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Safety and efficacy of a recombinant hepatitis E vaccine.
N Engl J Med 2007; 356(9):895-903NEJM

Abstract

BACKGROUND

Hepatitis E virus (HEV) is an important cause of viral hepatitis. We evaluated the safety and efficacy of an HEV recombinant protein (rHEV) vaccine in a phase 2, randomized, double-blind, placebo-controlled trial.

METHODS

In Nepal, we studied 2000 healthy adults susceptible to HEV infection who were randomly assigned to receive three doses of either the rHEV vaccine or placebo at months 0, 1, and 6. Active (including hospital) surveillance was used to identify acute hepatitis and adverse events. The primary end point was the development of hepatitis E after three vaccine doses.

RESULTS

A total of 1794 subjects (898 in the vaccine group and 896 in the placebo group) received three vaccine doses; the total vaccinated cohort was followed for a median of 804 days. After three vaccine doses, hepatitis E developed in 69 subjects, of whom 66 were in the placebo group. The vaccine efficacy was 95.5% (95% confidence interval [CI], 85.6 to 98.6). In an intention-to-treat analysis that included all 87 subjects in whom hepatitis E developed after the first vaccine dose, 9 subjects were in the vaccine group, with a vaccine efficacy of 88.5% (95% CI, 77.1 to 94.2). Among subjects in a subgroup randomly selected for analysis of injection-site findings and general symptoms (reactogenicity subgroup) during the 8-day period after the administration of any dose, the proportion of subjects with adverse events was similar in the two study groups, except that injection-site pain was increased in the vaccine group (P=0.03).

CONCLUSIONS

In a high-risk population, the rHEV vaccine was effective in the prevention of hepatitis E. (ClinicalTrials.gov number, NCT00287469 [ClinicalTrials.gov].).

Authors+Show Affiliations

Walter Reed-Armed Forces Research Institute of Medical Sciences Research Unit Nepal, Kathmandu, Nepal.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

17329696

Citation

Shrestha, Mrigendra Prasad, et al. "Safety and Efficacy of a Recombinant Hepatitis E Vaccine." The New England Journal of Medicine, vol. 356, no. 9, 2007, pp. 895-903.
Shrestha MP, Scott RM, Joshi DM, et al. Safety and efficacy of a recombinant hepatitis E vaccine. N Engl J Med. 2007;356(9):895-903.
Shrestha, M. P., Scott, R. M., Joshi, D. M., Mammen, M. P., Thapa, G. B., Thapa, N., ... Innis, B. L. (2007). Safety and efficacy of a recombinant hepatitis E vaccine. The New England Journal of Medicine, 356(9), pp. 895-903.
Shrestha MP, et al. Safety and Efficacy of a Recombinant Hepatitis E Vaccine. N Engl J Med. 2007 Mar 1;356(9):895-903. PubMed PMID: 17329696.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of a recombinant hepatitis E vaccine. AU - Shrestha,Mrigendra Prasad, AU - Scott,Robert McNair, AU - Joshi,Durga Man, AU - Mammen,Mammen P,Jr AU - Thapa,Gyan Bahadur, AU - Thapa,Narbada, AU - Myint,Khin Saw Aye, AU - Fourneau,Marc, AU - Kuschner,Robert A, AU - Shrestha,Sanjaya Kumar, AU - David,Marie Pierre, AU - Seriwatana,Jitvimol, AU - Vaughn,David W, AU - Safary,Assad, AU - Endy,Timothy P, AU - Innis,Bruce L, PY - 2007/3/3/pubmed PY - 2007/3/7/medline PY - 2007/3/3/entrez SP - 895 EP - 903 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 356 IS - 9 N2 - BACKGROUND: Hepatitis E virus (HEV) is an important cause of viral hepatitis. We evaluated the safety and efficacy of an HEV recombinant protein (rHEV) vaccine in a phase 2, randomized, double-blind, placebo-controlled trial. METHODS: In Nepal, we studied 2000 healthy adults susceptible to HEV infection who were randomly assigned to receive three doses of either the rHEV vaccine or placebo at months 0, 1, and 6. Active (including hospital) surveillance was used to identify acute hepatitis and adverse events. The primary end point was the development of hepatitis E after three vaccine doses. RESULTS: A total of 1794 subjects (898 in the vaccine group and 896 in the placebo group) received three vaccine doses; the total vaccinated cohort was followed for a median of 804 days. After three vaccine doses, hepatitis E developed in 69 subjects, of whom 66 were in the placebo group. The vaccine efficacy was 95.5% (95% confidence interval [CI], 85.6 to 98.6). In an intention-to-treat analysis that included all 87 subjects in whom hepatitis E developed after the first vaccine dose, 9 subjects were in the vaccine group, with a vaccine efficacy of 88.5% (95% CI, 77.1 to 94.2). Among subjects in a subgroup randomly selected for analysis of injection-site findings and general symptoms (reactogenicity subgroup) during the 8-day period after the administration of any dose, the proportion of subjects with adverse events was similar in the two study groups, except that injection-site pain was increased in the vaccine group (P=0.03). CONCLUSIONS: In a high-risk population, the rHEV vaccine was effective in the prevention of hepatitis E. (ClinicalTrials.gov number, NCT00287469 [ClinicalTrials.gov].). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/17329696/Safety_and_efficacy_of_a_recombinant_hepatitis_E_vaccine_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa061847?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -