1. Yintoni uphononongo lwesitofu?

Isitofu sifundisa umzimba ukuba uthintele ulosuleleko oluthile okanye ulwe isifo. Ukuze kuphuhliswe isitofu, abaphandi kufuneka basivavanye ebantwini. Olunye uphononongo lwesitofu luvavanya ukuba ingaba isitofu sikhuselekile kusini na (asibangeli iingxaki zezempilo) kwaye ingaba imixokelelwano yamajoni omzimba yabantu iyasabela kusini na kwizitofu zophononongo. Umxokelelwano wamajoni omzimba wakho ukukhusela kwizifo. Olunye uphononongo lwesitofu lungasetyenziselwa nokufumanisa ukuba ingaba isitofu sisenokunceda na ukuthintela okanye ukulwa ulosuleleko okanye isifo. Kuthatha uphononongo oluninzi ukuvelisa isitofu esikhuselekileyo, esisebenzayo.

Okwangoku akukho sitofu sokulwa i-HIV okanye i-AIDS sinelayisensi.

2. Yintoni uphononongo lwe HVTN 705/HPX2008?

I-HVTN 705/HPX2008 ivavanya izitofu ezi-2 ezilingwayo zokulwa i-HIV. Ezi zitofu zophononongo kuthiwa yi-Ad26.Mos4.HIV ne-Clade C gp140. Ezi zitofu ziphuhliswe ngu-Janssen Vaccines & Prevention B.V. Ukusukela apha, siza kuthi yi-Ad26 neProtheni okanye zizitofu zophononongo.

Isitofu i-Ad26

Isitofu i-Ad26 senziwe ngentsholongwane ekuthiwa yi-Adenovirus type 26. Esi sitofu sinamalungu e-HIV afakiweyo kuso. Siyilelwe ukuxelela umzimba ukuba uvelise iiprotheni ezifanayo neeprotheni ezifunyanwa kwi-HIV. (Iiprotheni zizinto zendalo ezifunyanwa kuzo zonke izinto eziphilayo, ezifana nomzimba womntu nakwiintsholongwane ezifana ne-HIV.) Umxokelelwano wamajoni omzimbi usenokusabela kwezi kopi zeeprotheni ze-HIV zikwisitofu sophononongo. Oku kuthiwa kukusabela kwamajoni omzimba. Ukusabela kwamajoni omzimba kulungiselela umzimba ukuba uphawule ezi protheni zifanayo kwi-HIV uze uyilwe intsholongwane ukuba umntu uthe wasesichengeni se-HIV kwixesha elizayo. I-Adenovirus type 26 iyafumaneka jikelele kubom bamihla le kwaye ingabangela ingqele kunye nolosuleleko lwamajelo okuphefumla. Ukanti, le adenovirus isetyenziswa kwesi sitofu sophononongo yenziwe buthathaka ngoko ayinakho ukubangela ulosuleleko kwaye ayiyongozi ebantwini.

Isitofu seProtheni

Isitofu seProtheni, i-Clade C gp140, senziwe ngeprotheni efanayo neprotheni efunyanwa kumphezulu we-HIV. Naso sinakho ukuvelisa ukusabela kwamajoni omzimba.

Isitofu seProtheni kolu phononongo sidityaniswe nesiphembeleli ekuthiwa yi-Aluminum Phosphate.Isiphembeleli yinto egalelwa kwisitofu ukuphucula ukusabela kwamajoni omzimba. I-Alum isetyenziswa kwizitofu ezininzi ezixhaphakileyo ezifana nezo ze-Hepatitis A no-B, ne-diphtheria, kunye ne-tetanus.

Iimveliso ezisetyenziswa kolu phononongo azenziwanga nge-HIV ephilayo, nge-HIV eye yabulawa, okanye ngeeseli zabantu abosulelwe nge-HIV. Ezi zitofu zophononongo azinakho ukubangela ulosuleleko lwe-HIV okanye i-AIDS

Singakunika iinkcukacha ezinatyisiweyo malunga nezitofu zophononongo, ukuba uyafuna.

3. Ngawaphi amaziko abandakanyekayo kolu phononongo?

I-National Institute of Allergy and Infectious Diseases (NIAID) ne-HIV Vaccine Trials Network (HVTN) ne-Janssen Vaccines & Prevention B.V. ziye zaphuhlisa olu phononongo. I-Janssen Vaccines & Prevention B.V. ngumxhasi ngokomgaqo kwaye ikwabonelela ngezitofu zophononongo. I-NIAID yinxalenye ye-National Institutes of Health (NIH), eyinxalenye karhulumente waseMelika.

