Ucwaningo kulindeleke ukuthi luqale ukubhalisa ababambiqhaza ngo-2016. Luzokwenziwa kulezi zindawo e-Afrika:
Olunye ucwaningo lwe-AMP olufana ncamashi nalolu luyenziwa e-US naseNingizimu Melika. Luzoqala nokubhalisa ababambiqhaza ngo-2016. Lolu cwaningo lwe-AMP lubizwa ngokuthi i-HVTN 704/HPTN 085.
I-National Institute of Allergy and Infectious Diseases (NIAID), eyingxenye ye-U.S. National Institutes of Health, iyona ekhokhela lolu cwaningo. I-NIAID, i-HIV Vaccine Trials Network (HVTN), ne-HIV Prevention Trials Network (HPTN) yizona ezisungule lolu cwaningo. I-Dale and Betty Bumpers Vaccine Research Center (VRC), eyingxenye ye-NIAID, ihlinzeka i-antibody ye-VRC01 yokwenza lolucwaningo. I-HVTN ne-HPTN zombili ziwumfelandawonye wamazwe ngamazwe wososayensi, othisha, namalungu omphakathi afuna izindlela eziphumelelayo zokuvimbela i-HIV. I-HVTN igxila ngemithi yokugomela i-HIV ephephile nesebenzayo, kanti i-HPTN igxila kwezinye izindlela zokuvimbela i-HIV njenge-pre-exposure prophylaxis nokwelashwa njengendlela yokuvimbela isifo. I-HVTN ixhaswa yi-NIAID ngezimali. I-HPTN ixhaswa futhi nayo yi-NIAID, i-National Institute on Drug Abuse (NIDA), kanye ne-National Institute of Mental Health (NIMH).
Lonke ucwaningo lwe-HVTN ne-HPTN lusebenzela umgomo wethu ohlanganyelwe wokuthola izindlela ezisebenzayo zokuvimbela igciwane le-HIV. Izinhloso eziyinhloko zocwaningo yilezi:
Ucwaningo lwe-AMP lwe-HVTN 703/HPTN 081 luhlola i-antibody esavivinywa yokulwa ne-HIV kwabesifazane abahlala e-Afrika eningizimu ye-Sahara. U-AMP umelela ukuthi Antibody Mediated Prevention (Ukunqanda Isifo Nge-antibody). Lona umqondo wokunika abantu ama-antibody alwa ne-HIV ukubona ukuthi azobavikela yini abantu ekungenweni yi-HIV.
Ama-antibody angenye yezindlela zemvelo umzimba wethu olwa ngazo nezifo. Ukunika abantu ama-antibody ukuze kuvinjelwe ukungenwa yigciwane kuwumkhuba wezokwelapha owamukelwayo oneminyaka engaphezu kweyi-100 ubudala. Ngokwesibonelo, odokotela banika abantu ama-antibody emvelo ukuze bavimbele izifo ezinjenge-hepatitis A no-B kanye nopokisi. Amanye ama-antibody asetshenziselwa ukuvimbela izifo enziwa emalabhorathri. Ama-antibody okwenziwa aye asetshenziswa ngempumelelo ukuvimbela isifo esiyingozi somgudu wokuphefumula ezinganeni okuthiwa i-RSV.
Ucwaningo lwe-AMP luhlola i-antibody okuthiwa i-VRC01, i-antibody yokwenziwa elwa ne-HIV. Lona umqondo omusha wokuvimbela i-HIV ohlobene nalokho okwenziwa ocwaningweni lokugomela i-HIV. Ocwaningweni oluvamile lokugomela i-HIV, abantu bathola umuthi wokugoma bese abacwaningi belinda ukuze babone ukuthi imizimba yabo iyawenza yini ama-antibody okulwa ne-HIV ngenxa yomuthi wokugoma. Kulolu cwaningo, sizoseqa leso sinyathelo, sinikeze abantu ama-antibody ngqo.
Ukuhlola kwaselabhorathri kubonise ukuthi i-antibody ye-VRC01 inganqanda izinhlobo eziningi ze-HIV zingangeni kumaseli. I-VRC01 yazivikela nezilwane ekungenweni yigciwane. Ucwaningo lwe-AMP luzosisiza sithole ukuthi ingabe i-antibody ye-VRC01 izoyivimbela yini i-HIV kubantu.
