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| | Journal Club Take part in the discussion of an article published in the various Medical Journal, Journal club info and more... | Safety and Efficacy of a Recombinant Hepatitis E Vaccine
Published by Mati
02-03-2007
| | Safety and Efficacy of a Recombinant Hepatitis E Vaccine
Hello all,
This is a very good paper in New England Journal of Medicine by Nepalese and Americans about Hepatitis E vaccine: a trial done in Nepal.
by the authors: Mrigendra Prasad Shrestha, M.B., B.S., Robert McNair Scott, M.D., Durga Man Joshi, M.D., Mammen P. Mammen, Jr., M.D., Gyan Bahadur Thapa, M.B., B.S., Narbada Thapa, Ph.D., Khin Saw Aye Myint, M.B., B.S., Marc Fourneau, B.S., Robert A. Kuschner, M.D., Sanjaya Kumar Shrestha, M.D., Marie Pierre David, M.S., Jitvimol Seriwatana, M.S., David W. Vaughn, M.D., Assad Safary, M.D., Timothy P. Endy, M.D., and Bruce L. Innis, M.D.
the abstract is 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).
for the fulltext: NEJM -- Sign In
enjoy the paper!
Best wishes,
mati | | | | | The Following User Says Thank You to Mati For This Useful Post: | | |
By
Mati
on
02-03-2007, 03:34 PM
| | Re: Safety and Efficacy of a Recombinant Hepatitis E Vaccine
The comment published about the article:
in: Journal Watch: Medicine that matters Quote:
Recombinant Hepatitis E Vaccine Is Effective in Preventing Infection
This vaccine could have a substantial effect on HEV-associated morbidity and mortality worldwide.
Although hepatitis E virus (HEV) infection is uncommon in the U.S., it is a major cause of acute hepatitis in developing countries. As much as one third of the entire world population probably has been infected with HEV. The overall case fatality rate for acute disease is 1% to 3%, but, in pregnant women, acute severe hepatitis is common, and the case fatality rate is 5% to 25%. The aim of this partially industry-sponsored, randomized, double-blind, phase II trial was to determine the efficacy of a recombinant-protein HEV (rHEV) vaccine.
A total of 5323 healthy adult men and nonpregnant women were recruited from 61 Nepalese Army units; however, only 2000 patients with absent or low anti-rHEV immunoglobulin levels (<20 Walter Reed antibody units/mL) were enrolled. Subjects were given doses of vaccine or placebo intramuscularly at 0, 1, and 6 months; 84% of subjects received all three doses. The primary study endpoint was prevention of definite HEV infection occurring at least 14 days after the third dose of vaccine. Acute HEV infection (signs, symptoms, and laboratory testing consistent with acute hepatitis) was identified by active surveillance. The presence of PCR-identified HEV RNA and appropriate titers of anti-rHEV immunoglobulins were required to diagnose hepatitis.
Acute HEV infection developed in 69 participants: 3 in the vaccine group (0.3%) and 66 in the placebo group (7.4%). The efficacy of a three-dose vaccine course was 95.5% (95% CI, 85.6%–98.6%). The efficacy of a two-dose vaccine course was 85.7%. Injection-site pain was more common in the vaccine group (P=0.03); other adverse events occurred at similar rates in the groups.
Comment: This very effective recombinant HEV vaccine could have a major effect on morbidity and mortality associated with HEV infection worldwide, and it could be very beneficial for travelers to HEV-endemic areas. However, further studies are required to evaluate its durability, its efficacy in pregnant women, and its potential role in preventing subclinical infections (which might contribute a large infectious reservoir).
— Atif Zaman, MD, MPH
Published in Journal Watch Gastroenterology February 28, 2007
Citation(s):
Shrestha MP et al. Safety and efficacy of a recombinant hepatitis E vaccine. N Engl J Med 2007 Mar 1; 356:895-903.
| best wishes,
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