I-HVTN yintsebenziswano yamazwe ngamazwe yoosonzululwazi, abezemfundo, kunye namalungu oluntu aphanda isitofu se-HIV esisebenzayo nesikhuselekileyo. I-HVTN ixhaswa ngemali yi-NIAID kwaye olu uphononongo lukwaxhaswa ngemali yi-Bill & Melinda Gates Foundation ne-Janssen Vaccines & Prevention B.V.

4. Luza kuqhutywa nini, phi olu phononongo?

Olu phononongo lulindeleke ukuba luqalise ukubhalisa abathathi-nxaxheba pha ku-Okthobha ka-2017. Luya kwenziwa kwezi ndawo zilandelayo:

  • EMalawi: eLilongwe
  • E-Mozambique: eMaputo
  • EMzantsi Afrika: e-Bloemfontein, e-Brits, eKapa (Emavundleni, eKhayelitsha, naseMasiphumelele), eThekwini (e-Chatsworth, eThekwini, e-Isipingo, e-Tongaat nase-Verulam), e-Elansdoorn, e-Klerksdorp, e-Ladysmith, eMamelodi, eMedunsa, eMthatha, e-Rustenburg, eSoshanguve, eSoweto (eBara nase-Kliptown), eTembisa
  • E-Zambia: eLusaka naseNdola
  • EZimbabwe: eHarare

5. Kutheni kusenziwa olu phononongo?

Lonke uphononongo lwe-HVTN lusebenzela ukufezekisa ubizo lwethu lokufumana isitofu se-HIV esikhuselekileyo nesisebenzayo. Iinjongo ezingundoqo zolu phononongo zezi:

  • Kukuvavanya ukuba ingaba izitofu zophononongo zingaluthintelo ulosuleleko lwe-HIV kusini na
  • Kukubonelela ngeenkcukacha ezongezelelekileyo malunga nokhuseleko lwezitofu zophononongo
  • Kukusinika ufifi malunga nendlela isitofu esinokusebenza ngayo ukuthintela ulosuleleko lwe-HIV 

6. Bangaphi abantu abazakuba kolu phononongo, kwaye ngubani onokujoyina?

Uphononongo luza kubandakanya abathathi-nxaxheba abangamabhinqa abangama-2600.

Ukuze ujoyine olu phononongo, kufuneka amabhinqa abesempilweni, abephakathi kweminyaka eli-18 nengama-35 ubudala, abe engena-HIV. Akumelanga abe akhulelwe okanye abe ayancancisa. Kukho neminye imimiselo ekumele ifezekiswe. Siza kubuza la mabhiqa malunga nembali yawo yezonyango, siwaxilonge umzimba, kwaye sithathe iisampuli zegazi nezomchamo ukuze zivavanywe. Siza kubuza amabhinqa nangezenzo zawo zokwabelana ngesondo kunye nokusebenzisa kwawo iziyobisi.

7. Ingaba ezi zitofu zophononongo zikhuselekile na?

Asiyazi yonke imingcipheko yezi zitofu zophononongo kuba bezinikwe abantu abambalwa ngaphambili. Isitofu seProtheni besinikezelwe kubantu abamalunga nama-300 sabe isitofu i-Ad26 sinikezelwe kubantu abamalunga ne-110. Nangona kolo phononongo lwangaphambili kungakhange kubekho mntu uneengxaki zempilo ezimandundu ezinxulumene nezi zitofu zophononongo, kuhlala kukho ithuba lokuba kungakho iingxaki ezingalindelwanga mntu. Yiloo nto enye yeenjongo zolu phononongo ikukuvavanya ukuba ingaba ezi zitofu zikhuselekile na ukuba zinganikezelwa ebantwini abongezelelekileyo. Impilo yomthathi-nxaxheba ngamnye iya kujongisiswa ngocoselelo ngabongi nogqirha abaqeqeshiweyo ngexesha lophononongo liphela.

8. Ingaba ezi zitofu zophononongo zingabakhusela abathathi-nxaxheba bangosulelwa nge-HIV?

Abathathi-nxaxheba akumelanga balindele ukuba bakhuselwe kwi-HIV zezi zitofu. Eneneni, abathathi-nxaxheba basenokungazifumani izitofu kolu phononongo, kuba isiqingatha sabathathi-nxaxheba siza kufumana usinga-yeza. Usinga-yeza kolu phononongo ngamanzi abilisiweyo anetyuwa.

Olu phononongo luyilelwe ukufumanisa ukuba ingaba ezi zitofu ziyasebenza na ukuthintela okanye ukulwa i-HIV.

