1. Thutopatlisiso ya moento ke eng?
Moento o ruta mmele go thibela tshwaetso e e rileng kgotsa go lwantsha bolwetse. Gore go dirwe moento, babatlisisi ba tlhoka go o leka mo bathong. Dithutopatlisiso dingwe tsa moento di leka gore a moento o babalesegile (ga o bake mathata a boitekanelo) le gore a dithulaganyo tsa mebele ya batho tsa go itshireletsa mo malwetseng di tsibogela meento ya thutopatlisiso. Thulaganyo ya mmele wa gago ya go itshireletsa mo malwetseng e go sireletsa mo malwetseng. Dithutopatlisiso dingwe tsa moento gape di ka dirisiwa go bona gore a moento o ka thusa go thibela kgotsa go lwantsha tshwaetso kgotsa bolwetse. Go tlhokega dithutopatlisiso tse dintsi tsa meento go dira moento o o babalesegileng, o o nonofileng.
Ga jaana ga go na moento o o nang le laesense o o kgatlhanong le HIV kgotsa AIDS.
2. Thutopatlisiso ya HVTN 705/HPX2008 ke eng?
HVTN 705/HPX2008 e leka meento e 2 ya tekeletso kgatlhanong le HIV. Meento ya thutopatlisiso e bidiwa Ad26.Mos4.HIV le Clade C gp140. Meento e e dirilwe ke Janssen Vaccines & Prevention B.V. Go simolola fa go ya pele, re tlaa e bitsa meento ya Ad26 le Poroteine kgotsa meento ya thutopatlisiso.
Moento wa Ad26
Moento wa Ad26 o dirilwe ka mogare o o bidiwang Adenovirus mofuta 26. Moento o o tsentswe dikarolo tsa HIV. O diretswe gore o bolelele mmele gore o dire diporoteine tse di tshwanang le diporoteine tse di fitlhelwag mo HIV. (Diporoteine ke dire tsa tlhago tse di fitlhelwang mo dilong tsotlhe tse di tshelang, tse di jaaka mmele wa motho le megare e e jaaka HIV.) Thulaganyo ya mmele ya go itshireletsa mo malwetseng e ka nna ya tsibogela dikhopi tsa diporoteine tsa HIV mo moentong wa thutopatlisiso. Se se bidiwa tsibogo ya masole a mmele. Tsibogo ya masole a mmele e baakanyetsa mmele go lemoga diporoteine tse di tshwanang mo HIV le go lwantsha mogare fa motho a amana le HIV mo isagong. Adenovirus mofuta 26 e tlwaelegile mo botshelong jwa letsatsi le letsatsi mme e ka baka mefikela le ditshwaetso tsa khemo. Le fa go le jalo, adenovirus e e dirisiwang mo thutopatlisisong e ya moento e koafaditswe ka jalo e ka se bake tshwaetso mme ga e kotsi mo bathong.
Moento wa Poroteine
Moento wa Poroteine, Clade C gp140, o dirilwe ka poroteine e e tshwanang le poroteine e e fitlhelwang fa godimo ga HIV. Se le sone se ka baka tsibogo ya masole a mmele.
Moento wa Poroteine mo thutopatlisisong e o tlhakanngwa le sere sa tlatseletso se se bidiwang Aluminum Phosphate. Sere sa tlatseletso ke sere se se tsenngwang mo moentong go oketsa tsibogo ya masole a mmele. Aluminum e dirisiwa mo meentong e mentsi e e tlwaelegileng e e jaaka ya Hepatitis A le B, diphtheria, le tetanus.
Dikumo tse di dirisiwang mo thutopatlisisong e ga di a dirwa ka HIV e e tshelang, HIV e e bolailweng, kgotsa ka disele tsa batho tse di tshwaeditsweng ke HIV. Meento e ya thutopatlisiso e ka se bake tshwaetso ya HIV kgotsa AIDS. Re ka go fa tshedimosetso ka botlalo go ya pele ka ga meento ya thutopatlisiso, fa o rata.
3. Ke mekgatlho efe e e tsayang karolo mo thutopatlisisong e?
The National Institute of Allergy and Infectious Diseases (NIAID), Janssen Vaccines & Prevention B.V. ke moetleetsi yo o laolang mme gape ba tlamela meento ya thutopatlisiso. NIAID ke karolo ya National Institutes of Health (NIH), e e leng karolo ya puso ya United States.
