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Open Access Research

Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the Cologne-Bonn cohort

B Steffens1, T Kümmerle1, S Koch1, A Birtel1, C Schwarze-Zander2, J Emmelkamp2, WV Kern3, C Hertenstein1, C Wyen1, C Lehmann1, OA Cornely14, J Rockstroh2 and G Fätkenheuer1*

Author Affiliations

1 Department of Internal Medicine, University of Cologne, Cologne, Germany

2 Department of Medicine, University of Bonn, Bonn, Germany

3 Center for Infectious Diseases and Travel Medicine, University Hospital Freiburg, Freiburg, Germany

4 Zentrum für Klinische Studien - ZKS Köln, BMBF 01KN0706, CIO KölnBonn, and Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Cologne, Germany

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European Journal of Medical Research 2011, 16:289-294  doi:10.1186/2047-783X-16-7-289

Published: 25 July 2011

Abstract

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.

Keywords:
nH1N1; influenza; HIV; vaccine; tolerability; adverse events; safety; acceptance