Allurar rigakafin cutar sankara

Alurar rigakafin Dengue Ya kasance wani maganin rigakafi ne da ake amfani da shi don hana zazzabin dengue a cikin mutane.  Ci gaban rigakafin dengue ya fara ne a cikin 1920s, amma an hana shi da buƙatar ƙirƙirar rigakafi daga duk nau'ikan dengue guda huɗu.  Ya zuwa 2023, akwai alluran rigakafi guda biyu na kasuwanci, ana siyar da su a ƙarƙashin alamun Dengvaxia da Qdenga .  

Dengvaxia ana ba da shawarar ne kawai a cikin waɗanda a baya suka kamu da zazzabin dengue ko yawan jama'ar da yawancin mutane suka kamu da cutar a baya saboda sabon abu da aka sani da haɓaka mai dogaro da antibody .  Ƙimar Dengavaxia yana iyakance ne ta hanyar gaskiyar cewa yana iya ƙara yawan haɗarin dengue mai tsanani a cikin waɗanda ba a taɓa kamuwa da su ba.   A cikin 2017, fiye da yara 733,000 da fiye da 50,000 masu aikin sa kai na manya an yi musu allurar Dengvaxia ba tare da la'akari da serostatus ba, wanda ya haifar da cece-kuce .  An keɓance Qdenga don mutanen da ba su kamu da cutar a baya ba.

Akwai wasu 'yan takarar allurar da ke cikin haɓaka ciki har da waɗanda ba a kunna su ba, DNA da alluran rigakafin subunit . 

 Tarihi 
A cikin Disamba 2018, Dengvaxia an amince da shi a cikin Tarayyar Turai. 

A cikin Mayu 2019, Dengvaxia an amince da shi a cikin Amurka a matsayin rigakafin farko da aka amince da shi don rigakafin cututtukan dengue wanda duk kwayoyin cutar dengue ke haifar (1, 2, 3 da 4) a cikin mutane masu shekaru tara zuwa 16 waɗanda ke da dakin gwaje-gwaje-tabbatar da dengue na baya. kamuwa da cuta da kuma wadanda ke zaune a yankunan da ke fama da cutar.   Dengue yana yaduwa a cikin yankunan Amurka na Samoa, Guam, Puerto Rico, da tsibirin Virgin na Amurka. 

An ƙaddara aminci da ingancin maganin a cikin bazuwar bincike guda uku, binciken da ake sarrafa wuribo wanda ya ƙunshi kusan mutane 35,000 a yankunan da ke fama da dengue, gami da Puerto Rico, Latin Amurka da yankin Asiya Pacific. An ƙaddara cewa maganin zai yi tasiri kusan kashi 76 cikin ɗari wajen hana alamun bayyanar cututtuka, cututtukan dengue da aka tabbatar da dakin gwaje-gwaje a cikin mutane masu shekaru 9 zuwa 16 waɗanda a baya suna da cutar dengue-tabbatar da dakin gwaje-gwaje.

A cikin Maris 2021, Hukumar Kula da Magunguna ta Turai kunshin yin rajista don TAK-003 (Qdenga) an yi niyya don kasuwannin waje na EU.

A cikin Agusta 2022, FDA ta Indonesiya ta amince da Qdenga don amfani da shi ga mutane masu shekaru shida zuwa 45 kuma sun zama hukuma ta farko a duniya don amincewa da Qdenga. An amince da Qdenga a cikin Tarayyar Turai a cikin Disamba 2022.

 CYD-TDV (Dengvaxia) 
CYD-TDV, wanda aka sayar a ƙarƙashin sunan alamar Dengvaxia kuma Sanofi Pasteur ya yi, wani maganin rigakafi ne mai rai wanda aka yi amfani da shi a matsayin allurar rigakafi guda uku, tare da kashi na farko da ya biyo bayan ƙarin harbi biyu da aka ba shi shida da goma sha biyu bayan watanni. Hukumar Abinci da Magunguna ta Amurka (FDA) ta ba da aikace-aikacen don tantance fifiko na Dengvaxia da takardar ba da fifiko kan cututtukan wurare masu zafi.  An ba da izinin Dengvaxia ga Sanofi Pasteur.