HVTN ke tirisano ya boditšhabatšhaba ya borasaense, barutisi, le maloko a setšhaba ba ba batlang moento o o nonofileng le o o babalesegileng wa HIV. HVTN e duelelwa ke NIAID mme thutopatlisiso e yone gape e duelelwa ke Bill & Melinda Gates Foundation le Janssen Vaccines & Prevention B.V.
4. Thutopatlisiso e e tlile go dirwa leng le gone kae?
Go lebeletswe gore thutopatlisiso e simolole go kwadisa batsayakarolo mo e ka nnang ka Diphalane 2017. E tlaa direlwa mo mafelong a:
- Malawi: Lilongwe
- Mozambique: Maputo
- Aforikaborwa: Bloemfontein, Brits, Cape Town (Emavundleni, Khayelitsha, le Masiphumelele), Durban (Chatsworth, eThekwini, Isipingo, Tongaat le Verulam), Elansdoorn, Klerksdorp, Ladysmith, Mamelodi, Medunsa, Mthatha, Rustenburg, Soshanguve, Soweto (Bara le Kliptown), le Tembisa
- Zambia: Lusaka le Ndola
- Zimbabwe: Harare
5. Ke eng fa thutopatlisiso e e dirwa?
Dithutopatlisiso tsotlhe tsa HVTN di direla maikaelelo a rona a go batla moento o o babalesegileng le o o nonofileng wa HIV. Maikaelelo a magolo a thutopatlisiso ke:
- Go leka gore a meento ya thutopatlisiso e ka thibela tshwaetso ya HIV
- Go naya tshedimosetso go ya pele ka ga pabalesego ya meento ya thutopatlisiso.
- Go re fa metlhala ka ga gore moento o ka dira jang go thibela tshwaetso ya HIV
6. Ke batho ba le kae ba ba tlaa nnang mo thutopatlisisong e, mme ke bomang ba ba ka e tsenelang?
Thutopatlisiso e tlaa akaretsa batsayakarolo ba basadi ba ka nna 2600.
Go tsenela thutopatlisiso e, basadi batshwanetse gore ba bo ba itekanetse, ba na le dingwaga tse di magareng ga 18 le 35, mme ba sa tshwaediwa ke HIV. A ka se nne moimana kgotsa go anyisa ka lebele. Gape o tshwanetse go tshwanelega mo dikarolong tse dingwe. Re tlaa botsa basadi ba ka ga hisetori ya bone ya kalafi, re ba dire tlhatlhobo ya mmele, le go tsaya disampole tsa madi le motlhapo go dira diteko. Gape re tlaa botsa basadi ba ka ga ditiro tsa bone tsa thobalano le tiriso ya diritibatsi.
7. A meento e ya thutopatlisiso e babalesegile?
Ga re itse dikotsi tsotlhe tsa meento ya thutopatlisiso ka gore e setse e filwe fela palo e e lekanyetsitsweng ya batho pele. Moento wa Poroteine o filwe batho ba ka nna 300 mme moento wa Ad26 o filwe batho ba ka nna 110. Le fa go se na ope mo dithutopatlisisong tsa pelenyana yo o nnileng le mathata a a masisi a boitekanelo a a amanang le meento e ya thutopatlisiso, go nna go na le kgonagalo ya gore go ka nna le mathata a go se nang ope yo o neng a a lebeletse. Ke sone se bongwe jwa maikaelelo a thutopatlisiso e e le go leka gore a meento e babalesegile fa e fiwa batho ba ba oketsegileng. Boitekanelo jwa motsayakarolo mongwe le mongwe bo tlaa bewa leitlho thata ke baoki ba ba katisitsweng le dingaka mo thutopatlisisong yotlhe.
8. A meento e ya thutopatlisiso e ka sireletsa batsayakarolo gore ba se ka ba tshwaediwa ke HIV?
Batsayakarolo ga ba a tshwanela go lebelela gore ba tlaa sirelediwa mo HIV ke meento e ya thutopatlisiso. Tota e bile, batsayakarolo ba ka nna ba se fiwe meento ya thutopatlisiso mo thutopatlisisong e, ka gonne halofo ya batsayakarolo ba tlaa fiwa placebo. Placebo mo thutopatlisisong e ke metsi a a letswai a a se nang megare.
Thutopatlisiso e e diretswe go batlisisa gore a meento ya thutopatlisiso e a dira go thibela kgotsa go lwantsha HIV.
Ka gonne ga re itse gore a meento ya thutopatlisiso e tlaa thibela HIV/AIDS, batsayakarolo mo thutopatlisisong e ba tlaa fiwa kgakololo ya go tila tshwaetso ya HIV mme ba tlaa romelwa kwa mafelong a ba ka bonang mekgwa e e leng teng ya thibelo ya HIV kwa go one.
