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Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus H5N1 Influenza Vaccine in Chronically Ill and Immunocompromised Patients
- Source :
- Clinical and Vaccine Immunology. 21:867-876
- Publication Year :
- 2014
- Publisher :
- American Society for Microbiology, 2014.
-
Abstract
- The development of vaccines against H5N1 influenza A viruses is a cornerstone of pandemic preparedness. Clinical trials of H5N1 vaccines have been undertaken in healthy subjects, but studies in risk groups have been lacking. In this study, the immunogenicity and safety of a nonadjuvanted cell culture-derived whole-virus H5N1 vaccine were assessed in chronically ill and immunocompromised adults. Subjects received two priming immunizations with a clade 1 A/Vietnam H5N1 influenza vaccine, and a subset also received a booster immunization with a clade 2.1 A/Indonesia H5N1 vaccine 12 to 24 months later. The antibody responses in the two populations were assessed by virus neutralization and single radial hemolysis assays. The T-cell responses in a subset of immunocompromised patients were assessed by enzyme-linked immunosorbent spot assay (ELISPOT). The priming and the booster vaccinations were safe and well tolerated in the two risk populations, and adverse reactions were predominantly mild and transient. The priming immunizations induced neutralizing antibody titers of ≥1:20 against the A/Vietnam strain in 64.2% of the chronically ill and 41.5% of the immunocompromised subjects. After the booster vaccination, neutralizing antibody titers of ≥1:20 against the A/Vietnam and A/Indonesia strains were achieved in 77.5% and 70.8%, respectively, of chronically ill subjects and in 71.6% and 67.5%, respectively, of immunocompromised subjects. The T-cell responses against the two H5N1 strains increased significantly over the baseline values. Substantial heterosubtypic T-cell responses were elicited against the 2009 pandemic H1N1 virus and seasonal A(H1N1), A(H3N2), and B subtypes. There was a significant correlation between T-cell responses and neutralizing antibody titers. These data indicate that nonadjuvanted whole-virus cell culture-derived H5N1 influenza vaccines are suitable for immunizing chronically ill and immunocompromised populations. (This study is registered at ClinicalTrials.gov under registration no. NCT00711295.)
- Subjects :
- Male
Microbiology (medical)
H5N1 vaccine
Influenza vaccine
T-Lymphocytes
Clinical Biochemistry
Immunology
Immunization, Secondary
Cross Reactions
Antibodies, Viral
Lymphocyte Activation
medicine.disease_cause
Cell Line
Immunocompromised Host
Influenza A Virus, H1N1 Subtype
Chlorocebus aethiops
Influenza, Human
Influenza A virus
medicine
Animals
Humans
Immunology and Allergy
Neutralizing antibody
Vero Cells
Vaccines
Influenza A Virus, H5N1 Subtype
biology
Influenza A Virus, H3N2 Subtype
Immunogenicity
Vaccination
virus diseases
Hemagglutination Inhibition Tests
Middle Aged
Antibodies, Neutralizing
Virology
Influenza A virus subtype H5N1
Influenza B virus
Immunization
Influenza Vaccines
Antibody Formation
Chronic Disease
biology.protein
Female
Subjects
Details
- ISSN :
- 1556679X and 15566811
- Volume :
- 21
- Database :
- OpenAIRE
- Journal :
- Clinical and Vaccine Immunology
- Accession number :
- edsair.doi.dedup.....ea98f9bcd536664191f7afd66a4fa14d