An amince da maganin a cikin ƙasashe 19 da Tarayyar Turai,  amma ba a yarda da ita a cikin Amurka don amfani da mutanen da ba su kamu da kwayar cutar dengue a baya ba ko kuma waɗanda ba a san wannan bayanin ba. 

Dengvaxia allurar rigakafi ce ta chimeric da aka yi ta amfani da fasahar DNA ta sake hadewa ta hanyar maye gurbin PrM (pre-membrane) da E (envelope) tsarin tsarin kwayoyin cutar zazzabin rawaya wanda ya rage 17D nau'in maganin alurar riga kafi tare da wadanda daga nau'ikan dengue serotypes hudu.   Shaidu sun nuna cewa CYD-TDV na da tasiri a wani bangare na hana kamuwa da cuta, amma yana iya haifar da haɗarin kamuwa da cuta mai tsanani a cikin waɗanda ba a taɓa kamuwa da su ba sannan su ci gaba da kamuwa da cutar. Ba a bayyana dalilin da ya sa yawan mutanen da aka yi wa alurar riga kafi ke da mummunan sakamako ba. Mahimman hasashe shine abin da ya faru na haɓakar dogaro da mutum (ADE).  Masanin ilimin halittu na Amurka Scott Halstead na ɗaya daga cikin masu bincike na farko don gano lamarin ADE.  Dokta Halstead da abokin aikinsa Dokta Phillip Russell sun ba da shawarar cewa za a yi amfani da maganin kawai bayan gwajin maganin rigakafi, don bincika kafin kamuwa da cutar dengue da kuma guje wa allurar rigakafin cutar sero-negative. 

Abubuwan da aka saba amfani da su sun haɗa da ciwon kai, jin zafi a wurin allura, da ciwon tsoka gaba ɗaya.  Mummunan illa na iya haɗawa da anaphylaxis .  Ba a ba da shawarar yin amfani da shi a cikin mutanen da ba su da aikin rigakafi mara kyau .  Tsaron amfani yayin daukar ciki ba shi da tabbas.  Dengvaxia allurar rigakafi ce mai rauni amma mai rai kuma tana aiki ta haifar da martanin rigakafi akan nau'ikan cutar dengue iri hudu. 

Dengvaxia ya zama kasuwanci a cikin 2016 a cikin kasashe 11: Mexico, Philippines, Indonesia, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Thailand, da Singapore.    A cikin 2019 an amince da shi don amfanin likita a Amurka.   Yana cikin jerin Mahimman Magunguna na Hukumar Lafiya ta Duniya .  

A cikin 2017, masana'anta sun ba da shawarar cewa a yi amfani da maganin kawai a cikin mutanen da a baya sun kamu da cutar dengue, saboda sakamakon na iya yin muni a cikin waɗanda ba a taɓa kamuwa da su ba saboda haɓakar dogaro da ƙwayoyin cuta .  Wannan ya haifar da cece-kuce a Philippines inda aka yi wa yara sama da 733,000 da kuma manya masu aikin sa kai sama da 50,000 allurar ba tare da la’akari da yanayin serostatus ba. 

Hukumar Lafiya ta Duniya (WHO) ta ba da shawarar cewa kasashe su yi la'akari da allurar rigakafin cutar Dengue CYD-TDV kawai idan ana iya rage haɗarin kamuwa da cutar dengue mai tsanani a cikin mutanen da ba su da ra'ayin mazan jiya ko dai ta hanyar yin gwajin riga-kafi ko kuma takaddun kwanan nan na yawan hauhawar jini a yankin. akalla 80% ta shekaru tara). 

WHO ta sabunta shawarwarin ta game da amfani da Dengvaxia a cikin 2018, dangane da bayanan aminci na dogon lokaci wanda serostatus ya tsara a ranar 29 ga Nuwamba 2017. Masu karɓar maganin alurar riga kafi suna da haɗarin haɗari mai tsanani na dengue idan aka kwatanta da mutanen da ba a yi musu allurar ba. Ga kowane asibiti 13 da aka hana a cikin alluran rigakafi, za a sami ƙarin asibiti 1 a cikin allurar seronegative a cikin allurar 1,000. WHO ta ba da shawarar gwajin serological don kamuwa da cutar dengue na baya 

