FAQ – IMIBUZO EBUZWA NJALO

1. Luyini ucwaningo lomuthi wokugoma?

Umuthi wokugoma ufundisa amasosha omzimba ukuthi anqande igciwane noma alwe nesifo esithile. Amasosha akho omzimba akuvikela ezifweni. Ukuze bathake umuthi wokugoma, abacwaningi kudingeka bawuhlole kubantu. Ucwaningo lomuthi wokugoma luhlola ukuthi ingabe imithi yokugoma yocwaningo iphephile yini (ayizidali izinkinga zempilo) nokuthi ingabe amasosha omzimba abantu ayasabela yini emithini yokugoma. Ucwaningo lomuthi wokugoma wocwaningo lungasetshenziselwa nokuthola ukuthi ingabe imithi yokugoma ingalinqanda yini noma ilwe nalo igciwane noma isifo esiqondiwe. Kuthatha ucwaningo oluningi lomuthi wokugoma ukukhiqiza umuthi wokugoma ophephile nosebenzayo.

Okwamanje awukho umuthi wokugomela i-HIV noma ingculaza onelayisensi yokusetshenziswa noma kuphi emhlabeni.

2. Luyini ucwaningo lwe-HVTN 702?

I-HVTN 702 ihlola inhlanganisela yemithi emibili yokugomela i-HIV esavivinywa. Imithi yokugoma yocwaningo ibizwa nge-ALVAC-HIV (vCP2438) ne-Bivalent Subtype C gp120/MF59. Le mithi yokugoma ihlinzekwa yi-Sanofi Pasteur ne-GlaxoSmithKline (GSK).

Singakunika ulwazi oluningiliziwe mayelana nemithi yokugoma yocwaningo, uma ufisa.

Ababambiqhaza abayisigamu kulolu cwaningo bazothola i-placebo esikhundleni semithi yokugoma yocwaningo. I-placebo iwumjovo ongenawo umuthi wokugoma wocwaningo. Kulolu cwaningo, i-placebo ingamanzi ahlanzekile anosawoti.

3. Ingabe kusetshenziswa i-HIV yangempela emithini yokugoma yocwaningo?

Cha! AKUSETSHENZISWA i-HIV yangempela ekwenzeni imithi yokugoma esetshenziswa kulolu cwaningo.

Imithi yokugomela ezinye izifo ingase yenziwe ngezinhlobo ezibuthaka zegciwane elidala leso sifo. Kodwa-ke AKUSETSHENZISWA indlela efanayo ekwenzeni imithi yokugomela i-HIV. Imithi yokugoma esetshenziswa kulolu cwaningo ayenziwa nge-HIV ephilayo, i-HIV ebulewe, izingxenye ezithathwe ku-HIV, noma amaseli omuntu anegciwane le-HIV. Yenziwa ngezinto ezenzelwe ukubukeka njengezingxenyana ezincane ze-HIV emasosheni omzimba. Imithi yokugoma yocwaningo ayikwazi ukudala i-HIV noma ingculaza.

4. Yimiphi imithi yokugoma esetshenziswa kulolu cwaningo?

Omunye wemithi yocwaningo, i-ALVAC vCP2438, wenziwa ngegciwane okuthiwa i-canarypox. Umuthi wokugoma wocwaningo wenzelwe ukutshela umzimba ukuthi wenze amaphrotheni anjengalawo atholakala ku-HIV. Amaphrotheni ayizinto zemvelo. Asiza ekwakheni nasekulondolozeni umzimba wakho, futhi enza okufanayo nakumagciwane anjenge-HIV. Amasosha omzimba angase athinteke ngenxa yala maphrotheni. Lokhu kuthiwa ukusabela kwamasosha omzimba. Ukusabela kwamasosha omzimba (immune response) kulungiselela umzimba ukuthi ubone amaphrotheni afanayo aku-HIV futhi ulwe negciwane uma umuntu echayeka ku-HIV esikhathini esizayo.

Omunye umuthi wokugoma, i-Bivalent Subtype C gp120, wenziwe ngamaphrotheni amabili afana namaphrotheni atholakala ku-HIV. Lokhu nakho kungadala ukusabela kwamasosha omzimba.

Umuthi wokugoma i-Bivalent Subtype C gp120 unikezwa kanye nesithasiselo. Isithasiselo siwutho olunezelwa emuthini wokugoma ukuze lwandise ukusabela kwamasosha omzimba. Isithasiselo kuthiwa i-MF59. Lesi sithasiselo sisetshenziswa emithini yokugoma edayiswayo (isib., umuthi i-Fluad® wokugomela umkhuhlane ngezikhathi ezithile zonyaka) ukuze kushukunyiswe amasosha omzimba kubantu abadala nabantwana. Sekusakazwe amadosi emithi yokugoma angaphezu kwezigidi eziyi-100 ane-MF59 emhlabeni wonke.

5. Yiziphi izinhlangano ezibandakanyekayo kulolu cwaningo?

I-National Institute of Allergy and Infectious Diseases (NIAID) kanye ne-HIV Vaccine Trials Network (HVTN) zasungula lolu cwaningo, kanye nezinkampani ezisakaza imithi yokugoma yocwaningo, i-Sanofi Pasteur ne-GSK. I-NIAID iyingxenye ye-National Institutes of Health (NIH), eyingxenye kahulumeni wase-United States. Lolu cwaningo lusekelwa nayi-Medical Research Council yaseNingizimu Afrika (i-SAMRC).

I-HVTN iwumfelandawonye wamazwe ngamazwe wososayensi, othisha, namalungu omphakathi afuna umuthi osebenza nophephile wokugomela i-HIV. I-HVTN ixhaswa yi-NIAID ngezimali.

Ukwesekwa kokuthaka le mithi yokugoma kanye nesivivinyo socwaningo se-HVTN 702 sivela naku-Bill & Melinda Gates Foundation.

6. Lolu cwaningo luyokwenziwa nini futhi kuphi?

Ucwaningo lwaqala ukubhalisa ababambiqhaza ngomhla ka-26 Okthoba 2016. Lwenziwa eNingizimu Afrika kulezi zindawo: E-Brits, eKapa (Emavundleni naseKhayelitsha), eThekwini (eThekwini, eSipingo, nase-Verulam), e-Klerksdorp, eMnambithi, eGa-Rankuwa, eMthatha, e-Rustenburg, eSoshanguve, eSoweto (e-Bara nase-Kliptown), kanye naseTembisa.

7. Kungani kwenziwa lolu cwaningo?

Lonke ucwaningo lwe-HVTN lusebenzela umgomo wethu wokuthola umuthi wokugomela i-HIV ophephile nosebenzayo. Izinhloso eziyinhloko zocwaningo yilezi:

  • Ukuhlola ukuthi ingabe imithi yokugoma ingalivimbela yini igciwane le-HIV,
  • Ukunikeza ulwazi oluthe xaxa mayelana nokuphepha kwemithi yokugoma yocwaningo, kanye
  • Nokuhlaziya ukuthi kungenzeka yini ukugunyaza le mithi yokugoma ukuze ithengiswe eNingizimu Afrika.

8. Bangaki abantu abazoba kulolu cwaningo, futhi obani abangajoyina?

Ucwaningo luzoba nababambiqhaza abangaba ngu-5400.

Ukuze ajoyine lolu cwaningo, umuntu kufanele abe nempilo enhle, abe neminyaka ephakathi kweyi-18 nengama-35 ubudala, futhi angabi negciwane le-HIV. Akufanele abe ekhulelwe noma encelisa ibele. Kukhona nezinye izimfuneko okufanele zifinyelelwe. Sizobuza abantu mayelana nomlando wabo wezokwelashwa, sibaxilonge umzimba, futhi sithathe amasampula egazi nomchamo ayohlolwa. Sizobuza abantu nangokuziphatha kwabo kwezocansi nokusebenzisa izidakamizwa.

9. Ingabe le mithi yokugoma yocwaningo iphephile?

Le mithi efanayo yokugoma yocwaningo yanikezwa abantu abangama-210 eNingizimu Afrika ocwaningweni okuthiwa i-HVTN 100. Imithi yokugoma efana nse yanikezwa abantu abangaphezu kwezi-8000 esivivinyweni sezokwelapha okuthiwa i-RV144 eThailand nasezivivinyweni zezokwelapha e-United States, e-France, eNingizimu Melika, nase-Caribbean. Azikho izinkinga ezinkulu zempilo ezake zavela ezihlobene nale mithi yokugoma. Kodwa-ke, kuhlale kunethuba lokuthi kuvele iezinkinga ezingakabonakali okwamanje. Yingakho enye inhloso yalolu cwaningo iwukuhlola ukuthi ingabe le mithi yokugoma iphephile uma inikwa abantu abaningana. Impilo yombambiqhaza ngamunye izonakekelwa ngokucophelela kulo lonke ucwaningo.

Imithi yokugoma ye-RV144 yayingahlanganisi ne-MF59, esetshenziswa komunye wemithi yokugoma yalolu cwaningo. I-MF59 iyisithasiselo, utho olusiza amasosha omzimba asabele kangcono emuthini wokugoma. I-MF59 isetshenziswa emithini yokugomela umkhuhlane enikwa abantu emazweni amaningi unyaka nonyaka.

Imithi yokugoma esetshenziswa kulolu cwaningo ayenziwanga nge-HIV ephilayo, i-HIV ebulewe, izingxenye ezithathwe ku-HIV, noma amaseli abantu anegciwane le-HIV. Le mithi yokugoma yocwaningo ngeke idale i-HIV noma ingculaza.

10. Ingabe le mithi yokugoma yocwaningo ingabavikela ababambiqhaza bangangenwa yi-HIV?

Ababambiqhaza akufanele bacabange ukuthi le mithi yokugoma yocwaningo izobavikela ku-HIV. Empeleni, ababambiqhaza bangase bangayitholi imithi yokugoma yocwaningo kulolu cwaningo, ngoba isigamu sababambiqhaza siyothola ama-placebo.

Lolu cwaningo lwenzela ukuthola ukuthi ingabe imithi yokugoma yocwaningo ingayivimbela yini i-HIV. Uma iyivimbela, kungase kudingeke ucwaningo oluthe xaxa lokuqinisekisa lokhu. Ngenxa yokuthi asazi ukuthi imithi yokugoma yocwaningo iyoyivimbela yini i-HIV/AIDS, ababambiqhaza bazolulekwa ngokuthi bangaligwema kanjani igciwane le-HIV futhi bayothunyelwa ezikhungweni lapho bengathola khona izindlela ezitholakalayo zokuvimbela i-HIV.

11. Kuyothatha isikhathi esingakanani ukuthola ukuthi ingabe imithi yokugoma yocwaningo iyasebenza yini?

Kule minyaka engaba mi-5 ezayo, silindele ukufunda ukuthi ingabe imithi yokugoma yocwaningo iyakuvimbela yini ukungenwa yi-HIV. Kungenzeka sazi ngaphambi kwalokho.

12. Ukuphepha, impilo, namalungelo ababambiqhaza kuzovikelwa kanjani?

Ukuvikela impilo nokuhlonipha amalungelo ababambiqhaza kuseqhulwini kuwo wonke umuntu e-HVTN. Ngaphandle kwamavolontiya, besingeke sikwazi ukuthola imithi yokugomela i-HIV.

Isinyathelo sokuqala sokuvikela amalungelo ababambiqhaza bocwaningo ukubanika ulwazi mayelana nocwaningo ngaphambi kokuthi bajoyine. Izisebenzi zasemtholampilo ziyonika abantu ulwazi ngemikhiqizo nezinqubo zocwaningo, izingcuphe ezingaba khona nezinzuzo kubabambiqhaza, kanye namalungelo abanawo. La malungelo ahlanganisa ilungelo lokuthola noma iluphi ulwazi olusha mayelana nocwaningo olungaba nomthelela wokuthi bayahlala yini kulo, kanye nelungelo lokushiya ucwaningo nganoma yisiphi isikhathi.

Ngesikhathi socwaningo, izisebenzi zasemtholampilo zizonakekela ababambiqhaza ukuze ziqiniseke ukuthi imithi yokugoma yocwaningo ayidali izinkinga ezithile zempilo. Izisebenzi zasemtholampilo zizobuza ababambiqhaza nanganoma yiziphi izinkinga zezenhlalo ababhekana nazo ngenxa yokuba socwaningweni. Uma umbambiqhaza enenkinga yezempilo noma yezenhlalo ehlobene nokuba socwaningweni, izisebenzi zasemtholampilo zizomsiza.

Kukhona namaqembu amaningana athintekayo ekuvikelweni kwamalungelo nenhlalakahle yababambiqhaza:

  • Ithimba elibuyekeza ukuphepha kocwaningo kanye neBhodi Elibhekele Ulwazi Nokuphepha (i-DSMB) elizimele njalo zihlola ulwazi lwezempilo locwaningo ukunquma ukuthi ingabe kubonakala kuphephile futhi kufanele yini ukuqhubeka nocwaningo.
  • IBhodi Elihlaziya Izikhungo (i-IRB) noma Ikomiti Lesimilo (i-EC) abuyekeza futhi abheke uhlelo lohlelo lomtholampilo ngamunye owenza ucwaningo, kubandakanye nolwazi olunikwa abantu mayelana nocwaningo, inqubekelaphambili yocwaningo, kanye nezinkinga zempilo zababambiqhaza. I-IRB/EC ibhekela nokuphepha kwababambiqhaza futhi ibheka nokuthi ingabe amalungelo ababambiqhaza ayahlonishwa yini.
  • I-Medicines Control Council yaseNingizimu Afrika yengamele ukuqhutshwa kocwaningo futhi ifuna imibiko yasikhathi sonke ephathelene nokuphepha kwababambiqhaza.
  • Umtholampilo ngamunye uneKomiti Lesikhungo Lokuphepha Kwezokwelapha (i-IBC) elengamele ukuthi imithi yokugoma yocwaningo ithakwa kanjani ekhemisi nokuthi isetshenziswa kanjani emtholampilo.
  • Imitholampilo ethile inamaKomiti Esimilo akhethekile aphethe izindawo lapho kugcinwa khona igazi namanye amasampula. Lezi zindawo kuthiwa ama-bio-bank noma ama-repository.
  • UMnyango Wezolimo, Wezamahlathi, Nezokudoba (i-DAFF) waseNingizimu Afrika unebhodi elikhethekile okufanele lihlaziye futhi ligunyaze zonke izicelo zokungenisa izinto ezishintshwe izithako zemvelo (ama-GMO). Lokhu kuhlanganisa omunye wemithi yokugoma kulolu cwaningo.
  • Umtholampilo wocwaningo ngamunye uneBhodi Lokwelulekwa Komphakathi (i-CAB). Amalungu alo angabantu bendawo abaletha izikhalazo nezinto ezithinta umphakathi nababambiqhaza bocwaningo kubacwaningi. Amalungu e-CAB ayingxenye yethimba elisungula ucwaningo ngalunye. Asiza nasekusunguleni noma ukuhlaziya ulwazi olunikwa ababambiqhaza. Ababambiqhaza belulekwa nangezindlela eziphumelela kangcono zokuvimbela igciwane le-HIV.

13. Ingabe imithi yokugoma yocwaningo ingaveza imiphumela yokuthi umuntu une-HIV uma ehlolwa?

Yebo, imithi yokugoma yocwaningo ingase yenze umbambiqhaza atholwe enegciwane ezinhlotsheni ezithile zokuhlolelwa i-HIV. Uma umbambiqhaza ethola umuthi wocwaningo wokugomela i-HIV, umzimba wakhe ungase wakhe ama-antibody e-HIV. Ama-antibody akusiza ukuthi ulwe nezifo. Ukuhlolelwa i-HIV okuvamile kufuna ama-antibody e-HIV njengophawu lokuthi kunegciwane. Ngenxa yalokhu, umuntu angase abe nemiphumela yokuhlolwa ebonisa ukuthi unegciwane ngisho noma engenayo ngempela i-HIV. Lokhu kubizwa ngokuthi yimiphumela yokuhlolwa ye-vaccine-induced seropositive (i-VISP). Ungase ubone nalokhu okuthiwa i-Vaccine-Induced Seroreactive. Asazi ukuthi ubani ozoba nemiphumela yokuhlolwa ye-VISP noma ukuthi le miphumela izohlala isikhathi eside kangakanani.

Abantu abanemiphumela yokuhlolwa ye-VISP badinga ukuhlolwa kwe-HIV okukhethekile ukuze kunqunywe ukuthi ingabe imiphumela ingenxa ye-VISP noma igciwane langempela yini. Imitholampilo ebamba iqhaza kulolu cwaningo iyakwazi ukwenza lokhu kuhlola okukhethekile okufuna igciwane uqobo esikhundleni sokufuna ama-antibody.

Azikho izinkinga zempilo ezihlotshaniswa nemiphumela yokuhlolwa ye-VISP, kodwa imiphumela yokuhlolwa ye-VISP ingadala izinkinga ekunakekelweni kwezokwelashwa noma kwamazinyo, ukuqashwa emisebenzini ethile, umshwalense, noma ivisa yomsebenzi noma yokuvakashela kwamanye amazwe. Abantu abanemiphumela ye-VISP lapho behlola bangase bangavunyelwa ukunikela ngegazi noma ezinye izitho zomzimba. Abantu abafuna ukujoyina ucwaningo futhi abahlela ukufaka isicelo somshwalense noma somsebenzi, kufanele baxoxe nesikhungo socwaningo ngokushesha okukhulu. Inkampani yomshwalense noma umqashi angase angayamukeli imiphumela yokuhlolelwa i-HIV evela e-HVTN. Kodwa-ke, i-HVTN ingasebenza nabo ukuqinisekisa ukuthi kwenziwa ukuhlola okufanele okuzobonisa isimo somuntu sangempela se-HIV.

14. Ngingalutholaphi ulwazi oluthe xaxa?

Mayelana nocwaningo oluphenya ngemithi yokugoma: www.clinicaltrials.gov

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

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

Uma uneminye imibuzo engaphendulwanga kule dokhumenti, sicela usibuze. 

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