A Clinical Trial of a Whole-Virus H5N1 Vaccine Derived from Cell Culture

• Published in: The New England journal of medicine Vol. 358; no. 24; pp. 2573 - 2584
• Main Authors: Ehrlich, Hartmut J, Müller, Markus, Oh, Helen M.L, Tambyah, Paul A, Joukhadar, Christian, Montomoli, Emanuele, Fisher, Dale, Berezuk, Greg, Fritsch, Sandor, Löw-Baselli, Alexandra, Vartian, Nina, Bobrovsky, Roman, Pavlova, Borislava G, Pöllabauer, Eva Maria, Kistner, Otfried, Barrett, P. Noel
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 12.06.2008
• Subjects: 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; Medicine; Prevention; Virus; Influenzavirus A(H5N1); Cell culture; Immunoprophylaxis; Clinical trial; Vaccine
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa073121

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 . . .