NDLI: Response to a monovalent 2009 influenza A (H1N1) vaccine.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Gittleson, Charmaine Hu, Wilson Lai, Michael H. Hartel, Gunter F. Basser, Russell L. Leggio, Connie Dawson, Gail Bennet, Jillian Washington, Diane Greenberg, Michael E. Wichems, Christine H.
Description	Author Affiliation: Greenberg ME ( Clinical Research and Development, CSL, Parkville, VIC, Australia. michael.greenberg@csl.com.au)
Abstract	BACKGROUND: A novel 2009 influenza A (H1N1) virus is responsible for the first influenza pandemic in 41 years. A safe and effective vaccine is needed. A randomized, observer-blind, parallel-group trial evaluating two doses of an inactivated, split-virus 2009 H1N1 vaccine in healthy adults between the ages of 18 and 64 years is ongoing at a single site in Australia. METHODS: We evaluated the immunogenicity and safety of the vaccine after each of two scheduled doses, administered 21 days apart. A total of 240 subjects, equally divided into two age groups (<50 years and >or=50 years), were enrolled and underwent randomization to receive either 15 microg or 30 microg of hemagglutinin antigen by intramuscular injection. We measured antibody titers using hemagglutination-inhibition and microneutralization assays at baseline and 21 days after vaccination. The coprimary immunogenicity end points were the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay, the proportion of subjects with either seroconversion or a significant increase in antibody titer, and the factor increase in the geometric mean titer. RESULTS: By day 21 after the first dose, antibody titers of 1:40 or more were observed in 114 of 120 subjects (95.0%) who received the 15-microg dose and in 106 of 119 subjects (89.1%) who received the 30-microg dose. A similar result was observed after the second dose of vaccine. No deaths, serious adverse events, or adverse events of special interest were reported. Local discomfort (e.g., injection-site tenderness or pain) was reported by 56.3% of subjects, and systemic symptoms (e.g., headache) by 53.8% of subjects after each dose. Nearly all events were mild to moderate in intensity. CONCLUSIONS: A single 15-microg dose of 2009 H1N1 vaccine was immunogenic in adults, with mild-to-moderate vaccine-associated reactions. (ClinicalTrials.gov number, NCT00938639).
ISSN	00284793
Issue Number	25
Volume Number	361
e-ISSN	15334406
Journal	New England Journal of Medicine
Language	English
Publisher	Massachusetts Medical Society (United States)
Publisher Date	2009-12-17
Publisher Place	United States
Access Restriction	Subscribed
Subject Keyword	Antibodies, Viral Blood Influenza A Virus, H1N1 Subtype Immunology Influenza Vaccines Influenza, Human Adolescent Adult Female Hemagglutination Inhibition Tests Humans Administration & Dosage Adverse Effects Prevention & Control Male Middle Aged Neutralization Tests Prospective Studies Single-Blind Method Young Adult Clinical Trial, Phase II Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't Medicine
Content Type	Text
Resource Type	Article
Subject	Medicine

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