Kuba kungaziwa ukuba ingaba ezi zitofu ziza kuthintela i-HIV/i-AIDS, abathathi-nxaxheba kolu phononongo baya kucetyiswa ngeendlela zokuphepha ulosuleleko nge-HIV kwaye bagqithiselwe kwiindawo apho benokufikelela kwiindlela ezifumanekayo zothintelo lwe-HIV.

9. Kuza kuthatha ixesha elingakanani ukufumanisa ukuba ingaba ezi zitofu ziyasebenza na ukuthintela i-HIV?

Silindele ukufunda ukuba ingaba izitofu zophononongo ziyaluthintela na ulosuleleko nge-HIV kwiminyaka emalunga nemi-4. Kungenzeka sikufumanise kwakamsinyane oko. 

10. Ingaba impilo namalungelo abathathi-nxaxheba ziza kukhuselwa njani?

Ukukhusela impilo nokuhlonipha amalungelo abathathi-nxaxheba yinto ephambili kumntu wonke kwa-HVTN nakwi-Janssen Vaccines. Ngaphandle kwamavolontiya angekhe sikwazi ukusifumana isitofu se-HIV.

Inyathelo lokuqala ekukhuseleni amalungelo abathathi-nxaxheba kukuwanika ulwazi malunga nophononongo ngaphambi kokuba ajoyine. Abasebenzi basekliniki baza kunika abantu ulwazi malunga neemveliso kunye neenkqubo zophononongo, imingcipheko neenzuzo ezinokufunyanwa ngabathathi-nxaxheba, kunye namalungelo abanawo. Oku kuquka ilungelo lokufumana naluphi na ulwazi olutsha malunga nophononogo olunokuchaphazela ukuba ingaba bayafuna ukuhlala kusini na kuphononongo, kunye nelungelo lokushiya uphononongo nanini na.

Ebudeni bophononongo, abasebenzi basekliniki baza kubeka esweni abathathi-nxaxheba ukuze baqinisekise ukuba isitofu sophononongo asibabangeli naziphi na iingxaki zempilo. Abasebenzi basekliniki baza kubuza abathathi-nxaxheba nangeengxaki zezentlalo abahlangabezana nazo ngokuba kolu phononongo. Ukuba umthathi-nxaxheba unengxaki yempilo okanye yezentlalo enxulumene nokuba kolu phononongo, abasebenzi basekliniki baya kumnceda.

Kukwakho namaqela aliqela abandakanyekayo ekukhuselweni kwamalungelo nempilo-ntle yabathathi-nxaxheba:

  • Iqela lokuhlola ukhuseleko lophononongo kunye nebhodi ezimeleyo yokubeka esweni ukhuseleko bahlala bejonga iinkcukacha zempilo ezivela kuphonononongo ukuze benze isigqibo sokuba ingaba lubonakala lukhuselekile kusini na ukuba lungaqhubeka nokunikezela ngeenaliti zophononongo.
  • IBhodi yoHlolo lwaMaziko (Institutional Review Board - IRB) okanye iKomiti yeMigaqo yoKuziphatha (Ethics Committee - EC) bahlola baze babeke esweni isicwangciso sophononongo sekliniki nganye eqhuba uphononongo, kuquka nenkcazelo enikezelwa ebantwini malunga nophononongo, nenkqubela yophononongo, neengxaki zempilo kubathathi-nxaxheba. I-IRB/EC bakwajonga nokuba ingaba amalungelo abathathi-nxaxheba ayahlonitshwa na.
  • IBhunga loLawulo lwamaYeza loMzantsi Afrika, kwakunye noosomagunya bolawulo lukazwelonke bamanye amazwe, bongamela ukuqhutywa kophononongo kwaye bafune ingxelo rhoqo malunga nokhuseleko lwabathathi-nxaxheba.
  • I-Food & Drug Administration (FDA) yaseMelika nayo ikwahlola olu phononongo. I-FDA inyanzelisa imithetho yase-Melika malunga nophando ebantwini kunye nokusetyenziswa kwezitofu zophononongo kuphando.
  • Ikliniki nganye yophononongo ineKomiti yeZiko yoKhuseleko lweNdalo (Institutional Biosafety Committee – IBC) eyongamela indlela izitofu zophononongo ezilungiselelwa ngayo ekhemesti kunye nendlela ezisetyenziswa ngayo ekliniki.
  • Ezinye iikliniki zineeKomiti zemiGaqo yoKuziphatha ezikhethekileyo ezongamela iindawo apho iisampuli zegazi nezezinye izinto ziyagcinwa. Ezi ndawo kuthiwa ngoovimba bezendalo okanye ngoovimba.
  • Isebe leZolimo, lezamaHlathi kunye nokuLoba laseMzantsi Afrika (i-South Africa Department of Agriculture, Forestry, and Fisheries - DAFF) linebhodi ekhethekileyo ihlola nevumela zonke izicelo zokuthumela ngaphandle izinto ezitshintshwe imfuza ezifana nesitofu i-Ad26 kolu phononongo. 
  • Ikliniki nganye yophononongo ineBhodi yeeNgcebiso yoLuntu (Community Advisory Board - CAB). Amalungu ayo ngabantu basekuhlaleni abacebisa abaphandi nabeza nenkxalabo kunye neemfuno zoluntu kunye nabathathi-nxaxheba bophononongo kubaphandi. Amalungu e-CAB ayinxalenye yeqela eliphuhlisa uphononongo ngalunye. Bakwanceda ukuphuhlisa okanye ukuhlola inkcazelo enikezelwa kubathathi-nxaxheba.

