title: A phase I evaluation of inactivated influenza A/H5N1 vaccine administered by the intradermal or the intramuscular route.
abstract: In a phase I clinical trial, one hundred healthy young adults were randomized to receive two doses 28 days apart of an inactivated, subvirion vaccine containing 15 or 45microg of influenza A/H5N1 hemagglutinin (HA) by the intramuscular (IM) route, or 3 or 9microg of H5 HA by the intradermal(ID) route. Seventy-seven subjects received a third dose. All regimens were safe and well tolerated. Antibody responses after two or three doses were low (<or=20% or <or=38%, respectively) and similar in groups given 3 or 9microg ID or 15microg IM, and were significantly lower than those given 45microg IM. Higher dosages of H5 HA and/or inclusion of adjuvant will be required to enhance immunogenicity by the ID route.
authors.affiliation: Baylor College of Medicine, Medicine - Infectious Diseases, BCM MS 280, One Baylor Plaza, Houston, TX 77030, United States. shitalp@bcm.edu
authors.forename: Shital M
authors.initials: SM
authors.lastname: Patel
authors.forename: Robert L
authors.initials: RL
authors.lastname: Atmar
authors.forename: Hana M
authors.initials: HM
authors.lastname: El Sahly
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Cate
authors.forename: Wendy A
authors.initials: WA
authors.lastname: Keitel
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D008297:Male; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated