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    Summary of clinical trials of inactivated influenza vaccine - 1978

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    Authors
    La Montagne, John R.
    Noble, Gary R.
    Quinnan, Gerald V.
    Curlin, George T.
    Blackwelder, William C.
    Smith, Jacqueline I.
    Ennis, Francis A.
    Bozeman, F. Marilyn
    UMass Chan Affiliations
    Department of Medicine, Division of Infectious Diseases and Immunology
    Center for Infectious Disease and Vaccine Research
    Document Type
    Journal Article
    Publication Date
    1983-07-01
    Keywords
    Vaccination
    Antibodies
    Antigens
    Dosage
    H1N1 subtype influenza A virus
    Placebos
    Influenza vaccines
    Viruses
    Clinical trials
    Guillain Barre syndrome
    Immunity
    Immunology and Infectious Disease
    Immunology of Infectious Disease
    Infectious Disease
    Influenza Virus Vaccines
    Virology
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    Link to Full Text
    http://www.jstor.org/stable/4453125
    Abstract
    This report summarizes the clinical trials of the A/USSR/77 (H1N1) influenza vaccines performed in 1978. A total of 2,091 subjects participated in these trials. The results of these clinical trials indicated that two doses of H1N1 viral antigen were necessary to produce serum titers of hemagglutinin-inhibiting (HAI) antibody of greater than 1:40 in 80% or more of the test subjects younger than 25 years of age, who were unlikely to have experienced natural infection during the earlier period of prevalence of H1N1 virus (1947-1957). Only one dose of the A/Texas/77 (H3N2) or B/Hong Kong/72 antigen was necessary to stimulate equivalent titers of HAI antibody in serum. Thus, previous natural exposure to H1N1 viruses primed individuals 26 years of age or older to respond to H1N1 antigens. No major differences in antigenicity were noted between whole-virus and split-virus vaccines. No differences in reaction indexes measuring systemic reactions were noted when vaccine types were compared. Only one vaccine was associated with a reaction index appreciably higher than that of placebo. The relatively uniform antibody responses observed were attributed to the newer methods of vaccine standardization introduced after the clinical trials in 1976. No cases of vaccine-related neurological problems, including Guillain-Barre syndrome, were found during these trials. Vaccines containing 7-21 micrograms of each viral antigen were antigenic and were well tolerated.
    Source
    Rev Infect Dis. 1983 Jul-Aug;5(4):723-36.
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/35144
    PubMed ID
    6353529
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