9. Go tlaa tsaya lobaka lo lo kana kang go bona gore a meento ya thutopatlisiso e a dira?
Re lebeletse go ithuta gore a meento ya thutopatlisiso e thibela ditshwaetso tsa HIV mo dingwageng di ka nna 4. Go ka direga gore e itse pele ga foo.
10. Boitekanelo le ditshwanelo tsa batsayakarolo di tlaa sirelediwa jang?
Go sireletsa boitekanelo le go tlotla ditshwanelo tsa batsayakarolo ke dilo tsa botlhokwa thata mo go mongwe le mongwe mo HVTN le Janssen Vaccines. Ntle le baithaopi, re ne re ka se kgone ka gope go bona moento wa HIV.
Kgato ya ntlha ya go sireletsa ditshwanelo tsa batsayakarolo ba thutopatlisiso ke go ba fa tshedimosetso ka ga thutopatlisiso pele ga ba e tsenela. Badiredi ba tleliniki ba tlaa fa batho tshedimosetso ka ga dikumo le ditsamaiso tsa thutopatlisiso, dikotsi le mesola e e ka nnang teng go batsayakarolo, le ditshwanelo tse ba nang le tsone. Tse di akaretsa tshwanelo ya go fiwa tshedimosetso nngwe le nngwe e ntšhwa ka ga thutopatlisiso e e ka amang gore a ba batla go tswelela ba le mo go yone, le tshwanelo ya go tswa mo thutopatlisisong ka nako nngwe le nngwe.
Ka nako ya thutopatlisiso, badiredi ba tleliniki, ba tlaa baya batsayakarolo leitlho go netefatsa gore meento ya thutopatlisiso ga e bake mathata a boitekanelo. Badiredi ba tleliniki gape ba tlaa botsa batsayakarolo ka mathata a loago a ba ka tswang ba a itemogela ka go nna mo thutopatlisisong. Fa motsaykarolo a na le bothata jwa boitekanelo kgotsa jwa loago jo bo amanang le go nna mo thutopatlisisong, badiredi ba tleliniki ba tlaa ba thusa.
Gape go na le ditlhopha tse mmalwa tse di tsayang karolo mo go sireletseng ditshwanelo tsa batsayakarolo le boitekanelo:
- Setlhopha se se sekasekang pabalesego ya thutopatlisiso le boto e e ikemetseng e e bayang pabalesego ya tshedimosetso leitlho ka gale di leba tshedimosetso ya boitekanelo go tswa mo thutopatlisisong go tsaya tshwetso ya gore a go lebega go babalesegile go tswelela ka go fa ditlhabo tsa thutopatlisiso.
- Lekgotla la Taolo ya Melemo la Aforikaborwa, gammogo le bathati ba melemo ba setšhaba mo dinageng tse dingwe, ba okamela tsamaiso ya thutopatlisiso mme ba batla dipego ka gale ka ga pabalesego ya batsayakarolo.
- Tleliniki nngwe le nngwe e na le Institutional Biosafety Committee (IBC) e e okamelang ka fa meento ya thutopatlisiso e baakanngwang ka teng kwa khemiseng le ka fa e dirisiwang ka teng kwa tleliniking.
- Boto ya Tshekatsheko ya Setheo (IRB) kgotsa Komiti e e Ikemetseng ya Maitsholo (EC) e sekaseka le go baya leitlho leano la thutopatlisiso la tleliniki nngwe le nngwe e e dirang thutopatlisiso, go akaretsa thutopatlisiso e e fiwang batho ka ga thutopatlisiso, kgatelopele ya thutopatlisiso, le mathata a boitekanelo a batsayakarolo. IRB/EC gape e leba gore a ditshwanelo tsa batsayakarolo di a tlotliwa.
- The US Food & Drug Administration (FDA) le yone e sekaseka thutopatlisiso. FDA e pateletsa melao ya US ka ga patlisiso mo bathong le tiriso ya meento ya thutopatlisiso mo patlisisong.
- Ditleliniki dingwe di na le Dikomiti tsa Maitsholo tse di kgethegileng tse di okamelang mafelo a madi le disampole tse dingwe di bolokiwang kwa go one. Mafelo a a bidiwa di-bio-bank kgotsa mabolokelo.
