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Direct comparison of an inactivated subvirion influenza A virus subtype H5N1 vaccine administered by the intradermal and intramuscular routes.

Abstract

BACKGROUND
Direct comparisons of similar doses of a novel influenza virus antigen administered by the intradermal route and the intramuscular route have not been reported.
METHODS
A total of 227 healthy adults aged 18-49 years were randomized to receive 2 doses 1 month apart of a subvirion inactivated influenza A virus subtype H5N1 (rgA/Vietnam/1203/2004) vaccine containing 38.7 μg of H5N1 hemagglutinin (HA), by the intramuscular route or by the intradermal route using the Mantoux technique. Clinical and serologic responses were assessed.
RESULTS
Injection site reactions were more frequent in the intradermal group. Immune responses and the geometric mean titer of serum hemagglutination inhibition and neutralizing antibodies 1 month after receipt of the first dose were similar and low but were significantly higher after 2 doses of vaccine in both groups.
CONCLUSIONS
Intramuscular and intradermal delivery of vaccine were both well tolerated. Immune responses after 2 doses of this influenza A/H5N1 HA (38.7 μg) were low and not significantly different when given by the intradermal or intramuscular route. Evaluation of higher dosages, alternative intradermal delivery methods, and the addition of adjuvants will be needed to enhance the immunogenicity of inactivated influenza A/H5N1 vaccines by the intradermal route. Clinical Trials Registration: NCT00439335.

Links

  • Publisher Full Text

    • Authors

    Patel SM, Atmar RL, El Sahly HM, Guo K, Hill H, Keitel WA

    Institution

    Section of Infectious Diseases, Department of Medicine, Baylor College of Medicine, Houston, Texas 77030, USA. shitalp@bcm.edu

    Source

    The Journal of infectious diseases 206:7 2012 Oct 1 pg 1069-77

    MeSH

    Adolescent
    Adult
    Antibodies, Neutralizing
    Antibodies, Viral
    Double-Blind Method
    Female
    Hemagglutination Inhibition Tests
    Humans
    Influenza A Virus, H5N1 Subtype
    Influenza Vaccines
    Influenza, Human
    Injections, Intradermal
    Injections, Intramuscular
    Male
    Middle Aged
    Treatment Outcome
    Vaccines, Inactivated
    Young Adult

    Pub Type(s)

    Clinical Trial, Phase I
    Clinical Trial, Phase II
    Comparative Study
    Journal Article
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural

    Language

    eng

    PubMed ID

    22891287