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

NCT00287469 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: WRAIR 749HSRRB A-9117.1GSK 304558/003 (HEV-003)IND 7815
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis

Keywords

Hepatitis E; clinical hepatitis; vaccine; efficacy; Nepal

Outcome Measures

Primary Outcomes (1)

• Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period

  Percent of participants of definite hepatitis E by category and immunological markers (anti HEV) during the follow-up period. * Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting * Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105) * Percent of Participants = n x 100 / N

  14 days after dose 3 at 6 months

Secondary Outcomes (2)

• Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period

  14 days after dose 2 until 14 days after dose 3

• Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases

  before dose 1 thru 14 days after dose 3

Study Arms (2)

20mcg Recombinant HEV

EXPERIMENTAL

20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule

Biological: Hepatitis E vaccine, recombinant (Sar 56 kDa)

Placebo

PLACEBO COMPARATOR

PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.

Other: Placebo

Interventions

Hepatitis E vaccine, recombinant (Sar 56 kDa) BIOLOGICAL

20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)

20mcg Recombinant HEV

Placebo OTHER

PBS buffer placebo containing alum

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• GlaxoSmithKline: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Shree Birendra Hospital

Kathmandu, Nepal

Location

Related Publications (6)

• Worm HC, Schlauder GG, Brandstatter G. Hepatitis E and its emergence in non-endemic areas. Wien Klin Wochenschr. 2002 Aug 30;114(15-16):663-70.

  PMID: 12602109 BACKGROUND

• Worm HC, van der Poel WH, Brandstatter G. Hepatitis E: an overview. Microbes Infect. 2002 May;4(6):657-66. doi: 10.1016/s1286-4579(02)01584-8.

  PMID: 12048035 BACKGROUND

• Emerson SU, Purcell RH. Running like water--the omnipresence of hepatitis E. N Engl J Med. 2004 Dec 2;351(23):2367-8. doi: 10.1056/NEJMp048285. No abstract available.

  PMID: 15575050 BACKGROUND

• Purcell RH. Hepatitis viruses: changing patterns of human disease. Proc Natl Acad Sci U S A. 1994 Mar 29;91(7):2401-6. doi: 10.1073/pnas.91.7.2401.

  PMID: 8146130 BACKGROUND

• Worm HC, Wirnsberger G. Hepatitis E vaccines: progress and prospects. Drugs. 2004;64(14):1517-31. doi: 10.2165/00003495-200464140-00002.

  PMID: 15233590 BACKGROUND

• Shrestha MP, Scott RM, Joshi DM, Mammen MP Jr, Thapa GB, Thapa N, Myint KS, Fourneau M, Kuschner RA, Shrestha SK, David MP, Seriwatana J, Vaughn DW, Safary A, Endy TP, Innis BL. Safety and efficacy of a recombinant hepatitis E vaccine. N Engl J Med. 2007 Mar 1;356(9):895-903. doi: 10.1056/NEJMoa061847.

  PMID: 17329696 DERIVED

MeSH Terms

Conditions

Hepatitis; Hepatitis E

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections

Results Point of Contact

• Title: Mrigendra P. Shrestha MD
• Organization: Armed Forces Research Institute of Medical Services

shrestham@afrims.org

662-644-4888

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 6, 2006
• Study Start: July 9, 2001
• Primary Completion: January 19, 2004
• Study Completion: January 1, 2005
• Last Updated: May 29, 2019
• Results First Posted: May 29, 2019

Record last verified: 2019-05

Locations

NE (1)