- Lefapha la Agriculture, Forestry, and Fisheries (DAFF) la Aforikaborwa le na le boto e e kgethegileng e e tshwanetseng go sekaseka le go letlelela dikopo tsotlhe go reka kwa dinageng tse dingwe genetically modified materials (GMO) tse di jaaka moento wa Ad26 mo thutopatlisisong e. Tleliniki nngwe le nngwe ya thutopatlisiso e na le Boto ya Kgakololo ya Setšhaba [Community Advisory Board] (CAB). Maloko a yone ke batho ba mo lefelong leo ba ba tlisang matshwenyego le dikgatlhegelo tsa setšhaba le batsayakarolo ba thutopatlisiso kwa babatlisising. Maloko a CAB ke karolo ya setlhopha se se dirang thutopatlisiso. Gape ba thusa go dira kgotsa go sekaseka tshedimosetso e e fiwang batsayakarolo.
11. A meento ya thutopatlisiso e ka baka pholo e e bontshang gore ke na le HIV fa go dirwa teko?
Ee, meento ya thutopatlisiso e ka nna ya dira gore go bonale batsayakarolo ba na le HIV fa ba dirwa teko mo mefuteng mengwe ya diteko tsa HIV. Fa motsayakarolo a fiwa moento wa thutopatlisiso wa HIV, mmele wa gagwe o ka nna wa dira dilwantsha-mogare tsa HIV. Dilwantsha-mogare di thusa batho go lwantsha tshwaetso. Diteko tse di tlwaelegileng tsa HIV di batla dilwantsha-mogare tsa HIV jaaka letshwao la tshwaetso. Ka ntlha ya se, motho a ka nna le pholo e e bontshang gore o na le HIV le fa a sa tshwaediwa ke HIV. Se se bidiwa pholo ya teko ya vaccine-induced seropositivity (VISP). Gape o ka bona se se bidiwa Vaccine-Induced Seroreactivity (VISR). Ga re itse gore ke bomang ba ba tlaa nnang le dipholo tsa teko ya VISP kgotsa gore dipholo tse di tlaa tshwarelela lebaka le le kana kang.
Batho ba ba nang le dipholo tsa teko tsaVISP ba tlhoka diteko tse di totobetseng tsa HIV go bona gore a pholo ya teko e e bontshang tshwaetso e bakiwa ke VISP kgotsa tshwaetso ya mmatota ya HIV. Ditleliniki tse di tsayang karolo mo thutopatlisisong e di ka fitlhelela diteko tse di totobetseng tse tse di batlang mogare ka boone, go na le go batla dilwantsha-mogare. Batsayakarolo ba tekeletso ba tshwanetse go dirwa diteko fela kwa ditleliniking tse di karolo mo thutopatlisisong e. Ga go na mathata a boitekanelo a a amanngwang le pholo ya teko ya VISP, mme dipholo tsa teko ya VISP di ka baka mathata mo dikarolong tse mmalwa tsa tlhokomelo ya bongaka kgotsa ya meno, tiro, inšorense, visa ya mesepele, kgotsa go tsena mo sesoleng. Batho ba ka nna ba se ka ba letlelelwa go aba madi kgotsa dirwe tse dingwe. Fa batsayakarolo ba rulaganya go tsenya kopo ya inšorense, kgotsa ya sesole, ba tshwanetse go itsise lefelo la thutopatlisiso ka gangwe. Setlamo sa inšorense, mothapi, kgotsa mokgatlho wa sesole ba ka nna ba se ka ba amogela dipholo tsa teko ya HIV e e tswang go HVTN. Le fa go le jalo, HVTN e ka dira le bone go netefatsa gore go dirwa teko e e tshwanetseng e e tlaa bontshang seemo sa mmatota sa motho sa HIV. Fa o na le dilwantsha-megare tse mme o bo o ima di ka nna tsa fetisediwa mo leseeng, le le ka nnang la dirwa tupo ya bolwetse e e seng yone ya gore le tshwaeditswe le bo le simolola go fiwa kalafi. Tleliniki ya patlisiso e ka go fa khopi ya dipholo tsa gago gore o di dirise mo maemong a fa o tlhoka go dira jalo.
12. Nka bona kae tshedimosetso go ya pele?
Ka ga dithutopatlisiso tsa bongaka tsa moento wa HIV: www.clinicaltrials.gov
Ka ga HIV Vaccine Trials Network: www.hvtn.org
Ka ga VISP: http://www.hvtn.org/VISP
Fa o na le dipotso tse dingwe tse di sa arabiwang ke tokomane e, tsweetswee re botse. O ka ikgolaganya le: [email protected]
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