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, Rockstroh J, Cornely Oa, Fätkenheuer G

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.

Sujets

• Influenza
• HIV
• Vaccine
• Tolerability
• Adverse Events
• SAFETY
• Acceptance

Informations

• Publié par: biomed
• Publié le: 01 janvier 2011
• Nombre de lectures: 8
• Langue: English
• Poids de l'ouvrage: 1 Mo

Extrait

JULY 25, 2011

EUr J MeD Res (2011) 16: 289-294

EuRoPEAn JouRnAl oF MEdIcAl RESEARcH

289 © I. HOLzapfeL PUbLishers 2011

A ccEPtAncE And t olERABIlIty oF An A dJuvAntEd n H1n1 v AccInE In HIv- InFEctEd P AtIEntS In tHE c olognE -B onn c oHoRt

1 11 12 23 B. STeffeNs *, t. KümmerLe *, S. KOCh , A. BirTeL , c. SChwarze-ZaNDer , J. EmmeLkamp , W. v. KerN , 1 1#1# 1,4 21# c. HerTeNsTeiN , c. WYeN, c. lehmaNN, o. A. cOrNeLY, J. ROCksTrOh , g. FäTkeNheUer

1 sT 1 deparTmeNTOf 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

Abstract Objective:tO eVaLUaTe The aCCepTaNCe aND TOLerabiLiTY Of TheNH1n1 2009 VaCCiNe iN HIv-pOsiTiVe iNDiViDU- aLs. Method:758 paTieNTs were iNCLUDeD iN This prOspeCTiVe sTUDY. differeNT sTUDY pOpULaTiONs were fOrmeD: the tOLerabiLiTY STUDY grOUp CONsisTs OfHIv-iNfeCTeD pa- TieNTs whO VisiTeD Three OUTpaTieNT CLiNiCs (cOLOGNe, BONN, FreibUrG) DUriNG a preDefiNeD Time periOD. Pa- TieNTs were OffereD NH1n1 VaCCiNaTiON. thOse aCCepT- iNG were aDmiNisTereD a sTaNDarD DOse AS03 aDjUVaNT NH1n1 VaCCiNe. QUesTiONNaires TO repOrT siDe effeCTs OCCUrriNG wiThiN 7 DaYs afTer immUNizaTiON were haND- eD OUT. IN a sUbsTUDY CONDUCTeD DUriNG The same Time peri- OD, aCCepTaNCe TOwarDs immUNizaTiON was reCOrDeD. this ACCepTaNCe STUDY grOUp CONsisTs OfaLL HIv-iN- feCTeD paTieNTs VisiTiNG The cOLOGNe CLiNiC . theY were OffereD VaCCiNaTiON. IN Case OfrefUsaL, mOTiVaTiON was reCOrDeD. Results:IN The tOLerabiLiTY STUDY grOUp, a TOTaL Of475 paTieNT Diaries reTUrNeD iN The Three sTUDY CeNTres COULD be eVaLUaTeD, 119 OfThOse (25%) repOrTeD NO siDe effeCTs. disTribUTiON OfsYmpTOms was as fOLLOws: PaiN 285/475 paTieNTs (60%), sweLLiNG 96 (20%), reD- Ness 54 (11%), feVer 48/475 (10%), mUsCLe/jOiNT aChe 173 (36%), heaDaChe 127 (27%), aND faTiGUe 210 (44%). AssOCiaTiON OfsiDe effeCTs wiTh CLiNiCaL DaTa was CaLCULaTeD fOr paTieNTs iN cOLOGNe aND BONN. INCi- DeNCe OfsiDe 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%), iN- fLUeNza NOT seeN as persONaL ThreaT (19%) aND sCepTi- Cism TOwarDs immUNizaTiON iN GeNeraL (10%).

* BOThaUThOrs haVe CONTribUTeD eqUaLLY TO The sTUDY. # SUppOrTeD bei „BUNDesmiNisTeriUm für BiLDUNG UND FOrsChUNG“ (BMBF) GraNT 01 KI 0771

Conclusion:A TOTaL Of622 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 VaCCi- NaTiON was hiGh (75%). thOse refUsiNG The immUNiza- TiON meNTiONeD NeGaTiVe meDia COVeraGe as The majOr iNfLUeNCe ON Their DeCisiON.

Key words:NH1n1, iNfLUeNza, HIv, VaCCiNe, TOLerabiLi- TY, aDVerse eVeNTs, safeTY, aCCepTaNCe

I ntRoductIon

A NOVeL swiNe-OriGiN iNfLUeNza A (H1n1) VirUs sTraiN was firsT DesCribeD iN ApriL 2009 iN MexiCO aND The uSA [1]. IT rapiDLY spreaD wOrLDwiDe aND CaUseD a LarGe NUmber OfiNfeCTiONs aND DeaThs. IN germaNY, The firsT Cases were iDeNTifieD iN ApriL [2], NUmbers rOse TO mOre ThaN 15.000 DOCUmeNTeD Cases UNTiL The eND OfAUGUsT [3] aND The firsT aTTribUTabLe DeaTh iN germaNY OCCUrreD iN SepTember 2009 [4]. the WHo DeCLareD a paNDemiC iN JUNe 2009, whiCh, iN germaNY, LeD TO The impLemeNTaTiON Ofa pre-exisTiNG paNDemia emerGeNCY pLaN (hTTp://www. rki.De/CLN_160/NN_1960682/dE/cONTeNT/INfAZ/I/ INfLUeNza/INfLUeNzapaNDemiepLaN.hTmL; LasT aCCesseD SepTember 20, 2010). AmONG OTher reCOmmeNDaTiONs aND GUiDeLiNes, This pLaN reCOmmeNDeD aCTiVe immU- NizaTiON as The mOsT effeCTiVe apprOaCh TO reDUCe iLL- Ness aND DeaTh frOm paNDemiC iNfLUeNza baseD ON a risk-beNefiT aNaLYsis. IN SepTember 2009, The EUrOpeaN cOmmissiON LiCeNseD TwO aDjUVaNT VaCCiNes, OfwhiCh ® The mONOVaLeNT AS03 aDjUVaNT VaCCiNe PaNDemrix ® was UseD iN germaNY [5]. PaNDemrixCONTaiNs iNaCTi- VaTeD, spLiT iNfLUeNza VirUs wiTh aNTiGeN eqUiVaLeNT TO A/caLifOrNia/7/2009 (H1n1)V-Like sTraiN (X-179A). oN oCTOber 2ND 2009, The FeDeraL germaN vaCCi- NaTiON cOmmiTTee (StIKo) issUeD a COmmON reCOm- ® meNDaTiON fOr The immUNizaTiON wiTh PaNDemrix, iN parTiCULar fOr peOpLe aGeD 6 Years aND OLDer wiTh iN- CreaseD heaLTh risks as CONseqUeNCe OfaN UNDerLYiNG ChrONiC Disease [6]. these reCOmmeNDaTiONs iNCLUDe paTieNTs wiTh HIv iNfeCTiON.