Dipotso Tse di Bodiwang Gantsi: Thutopatlisiso ya moento wa HVTN 702
1. Thutopatlisiso ya moento ke eng?
Moento o ruta thulaganyo ya mmele ya go itshireletsa mo malwetseng go thibela tshwaetso e e rileng kgotsa go lwantsha bolwetse jo bo rileng. Thulaganyo ya mmele wa gago ya go itshireletsa mo malwetseng e go sireletsa mo malwetseng. Gore go dirwe moento, babatlisisi ba tlhoka go o leka mo bathong. Thutopatlisiso ya moento e leka gore a meento ya thutopatlisiso babalesegile (ga e bake mathata a boitekanelo) le gore a dithulaganyo tsa mebele ya batho tsa go itshireletsa mo malwetseng di tsibogela meento ya thutopatlisiso. Thutopatlisiso ya moento e ka dirisiwa gape go bona gore a moento e thibela kgotsa go lwantsha tshwaetso kgotsa bolwetse. Go tlhokega dithutopatlisiso tse dintsi tsa moento go dira moento o o babalesegileng, o o nonofileng.
Ga jaana ga go na moento ope o o kgatlhanong le HIV kgotsa AIDS o o ntsheditsweng laesense go dirisiwa gope mo lefatsheng.
2. Thutopatlisiso ya HVTN 702 ke eng?
HVTN 702 e leka meento e mebedi ya tekeletso e e leng kgatlhanong le HIV. Meento ya thutopatlisiso e bidiwa ALVAC-HIV (vCP2438) le Bivalent Subtype C gp120/MF59. Meento e e tlamelwa ke Sanofi Pasteur le GlaxoSmithKline (GSK) ka go latelana goo.
Re ka go fa tshedimosetso go ya pele kaga meento ya thutopatlisiso, fa o rata.
Halofo ya batsayakarolo bangwe mo thutopatlisisong e ba tlaa amogela placebo mo boemong jwa meento ya thutopatlisiso. Placebo ke tlhabo e e se nang moento wa thutopatlisiso mo teng ga yone. Mo thutopatlisisong e, placebo ke metsi a a letswai a a se nang megare.
3. A go dirisiwa HIV ya mmatota mo meentong ya thutopatlisiso?
Nnyaa! HIV ya mmatota GA E dirisiwe go dira meento e e dirisiwang mo thutopatlisisong e.
Meento ya malwetse a mangwe e ka tswa e dirilwe ka mefuta e e koafetseng ya mogare o o bakang bolwetse. Le fa go le jalo meento ya HIV GA E dirwe ka tsela e e ntseng jalo. Meento e e dirisiwang mo thutopatlisisong e ga e a dirwa ka HIV e e tshelang, HIV e e bolailweng, dikarolo tse di tserweng mo HIV, kgotsa disele tsa batho tse di tshwaeditsweng ke HIV. E dirilwe ka dire tse di dirilweng gore di lebege jaaka dikarolo tse dinnye tsa HIV mo thulaganyong ya mmele ya go itshireletsa mo malwetseng. Meento ya thutopatlisiso e ka se bake tshwaetso ya HIV kgotsa AIDS.
4. Go dirisiwa meento efe mo thutopatlisisong e?
Mongwe wa meento ya thutopatlisiso, ALVAC vCP2438, o dirilwe ka mogare o o bidiwang canarypox. Moento wa thutopatlisiso o tlhametswe gore o bolelele mmele go dira diporoteine tse di tshwanang le tse di fitlhelwang mo HIV. Diporoteine ke dire tsa tlhago. Di thusa go aga le go tlhokomela mmele wa gago, mme di dira se se tshwanang mo megareng e e jaaka HIV. Thulaganyo ya mmele ya go itshireletsa mo malwetseng e ka nna ya tsibogela diporoteine tse. 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 ka lebana le HIV mo isagong.
Moento o mongwe, Bivalent Subtype C gp120, o dirilwe ka diporoteine tse pedi tse di tshwanang le diporoteine tse di fitlhelwang mo HIV. Se le sone se ka baka tsibogo ya masole a mmele.
Moento wa Bivalent Subtype C gp120 o fiwa le sere sa tlatseletso. Sere sa tlatseletso ke sere se se tsenngwang mo moentong go oketsa tsibogo ya masole a mmele. Sere sa tlatseletso se bidiwa MF59. Sere se sa tlatseletso se dirisiwa mo meentong e e rekisiwang (s.k., Fluad® moento wa mofikela wa setlha) go oketsa tsibogo ya masole a mmele mo bathong ba ba godileng le masea. Methamo ya meento e e fetang dimilione tse 100 e e nang le MF59 e phasaladitswe lefatshe ka bophara.
5. Ke mekgatlho efe e e tsayang karolo mo thutopatlisisong e?
The National Institute of Allergy and Infectious Diseases (NIAID) le HIV Vaccine Trials Network (HVTN) ba tlhamile thutopatlisiso e, gammogo le ditlamo tse di tlamelang meento ya thutopatlisiso, Sanofi Pasteur le GSK. NIAID ke karolo ya National Institutes of Health (NIH), e e leng karolo ya puso ya United States. Tshegetso ya thutopatlisiso e gape e tlamelwa ke South African Medical Research Council (SAMRC).
HVTN ke tirisano ya boditšhabatšhaba ya borasaense, barutabana, le maloko a setšhaba a a batlang moento o o nonofileng le o o babalesegileng wa HIV. HVTN e duelelwa ke NIAID.
Tshegetso ya go dirwa ga meento e le ya tekeletso ya kalafi ya HVTN 702 gape e tlamelwa ke Bill & Melinda Gates Foundation.
6. Thutopatlisiso e e tlaa dirwa leng le gone e tlaa direlwa kae?
Thutopatlisiso e simolotse go kwadisa batsayakarolo ka Diphalane 26, 2016. E direlwa mo Aforikaborwa mo mafelong a: Brits, Cape Town (Emavundleni le Khayelitsha), Durban (eThekwini, Isipingo, le Verulam), Klerksdorp, Ladysmith, Ga-Rankuwa, Mthatha, Rustenburg, Soshanguve, Soweto (Bara le Kliptown), le Tembisa.
7. Goreng go dirwa thutopatlisiso eno?
Dithutopatlisiso tsotlhe tsa HVTN di diragatsa boikaelelo jwa rona jwa go bona moento o o babalesegileng le o o nonofileng wa HIV. Maikaelelo a konokono a thutopatlisiso e ke:
- Go leka gore a meento ya thutopatlisiso e ka thibela tshwaetso ya HIV,
- Go tlamela ka tshedimosetso go ya pele ka ga pabalesego ya meento ya thutopatlisiso, le
- Go sekaseka gore a go a kgonega gore meento e e nne le laesense ya gore e rekisiwe mo Aforikaborwa.
8. Ke batho ba le bakae ba ba tlaa nnang mo thutopatlisisong e, mme ke bomang ba ba ka e tsenelang?
Thutopatlisiso e tlaa akaretsa batsayakarolo ba le 5400.
Gore motho a tsenele thutopatlisiso e, o tshwanetse gore a bo a itekanetse, a na le dingwaga tse di magareng ga 18 le 35, mme a sa tshwaediwa ke HIV. Ga a tshwanela gore a bo a le moimana kgotsa a amusa ka lebele. Gape go na le ditlhokego tse dingwe tse di tshwanetseng go fitlhelelwa. Re tlaa botsa batho ka ga hisetori ya bone ya kalafi, re ba tlhatlhobe mmele, mme re tseye disampole tsa madi le tsa motlhapo gore di ye go dirwa diteko. Gape re tlaa botsa batho ka ga mekgwa ya bone ya thobalano le tiriso ya diritibatsi.
9. A meento e ya thutopatlisiso e babalesegile?
Meento yone e ya thutopatlisiso e ne ya fiwa batho ba le 210 mo Aforikaborwa mo thutopatlisisong e e bidiwang HVTN 100. Meento e e tshwanang thata le yone e ne ya fiwa batho ba ba fetang 8000 mo tekeletsong ya kalafi e e bidiwang RV144 kwa Thailand le mo ditekeletsong tsa kalafi kwa United States, France, South America, le Caribbean. Ga go ise go nne le mathata a a masisi a boitekanelo a a amanang le meento e. Le fa go le jalo, ka gale go na le kgonego ya mathata a a iseng a bonwe pele. Ke sone se boikaelelo bongwe jwa thutopatlisiso e e leng 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 mo thutopatlisisong yotlhe.
Meento e e mo RV144 e ne e sa akaretse MF59, e e dirisiwang mo go mongwe wa meento mo thutopatlisisong e. MF59 ke sere sa tlaleletso, sere se se dirang gore thulaganyo ya mmele ya go itshireletsa mo malwetseng e tsibogele moento ka maatla. MF59 e dirisiwa mo meentong ya mofikela e e fiwang batho mo dinageng tse dintsi ngwaga le ngwaga.
Meento e e dirisiwang mo thutopatlisisong e ga e a dirwa ka HIV e e tshelang, HIV e e bolailweng, dikarolo tse di tserweng mo HIV, kgotsa disele tsa batho tse di tshwaeditsweng ke HIV. Meento e ya thutopatlisiso e ka se bake tshwaetso ya HIV kgotsa AIDS.
10. A meento e ya thutopatlisiso e ka sireletsa batsayakarolo gore ba se ka ba tshwaediwa ke HIV?
Batsayakarolo ga ba a tshwanela go tsaya gore meento e ya thutopatlisiso e tlaa ba sireletsa mo HIV. Tota e bile, batsayakarolo ba ka nna ba se ka ba fiwa meento ya thutopatlisiso mo thutopatlisisong e, ka gonne halofo ya batsayakarolo ba tlaa fiwa di-placebo.
Thutopatlisiso e e dirwa go bona gore a meento ya thutopatlisiso e ka thibela HIV. Fa e le gore e a e thibela, go ka nna ga tlhokega dithutopatlisiso tse dingwe go tlhomamisa se.
Ka gonne ga re itse gore a meento ya thutopatlisiso e tlaa thibela HIV/AIDS, batsayakarolo ba tlaa fiwa kgakololo ya kafa ba ka tilang ka teng tshwaetso ya HIV mme ba tlaa romelwa kwa mafelong a kwa go one ba ka fitlhelelang mekgwa e e leng teng ya go thibela HIV.
11. Go tlaa tsaya nako e e kana kang go bona gore a meento ya thutopatlisiso e a dira?
Re solofetse go itse gore a meento ya thutopatlisiso e thibela ditshwaetso tsa HIV mo dingwageng di ka nna 5. Go ka kgonega gore re itse pele ga foo.
12. Pabalesego, boitekanelo, le ditshwanelo tsa batsayakarolo di tlaa sirelediwa jang?
Go sireletsa boitekanelo le go tlotla ditshwanelo tsa batsayakarolo ke dilo tsa botlhokwa mo go mongwe le mongwe kwa HVTN. Ntle le baithaopi, re ka se tsoge re kgonne 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. Badiri ba kwa tleliniking ba tlaa fa batho tshedimosetso ka ga dikumo tsa thutopatlisiso le ditsamaiso, dikotsi le mesola e e ka nnang teng go batsayakarolo, le ditshwanelo tse ba nang le tsone. Tse di akaretsa tshwanelo ya go amogela tshedimosetso e ntšhwa ka ga thutopatlisiso e e ka amang gore a ba batla go tswelela ba le mo go yone, le tshwanelo ya go tlogela thutopatlisiso ka nako nngwe le nngwe.
Ka nako ya thutopatlisiso, badiri ba kwa tleliniking ba tlaa baya batsayakarolo leitlho go netefatsa gore meento ya thutopatlisiso ga e bake mathata ape a boitekanelo. Gape badiri ba kwa tleliniking ba tlaa botsa batsayakarolo ka ga mathata ape a loago a ba ka tswang ba a itemogela ka ntlha ya go nna mo thutopatlisisong. Fa motsayakarolo a na le bothata jwa boitekanelo kgotsa jwa loago jo bo amanang le go nna mo thutopatlisisong, badiri ba kwa tleliniking ba tlaa mo thusa.
Gape go na le ditlhopha di le mmalwa tse di amegang mo go sireletseng ditshwanelo tsa batsayakarolo le boitekanelo jwa bone:
- Setlhopha se se sekasekang pabalesego ya thutopatlisiso le Data and Safety Monitoring Board (DSMB) ka gale ba tlhola tshedimosetso ya boitekanelo ya thutopatlisiso go tsaya tshwetso ya gore a go lebega go babalesegile e bile go na le mosola go tswelela ka thutopatlisiso.
- Boto ya Tshekatsheko ya Setheo (IRB) kgotsa Komiti ya Maitsholo (EC) e sekaseka le go baya leitlho leano la thutopatlisiso la tleliniki nngwe le nngwe e e dirang thutopatlisiso, go akaretsa tshedimosetso e e fiwang batho ka ga thutopatlisiso, tswelopele ya thutopatlisiso, le mathata a boitekanelo mo batsayakarolong. Gape IRB/EC e baya leitlho pabalesego ya batsayakarolo le go tlhola gore a ditshwanelo tsa motsayakarolo mongwe le mongwe di a tlotliwa.
