A Clinical Trial of a Whole-Virus H5N1 Vaccine Derived from Cell Culture
There is a need for a vaccine against avian influenza (H5N1). In this initial study, the administration of two doses of a whole-virus H5N1 vaccine derived from Vero cell culture was shown to induce neutralizing-antibody responses to clades 1, 2, and 3 of H5N1 virus strains. The administration of two...
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| Published in | The New England journal of medicine Vol. 358; no. 24; pp. 2573 - 2584 |
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| Main Authors | , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Boston, MA
Massachusetts Medical Society
12.06.2008
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| Subjects | |
| Online Access | Get full text |
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| Abstract | There is a need for a vaccine against avian influenza (H5N1). In this initial study, the administration of two doses of a whole-virus H5N1 vaccine derived from Vero cell culture was shown to induce neutralizing-antibody responses to clades 1, 2, and 3 of H5N1 virus strains.
The administration of two doses of a whole-virus H5N1 vaccine derived from Vero cell culture was shown to induce neutralizing-antibody responses to clades 1, 2, and 3 of H5N1 virus strains.
The emergence of a new human influenza pandemic caused by an avian virus strain is possible. Vaccination against pandemic influenza is considered to be the most effective option to limit its spread. However, the conventional approaches to the manufacture of influenza vaccines have a number of disadvantages and raise concern about whether sufficient quantities of an effective vaccine can be made available early enough at the onset of a pandemic to have a major effect on public health.
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In addition, clinical studies of conventional split-vaccine formulations without adjuvant have shown poor immunogenicity.
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It has been suggested that whole-virus vaccines . . . |
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| AbstractList | Widespread infections of avian species with avian influenza H5N1 virus and its limited spread to humans suggest that the virus has the potential to cause a human influenza pandemic. An urgent need exists for an H5N1 vaccine that is effective against divergent strains of H5N1 virus.
In a randomized, dose-escalation, phase 1 and 2 study involving six subgroups, we investigated the safety of an H5N1 whole-virus vaccine produced on Vero cell cultures and determined its ability to induce antibodies capable of neutralizing various H5N1 strains. In two visits 21 days apart, 275 volunteers between the ages of 18 and 45 years received two doses of vaccine that each contained 3.75 microg, 7.5 microg, 15 microg, or 30 microg of hemagglutinin antigen with alum adjuvant or 7.5 microg or 15 microg of hemagglutinin antigen without adjuvant. Serologic analysis was performed at baseline and on days 21 and 42.
The vaccine induced a neutralizing immune response not only against the clade 1 (A/Vietnam/1203/2004) virus strain but also against the clade 2 and 3 strains. The use of adjuvants did not improve the antibody response. Maximum responses to the vaccine strain were obtained with formulations containing 7.5 microg and 15 microg of hemagglutinin antigen without adjuvant. Mild pain at the injection site (in 9 to 27% of subjects) and headache (in 6 to 31% of subjects) were the most common adverse events identified for all vaccine formulations.
A two-dose vaccine regimen of either 7.5 microg or 15 microg of hemagglutinin antigen without adjuvant induced neutralizing antibodies against diverse H5N1 virus strains in a high percentage of subjects, suggesting that this may be a useful H5N1 vaccine. (ClinicalTrials.gov number, NCT00349141.) There is a need for a vaccine against avian influenza (H5N1). In this initial study, the administration of two doses of a whole-virus H5N1 vaccine derived from Vero cell culture was shown to induce neutralizing-antibody responses to clades 1, 2, and 3 of H5N1 virus strains. The administration of two doses of a whole-virus H5N1 vaccine derived from Vero cell culture was shown to induce neutralizing-antibody responses to clades 1, 2, and 3 of H5N1 virus strains. The emergence of a new human influenza pandemic caused by an avian virus strain is possible. Vaccination against pandemic influenza is considered to be the most effective option to limit its spread. However, the conventional approaches to the manufacture of influenza vaccines have a number of disadvantages and raise concern about whether sufficient quantities of an effective vaccine can be made available early enough at the onset of a pandemic to have a major effect on public health. 1 In addition, clinical studies of conventional split-vaccine formulations without adjuvant have shown poor immunogenicity. 2 , 3 It has been suggested that whole-virus vaccines . . . Background Widespread infections of avian species with avian influenza H5N1 virus and its limited spread to humans suggest that the virus has the potential to cause a human influenza pandemic. An urgent need exists for an H5N1 vaccine that is effective against divergent strains of H5N1 virus. Methods In a randomized, dose-escalation, phase 1 and 2 study involving six subgroups, we investigated the safety of an H5N1 whole-virus vaccine produced on Vero cell cultures and determined its ability to induce antibodies capable of neutralizing various H5N1 strains. In two visits 21 days apart, 275 volunteers between the ages of 18 and 45 years received two doses of vaccine that each contained 3.75 μg, 7.5 μg, 15 μg, or 30 μg of hemagglutinin antigen with alum adjuvant or 7.5 μg or 15 μg of hemagglutinin antigen without adjuvant. Serologic analysis was performed at baseline and on days 21 and 42. Results The vaccine induced a neutralizing immune response not only against the clade 1 (A/Vietnam/1203/2004) virus strain but also against the clade 2 and 3 strains. The use of adjuvants did not improve the antibody response. Maximum responses to the vaccine strain were obtained with formulations containing 7.5 μg and 15 μg of hemagglutinin antigen without adjuvant. Mild pain at the injection site (in 9 to 27% of subjects) and headache (in 6 to 31% of subjects) were the most common adverse events identified for all vaccine formulations. Conclusions A two-dose vaccine regimen of either 7.5 μg or 15 μg of hemagglutinin antigen without adjuvant induced neutralizing antibodies against diverse H5N1 virus strains in a high percentage of subjects, suggesting that this may be a useful H5N1 vaccine. (ClinicalTrials.gov number, NCT00349141 .) Widespread infections of avian species with avian influenza H5N1 virus and its limited spread to humans suggest that the virus has the potential to cause a human influenza pandemic. An urgent need exists for an H5N1 vaccine that is effective against divergent strains of H5N1 virus.BACKGROUNDWidespread infections of avian species with avian influenza H5N1 virus and its limited spread to humans suggest that the virus has the potential to cause a human influenza pandemic. An urgent need exists for an H5N1 vaccine that is effective against divergent strains of H5N1 virus.In a randomized, dose-escalation, phase 1 and 2 study involving six subgroups, we investigated the safety of an H5N1 whole-virus vaccine produced on Vero cell cultures and determined its ability to induce antibodies capable of neutralizing various H5N1 strains. In two visits 21 days apart, 275 volunteers between the ages of 18 and 45 years received two doses of vaccine that each contained 3.75 microg, 7.5 microg, 15 microg, or 30 microg of hemagglutinin antigen with alum adjuvant or 7.5 microg or 15 microg of hemagglutinin antigen without adjuvant. Serologic analysis was performed at baseline and on days 21 and 42.METHODSIn a randomized, dose-escalation, phase 1 and 2 study involving six subgroups, we investigated the safety of an H5N1 whole-virus vaccine produced on Vero cell cultures and determined its ability to induce antibodies