IER – IMIBUZO EBUZWA RHOQO

1. Yintoni isitofu esiphantsi kophando?

Isitofu sifundisa amajoni omzimba ukuba athintele usulelo oluthile okanye alwe isifo esithile. Amajoni omzimba akho akukhusela kwisifo. Ukuze kuveliswe isitofu, abaphandi kufuneka basivavanye ebantwini. Uphando lwesitofu luvavanya ukuba sikhuselekile na isitofu (asidali zingxaki zempilo kusini na) nokuba amajoni omzimba abantu ayasamkela na isitofu esiphantsi kophando. Isitofu esiphantsi kophando kananjalo singasetyenziswa ukujonga ukuba isitofu singathintela okanye silwe usulelo okanye isifo. Kuthatha isitofu esiphantsi kophando esininzi ukuvelisa isitofu esikhuselekileyo nesisebenzayo.

Ngoku asikho isitofu se-HIV okanye sikaGAWULAYO esinelayisensi yokuba sisetyenziswe naphi na ehlabathini.

2. Luyintoni uphando lwe-HVTN 702?

I-HVTN 702 ivavanya indibanisela ezimbini zesitofu esivavanywayo se-HIV. Isitofu esiphantsi kophando sibizwa i-ALVAC-HIV (vCP2438) ne-Bivalent Subtype C gp120/MF59. Esi sitofu sibonelelwa yi-Sanofi Pasteur ne-GlaxoSmithKline (i-GSK) ngokwahlukahlukeneyo.

Singakunika iinkcukacha ezithe vetshe ngesitofu esiphantsi kophando, ukuba ungathanda.

Isiqithanga sabathathi-nxaxheba abakolu phando siza kufumana usinga-yeza endaweni yesitofu esiphantsi kophando. Usingayeza yinaliti engenalo iyeza eliphantsi kophando. Kolu phando, usinga-yeza ngamanzi anetyuwa nje.

3. Ingaba kusetyenziswa i-HIV yoqobo kwezi zitofu zophononongo?

Hayi! AKUSETYENZISWA uqobo lwe-HIV ukwenza izitofu ezisetyenziswa kolu phononongo.

Izitofu zezinye izifo zisenokwenziwa ngeentlobo zale ntsholongwane ibangela eso sifo ezenziwe buthathaka. Ukanti le ndlela AYISETYENZISWA ekwenziweni kwezitofu ze-HIV. Izitofu ezisetyenziswa kolu phononongo azenziwanga nge-HIV ephilayo, nge-HIV ebuleweyo, okanye ngamalungu athatyathwe kwi-HIV okanye ngeeseli zomntu ezosulelwe nge-HIV. Zenziwe ngezinto eziyiliweyo ukuze zikhangeleke njengamalungu amancinci e-HIV kumxokelelwano wamajoni omzimba. Izitofu zophononongo azinakho ukubangela ulosuleleko lwe-HIV okanye i-AIDS.

4. Ziintoni izitofu ezisetyenziswa kolu phononongo?

Esinye isitofu sophononongo, i-ALVAC vCP2438, yenziwe ngentsholongwane ekuthiwa yi-canarypox. Isitofu sophononongo siyilelwe ukuyalela umzimba ukuba wenze iiprotini ezifunyanwa kwi-HIV. Iiprotini zizinto zemvelo. Zinceda ekwakheni nasekugcineni umzimba wakho, kwaye zenze kwale nto inye kwiintsholongwane ezifana ne-HIV. Amajoni omzimba anokusabela kwezi protini. Oku kubizwa ukwamkelwa ngamajoni ozimba. Ukwamkelwa ngamajoni omzimba lulungiselela umzimba uqonde iiprotini ze-HIV uze ulwe intsholongwane ukuba umntu uthe wasesichengeni se-HIV kwixesha elizayo.

Esinye isitofu, i-Bivalent Subtype C gp120, yenziwe ngeeprotini ezimbini ezifana neeprotini ezifunyanwa kwi-HIV. Oku nako kungavelisa ukusabela kwamajoni omzimba. Isitofu i-Bivalent Subtype C gp120 inikezelwa kunye ne-adjuvant. I-adjuvant lulwelo olongezelelwe kwisitofu ukuze kwandiswe ukwamkelwa ngamajoni omzimba. I-adjuvant ibizwa i-MF59. I-adjuvant isetyenziswa kwizitofu ezithengiswayo ezifumanekayo (umz. isitofu somkhuhlane esifumaneka ngamaxesha athile ekuthiwa yi-Fluad®) ukuze kwandiswe ukwamkelwa ngamajoni omzimba ebantwini abadala nakwiimveku. Ngaphezu kwamathamo ali-100 ezigidi zezitofu ezine-MF59 zihanjisiwe kwihlabathi liphela.

5. Yeyiphi imibutho ebandakanyeka kolu phando?

I-National Institute of Allergy and Infectious Diseases (i-NIAID) ne-HIV Vaccine Trials Network (i-HVTN) zivelise olu phando, kwakunye neenkampani ezibonelela ngezitofu eziphantsi kophando, i-Sanofi-Pasteur ne-GSK. I-NIAID yinxalenye yamaZiko eSizwe ezeMpilo (i-National Institutes of Health), ayinxalenye yorhulumente wase-United States. Inkxaso yolu phando ikwabonelelwa liBhunga lezoNyango loPhononongo loMzantsi Afrika (i-SAMRC).

I-HVTN yintsebenziswano yeenzululwazi zamazwe ngamazwe, abafundisi-ntsapho neenkokeli zokuhlala ezikhangela izitofu ze-HIV ezisebenzayo nezikhuselekileyo. I-HVTN ixhaswa yi-NIAID. Inkxaso yophuhliso lwesi sitofu novavanyo lophononongo lwe-HVTN 702 ikwabonelelwa yi-Bill & Melinda Gates Foundation.

6. Olu phando luza kwenziwa nini kwaye luza kwenzelwa phi?

Uphando luqae ukubhalisa abathathi-nxaxheba ngomhla wama-26 ku-Okthobha 2016. Lwenziwa eMzantsi Afrika kwezi ndawo: e-Brits, eKapa (Emavundleni naseKhayelitsha), eThekwini (eThekwini, Isipingo,nase-Verulam), e-Klerksdorp, e-Ladysmith, e-Ga-Raankuwa, eMthatha, e-Rustenburg, e-Soshanguve, e-Soweto (eBara nase-Kliptown), naseTembis.

7. Kutheni kusenziwa olu phando nje?

Wonke umsebenzi wophando lwe-HVTN usebenzela injongo yethu yokufumana isitofu se-HIV esisebenzayo nesikhuselekileyo. Ezona njongo ziphambili zophando:

  • Ukuvavanya ukuba isitofu esiphantsi kophando singaluthintela kusini na usulelo lwe-HIV,
  • Ukubonelela ngeenkcukacha ezithe vetshe ezingokhuseleko lwesitofu esiphantsi kophando, kunye
  • Nokuhlola ukuba kungenzeka na esi sitofu sibenephepha-mvume lokuthengiswa eMzantsi Afrika.

8. Bangaphi abantu abaza kuba kolu phando, kwaye ngubani ongajoyina?

Uphando luza kubandakanya abathathi-nxaxheba abangama-5400.

Ukuze ujoyine olu phando, kufanele umntu abesempilweni, abephakathi kwe-18 nama-35 ubudala, abe akosulelwanga yi-HIV. Abakwazi ukuba bakhulelwe okanye babe bayancancisa. Zikhona nezinye iinqobo ekufanele babenazo. Siza kubuza abantu ngembali yabo yezempilo, sibaxilonge, size sithathe iisampulu zegazi nezomchamo ukuze zivavanywe. Kananjalo siza kubuza abantu ngokuzibandakanya kwabo kwezesondo nangokusebenzisa iziyobisi.

9. Ingaba esi sitofu siphantsi kophando sikhuselekile na?

Kwa esi stofu sinye sinikwe abantu abangama-210 eMzantsi Afrika kuphando olubizwa i-HVTN 100. Esi sitofu sifanayo sinikwe ngaphezu kwama-8000 abantu kuvavanyo lophononongo elibizwa i-RV144 e-Thailand nakulingo lwezonyango eMelika, eFransi, e-South America nase-Caribbean. Khange kubekho ngxaki zempilo ezinobuzaza ezayanyaniswe nesi sitofu. Noko kunjalo, soloko likhona ithuba lokuba zikhona ingxaki ezingakhange zibonwe ngaphambili. Yiyo loo nto enye yenjongo yolu phando ikukuvavanya isitofu ukuba sikhuselekile na xa sinikwa abantu abaninzi. Impilo yomthathi-nxaxheba ngamnye iza kuqwalaselwa de kugqitywe uphando.

Isitofu esikwi-RV144 khange siqulathe i-MF59, esetyenziswa kwesinye isitofu kolu phando. I-MF59 yi-adjuvant, ulwelo olwenza amajoni omzimba amkele ngamandla isitofu. I-MF59 isetyenziswa nesitofu somkhuhlane esinikwa abantu kumazwe amaninzi rhoqo ngonyaka. Isitofu esisetyenziswe kolu phando asenziwanga nge-HIV ephilayo, i-HIV ebulelweyo, amasuntswana amalungu athathwe kwi-HIV, okanye kwiiseli zomntu ezosulelwe yi-HIV. Isitofu esiphantsi kophando asinakudala usulelo lwe-HIV okanye UGAWULAYO.

