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Response to a monovalent 2009 influenza A (H1N1) vaccine.
N Engl J Med. 2009 Dec 17; 361(25):2405-13.NEJM

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).

Authors+Show Affiliations

Clinical Research and Development, CSL, Parkville, VIC, Australia. michael.greenberg@csl.com.auNo 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, Non-U.S. Gov't

Language

eng

PubMed ID

19745216

Citation

Greenberg, Michael E., et al. "Response to a Monovalent 2009 Influenza a (H1N1) Vaccine." The New England Journal of Medicine, vol. 361, no. 25, 2009, pp. 2405-13.
Greenberg ME, Lai MH, Hartel GF, et al. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009;361(25):2405-13.
Greenberg, M. E., Lai, M. H., Hartel, G. F., Wichems, C. H., Gittleson, C., Bennet, J., Dawson, G., Hu, W., Leggio, C., Washington, D., & Basser, R. L. (2009). Response to a monovalent 2009 influenza A (H1N1) vaccine. The New England Journal of Medicine, 361(25), 2405-13. https://doi.org/10.1056/NEJMoa0907413
Greenberg ME, et al. Response to a Monovalent 2009 Influenza a (H1N1) Vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. PubMed PMID: 19745216.
* Article titles in AMA citation format should be in sentence-case
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_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa0907413?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -