1. Luyini ucwaningo lomuthi wokugoma?

Umuthi wokugoma ufundisa umzimba ukuthi unqande igciwane elithile noma ulwe nesifo. Ukuze bathake umuthi wokugoma, abacwaningi kudingeka bawuhlole kubantu. Olunye ucwaningo lomuthi wokugoma luhlola ukuthi ingabe umuthi wokugoma uphephile yini (awuzidali izinkinga zempilo) nokuthi ingabe amasosha omzimba abantu ayasabela emithini yokugoma. Amasosha akho omzimba akuvikela ezifweni. Olunye ucwaningo lomuthi wocwaningo lungasetshenziselwa nokuthola ukuthi ingabe umuthi wokugoma ungalinqanda yini noma ulwe nalo igciwane noma isifo esithile. Kuthatha ucwaningo oluningi lomuthi wokugoma ukukhiqiza umuthi wokugoma ophephile nosebenzayo.

Okwamanje awukho umuthi wokugomela i-HIV noma ingculaza.

2. Luyini ucwaningo lwe-HVTN 705/HPX2008?

I-Luyini ucwaningo ihlola imithi emi-2 esavivinywa yokugomela i-HIV. Imithi yokugoma yocwaningo ibizwa nge-Ad26.Mos4.HIV ne-Clade C gp140. Le mithi yokugoma yathakwa yi-Janssen Vaccines & Prevention B.V. Kusukela manje kuqhubeke, sizoyibiza nge-Ad26 ne-Protein noma imithi yokugoma yocwaningo.

Umuthi wokugoma we-Ad26

Umuthi wokugoma we-Ad26 wenziwe ngegciwane okuthiwa i-Adenovirus uhlobo 26. Lo muthi wokugoma ufakwe izingxenye ezithile ze-HIV. Wenzelwe ukutshela umzimba ukuthi wenze amaphrotheni afana nalawo atholakala ku-HIV. (Amaphrotheni ayizinto ezingokwemvelo ezitholakala kuzo zonke izinto eziphilayo, njengomzimba womuntu kanye namagciwane anjenge-HIV.) Amasosha omzimba angase athinteke ngenxa yala makhophi e-HIV asemuthini wokugoma wocwaningo. 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. I-Adenovirus uhlobo 26 ivamile ekuphileni kwansuku zonke futhi ingadala imikhuhlane nokugula kwemigudu yokuphefumula. Kodwa-ke, i-adenovirus esetshenziswa kulo muthi wocwaningo yenziwe buthaka ukuze ingadali ukugula futhi ingabi yingozi kubantu.

Umuthi wokugoma we-Protein

Umuthi wokugoma we-Protein, i-Clade C gp140, wenziwe ngephrotheni efana nephrotheni etholakala phezulu ku-HIV. Lokhu nakho kungadala ukusabela kwamasosha omzimba.

Umuthi wokugoma we-Protein kulolu cwaningo uxutshwa nesithasiselo okuthiwa i-Aluminum Phosphate. Isithasiselo siwutho olunezelwa emuthini wokugoma ukuze lwandise ukusabela kwamasosha omzimba. I-aluminum isetshenziswa emithini eminingi yokugoma evamile njengeye-Hepatitis A no-B, i-diphtheria, nomhlathi-ngqi.

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

Singakunika ulwazi oluningiliziwe mayelana nemithi yokugoma yocwaningo, uma ufisa.

3. Yiziphi izinhlangano ezibandakanyekayo kulolu cwaningo?

I-National Institute of Allergy and Infectious Diseases (NIAID), i-HIV Vaccine Trials Network (HVTN) ne-Janssen Vaccines & Prevention B.V. yizo ezisungule lolu cwaningo. I-Janssen Vaccines & Prevention B.V. iwumxhasi osemthethweni futhi yiyo ekhipha imithi yokugoma. I-NIAID iyingxenye ye-National Institutes of Health (NIH), eyingxenye kahulumeni wase-United States.

I-HVTN iwumfelandawonye wamazwe ngamazwe wososayensi, othisha, namalungu omphakathi afuna umuthi osebenza nophephile wokugomela i-HIV. I-HVTN ixhaswa yi-NIAID futhi lolu cwaningo ngokukhethekile luxhaswa nayi-Bill & Melinda Gates Foundation ne-Janssen Vaccines & Prevention B.V.

4. Lolu cwaningo luyokwenziwa nini futhi kuphi?

Ucwaningo kulindeleke ukuthi luqale ukubhalisa ababambiqhaza cishe ngo-Okthoba 2017. Luzokwenziwa kulezi zindawo ezilandelayo:

  • E-Malawi: e-Lilongwe
  • E-Mozambique: e-Maputo
  • ENingizimu Afrika: e-Bloemfontein, e-Brits, eKapa (Emavundleni, Khayelitsha, nase-Masiphumelele), eThekwini (e-Chatsworth, eThekwini, Isipingo, Tongaat nase-Verulam), e-Elansdoorn, e-Klerksdorp, eMnambithi, eMamelodi, Medunsa, eMthatha, e-Rustenburg, eSoshanguve, eSoweto (e-Bara nase-Kliptown), nase-Tembisa
  • EZambia: e-Lusaka nase-Ndola
  • EZimbabwe: e-Harare

5. 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
  • Ukusinikeza umbono wokuthi umuthi wokugoma ungasebenza kanjani ekuvimbeleni igciwane le-HIV

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

Ucwaningo luzoba nababambiqhaza besifazane abangaba yizi-2600.

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

7. Ingabe le mithi yokugoma yocwaningo iphephile?

Asizazi zonke izingcuphe zemithi yocwaningo ngoba inikezwe kuphela abantu abambadlwana kuphela ngaphambilini. Umuthi wokugoma we-Protein unikezwe abantu abangaba ngama-300 kanti umuthi wokugoma i-Ad26 unikezwe abantu abangaba yi-110. Yize engekho ocwaningweni lokuqala owaba nezinkinga ezinkulu zempilo ezihlobene nale mithi yokugoma, kuhlale kunethuba lokuthi kungaba nezinkinga okungekho muntu ozilindele. Yingakho enye inhloso yalolu cwaningo iwukuhlola ukuthi ingabe le mithi yokugoma iphephile uma inikwa abantu abaningana. Impilo yombambiqhaza ngamunye izobhekwa ngokucophelela abahlengikazi abaqeqeshiwe nodokotela kulo lonke ucwaningo.

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

Ababambiqhaza akufanele balindele ukuthi le mithi yokugoma yocwaningo izobavikela ku-HIV. Empeleni, ababambiqhaza bangase bangayitholi imithi yokugoma yocwaningo kulolu cwaningo, ngoba isigamu sababambiqhaza siyothola i-placebo. I-placebo ekulolu cwaningo ingamanzi ahlanzekile anosawoti.

Lolu cwaningo lwenzelwe ukuthola ukuthi ingabe imithi yokugoma yocwaningo iyasebenza yini ekuvimbeleni noma ekulweni ne-HIV.

Ngenxa yokuthi asazi ukuthi imithi yokugoma yocwaningo izoyivimbela yini i-HIV/AIDS, ababambiqhaza abakulolu cwaningo bazokwelulekwa ukuthi bangakugwema kanjani ukungenwa yi-HIV futhi bayothunyelwa ezikhungweni lapho bengathola khona izindlela ezitholakalayo zokuvimbela i-HIV.

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

Kule minyaka engaba mi-4 ezayo, silindele ukufunda ukuthi ingabe imithi yokugoma yocwaningo iyakuvimbela yini ukungenwa yi-HIV. Kungenzeka sazi ngaphambi kwalokho.

10. Impilo namalungelo ababambiqhaza kuzovikelwa kanjani?

Ukuvikela impilo nokuhlonipha amalungelo ababambiqhaza kuseqhulwini kuwo wonke umuntu e-HVTN nase-Janssen Vaccines. 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 ucwaningo kanye nebhodi elizimele elibhekele ukuphepha kolwazi njalo zihlola ulwazi lwezempilo locwaningo ukunquma ukuthi ingabe kubonakala kuphephile yini ukuqhubeka nokunika abantu umjovo.
  • I-South Africa Medicines Control Council, kanye neziphathimandla zikazwelonke eziphethe kwamanye amazwe, zengamela indlela ucwaningo oluqhutshwa ngayo futhi zifuna imibiko njalo mayelana nokuphepha kwababambiqhaza.
  • Umtholampilo ngamunye uneKomidi Lokuphepha Kwezokwelapha Lesikhungo (i-IBC) elengamele ukuthi imithi yokugoma yocwaningo ithakwa kanjani ekhemisi nokuthi isetshenziswa kanjani emtholampilo.
  • IBhodi Elihlaziya Izikhungo (i-IRB) noma Ikomiti Lesimilo (i-EC) libuyekeza futhi libheke uhlelo lohlelo lomtholampilo ngamunye owenza ucwaningo, kubandakanye nolwazi olunikwa abantu mayelana nocwaningo, inqubekelaphambili yocwaningo, kanye nezinkinga zempilo zababambiqhaza. I-IRB/EC ibheka nokuthi ingabe amalungelo ababambiqhaza ayahlonishwa yini.
  • I-US Food & Drug Administration (FDA) nayo ibuyekeza ucwaningo. I-FDA igcizelela imithetho yase-US ephathelene nocwaningo kubantu nokusetshenziswa kwemithi yokugoma yocwaningo.
  • 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), njengomuthi wokugoma we-Ad26 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.

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

Yebo, imithi yokugoma yocwaningo cishe ingenza ababambiqhaza batholwe benegciwane ezinhlotsheni ezithile zokuhlolelwa i-HIV. Uma umbambiqhaza ethola umuthi wocwaningo wokugomela i-HIV, umzimba wakhe ungase wakhe ama-antibody e-HIV. Ama-antibody asiza abantu ukuthi balwe 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 Seroreactivity (i-VISR). 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. Ababambiqhaza besivivinyo kufanele bahlolwe kuphela emitholampilo ebamba iqhaza kulolu cwaningo.

Azikho izinkinga zempilo ezihlotshaniswa nemiphumela yokuhlolwa ye-VISP, kodwa imiphumela yokuhlolwa ye-VISP ingadala izinkinga ezicini eziningana njengokunakekelwa kwezokwelashwa noma kwamazinyo, ukuqashwa emsebenzini, umshwalense, ivisa yokuya kwamanye amazwe, noma ukubuthelwa empini. Abantu bangase bangavunyelwa ukunikela ngegazi noma ezinye izitho zomzimba. Uma ababambiqhaza behlela ukufaka isicelo somshwalense, somsebenzi, noma sokuya empini, kufanele batshele isikhungo socwaningo ngokushesha okukhulu. Inkampani yomshwalense, umqashi, noma umnyango wezempi ungase ungayamukeli imiphumela yokuhlolelwa i-HIV evela e-HVTN. Kodwa-ke, i-HVTN ingasebenza nabo ukuqinisekisa ukuthi kwenziwa ukuhlola okufanele okuzobonisa isimo somuntu sangempela se-HIV. Uma unala ma-antibody bese uyakhulelwa angase adluliselwe kumntwana, naye ongase ahlonzwe ngokungeyikho ukuthi unegciwane bese eqaliswa ekwelashweni. Umtholampilo wocwaningo ungakunika ikhophi yemiphumela yakho ukuze uyisebenzise kulezi zimo uma ukudinga lokhu.

12. 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. Ungathinta: [email protected]