tetano
Editor, Senior Moderator
PLoS One. 2011;6(11):e27214. Epub 2011 Nov 8.
Immunogenicity and Reactogenicity of 2009 Influenza A (H1N1) Inactivated Monovalent Non-Adjuvanted Vaccine in Elderly and Immunocompromised Patients.
Miraglia JL, Abdala E, Hoff PM, Luiz AM, Oliveira DS, Saad CG, Laurindo IM, Viso AT, Tayra A, Pierrotti LC, Azevedo LS, Campos LM, Aikawa NE, Timenetsky Mdo C, Luna E, Cardoso MR, Guedes Jda S, Raw I, Kalil J, Precioso AR.
Source
Butantan Institute - Clinical Trials Division, S?o Paulo, Brazil.
Abstract
BACKGROUND:
Immunosuppressed individuals present serious morbidity and mortality from influenza, therefore it is important to understand the safety and immunogenicity of influenza vaccination among them.
METHODS:
This multicenter cohort study evaluated the immunogenicity and reactogenicity of an inactivated, monovalent, non-adjuvanted pandemic (H1N1) 2009 vaccine among the elderly, HIV-infected, rheumatoid arthritis (RA), cancer, kidney transplant, and juvenile idiopathic arthritis (JIA) patients. Participants were included during routine clinical visits, and vaccinated according to conventional influenza vaccination schedules. Antibody response was measured by the hemagglutination-inhibition assay, before and 21 days after vaccination.
RESULTS:
319 patients with cancer, 260 with RA, 256 HIV-infected, 149 elderly individuals, 85 kidney transplant recipients, and 83 with JIA were included. THE PROPORTIONS OF SEROPROTECTION, SEROCONVERSION, AND THE GEOMETRIC MEAN TITER RATIOS POSTVACCINATION WERE, RESPECTIVELY: 37.6%, 31.8%, and 3.2 among kidney transplant recipients, 61.5%, 53.1%, and 7.5 among RA patients, 63.1%, 55.7%, and 5.7 among the elderly, 59.0%, 54.7%, and 5.9 among HIV-infected patients, 52.4%, 49.2%, and 5.3 among cancer patients, 85.5%, 78.3%, and 16.5 among JIA patients. The vaccine was well tolerated, with no reported severe adverse events.
CONCLUSIONS:
The vaccine was safe among all groups, with an acceptable immunogenicity among the elderly and JIA patients, however new vaccination strategies should be explored to improve the immune response of immunocompromised adult patients. (ClinicalTrials.gov, NCT01218685).
PMID:
22087267
[PubMed - in process]
PMCID: PMC3210772
Free full text
http://www.ncbi.nlm.nih.gov/pubmed/22087267
Immunogenicity and Reactogenicity of 2009 Influenza A (H1N1) Inactivated Monovalent Non-Adjuvanted Vaccine in Elderly and Immunocompromised Patients.
Miraglia JL, Abdala E, Hoff PM, Luiz AM, Oliveira DS, Saad CG, Laurindo IM, Viso AT, Tayra A, Pierrotti LC, Azevedo LS, Campos LM, Aikawa NE, Timenetsky Mdo C, Luna E, Cardoso MR, Guedes Jda S, Raw I, Kalil J, Precioso AR.
Source
Butantan Institute - Clinical Trials Division, S?o Paulo, Brazil.
Abstract
BACKGROUND:
Immunosuppressed individuals present serious morbidity and mortality from influenza, therefore it is important to understand the safety and immunogenicity of influenza vaccination among them.
METHODS:
This multicenter cohort study evaluated the immunogenicity and reactogenicity of an inactivated, monovalent, non-adjuvanted pandemic (H1N1) 2009 vaccine among the elderly, HIV-infected, rheumatoid arthritis (RA), cancer, kidney transplant, and juvenile idiopathic arthritis (JIA) patients. Participants were included during routine clinical visits, and vaccinated according to conventional influenza vaccination schedules. Antibody response was measured by the hemagglutination-inhibition assay, before and 21 days after vaccination.
RESULTS:
319 patients with cancer, 260 with RA, 256 HIV-infected, 149 elderly individuals, 85 kidney transplant recipients, and 83 with JIA were included. THE PROPORTIONS OF SEROPROTECTION, SEROCONVERSION, AND THE GEOMETRIC MEAN TITER RATIOS POSTVACCINATION WERE, RESPECTIVELY: 37.6%, 31.8%, and 3.2 among kidney transplant recipients, 61.5%, 53.1%, and 7.5 among RA patients, 63.1%, 55.7%, and 5.7 among the elderly, 59.0%, 54.7%, and 5.9 among HIV-infected patients, 52.4%, 49.2%, and 5.3 among cancer patients, 85.5%, 78.3%, and 16.5 among JIA patients. The vaccine was well tolerated, with no reported severe adverse events.
CONCLUSIONS:
The vaccine was safe among all groups, with an acceptable immunogenicity among the elderly and JIA patients, however new vaccination strategies should be explored to improve the immune response of immunocompromised adult patients. (ClinicalTrials.gov, NCT01218685).
PMID:
22087267
[PubMed - in process]
PMCID: PMC3210772
Free full text
http://www.ncbi.nlm.nih.gov/pubmed/22087267