Title

Summary of clinical trials of inactivated influenza vaccine - 1978

UMMS Affiliation

Center for Infectious Disease and Vaccine Research; Department of Medicine, Division of Infectious Diseases and Immunology

Publication Date

1983-07-01

Document Type

Article

Disciplines

Immunity | Immunology and Infectious Disease | Immunology of Infectious Disease | Infectious Disease | Influenza Virus Vaccines | Virology

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.

Keywords

Vaccination, Antibodies, Antigens, Dosage, H1N1 subtype influenza A virus, Placebos, Influenza vaccines, Viruses, Clinical trials, Guillain Barre syndrome

Source

Rev Infect Dis. 1983 Jul-Aug;5(4):723-36.

Journal/Book/Conference Title

Reviews of infectious diseases

Related Resources

Link to Article in PubMed

PubMed ID

6353529

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