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Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the Cologne-Bonn cohort
OBJECTIVE: To evaluate the acceptance and tolerability of the nH1N1 2009 vaccine in HIV-positive individuals. METHOD: 758 patients were included in this prospective study. Different study populations were formed: The Tolerability Study Group consists of HIV-infected patients who visited three outpat...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3352000/ https://www.ncbi.nlm.nih.gov/pubmed/21813369 http://dx.doi.org/10.1186/2047-783X-16-7-289 |
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author | Steffens, B Kümmerle, T Koch, S Birtel, A Schwarze-Zander, C Emmelkamp, J Kern, WV Hertenstein, C Wyen, C Lehmann, C Cornely, OA Rockstroh, J Fätkenheuer, G |
author_facet | Steffens, B Kümmerle, T Koch, S Birtel, A Schwarze-Zander, C Emmelkamp, J Kern, WV Hertenstein, C Wyen, C Lehmann, C Cornely, OA Rockstroh, J Fätkenheuer, G |
author_sort | Steffens, B |
collection | PubMed |
description | OBJECTIVE: To evaluate the acceptance and tolerability of the nH1N1 2009 vaccine in HIV-positive individuals. METHOD: 758 patients were included in this prospective study. Different study populations were formed: The Tolerability Study Group consists of HIV-infected patients who visited three outpatient clinics (Cologne, Bonn, Freiburg) during a predefined time period. Patients were offered nH1N1 vaccination. Those accepting were administered a standard dose AS03 adjuvant nH1N1 vaccine. Questionnaires to report side effects occurring within 7 days after immunization were handed out. In a substudy conducted during the same time period, acceptance towards immunization was recorded. This Acceptance Study Group consists of all HIV-infected patients visiting the Cologne clinic. They were offered vaccination. In case of refusal, motivation was recorded. RESULTS: In the Tolerability Study Group, a total of 475 patient diaries returned in the three study centres could be evaluated, 119 of those (25%) reported no side effects. Distribution of symptoms was as follows: Pain 285/475 patients (60%), swelling 96 (20%), redness 54 (11%), fever 48/475 (10%), muscle/joint ache 173 (36%), headache 127 (27%), and fatigue 210 (44%). Association of side effects with clinical data was calculated for patients in Cologne and Bonn. Incidence of side effects was significantly associated with CDC stages A, B compared to C, and with a detectable viral load (> 50 copies/mL). No correlation was noted for CD4 cell count, age, gender or ethnicity. In the Acceptance Study Group, 538 HIV-infected patients were offered vaccination, 402 (75%) accepted, while 136 (25%) rejected. Main reasons for rejection were: Negative media coverage (35%), indecisiveness with preference to wait until a later date (23%), influenza not seen as personal threat (19%) and scepticism towards immunization in general (10%). CONCLUSION: A total of 622 HIV-infected patients were vaccinated against nH1N1-influenza in the three study centres. No severe adverse events were reported. The tolerability was in most parts comparable to general population. Acceptance rate towards influenza vaccination was high (75%). Those refusing the immunization mentioned negative media coverage as the major influence on their decision. |
format | Online Article Text |
id | pubmed-3352000 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-33520002012-05-16 Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the Cologne-Bonn cohort Steffens, B Kümmerle, T Koch, S Birtel, A Schwarze-Zander, C Emmelkamp, J Kern, WV Hertenstein, C Wyen, C Lehmann, C Cornely, OA Rockstroh, J Fätkenheuer, G Eur J Med Res Research OBJECTIVE: To evaluate the acceptance and tolerability of the nH1N1 2009 vaccine in HIV-positive individuals. METHOD: 758 patients were included in this prospective study. Different study populations were formed: The Tolerability Study Group consists of HIV-infected patients who visited three outpatient clinics (Cologne, Bonn, Freiburg) during a predefined time period. Patients were offered nH1N1 vaccination. Those accepting were administered a standard dose AS03 adjuvant nH1N1 vaccine. Questionnaires to report side effects occurring within 7 days after immunization were handed out. In a substudy conducted during the same time period, acceptance towards immunization was recorded. This Acceptance Study Group consists of all HIV-infected patients visiting the Cologne clinic. They were offered vaccination. In case of refusal, motivation was recorded. RESULTS: In the Tolerability Study Group, a total of 475 patient diaries returned in the three study centres could be evaluated, 119 of those (25%) reported no side effects. Distribution of symptoms was as follows: Pain 285/475 patients (60%), swelling 96 (20%), redness 54 (11%), fever 48/475 (10%), muscle/joint ache 173 (36%), headache 127 (27%), and fatigue 210 (44%). Association of side effects with clinical data was calculated for patients in Cologne and Bonn. Incidence of side effects was significantly associated with CDC stages A, B compared to C, and with a detectable viral load (> 50 copies/mL). No correlation was noted for CD4 cell count, age, gender or ethnicity. In the Acceptance Study Group, 538 HIV-infected patients were offered vaccination, 402 (75%) accepted, while 136 (25%) rejected. Main reasons for rejection were: Negative media coverage (35%), indecisiveness with preference to wait until a later date (23%), influenza not seen as personal threat (19%) and scepticism towards immunization in general (10%). CONCLUSION: A total of 622 HIV-infected patients were vaccinated against nH1N1-influenza in the three study centres. No severe adverse events were reported. The tolerability was in most parts comparable to general population. Acceptance rate towards influenza vaccination was high (75%). Those refusing the immunization mentioned negative media coverage as the major influence on their decision. BioMed Central 2011-07-25 /pmc/articles/PMC3352000/ /pubmed/21813369 http://dx.doi.org/10.1186/2047-783X-16-7-289 Text en Copyright ©2011 I. Holzapfel Publishers |
spellingShingle | Research Steffens, B Kümmerle, T Koch, S Birtel, A Schwarze-Zander, C Emmelkamp, J Kern, WV Hertenstein, C Wyen, C Lehmann, C Cornely, OA Rockstroh, J Fätkenheuer, G Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the Cologne-Bonn cohort |
title | Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the Cologne-Bonn cohort |
title_full | Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the Cologne-Bonn cohort |
title_fullStr | Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the Cologne-Bonn cohort |
title_full_unstemmed | Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the Cologne-Bonn cohort |
title_short | Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the Cologne-Bonn cohort |
title_sort | acceptance and tolerability of an adjuvanted nh1n1 vaccine in hiv-infected patients in the cologne-bonn cohort |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3352000/ https://www.ncbi.nlm.nih.gov/pubmed/21813369 http://dx.doi.org/10.1186/2047-783X-16-7-289 |
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