TY - JOUR T1 - Response to a monovalent 2009 influenza A (H1N1) vaccine. AU - Greenberg,Michael E, AU - Lai,Michael H, AU - Hartel,Gunter F, AU - Wichems,Christine H, AU - Gittleson,Charmaine, AU - Bennet,Jillian, AU - Dawson,Gail, AU - Hu,Wilson, AU - Leggio,Connie, AU - Washington,Diane, AU - Basser,Russell L, Y1 - 2009/09/10/ PY - 2009/9/12/entrez PY - 2009/9/12/pubmed PY - 2010/1/6/medline SP - 2405 EP - 13 JF - The New England journal of medicine JO - N Engl J Med VL - 361 IS - 25 N2 - 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). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/19745216/Response_to_a_monovalent_2009_influenza_A__H1N1__vaccine_ DB - PRIME DP - Unbound Medicine ER -