title: A double-blind, placebo-controlled study of the safety and immunogenicity of live, oral type 4 and type 7 adenovirus vaccines in adults.
abstract: Adenovirus serotypes 4 (ADV-4) and 7 (ADV-7) are important causes of febrile acute respiratory disease (ARD) in US military recruits. Previously licensed vaccines, which effectively controlled adenovirus-associated ARD, are no longer available. In the Fall of 2004 we conducted this Phase 1 randomized, double-blind, placebo-controlled trial of the live, oral ADV-4 and ADV-7 vaccines made by a new manufacturer to assess their safety and immunogenicity. The adenovirus vaccines were administered orally together in a single dose to thirty subjects. Twenty eight additional subjects received placebo. Subjects were then observed for 8 weeks. The most commonly reported adverse events were nasal congestion (33%), cough (33%), sore throat (27%), headache (20%), abdominal pain (17%), arthralgia (13%), nausea (13%) and diarrhea (13%). None of these rates differed significantly from placebo. The duration of vaccine virus fecal shedding was 7-21 days. Seventy three percent of vaccine recipients seroconverted to ADV-4 (GMT 23.3) while 63% seroconverted to ADV-7 (GMT 51.1) by Day 28. The new ADV-4 and ADV-7 vaccines were safe and induced a good immune response in the study population. Expanded trials for safety and efficacy are in progress.
authors.affiliation: Department of Virus Diseases, Division of Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Silver Spring, MD, USA. arthur.lyons@na.amedd.army.mil
authors.forename: Arthur
authors.initials: A
authors.lastname: Lyons
authors.forename: Jenice
authors.initials: J
authors.lastname: Longfield
authors.forename: Robert
authors.initials: R
authors.lastname: Kuschner
authors.forename: Timothy
authors.initials: T
authors.lastname: Straight
authors.forename: Leonard
authors.initials: L
authors.lastname: Binn
authors.forename: Jitvimol
authors.initials: J
authors.lastname: Seriwatana
authors.forename: Raven
authors.initials: R
authors.lastname: Reitstetter
authors.forename: Irma B
authors.initials: IB
authors.lastname: Froh
authors.forename: David
authors.initials: D
authors.lastname: Craft
authors.forename: Kevin
authors.initials: K
authors.lastname: McNabb
authors.forename: Kevin
authors.initials: K
authors.lastname: Russell
authors.forename: David
authors.initials: D
authors.lastname: Metzgar
authors.forename: Alan
authors.initials: A
authors.lastname: Liss
authors.forename: Xiao
authors.initials: X
authors.lastname: Sun
authors.forename: Andrew
authors.initials: A
authors.lastname: Towle
authors.forename: Wellington
authors.initials: W
authors.lastname: Sun
mesh_terms: D000256:Adenoviridae / Q000276:immunology*; D000257:Adenoviridae Infections / Q000276:immunology* / Q000517:prevention & control* / Q000821:virology; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D004311:Double-Blind Method; D005243:Feces / Q000821:virology; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D007157:Immunologic Surveillance; D008297:Male; D010614:Pharynx / Q000821:virology; D012007:Rectum / Q000821:virology; D020133:Reverse Transcriptase Polymerase Chain Reaction; D013608:Tablets, Enteric-Coated; D014765:Viral Vaccines / Q000009:adverse effects* / Q000627:therapeutic use*; D014766:Viremia / Q000097:blood / Q000821:virology
chemical_list: D000914:Antibodies, Viral; D013608:Tablets, Enteric-Coated; D014765:Viral Vaccines