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【文摘发布】随机对照研究：杆状病毒表达的H
Author:Treanor JJ, Schiff GM, Hayden FG, Brady RC, Hay CM, Meyer AL, Holden-Wiltse J, Liang H, Gilbert A, Cox M.
Resourse:JAMA. 2007 Apr 11;297(14):1577-82.
Abstract
Context: A high priority in vaccine research is the development of influenza vaccines that do not use embryonated eggs as the substrate for vaccine production.
Objective: To determine the dose-related safety, immunogenicity, and protective efficacy of an experimental trivalent influenza virus hemagglutinin (rHA0) vaccine produced in insect cells using recombinant baculoviruses.
Design, Setting, and Participants: Randomized, double-blind, placebo-controlled clinical trial at 3 US academic medical centers during the 2004–2005 influenza season among 460 healthy adults without high-risk indications for influenza vaccine.
Interventions: Participants were randomly assigned to receive a single injection of saline placebo (n = 154); 75 µg of an rHA0 vaccine containing 15 µg of hemagglutinin from influenza A/New Caledonia/20/99(H1N1) and influenza B/Jiangsu/10/03 virus and 45 µg of hemagglutinin from influenza A/Wyoming/3/03(H3N2) virus (n = 153); or 135 µg of rHA0 containing 45 µg of hemagglutinin each from all 3 components (n = 153). Serum samples were taken before and 30 days following immunization.
Main Outcome Measures: Primary safety end points were the rates and severity of solicited and unsolicited adverse events. Primary immunogenicity end points were the rates of 4-fold or greater increases in serum hemagglutinin inhibition antibody to each of the 3 vaccine strains before and 28 days after inoculation. The prespecified primary efficacy end point was culture-documented influenza illness, defined as development of influenza-like illness associated with influenza virus on a nasopharyngeal swab.
Results: Rates of local and systemic adverse effects were low, and the rates of systemic adverse effects were not different in either vaccine group than in the placebo group. Hemagglutinin inhibition antibody responses to the H1 component were seen in 3% of placebo, 51% of 75-µg vaccine, and 67% of 135-µg vaccine recipients, while responses to B were seen in 4% of placebo, 65% of 75-µg vaccine, and 92% of 135-µg vaccine recipients. Responses to the H3 component occurred in 11% of placebo, 81% of 75-µg vaccine, and 77% of 135-µg vaccine recipients. Influenza infections in the study population were due to influenza B and A(H3N2), and influenza A infections were A/California/7/2004–like viruses, an antigenically drifted strain. Seven cases of culture-confirmed CDC-defined influenza-like illness occurred in 153 placebo recipients (4.6%) compared with 2 cases (1.3%) in 150 recipients of 75 µg of vaccine, and 0 cases in recipients of 135 µg of vaccine.
Conclusions: In this study, a trivalent rHA0 vaccine was safe and immunogenic in a healthy adult population. Preliminary evidence of protection against a drifted influenza A(H3N2) virus was obtained, but the sample size was small. Inclusion of a neuraminidase component did not appear to be required for protection.
Trial Registration: clinicaltrials.gov Identifier: NCT00328107
PMID: 17426277 本人已认领该文翻译，如48小时内未提交译文，请其他战友自由认领。 Title: Safety and Immunogenicity of a Baculovirus-Expressed Hemagglutinin Influenza Vaccine: A Randomized Controlled Trial
题目：一个随机对照试验：杆状病毒表达的血凝素流感疫苗的安全性和免疫原性
Author:Treanor JJ, Schiff GM, Hayden FG, Brady RC, Hay CM, Meyer AL, Holden-Wiltse J, Liang H, Gilbert A, Cox M.
Resourse:JAMA. 2007 Apr 11;297(14):1577-82.
Abstract
Context: A high priority in vaccine research is the development of influenza vaccines that do not use embryonated eggs as the substrate for vaccine production.
摘要
背景：疫苗研究中，优先考虑以不使用鸡胚作为生产底物来研制流感疫苗。
Objective: To determine the dose-related safety, immunogenicity, and protective efficacy of an experimental trivalent influenza virus hemagglutinin (rHA0) vaccine produced in insect cells using recombinant baculoviruses.
目的：研究应用重组的杆状病毒在昆虫细胞中产生的三价流感病毒血红素（rHAO）疫苗的剂量安全性、免疫原性和保护效率。
Design, Setting, and Participants: Randomized, double-blind, placebo-controlled clinical trial at 3 US academic medical centers during the 2004–2005 influenza season among 460 healthy adults without high-risk indications for influenza vaccine.
设计、地点和参与者：于2004－2005年流感季节在3 US学术医学中心对460个对流感疫苗没有高危指标的健康成人中进行随机、双盲和安慰剂对照的临床试验。
Interventions: Participants were randomly assigned to receive a single injection of saline placebo (n = 154); 75 µg of an rHA0 vaccine containing 15 µg of hemagglutinin from influenza A/New Caledonia/20/99(H1N1) and influenza B/Jiangsu/10/03 virus and 45 µg of hemagglutinin from influenza A/Wyoming/3/03(H3N2) virus (n = 153); or 135 µg of rHA0 containing 45 µg of hemagglutinin each from all 3 components (n = 153). Serum samples were taken before and 30 days following immunization.
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作者:admin@医学,生命科学 2011-03-25 05:12
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