A cikin 2017, masana'anta sun ba da shawarar cewa a yi amfani da maganin kawai a cikin mutanen da suka kamu da cutar dengue a baya don in ba haka ba akwai shaidar cewa na iya cutar da cututtukan da ke biyo baya.  Yarjejeniya ta farko ba ta buƙatar samfuran jini na asali kafin a yi maganin alurar riga kafi don tabbatar da fahimtar haɗarin haɗari mai tsanani a cikin mahalarta waɗanda ba a bayyana su a baya ba. A cikin Nuwamba 2017, Sanofi ya yarda cewa wasu mahalarta an sanya su cikin haɗari mai tsanani na dengue idan ba su da kamuwa da kamuwa da cutar; daga baya gwamnatin Philippine ta dakatar da shirin na rigakafi da yawa tare da goyon bayan hukumar ta WHO wacce ta fara nazarin bayanan lafiya. 

Gwajin kashi na III a Latin Amurka da Asiya ya shafi yara sama da 31,000 tsakanin shekaru biyu zuwa 14. A cikin rahotannin farko daga gwaje-gwajen, ingancin rigakafin ya kasance 56.5% a cikin binciken Asiya da 64.7% a cikin binciken Latin Amurka a cikin marasa lafiya waɗanda suka karɓi aƙalla allurar rigakafin.   Tasiri ya bambanta ta hanyar serotype. A cikin gwaje-gwajen biyun rigakafin rigakafin ya ragu da kusan kashi 80% yawan cututtukan dengue masu tsanani. Wani bincike na duka biyun binciken Latin Amurka da na Asiya a shekara ta 3 na bin diddigin ya nuna cewa ingancin maganin ya kasance 65.6% wajen hana kwantar da yara a asibiti a cikin yara waɗanda suka girmi shekaru tara, amma ya fi girma (81.9%) ga yaran da suka kamu da cutar. sun kasance seropositive (yana nuna kamuwa da cutar dengue na baya) a asali.  Jerin rigakafin ya ƙunshi allura uku a cikin watanni 0, 6 da 12.  An amince da maganin a Mexico, Philippines, da Brazil a watan Disamba 2015, da kuma a El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand, da Singapore a 2016.  A ƙarƙashin sunan alamar Dengvaxia, an yarda da shi don amfani ga waɗanda shekarunsu suka wuce shekaru tara da haihuwa kuma yana iya hana duk nau'ikan serotypes guda huɗu. 

 TAK-003 (Qdenga) 
TAK-003 ko DENVax, wanda aka sayar a ƙarƙashin sunan alamar Qdenga kuma Takeda ya yi, wani maganin rigakafi ne na recombinant chimeric attenuated tare da sassan DENV1, DENV3, da DENV4 akan kwayar cutar dengue 2 (DENV2) kashin baya wanda aka samo asali a Jami'ar Mahidol Bangkok kuma yanzu Inviragen (DENVax) da (TAK-003) ke tallafawa.   An gudanar da gwaji na Mataki na I da na II a Amurka, Kolombiya, Puerto Rico, Singapore da Thailand.  Bayanan watanni 18 da aka buga a cikin mujallar Lancet Cututtuka masu Yaduwa, sun nuna cewa TAK-003 ta haifar da ci gaba da amsawar rigakafi ga dukkanin nau'o'in ƙwayoyin cuta guda hudu, ba tare da la'akari da bayyanar dengue da aka yi a baya ba da kuma jadawalin dosing.

Bayanai daga gwajin lokaci na III, wanda ya fara a watan Satumba na 2016, ya nuna cewa TAK-003 yana da tasiri a kan dengue na alama.  TAK-003 ya bayyana baya rasa inganci a cikin mutanen da ba su da ƙarfi ko kuma zai iya cutar da su, sabanin CYD-TDV. Bayanan sun bayyana suna nuna matsakaicin inganci kawai a cikin wasu nau'ikan dengue fiye da DENV2. 

Qdenga ya sami izini don amfani a cikin Tarayyar Turai a cikin 2022 ga mutane masu shekaru 4 da sama,    kuma an amince da shi a cikin United Kingdom, Brazil, Argentina, Indonesia, da Thailand. Takeda da son rai ya janye aikace-aikacen su don amincewar allurar a cikin Amurka a cikin Yuli 2023 bayan FDA ta nemi ƙarin bayanai daga kamfanin, wanda kamfanin ya ce ba za a iya ba da shi ba yayin sake zagayowar yanzu. 

