Safety and Immunogenicity of an Inactivated Subvirion Influenza A (H5N1) Vaccine

• Published in: The New England journal of medicine Vol. 354; no. 13; pp. 1343 - 1351
• Main Authors: Treanor, John J, Campbell, James D, Zangwill, Kenneth M, Rowe, Thomas, Wolff, Mark
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 30.03.2006
• Subjects: Adolescent; Adult; Antibodies, Viral - blood; Avian flu; Biological and medical sciences; Dose-Response Relationship, Drug; Double-Blind Method; Female; General aspects; Hemagglutination Inhibition Tests; Humans; Immunization, Secondary; Influenza A Virus, H5N1 Subtype - immunology; Influenza Vaccines - administration & dosage; Influenza Vaccines - adverse effects; Influenza Vaccines - immunology; Influenza, Human - immunology; Influenza, Human - prevention & control; Male; Medical sciences; Middle Aged; Vaccines; Vaccines, Inactivated - administration & dosage; Vaccines, Inactivated - adverse effects; Vaccines, Inactivated - immunology; Viruses; Medicine; Prevention; Influenzavirus A(H5N1); Immunoprophylaxis; Immune response; Immunogenicity; Toxicity; Vaccine; Safety
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa055778

This trial involving 451 healthy adults assessed responses to two intramuscular doses of a subvirion H5N1 influenza vaccine. At the highest dose (90 μg of hemagglutinin), 54 percent of the subjects had neutralization antibody titers of 1:40 or greater. The subvirion vaccine did not cause severe side effects, and in most subjects, it generated neutralizing-antibody responses typically associated with protection against influenza. A conventional subvirion H5 influenza vaccine may be effective in preventing influenza A (H5N1) disease (avian influenza) in humans. This trial involving 451 healthy adults assessed responses to two intramuscular doses of a subvirion H5N1 influenza vaccine. This vaccine may be effective in preventing influenza A (H5N1) disease in humans. Avian influenza A viruses of the H5N1 subtype are currently causing widespread infections in bird populations throughout Southeast Asia, with spread into Central Asia, Africa, and Europe. 1 There have been numerous instances of transmission of these viruses to humans, resulting in severe disease or death. 2 These viruses possess a new H5 subtype of hemagglutinin, against which at present there is little immunity in human populations. The viruses have the potential to cause extremely severe respiratory illness in humans, and of the 169 cases reported to the World Health Organization as of February 13, 2006, 91 (54 percent) have been fatal. . . .