subset will be monitored for 7 days after each vaccination to solicit specific symptoms at the injection site and generally. Additionally, all adverse events will be collected for 30 days after each vaccine dose and all serious adverse events will be collected throughout the trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287469

Locations
Nepal
Shree Birendra Hospital
Kathmandu, Nepal
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
GlaxoSmithKline
Investigators
Principal Investigator: Mrigendra P Shrestha, MD Armed Forces Research Institute of Medical Sciences, Thailand
Principal Investigator: Robert M Scott, MD Walter Reed Army Institute of Research (WRAIR)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00287469     History of Changes
Other Study ID Numbers: WRAIR 749, HSRRB A-9117.1, GSK 304558/003 (HEV-003)
Study First Received: February 2, 2006
Last Updated: February 2, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):
Hepatitis E
clinical hepatitis
vaccine
efficacy
Nepal

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis E
Digestive System Diseases
Enterovirus Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014