11. Ingaba izitofu zophononongo zingabangela iziphumo ezithi une-HIV kuvavanyo lwe-HIV?

Ewe, izitofu zophononongo zisenakho ukubangela ukuba abathathi-nxaxheba babeneziphumo ezithi bane-HIV kwiintlobo ezithile zovavanyo lwe-HIV. Ukuba umthathi-nxaxheba ufumana isitofu sophononongo se-HIV, umzimba wakhe usenokwenza izilwi-ntsholongwane ze-HIV. Izilwi-ntsholongwane zikunceda ulwe ulosuleleko. Uvavanyo oluqhelekileyo lwe-HIV lukhangela izilwi-ntsholongwane ze-HIV njengophawu lokuba wosulelekile. Ngenxa yoku, umntu anganeziphumo zovavanyo ezithi une-HIV nokuba akosulelwanga nge-HIV. Oku kuthiwa sisiphumo sovavanyo esibonisa ingathi une-HIV esibangelwa sisitofu (yi-vaccine-induced seropositive - VISP). Usenakho nokuyibona le nto kusithiwa yi-Vaccine-Induced Seroreactive (i-VISR). Asazi ukuba ngubani oyakuba neziphumo zovavanyo ezine-VISP okanye ezi ziphumo zovavanyo ziya kuhlala ixesha elingakanani.

Abantu abaneziphumo zovavanyo ezine-VISP bafuna uvavanyo lwe-HIV oluthile ukuze kufunyaniswe ukuba ingaba iziphumo zabo zovavanyo zithe bane-HIV ngenxa ye-VISP okanye bosuleleke nyani. Iikliniki ezithatha inxaxheba kolu phononongo ziyakwazi ukufikelela kolu vavanyo lukhangela ubuqu bentsholongwane endaweni yokukhangela izilwi-ntsholongwane. Abathathi-nxaxheba kulingo kumele bavavanywe kwiikliniki ezithatha inxaxhea kolu phononongo. 

Akukho ziingxaki zezempilo zayanyaniswa nesiphumo sovavanyo esine-VISP, kodwa iziphumo zovavanyo ezine-VISP zisenokubangela iingxaki kwiinkalo eziliqela ezifana nonakekelo lwezonyango okanye olwamazinyo, nezengqesho, ne-inshorensi, i-visa yokukhenketha, okanye ukungena emkhosini. Abantu basenakho nokungavunyelwa ukuba baphise ngegazi okanye ngamanye amalungu. Ukuba abathathi-nxaxheba baceba ukwenza isicelo se-inshorensi, sengqesho okanye sokungena emkhosini mabachazele isayithi yophononongo ngoko nangoko. Inkampani ye-inshorensi, umqeshi okanye i-arhente yasemkhosini isenokungazamkeli iziphumo zovavanyo lwe-HIV ezivela kwi-HVTN. Kodwa ke, i-HVTN ingasebenza kunye nabo ukuqinisekisa ukuba kwenziwa uvavanyo olulungileyo oluya kubonisa ubume bakho be-HIV bokwenene. Ukuba unezi zilwi-ntsholongwane uze ukhulelwe, zingagqithiselwa elusaneni, luze nalo lufunyaniswe njengolune-HIV ngoku lungenayo, luze lunikwe unyango. Ikliniki yophando ingakunika ikopi yeziphumo zakho ukuze uzisebenzise kuyo nayiphi na kwezi ndawo ukuba oku kuyimfuneko. 

12. Ndingayifumana phi inkcazelo ethe vetshe?

Malunga nophononongo lwezonyango lwesitofu se-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 eyongezelelekileyo ebingaphendulwanga lolu xwebhu, nceda usibuze. Ungaqhagamshelana: [email protected]