capable of neutralizing various H5N1 strains. In two visits 21 days apart, 275 volunteers between the ages of 18 and 45 years received two doses of vaccine that each contained 3.75 microg, 7.5 microg, 15 microg, or 30 microg of hemagglutinin antigen with alum adjuvant or 7.5 microg or 15 microg of hemagglutinin antigen without adjuvant. Serologic analysis was performed at baseline and on days 21 and 42.The vaccine induced a neutralizing immune response not only against the clade 1 (A/Vietnam/1203/2004) virus strain but also against the clade 2 and 3 strains. The use of adjuvants did not improve the antibody response. Maximum responses to the vaccine strain were obtained with formulations containing 7.5 microg and 15 microg of hemagglutinin antigen without adjuvant. Mild pain at the injection site (in 9 to 27% of subjects) and headache (in 6 to 31% of subjects) were the most common adverse events identified for all vaccine formulations.RESULTSThe vaccine induced a neutralizing immune response not only against the clade 1 (A/Vietnam/1203/2004) virus strain but also against the clade 2 and 3 strains. The use of adjuvants did not improve the antibody response. Maximum responses to the vaccine strain were obtained with formulations containing 7.5 microg and 15 microg of hemagglutinin antigen without adjuvant. Mild pain at the injection site (in 9 to 27% of subjects) and headache (in 6 to 31% of subjects) were the most common adverse events identified for all vaccine formulations.A two-dose vaccine regimen of either 7.5 microg or 15 microg of hemagglutinin antigen without adjuvant induced neutralizing antibodies against diverse H5N1 virus strains in a high percentage of subjects, suggesting that this may be a useful H5N1 vaccine. (ClinicalTrials.gov number, NCT00349141.)CONCLUSIONSA two-dose vaccine regimen of either 7.5 microg or 15 microg of hemagglutinin antigen without adjuvant induced neutralizing antibodies against diverse H5N1 virus strains in a high percentage of subjects, suggesting that this may be a useful H5N1 vaccine. (ClinicalTrials.gov number, NCT00349141.) |
| Author | Tambyah, Paul A Müller, Markus Fritsch, Sandor Vartian, Nina Barrett, P. Noel Fisher, Dale Pöllabauer, Eva Maria Berezuk, Greg Ehrlich, Hartmut J Oh, Helen M.L Bobrovsky, Roman Pavlova, Borislava G Joukhadar, Christian Löw-Baselli, Alexandra Montomoli, Emanuele Kistner, Otfried |
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| Contributor | Lambers, C Loke, C W P Kraft, M Chua, S K Zeitlinger, M Robotka, E Yap, S Y Foo, A S Chuin, S Thallinger, C Phillipson, L Toh, E L Brunner, M Konior, R Fong, R Leitner, I Geyer, S Sodeck, G Sauermann, R Ng, J Y C Marsik, C Abrahim, A Yew, L H Leitgeb, M C Hsu, L Y Maritsch, F Griss, J Poeppl, W Goh, J W L Marth, E Sonnenburg, F Lackner, E Lim, P K Langer, O Schaberl, R Dvorak, T Zhou, Y P Popovic, M Weatherill, P Bauer, M Cornea, A Koh, A G Erdogan, Z Heinisch, B Traunmueller, F Birthistle, K Drucker, C Kovar, F Wagner, C |
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| Copyright | Copyright © 2008 Massachusetts Medical Society. All rights reserved. 2008 INIST-CNRS 2008 Massachusetts Medical Society |
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| Snippet | There is a need for a vaccine against avian influenza (H5N1). In this initial study, the administration of two doses of a whole-virus H5N1 vaccine derived from... Widespread infections of avian species with avian influenza H5N1 virus and its limited spread to humans suggest that the virus has the potential to cause a... Background Widespread infections of avian species with avian influenza H5N1 virus and its limited spread to humans suggest that the virus has the potential to... |
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| SubjectTerms | Adjuvants, Immunologic - administration & dosage Adult Animals Antibodies, Viral - blood Avian flu Biological and medical sciences Cercopithecus aethiops Cross Reactions Female General aspects Humans Immunization Influenza A Virus, H5N1 Subtype - immunology Influenza Vaccines - administration & dosage Influenza Vaccines - adverse effects Influenza Vaccines - immunology Influenza, Human - immunology Influenza, Human - prevention & control Injections, Intramuscular - adverse effects Male Medical sciences Neutralization Tests Pandemics Prevention and actions Public health. Hygiene Public health. Hygiene-occupational medicine Vaccines Vero Cells |
| Title | A Clinical Trial of a Whole-Virus H5N1 Vaccine Derived from Cell Culture |
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