10. Ingaba esi sitofu siphantsi kophando singabakhusela na abathathi-nxaxheba ekosulelweni yi-HIV?

Abathathi-nxaxheba akufuneki bacingele ukuba esi sitofu siphantsi kophando siza kubakhusela kwi-HIV. Enyanisweni, abathathi-nxaxheba basenokungafumani isitofuesiphantsi kophando kolu phando, ngenxa yokuba isiqingatha sabathathi-nxaxheba bazakufumana oosinga-yeza.

Olu phando lwenziwa ukuze kufunyanwe isitofu esiphantsi kophando esingathintela i-HIV. Ukuba lwenza njalo, uphando oluninzi lungafuneka ukuze kuqinisekiswe oku.

Kuba singazi ukuba isitofu esiphantsi kophando sizakuthintela i-HIV/UGAWULAYO, abathathi-nxaxheba bazakucetyiswa ngendlela ekufuneka bephephe ngayo usulelo lwe-HIV kwaye bagqithiselwe kwiindawo apho benokufikelela kwiindlela zothintelo lwe-HIV ezifumanekayo.

11. Kuzakuthatha ixesha elingakanani ukufumanisa ukuba isitofu esiphantsi kophando siyasebenza na?

Silende ukufunda ukuba isitofu esiphantsi kophando sizakuthintela usulelo lwe-HIV kwisithuba seminyaka emi-5. Kusenokwenzeka ukuba sazi kwamsinya

12. Luza kukhuselwa njani ukheseleko, impilo namalungelo abathathi-nxaxheba?

Ukukhusela impilo nokuhlonipha amalungelo abathathi-nxaxheba zizinto zokuqala ezibalulekileyo ekufuneka zenziwe kwi-HVTN. Ngaphandle kwamavolontiya, asisokuze sikwazi ukufumana isitofu se-HIV.

Inyathelo lokuqala ekukhuseleni amalungelo abathathi-nxaxheba kuphando kukubanika ulwazi malunga nophando phambi kokuba bajoyine. Abasebenzi basekliniki bazakunika abantu ulwazi malunga neemveliso neenkqubo zophando, imingcipheko enokubakho noncedo kubathathi-nxaxheba, kwanamalungelo abanawo. Oku kuquka ilungelo lokufumana ulwazi olutsha malunga nophando olunokuchaphazela nokuba basafuna ukuhlala kulo na, kwanelungelo lokushiya uphando nangaliphi na ixesha.

Ngexesha lophando, abasebenzi basekliniki baza kujonga abathathi-nxaxheba ukuqinisekisa ukuba isitofu sophando asibangeli naziphi na iingxaki zempilo. Abasebenzi basekliniki nabo baza kubuza abathathi-nxaxheba malunga ngazo naziphi na iingxaki zokuhlala abanokuba badibana nazo ngokuba kuphando. Ukuba umthathi-nxaxheba unengxaki yempilo okanye yokuhlala enxulumene nokuba kuphando, abasebenzi basekliniki baza kuzama ukubanceda.

Kukwakho namanye amaqela abandakanyeka ekukhuseleni amalungelo nentlalo-ntle yabathathi-nxaxheba:

  • Iqela eliqwalasela ukhuseleko lophando neBhodi ezimeleyo eJonga iiNgcombolo noKhuseleko (i-Data and Safety Monitoring Board - DSMB) rhoqo zijonga kulwazi lwezempilo kuphando ukuze zithathe isigqibo ukuba kubonakala kukhuselekile na ukuqhubekeka nophando.
  • IBhodi yoQwalaselo yeZiko (i-IRB) okanye iKomiti yeNdlela yokuziphatha (i-EC) ziqwalasela ze zijonge isicwangciso sophando sekliniki nganye eyenza uphando, kuquka ulwazi olunikwa abantu malunga nophando, inkqubela-phambili yophando, neengxaki zempilo kubathathi-nxaxheba. I-IRB/EC nayo ikwajonga ukheseleko lwabathathi-nxaxheba nokuba ingaba amalungelo abathathi-nxaxheba ayahlonitshwa kusini na.
  • IBhunga loLawulo lwamaYeza lwaseMzantsi Afrika longamela ukuqhutywa kophononongo kwaye lifuna iingxelo rhoqo ngokhuseleko lwabathathi-nxaxheba.
  • Ikliniki nganye ineKomiti yeZiko ye-Biosafety (i-Institutional Biosafety Committee - IBC) ejonga indlela esilungiselelwa ngayo isitofu esiphantsi kophando ekhemesti nendlela esisetyenziswa ngayo ekliniki.
  • Ezinye iikliniki zineeKomiti zeendlela zokuziPhatha ezijonga iindawo apho kuthi kugcinwe igazi neesampulu khona. Ezi ndawo kuthiwa zii-bio-bank okanye oovimba.
  • ISebe lezoLimo, elamaHlathi nelozokuLoba (i-DAFF) laseMzantsi Afrika linebhodi eyodwa ekumele iqwalasele ize iphumeze zonke izicelo zokuzisa iimathiriyali ezingento zemvelo (i-GMO). Oko kuquka esinye isitofu kolu phando.
  • Ikliniki yophando nganye ineBhodi yeNgcebiso zoLuntu (i-CAB). Amalungu ayo ngabantu bokuhlala abaza neenkxalabo nemidla yoluntu nabathathi-nxaxheba bophando kubaphandi. Amalungu e-CAB ayinxalenye yeqela elivelisa uphando ngalunye. Bakwancedisa ekuveliseni okanye ekuqwalaseleni ulwazi olunikwe abathathi-nxaxheba. Abathathi-nxaxheba bakwanikwa iingcebiso ngeendlela ezipheleleyo zokuthintela ulosuleleko lwe-HIV.

