A Phase I Evaluation of Inactivated Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route
Identifieur interne : 001134 ( Main/Exploration ); précédent : 001133; suivant : 001135A Phase I Evaluation of Inactivated Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route
Auteurs : Shital M. Patel [États-Unis] ; Robert L. Atmar [États-Unis] ; Hana El Sahly [États-Unis] ; Thomas R. Cate [États-Unis] ; Wendy A. Keitel [États-Unis]Source :
- Vaccine [ 0264-410X ] ; 2009.
Abstract
In a phase I clinical trial, one hundred healthy young adults were randomized to receive two doses 28 days apart of an inactivated, subvirion vaccine containing 15µg or 45µg of influenza A/H5N1 hemagglutinin (HA) by the intramuscular (IM) route, or 3µg or 9µg of H5 HA by the intradermal(ID) route. Seventy-seven subjects received a third dose. All regimens were safe and well tolerated. Antibody responses after two or three doses were low (≤20% or ≤38%, respectively) and similar in groups given 3µg or 9µg ID or 15µg IM, and were significantly lower than those given 45µg IM. Higher dosages of H5 HA and/or inclusion of adjuvant will be required to enhance immunogenicity by the ID route.
Url:
DOI: 10.1016/j.vaccine.2009.10.152
PubMed: 19931380
PubMed Central: 2913582
Affiliations:
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Le document en format XML
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<front><div type="abstract" xml:lang="en"><p id="P1">In a phase I clinical trial, one hundred healthy young adults were randomized to receive two doses 28 days apart of an inactivated, subvirion vaccine containing 15µg or 45µg of influenza A/H5N1 hemagglutinin (HA) by the intramuscular (IM) route, or 3µg or 9µg of H5 HA by the intradermal(ID) route. Seventy-seven subjects received a third dose. All regimens were safe and well tolerated. Antibody responses after two or three doses were low (≤20% or ≤38%, respectively) and similar in groups given 3µg or 9µg ID or 15µg IM, and were significantly lower than those given 45µg IM. Higher dosages of H5 HA and/or inclusion of adjuvant will be required to enhance immunogenicity by the ID route.</p>
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