title: Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the Cologne-Bonn cohort.
abstract: OBJECTIVE
  To evaluate the acceptance and tolerability of the nH1N1 2009 vaccine in HIV-positive individuals.
  
  
  METHODS
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Cologne, Department of Internal Medicine I, Kerpener Str. 62, 50924 Köln, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Steffens
authors.forename: T
authors.initials: T
authors.lastname: Kümmerle
authors.forename: S
authors.initials: S
authors.lastname: Koch
authors.forename: A
authors.initials: A
authors.lastname: Birtel
authors.forename: C
authors.initials: C
authors.lastname: Schwarze-Zander
authors.forename: J
authors.initials: J
authors.lastname: Emmelkamp
authors.forename: W V
authors.initials: WV
authors.lastname: Kern
authors.forename: C
authors.initials: C
authors.lastname: Hertenstein
authors.forename: C
authors.initials: C
authors.lastname: Wyen
authors.forename: C
authors.initials: C
authors.lastname: Lehmann
authors.forename: O A
authors.initials: OA
authors.lastname: Cornely
authors.forename: J
authors.initials: J
authors.lastname: Rockstroh
authors.forename: Gerd
authors.initials: G
authors.lastname: Fätkenheuer
mesh_terms: D000328:Adult; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D014611:Vaccination / Q000523:psychology
chemical_list: D007252:Influenza Vaccines