13. Ingaba isitofu sophando singabangela isiphumo esithi une-HIV kuvavanyo lwe-HIV?

Ewe, isitofu esiphantsi kophando sisenokwenza umthathi-nxaxheba athi xa evavanywa afunyaniswe enentsholongwane kwezinye iindidi zeemvamvanyo ze-HIV. Ukuba umthathi-nxaxheba ufumana isitofu sophando se-HIV, umzimba wakhe ungenza izithinteli-ntsholongwane egazini (i-antibodies) kwi-HIV. Izithinteli-ntsholongwane egazini zikunceda ukuba ulwe usulelo. Uphando lovavanyo lwe-HIV olusemgangathweni lukhangela izithinteli-ntsholongwane egazini ze-HIV njengophawu losulelo. Ngenxa yoku, umntu anganeziphumo zovavanyo lwe-HIV ezimfumanisa enentsholongwane nokuba abosulelwanga nge-HIV. Ezi ziphumo zovavanyo zibizwa i-vaccine-induced seropositive (i-VISP). Usenokubona oku kubizwa i-Vaccine-Induced Seroreactive. Asazi ukuba ngubani ozakuba neziphumo zovavanyo lwe-VISP okanye zingathatha ixesha elide kangakanani ezi ziphumo.

Abantu abaneziphumo zovavanyo lwe-VISP bafuna uvavanyo lwe-HIV oluthile ukuqinisekisa ukuba isiphumo sovavanyo lokufunyaniswa unentsholongwane lubangelwa yi-VISP okanye usuleleko lokwenene. Iikliniki ezithatha inxaxheba kolu phando zinako ukufikelela kwimvamvanyo ezithile ezikhangela intsholongwane ngokwazo endaweni yokukhangela izithinteli ntsholongwane.

Azikho iingxaki zempilo ezinxulumene nesiphumo sovavanyo lwe-VISP, kodwa iziphumo zovavanyo lwe-VISP zinokubangela iingxaki kukhathalelo lwempilo okanye lwamazinyo, kwimisebenzi ethile, i-inshorensi, okanye i-visa yokusebenza okanye yokuhambela kumazwe athile. Abantu abaneziphumo zovavanyo lwe-VISP basenokungavunyelwa ukuba banikezele ngegazi okanye ngamanye amalungu omzimba. Abantu abanomdla wokujoyina uphando nabaceba ukwenza isicelo se-inshorensi, okanye sengqesho, kufanele bathethe neziko lophando malunga noku kwamsinya. Inkampani ye-insorensi, umqeshi, okanye i-arhente yomkhosi inokungazamkeli iziphumo zovavanyo lwe-HIV ezivela kwi-HVTN. Nangona kunjalo, i-HVTN ingasebenzisana nabo ukuqinisekisa uvavanyo olululo luyenziwa oluzakuthi lubonise imeko yomntu ye-HIV yokwenene.

14. Ndingalufumana phi ulwazi oluthe vetshe?

Ngesitofu esiphantsi kophando lophononongo lwe-HIV: www.clinicaltrials.gov

Malunga ne-HIV Vaccine Trials Network: www.hvtn.org

Malunga ne-VISP: http://www.hvtn.org/en/participants/visp-hiv-testing.html

Ukuba unemibuzo eyongezelelweyo engaphendulwanga lolu xwebhu, nceda sibuze. 

Ungaqhagamshelana: [email protected]