- Lekgotla la Taolo ya Melemo la Aforikaborwa le okametse tsamaiso ya thutopatlisiso mme le batla dipego tsa ka gale ka ga pabalesego ya batsayakarolo.
- Tleliniki nngwe le nngwe e na le Institutional Biosafety Committee (IBC) e e okamelang kafa meento ya thutopatlisiso e baakanngwang ka teng kwa khemiseng le kafa e dirisiwang ka teng kwa tleliniking.
- Ditleliniki dingwe di na le Dikomiti tsa Maitsholo tse di okamelang mafelo a madi le disampole tse dingwe di bolokiwang teng. Mafelo a a bidiwa di-bio-bank kgotsa di-repository.
- Lefapha la Aforikaborwa la Temothuo, Jalo ya Dikgwa, le Bodirelatlhapi (DAFF) le na le boto e e kgethegileng e e tshwanetseng go sekaseka le go letlelela dikopo tsotlhe tsa go romela teng dire tse di fetotsweng dijini (GMO). Seo se akaretsa mongwe wa meento ya thutopatlisiso e.
- Tleliniki nngwe le nngwe ya thutopatlisiso e na le Boto e e Gakololang Setšhaba (CAB). Maloko a yone ke batho ba mo lefelong leo ba ba tlisang matshwenyego le dikgatlhegelo tsa setšhaba le tsa batsayakarolo ba thutopatlisiso kwa babatlisising. Maloko a CAB ke karolo ya setlhopha se se tlhamang thutopatlisiso nngwe le nngwe. Gape ba thusa go tlhama kgotsa go sekaseka tshedimosetso e e fiwang batsayakarolo. Gape batsayakarolo ba fiwa kgakololo ka ga ditsela tse dikgolo tsa go thibela tshwaetso ya HIV.
13. A meento ya thutopatlisiso e ka baka gore go nne le dipholo tsa tshwaetso ya HIV mo tekong ya HIV?
Ee. Meento ya thutopatlisiso e ka nna ya dira gore motsayakarolo a nne le maduo a teko a a bontshang gore o na le tshwaetso mo mefuteng mengwe ya diteko tsa HIV. Fa motsayakarolo a fiwa moento wa thutopatlisiso wa HIV, mmele wa gagwe o dira dilwantsha-mogare tsa HIV. Dilwantsha-mogare di go thusa 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 ya teko e e bontshang gore o na le tshwaetso ya HIV le fa a sa tshwaediwa ke HIV. Se se bidiwa pholo ya teko e e tlisiwang ke moento e e leng “vaccine-induced seropositivity” (VISP). Gape o ka nna wa bona se se bidiwa Vaccine-Induced Seroreactivity (VISR). Ga re itse gore ke mang yo o tlaa nnang le dipholo tsa teko tsa VISP kgotsa gore dipholo tse di ka tshwarelela ka lobaka lo lo kana kang.
Batho ba ba nang le dipholo tsa teko tsa VISP ba tlhoka diteko tse di maleba tsa HIV go bona gore a pholo ya teko e e bontshang gore o na le HIV e bakwa ke VISP kgotsa ke tshwaetso ya nnete. Ditleliniki tse di tsayang karolo mo thutopatlisisong e di ka kgona go dira diteko tse di maleba tse di batlang mogare ka boone go na le go batla dilwantsha-mogare.
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 tlhokomelong ya kalafi kgotsa ya meno, ditiro dingwe, inšorense, kgotsa visa ya go dira kwa dinageng tse di rileng kgotsa go tsaya mesepele go ya kwa go tsone. Batho ba ba nang le pholo ya teko ya VISP ba ka nna ba se ka ba letlelelwa go aba madi kgotsa dirwe tse dingwe. Batho ba ba kgatlhegelang go tsenela thutopatlisiso le ba ba rulaganyang go tsenya kopo ya inšorense kgotsa ya tiro ba tshwanetse go itsise lefelo la thutopatlisiso gone fela foo. Setlamo sa inšorense kgotsa mothapi ba ka nna ba se ka ba amogela dipholo tsa teko ya HIV go tswa go HVTN. Le fa go le jalo, HVTN e ka dirisana le bone go netefatsa gore go dirwa teko e e tshwanetseng e e tlaa bontshang boemo jwa motho jwa nnete jwa HIV.
14. Nka bona kae tshedimosetso go ya pele?
Ka ga dithutopatlisiso tsa kalafi tsa moento wa HIV: www.clinicaltrials.gov
Ka ga HIV Vaccine Trials Network: www.hvtn.org
Ka ga VISP: http://www.hvtn.org/en/participants/visp-hiv-testing.html
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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