Safety and Immunogenicity of an Inactivated Subvirion Influenza A (H5N1) Vaccine
This trial involving 451 healthy adults assessed responses to two intramuscular doses of a subvirion H5N1 influenza vaccine. At the highest dose (90 μg of hemagglutinin), 54 percent of the subjects had neutralization antibody titers of 1:40 or greater. The subvirion vaccine did not cause severe side...
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| Published in | The New England journal of medicine Vol. 354; no. 13; pp. 1343 - 1351 |
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| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Boston, MA
Massachusetts Medical Society
30.03.2006
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| Subjects | |
| Online Access | Get full text |
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| Abstract | This trial involving 451 healthy adults assessed responses to two intramuscular doses of a subvirion H5N1 influenza vaccine. At the highest dose (90 μg of hemagglutinin), 54 percent of the subjects had neutralization antibody titers of 1:40 or greater. The subvirion vaccine did not cause severe side effects, and in most subjects, it generated neutralizing-antibody responses typically associated with protection against influenza. A conventional subvirion H5 influenza vaccine may be effective in preventing influenza A (H5N1) disease (avian influenza) in humans.
This trial involving 451 healthy adults assessed responses to two intramuscular doses of a subvirion H5N1 influenza vaccine. This vaccine may be effective in preventing influenza A (H5N1) disease in humans.
Avian influenza A viruses of the H5N1 subtype are currently causing widespread infections in bird populations throughout Southeast Asia, with spread into Central Asia, Africa, and Europe.
1
There have been numerous instances of transmission of these viruses to humans, resulting in severe disease or death.
2
These viruses possess a new H5 subtype of hemagglutinin, against which at present there is little immunity in human populations. The viruses have the potential to cause extremely severe respiratory illness in humans, and of the 169 cases reported to the World Health Organization as of February 13, 2006, 91 (54 percent) have been fatal. . . . |
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| AbstractList | This trial involving 451 healthy adults assessed responses to two intramuscular doses of a subvirion H5N1 influenza vaccine. At the highest dose (90 μg of hemagglutinin), 54 percent of the subjects had neutralization antibody titers of 1:40 or greater. The subvirion vaccine did not cause severe side effects, and in most subjects, it generated neutralizing-antibody responses typically associated with protection against influenza. A conventional subvirion H5 influenza vaccine may be effective in preventing influenza A (H5N1) disease (avian influenza) in humans.
This trial involving 451 healthy adults assessed responses to two intramuscular doses of a subvirion H5N1 influenza vaccine. This vaccine may be effective in preventing influenza A (H5N1) disease in humans.
Avian influenza A viruses of the H5N1 subtype are currently causing widespread infections in bird populations throughout Southeast Asia, with spread into Central Asia, Africa, and Europe.
1
There have been numerous instances of transmission of these viruses to humans, resulting in severe disease or death.
2
These viruses possess a new H5 subtype of hemagglutinin, against which at present there is little immunity in human populations. The viruses have the potential to cause extremely severe respiratory illness in humans, and of the 169 cases reported to the World Health Organization as of February 13, 2006, 91 (54 percent) have been fatal. . . . Background Influenza A (H5N1) viruses could cause a severe worldwide epidemic, with high attack rates, large numbers of deaths and hospitalizations, and wide disruption. Effective vaccines against these viruses in humans are urgently needed. Methods We conducted a multicenter, double-blind two-stage study involving 451 healthy adults 18 to 64 years of age who were randomly assigned in a 2:2:2:2:1 ratio to receive two intramuscular doses of a subvirion influenza A (H5N1) vaccine of 90, 45, 15, or 7.5 μg of hemagglutinin antigen or placebo. The subjects were followed for the safety analysis for 56 days. Serum samples obtained before each vaccination and again 28 days after the second vaccination were tested for H5 antibody by microneutralization and hemagglutination inhibition. Results Mild pain at the injection site was the most common adverse event for all doses of vaccine. The frequency of a serum antibody response was highest among subjects receiving doses of 45 μg or 90 μg. Among those who received two doses of 90 μg, neutralization antibody titers reached 1:40 or greater in 54 percent, and hemagglutination-inhibition titers reached 1:40 or greater in 58 percent. Neutralization titers of 1:40 or greater were seen in 43 percent, 22 percent, and 9 percent of the subjects receiving two doses of 45, 15, and 7.5 μg, respectively. No responses were seen in placebo recipients. Conclusions A two-dose regimen of 90 μg of subvirion influenza