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. 2011 Jul 25;16(7):289-94.
doi: 10.1186/2047-783x-16-7-289.

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

B Steffens  1 , T Kümmerle, S Koch, A Birtel, C Schwarze-Zander, J Emmelkamp, W V Kern, C Hertenstein, C Wyen, C Lehmann, O A Cornely, J Rockstroh, Gerd Fätkenheuer
Affiliations

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

B Steffens et al. Eur J Med Res. .

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.

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Figures

Figure 1
Figure 1
Profile of participants in this study.
Figure 2
Figure 2
Reasons to reject the vaccination. HIV infected patients, visiting the outpatient clinic in Cologne in a predefined time period and generally suitable for an active immunization, were offered a pandemic influenza vaccination. If rejected, reasons for the refusal were recorded with the help of the preset answers 1-8. (total N = 136)
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