A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine.
Concern for a pandemic caused by a newly emerged avian influenza A virus has led to clinical trials with candidate vaccines as preparation for such an event. Most trials have involved vaccines for influenza A (H5N1), A (H7N7) or A (H9N2).To evaluate dosage-related safety and immunogenicity of an ina...
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doaj-46b6c432cc9340afa7d1ed84537fd8b42020-11-25T02:47:05ZengPublic Library of Science (PLoS)PLoS ONE1932-62032012-01-01712e4970410.1371/journal.pone.0049704A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine.Robert B CouchShital M PatelChianti L Wade-BowersDiane NiñoConcern for a pandemic caused by a newly emerged avian influenza A virus has led to clinical trials with candidate vaccines as preparation for such an event. Most trials have involved vaccines for influenza A (H5N1), A (H7N7) or A (H9N2).To evaluate dosage-related safety and immunogenicity of an inactivated influenza A (H7N7) vaccine in humans.One hundred twenty-five healthy young adults were randomized to receive two doses intramuscularly of placebo or 7.5, 15, 45 or 90 µg of HA of an inactivated subunit influenza A (H7N7) vaccine (25 per group), four weeks apart. Reactogenicity was evaluated closely for one week and for any adverse effect for six months after each dose. Serum hemagglutination-inhibiting and neutralizing antibody responses were determined four weeks after each dose and at six months.Reactogenicity evaluations indicated the vaccinations were well tolerated. Only one subject developed a ≥4-fold serum hemagglutination-inhibition (HAI) antibody response and a final titer of ≥1:40 four weeks after dose two and only five subjects developed a neutralizing antibody rise and a final titer of ≥1:40 in tests performed at a central laboratory. Four of the five were given the 45 or 90 µg HA dosage. A more sensitive HAI assay at the study site revealed a dose-response with increasing HA dosage but only 36% in the 90 µg HA group developed a ≥4-fold rise in antibody in this test and only one of these achieved a titer of ≥1:32.This inactivated subunit influenza A (H7N7) vaccine was safe but poorly immunogenic in humans.ClinicalTrials.gov NCT00546585.http://europepmc.org/articles/PMC3519847?pdf=render |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Robert B Couch Shital M Patel Chianti L Wade-Bowers Diane Niño |
spellingShingle |
Robert B Couch Shital M Patel Chianti L Wade-Bowers Diane Niño A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine. PLoS ONE |
author_facet |
Robert B Couch Shital M Patel Chianti L Wade-Bowers Diane Niño |
author_sort |
Robert B Couch |
title |
A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine. |
title_short |
A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine. |
title_full |
A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine. |
title_fullStr |
A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine. |
title_full_unstemmed |
A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine. |
title_sort |
randomized clinical trial of an inactivated avian influenza a (h7n7) vaccine. |
publisher |
Public Library of Science (PLoS) |
series |
PLoS ONE |
issn |
1932-6203 |
publishDate |
2012-01-01 |
description |
Concern for a pandemic caused by a newly emerged avian influenza A virus has led to clinical trials with candidate vaccines as preparation for such an event. Most trials have involved vaccines for influenza A (H5N1), A (H7N7) or A (H9N2).To evaluate dosage-related safety and immunogenicity of an inactivated influenza A (H7N7) vaccine in humans.One hundred twenty-five healthy young adults were randomized to receive two doses intramuscularly of placebo or 7.5, 15, 45 or 90 µg of HA of an inactivated subunit influenza A (H7N7) vaccine (25 per group), four weeks apart. Reactogenicity was evaluated closely for one week and for any adverse effect for six months after each dose. Serum hemagglutination-inhibiting and neutralizing antibody responses were determined four weeks after each dose and at six months.Reactogenicity evaluations indicated the vaccinations were well tolerated. Only one subject developed a ≥4-fold serum hemagglutination-inhibition (HAI) antibody response and a final titer of ≥1:40 four weeks after dose two and only five subjects developed a neutralizing antibody rise and a final titer of ≥1:40 in tests performed at a central laboratory. Four of the five were given the 45 or 90 µg HA dosage. A more sensitive HAI assay at the study site revealed a dose-response with increasing HA dosage but only 36% in the 90 µg HA group developed a ≥4-fold rise in antibody in this test and only one of these achieved a titer of ≥1:32.This inactivated subunit influenza A (H7N7) vaccine was safe but poorly immunogenic in humans.ClinicalTrials.gov NCT00546585. |
url |
http://europepmc.org/articles/PMC3519847?pdf=render |
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