A (H5N1) vaccine does not cause severe side effects and, in the majority of recipients, generates neutralizing antibody responses typically associated with protection against influenza. A conventional subvirion H5 influenza vaccine may be effective in preventing influenza A (H5N1) disease in humans. (ClinicalTrials.gov number, NCT00115986 .) Influenza A (H5N1) viruses could cause a severe worldwide epidemic, with high attack rates, large numbers of deaths and hospitalizations, and wide disruption. Effective vaccines against these viruses in humans are urgently needed.BACKGROUNDInfluenza A (H5N1) viruses could cause a severe worldwide epidemic, with high attack rates, large numbers of deaths and hospitalizations, and wide disruption. Effective vaccines against these viruses in humans are urgently needed.We conducted a multicenter, double-blind two-stage study involving 451 healthy adults 18 to 64 years of age who were randomly assigned in a 2:2:2:2:1 ratio to receive two intramuscular doses of a subvirion influenza A (H5N1) vaccine of 90, 45, 15, or 7.5 microg of hemagglutinin antigen or placebo. The subjects were followed for the safety analysis for 56 days. Serum samples obtained before each vaccination and again 28 days after the second vaccination were tested for H5 antibody by microneutralization and hemagglutination inhibition.METHODSWe conducted a multicenter, double-blind two-stage study involving 451 healthy adults 18 to 64 years of age who were randomly assigned in a 2:2:2:2:1 ratio to receive two intramuscular doses of a subvirion influenza A (H5N1) vaccine of 90, 45, 15, or 7.5 microg of hemagglutinin antigen or placebo. The subjects were followed for the safety analysis for 56 days. Serum samples obtained before each vaccination and again 28 days after the second vaccination were tested for H5 antibody by microneutralization and hemagglutination inhibition.Mild pain at the injection site was the most common adverse event for all doses of vaccine. The frequency of a serum antibody response was highest among subjects receiving doses of 45 microg or 90 microg. Among those who received two doses of 90 microg, neutralization antibody titers reached 1:40 or greater in 54 percent, and hemagglutination-inhibition titers reached 1:40 or greater in 58 percent. Neutralization titers of 1:40 or greater were seen in 43 percent, 22 percent, and 9 percent of the subjects receiving two doses of 45, 15, and 7.5 microg, respectively. No responses were seen in placebo recipients.RESULTSMild pain at the injection site was the most common adverse event for all doses of vaccine. The frequency of a serum antibody response was highest among subjects receiving doses of 45 microg or 90 microg. Among those who received two doses of 90 microg, neutralization antibody titers reached 1:40 or greater in 54 percent, and hemagglutination-inhibition titers reached 1:40 or greater in 58 percent. Neutralization titers of 1:40 or greater were seen in 43 percent, 22 percent, and 9 percent of the subjects receiving two doses of 45, 15, and 7.5 microg, respectively. No responses were seen in placebo recipients.A two-dose regimen of 90 mug of subvirion influenza A (H5N1) vaccine does not cause severe side effects and, in the majority of recipients, generates neutralizing antibody responses typically associated with protection against influenza. A conventional subvirion H5 influenza vaccine may be effective in preventing influenza A (H5N1) disease in humans. (ClinicalTrials.gov number, NCT00115986.).CONCLUSIONSA two-dose regimen of 90 mug of subvirion influenza A (H5N1) vaccine does not cause severe side effects and, in the majority of recipients, generates neutralizing antibody responses typically associated with protection against influenza. A conventional subvirion H5 influenza vaccine may be effective in preventing influenza A (H5N1) disease in humans. (ClinicalTrials.gov number, NCT00115986.). Background Influenza A (H5N1) viruses could cause a severe worldwide epidemic, with high attack rates, large numbers of deaths and hospitalizations, and wide disruption. Effective vaccines against these viruses in humans are urgently needed. Methods We conducted a multicenter, double-blind two-stage study involving 451 healthy adults 18 to 64 years of age who were randomly assigned in a 2:2:2:2:1 ratio to receive two intramuscular doses of a subvirion influenza A (H5N1) vaccine of 90, 45, 15, or 7.5 mu g of hemagglutinin antigen or placebo. The subjects were followed for the safety analysis for 56 days. Serum samples obtained before each vaccination and again 28 days after the second vaccination were tested for H5 antibody by microneutralization and hemagglutination inhibition. Results Mild pain at the injection site was the most common adverse event for all doses of vaccine. The frequency of a serum antibody response was highest among subjects receiving doses of 45 mu g or 90 mu g. Among those who received two doses of 90 mu g, neutralization antibody titers reached 1:40 or greater in 54 percent, and hemagglutination-inhibition titers reached 1:40 or greater in 58 percent. Neutralization titers of 1:40 or greater were seen in 43 percent, 22 percent, and 9 percent of