I-antibody ye-VRC01 yatholwa egazini lomuntu owayene-HIV futhi onomzimba owawukwazi ukulawula igciwane ngaphandle kwemishanguzo iminyaka eminingi ngaphambi kokuthi adinge ukwelashwa. I-antibody ye-VRC01 ayenziwa nge-HIV ephilayo, ebulewe, noma amaseli abantu anegciwane le-HIV. Ayikwazi ukudala i-HIV noma ingculaza. Le antibody yenziwa kusetshenziswa izinqubo ezifanayo nezisetshenziswa ekwenzeni eminye imithi.
I-VRC01 izonikezwa ngemijovo emthanjeni. Lokhu kwaziwa kakhulu ngokuthi ukuthola i-IV, noma ukuthola idriphu. Umjovo we-IV/driphu unikezwa umbambiqhaza wocwaningo imizuzu engama-15-60. Ukuze unikwe umjovo we-IV/we-driphu, kusetshenziswa inaliti engenagciwane ukufaka ishubhu elincane lepulasitiki emthanjeni engalweni yombambiqhaza. Kulengiswa isikhwama esinoketshezi esigxotsheni bese sixhunywa kuphampu, elawula ukuthi okungaphakathi kwesikhwama kungena ngokushesha okungakanani ngeshubhu elisengalweni yombambiqhaza.
Kuyoba namaqembu ama-3 ahlukene kulolu cwaningo. Ingxenye eyodwa kokuthathu yababambiqhaza izonikwa idosi ephakeme ye-antibody emjovweni wabo we-IV/driphu. Ingxenye eyodwa kokuthathu izonikwa idosi ephansi ye-antibody ngomjovo we-IV/driphu. Ingxenye eyodwa kokuthathu izonikwa umjovo wengxube yamanzi anosawoti angenalutho angenayo i-antibody. Lokhu kuthiwa i-placebo.
Ucwaningo luzobhalisa futhi lulandelele abesifazane abangaba yi-1900 ezikhungweni zocwaningo zase-Afrika.
Abesifazane abase-Afrika eningizimu ye-Sahara baphakathi kwabasengcupheni ephakeme kakhulu yokungenwa yi-HIV. Bazidinga ngempela izindlela ezintsha zokuvimbela i-HIV, futhi kubalulekile ukuthi bafakwe ocwaningweni olufuna izindlela ezintsha zokuvimbela lesi sifo. Ukuze ajoyine lolu cwaningo, owesifazane kufanele abe nempilo enhle, abe neminyaka ephakathi kweyi-18 nengama-40 ubudala, futhi angabi negciwane le-HIV. Akufanele abe ekhulelwe noma encelisa ibele. Kukhona nezinye izimfuneko okufanele zifinyelelwe/zifezeke. Sizobuza ngomlando wabo wezokwelashwa, sibaxilonge umzimba, futhi sithathe amasampula egazi nomchamo ayohlolwa. Sizobuza nangokuziphatha kwabo kwezocansi kwamuva nje nokusebenzisa izidakamizwa.
Asizazi zonke izingcuphe ze-VCR01 ngoba inikezwe abantu abangaba yi-140 kuphela ocwaningweni lwangaphambilini. Yize engekho kulolo cwaningo owaba nezinkinga ezinkulu zempilo ezihlobene ne-antibody, kuhlale kunethuba lokuvela kwezinkinga okungekho muntu ozilindele.
Yingakho enye inhloso yalolu cwaningo iwukuhlola ukuthi ingabe le antibody iphephile uma inikwa abantu abaningana. Impilo yombambiqhaza ngamunye izonakekelwa ngokucophelela kulo lonke ucwaningo.
Asazi. Ucwaningo lwe-AMP olokuqala olwenzelwe ukuthola ukuthi ingabe i-antibody ye-VCR01 iyakuvimbela yini ukungenwa i-HIV. Ababambiqhaza akufanele balindele ukuvikeleka kwi-HIV ngokubamba iqhaza ocwaningweni lwe-AMP. Empeleni, ababambiqhaza abayingxenye eyodwa kwezintathu bazothola i-placebo.
