title: Comparison of live, attenuated H1N1 and H3N2 cold-adapted and avian-human influenza A reassortant viruses and inactivated virus vaccine in adults.
abstract: The infectivity, immunogenicity, and efficacy of live, attenuated influenza A/Texas/1/85 (H1N1) and A/Bethesda/1/85 (H3N2) avian-human (ah) and cold-adapted (ca) reassortant vaccines were compared in 252 seronegative adult volunteers. The immunogenicity and efficacy of the H1N1 reassortant vaccine were also compared with those of the trivalent inactivated virus vaccine. Each reassortant vaccine was satisfactorily attenuated. The 50% human infectious dose was 10(4.9) for ca H1N1, 10(5.4) for ah H1N1, 10(6.4) for ca H3N2, and 10(6.5) TCID50 for ah H3N2 reassortant virus. Within a subtype, the immunogenicities of ah and ca vaccines were comparable. Five to seven weeks after vaccination, volunteers were challenged with homologous wild-type influenza A virus. The magnitude of shedding of virus after challenge was greater than 100-fold less in H1N1 vaccinees and greater than 10-fold less in H3N2 vaccinees compared with unimmunized controls. The vaccines were equally efficacious, as indicated by an 86%-100% reduction in illness. Thus, the ah A/Mallard/New York/6750/78 and the ca A/Ann Arbor/6/60 reassortant viruses are comparable.
authors.affiliation: Center for Immunization Research, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, Maryland 21205.
authors.forename: S D
authors.initials: SD
authors.lastname: Sears
authors.forename: M L
authors.initials: ML
authors.lastname: Clements
authors.forename: R F
authors.initials: RF
authors.lastname: Betts
authors.forename: H F
authors.initials: HF
authors.lastname: Maassab
authors.forename: B R
authors.initials: BR
authors.lastname: Murphy
authors.forename: M H
authors.initials: MH
authors.lastname: Snyder
mesh_terms: D000328:Adult; D000818:Animals; D000914:Antibodies, Viral / Q000096:biosynthesis; D003080:Cold Temperature; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D053122:Influenza A Virus, H3N2 Subtype; D009980:Influenza A virus / Q000276:immunology* / Q000472:pathogenicity / Q000502:physiology; D007252:Influenza Vaccines; D007251:Influenza, Human / Q000517:prevention & control*; D011897:Random Allocation; D014613:Vaccines, Attenuated; D014614:Vaccines, Synthetic; D014779:Virus Replication
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated; D014614:Vaccines, Synthetic