the subjects receiving two doses of 45, 15, and 7.5 mu g, respectively. No responses were seen in placebo recipients. Conclusions A two-dose regimen of 90 mu g of subvirion influenza A (H5N1) vaccine does not cause severe side effects and, in the majority of recipients, generates neutralizing antibody responses typically associated with protection against influenza. A conventional subvirion H5 influenza vaccine may be effective in preventing influenza A (H5N1) disease in humans. Influenza A (H5N1) viruses could cause a severe worldwide epidemic, with high attack rates, large numbers of deaths and hospitalizations, and wide disruption. Effective vaccines against these viruses in humans are urgently needed. We conducted a multicenter, double-blind two-stage study involving 451 healthy adults 18 to 64 years of age who were randomly assigned in a 2:2:2:2:1 ratio to receive two intramuscular doses of a subvirion influenza A (H5N1) vaccine of 90, 45, 15, or 7.5 microg of hemagglutinin antigen or placebo. The subjects were followed for the safety analysis for 56 days. Serum samples obtained before each vaccination and again 28 days after the second vaccination were tested for H5 antibody by microneutralization and hemagglutination inhibition. Mild pain at the injection site was the most common adverse event for all doses of vaccine. The frequency of a serum antibody response was highest among subjects receiving doses of 45 microg or 90 microg. Among those who received two doses of 90 microg, neutralization antibody titers reached 1:40 or greater in 54 percent, and hemagglutination-inhibition titers reached 1:40 or greater in 58 percent. Neutralization titers of 1:40 or greater were seen in 43 percent, 22 percent, and 9 percent of the subjects receiving two doses of 45, 15, and 7.5 microg, respectively. No responses were seen in placebo recipients. A two-dose regimen of 90 mug of subvirion influenza A (H5N1) vaccine does not cause severe side effects and, in the majority of recipients, generates neutralizing antibody responses typically associated with protection against influenza. A conventional subvirion H5 influenza vaccine may be effective in preventing influenza A (H5N1) disease in humans. (ClinicalTrials.gov number, NCT00115986.). |
| Author | Campbell, James D Rowe, Thomas Treanor, John J Wolff, Mark Zangwill, Kenneth M |
| Author_xml | – sequence: 1 givenname: John J surname: Treanor fullname: Treanor, John J – sequence: 2 givenname: James D surname: Campbell fullname: Campbell, James D – sequence: 3 givenname: Kenneth M surname: Zangwill fullname: Zangwill, Kenneth M – sequence: 4 givenname: Thomas surname: Rowe fullname: Rowe, Thomas – sequence: 5 givenname: Mark surname: Wolff fullname: Wolff, Mark |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17639961$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/16571878$$D View this record in MEDLINE/PubMed |
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| Copyright | Copyright © 2006 Massachusetts Medical Society. All rights reserved. 2006 INIST-CNRS Copyright 2006 Massachusetts Medical Society. |
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| Keywords | Medicine Prevention Influenzavirus A(H5N1) Immunoprophylaxis Immune response Immunogenicity Toxicity Vaccine Safety |
| Language | English |
| License | CC BY 4.0 Copyright 2006 Massachusetts Medical Society. |
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| References | Cate TR (r018) 1982; 38 Walls HH (r011) 1986; 23 r020 r021 r022 r012 r023 Rowe T (r010) 1999; 37 r006 r017 r007 r019 r009 r002 r013 r024 (r008) 2005; 54 r014 r004 r015 r005 r016 16790710 - N Engl J Med. 2006 Jun 22;354(25):2724-5; author reply 2724-5 16795150 - N Engl J Med. 2006 Jun 22;354(25):2724-5; author reply 2724-5 16571885 - N Engl J Med. 2006 Mar 30;354(13):1411-3 |
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| Snippet | This trial involving 451 healthy adults assessed responses to two intramuscular doses of a subvirion H5N1 influenza vaccine. At the highest dose (90 μg of... Influenza A (H5N1) viruses could cause a severe worldwide epidemic, with high attack rates, large numbers of deaths and hospitalizations, and wide disruption.... Background Influenza A (H5N1) viruses could cause a severe worldwide epidemic, with high attack rates, large numbers of deaths and hospitalizations, and wide... |
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| SubjectTerms | Adolescent Adult Antibodies, Viral - blood Avian flu Biological and medical sciences Dose-Response Relationship, Drug Double-Blind Method Female General aspects Hemagglutination Inhibition Tests Humans Immunization, Secondary Influenza A Virus, H5N1 Subtype - immunology Influenza Vaccines - administration & dosage Influenza Vaccines - adverse effects Influenza Vaccines - immunology Influenza, Human - immunology Influenza, Human - prevention & control Male Medical sciences Middle Aged Vaccines Vaccines, Inactivated - administration & dosage Vaccines, Inactivated - adverse effects Vaccines, Inactivated - immunology Viruses |
| Title | Safety and Immunogenicity of an Inactivated Subvirion Influenza A (H5N1) Vaccine |
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