Bonke ababambiqhaza kulolu cwaningo bazokwelulekwa ngezindlela zokunciphisa ingcuphe yabo yokungenwa yi-HIV. Uma kudingidwa izindlela zokunciphisa ingcuphe ye-HIV, ababambiqhaza nabeluleki bazoxoxa ngezinto ezinjengokusebenzisa amakhondomu, i-PrEP, ukungadakwa nokungadli izidakamizwa uma uya ocansini, ukunciphisa isibalo sophathina, nokuxoxa ngesimo se-HIV nabantu abangaba ophathina bakho. Abeluleki banganika ababambiqhaza nolwazi mayelana nendlela yokuthola i-PrEP endaweni eseduzane nabo.
Ucwaningo alubafaki ababambiqhaza ngohlelo oluthile. Lokho kusho ukuthi kungakhathaliseki ukuthi umbambiqhaza uthola idosi ephakeme ye-antibody, idosi ephansi ye-antibody, noma i-placebo, lokho kwenzeka ngendlela engahleliwe ngokuphelele, kufana njengokuphonsa uhlamvu lwemali. Ukungahleli kwenzelwa ukuthi abantu emaqenjini woma-3 bafane. Ababambiqhaza kuwo wonke amaqembu bazothola uhlobo olufanayo lokwelulekwa komuntu siqu ukuze banciphise ingcuphe yabo ye-HIV, ngakho ingcuphe ye-HIV kufanele ifane kuwo wonke amaqembu. Siyazi ukuthi ngisho nalapho kunemizamo yokunciphisa ingcuphe abantu abathile basazoyithola i-HIV. Umehluko omkhulu phakathi kwamaqembu ocwaningo ukuthi ingabe abantu bathola i-antibody ye-VRC01 noma i-placebo. Ngenxa yokuthi konke okunye ngala maqembu kuyafana, noma imuphi umehluko ekungenweni yi-HIV phakathi kwala maqembu cishe udalwa yi-antibody.
Ucwaningo kulindeleke ukuthi luthathe iminyaka engaba mi-5 sekukonke. Umbambiqhaza ngamunye uzoba socwaningweni ngaphansana nje kweminyaka emi-2.
Okwamanje azikho izinhlelo zokunikeza ababambiqhaza i-antibody ngemva kocwaningo noma ukuthola imvume yokuyisebenzisa emphakathini. Esikhundleni salokho, sizosebenzisa esikufunde kulolu cwaningo ukuze:
Cha, asilindele ukuthi abantu batholakale bene-HIV uma behlolwa ngendlela evamile. Amasampula egazi lomuntu eline-VRC01 aye ahlolwa kusetshenziswa amakhithi ahlukene okuhlolela i-HIV ukuze kubonakale ukuthi ingabe i-VRC01 ingayiveza yini imiphumela ebonisa i-HIV. Kulezi zivivinyo zaselabhorathri, lokhu akuzange kwenzeke. Kwenziwe ukuhlola okuthe xaxa ukuze kuqinisekiswe le miphumela.
Ukuvikela impilo nokuhlonipha amalungelo ababambiqhaza kuseqhulwini kuwo wonke umuntu e-HVTN ne-HPTN. Ngaphandle kwamavolontiya, besingeke sikwazi ukuthola izindlela ezintsha zokuvimbela i-HIV.
Isinyathelo sokuqala sokuvikela amalungelo ababambiqhaza bocwaningo ukubanika ulwazi mayelana nocwaningo ngaphambi kokuthi bajoyine. Le nqubo kuthiwa yimvume enolwazi. Izisebenzi zasemtholampilo ziyonika abantu ulwazi nge-antibody 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 i-antibody 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:
Mayelana noCwaningo lwe-AMP: www.ampstudy.org.za
Mayelana ne-HIV Vaccine Trials Network: www.hvtn.org
Mayelana ne-HIV Prevention Trials Network: www.hptn.org
Uma uneminye imibuzo engaphendulwanga ngale dokhumenti, sicela usibuze. Ungathintana: [email protected]