A double-blind, placebo-controlled study of the safety and immunogenicity of live, oral type 4 and type 7 adenovirus vaccines in adults

Vaccine. 2008 Jun 2;26(23):2890-8. doi: 10.1016/j.vaccine.2008.03.037. Epub 2008 Apr 10.


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.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adenoviridae / immunology*
  • Adenoviridae Infections / immunology*
  • Adenoviridae Infections / prevention & control*
  • Adenoviridae Infections / virology
  • Administration, Oral
  • Adolescent
  • Adult
  • Antibodies, Viral / analysis
  • Antibodies, Viral / biosynthesis
  • Double-Blind Method
  • Feces / virology
  • Female
  • Humans
  • Immunization, Secondary
  • Immunologic Surveillance
  • Male
  • Pharynx / virology
  • Rectum / virology
  • Reverse Transcriptase Polymerase Chain Reaction
  • Tablets, Enteric-Coated
  • Viral Vaccines / adverse effects*
  • Viral Vaccines / therapeutic use*
  • Viremia / blood
  • Viremia / virology


  • Antibodies, Viral
  • Tablets, Enteric-Coated
  • Viral Vaccines