 A cikin ci gaba 

 TV-003/005 
TV-003/005 wani tetravalent admixture ne na maganin rigakafi guda ɗaya, wanda NIAID ta haɓaka, waɗanda aka gwada daban don aminci da rigakafi. Alurar riga kafi ta wuce gwajin lokaci na I da nazarin lokaci na II a cikin Amurka, Thailand, Bangladesh, India, da Brazil. 

NIH ta gudanar da karatun kashi na I da na II a cikin mahalarta sama da 1,000 a Amurka. Hakanan ya gudanar da karatun ƙalubalen ɗan adam  yayin da ya gudanar da nazarin ƙirar NHP cikin nasara. 

NIH ta ba da lasisin fasahar su don ƙarin haɓakawa da masana'antar sikelin kasuwanci zuwa Panacea Biotec,  Cibiyar Serum ta Indiya,  Instituto Butantan,  Vabiotech,  Merck,  da Medigen. 

A Brazil, Instituto Butantan tare da haɗin gwiwar NIH ke gudanar da karatun kashi na III. Panacea Biotec ta gudanar da karatun asibiti na kashi II a Indiya. 

Wani kamfani a Vietnam (Vabiotech) yana gudanar da gwaje-gwajen aminci da haɓaka shirin gwaji na asibiti.  Dukan kamfanoni huɗu suna da hannu a cikin nazarin rigakafin TetraVax-DV tare da Cibiyar Kiwon Lafiya ta Amurka. 

 Farashin TDENV 
TDENV PIV (tetravalent dengue virus purified inactivated alluran rigakafi) yana jurewa gwajin lokaci na a matsayin wani ɓangare na haɗin gwiwa tsakanin GlaxoSmithKline (GSK) da Walter Reed Army Institute of Research (WRAIR). Hakanan ana kimanta tsarin haɗin gwiwa tare da wani rigakafin ɗan takara mai rai (dabarun haɓakawa na farko) a cikin binciken lokaci na II. A cikin haɓakawa na farko, nau'in rigakafin guda ɗaya yana biye da haɓaka tare da wani nau'in a ƙoƙarin haɓaka rigakafi. 

 V180 
Merck yana nazarin recombinant subunit allurar da aka bayyana a cikin kwayoyin Drosophila .  , ya kammala mataki I mataki kuma ya sami tsarin V180 don a jure shi gabaɗaya. 

 Magungunan DNA 
A cikin 2011, Cibiyar Nazarin Kiwon Lafiya ta Naval ta yi ƙoƙarin samar da maganin rigakafi na DNA plasmid monovalent, amma sakamakon farko ya nuna cewa yana da matsakaicin matsakaici.  [ bukatar sabuntawa ]

 Al'umma da al'adu 

 Matsayin doka 
A ranar 13 ga Oktoba 2022, Kwamitin Kula da Magunguna don Amfani da Dan Adam (CHMP) na Hukumar Kula da Magunguna ta Turai (EMA) ya karɓi ra'ayi mai kyau, yana ba da shawarar ba da izinin tallan don samfurin magani na Qdenga, wanda aka yi niyya don rigakafin cututtukan dengue.   Mai neman wannan samfurin magani shine Takeda GmbH.  Abubuwan da ke aiki na Qdenga shine maganin rigakafi na dengue tetravalent (rayuwa, wanda aka rage), maganin kwayar cutar kwayar cuta mai dauke da ƙwayoyin cuta na dengue masu rai waɗanda ke yin kwafi a cikin gida kuma suna haifar da martani mai ban dariya da salon salula akan serotypes na cutar dengue guda huɗu.  An amince da Qdenga don amfani da magani a cikin Tarayyar Turai a cikin Disamba 2022.   

A cikin Fabrairu 2023, Hukumar Kula da Magunguna da Kula da Lafiya ta Burtaniya (MHRA) ta amince da Qdenga ga mutane masu shekaru hudu da haihuwa. 

A cikin Afrilu 2023,  (ANMAT) ya ba da hasken kore don amfani da tetravalent rigakafin TAK-003 da aka fi sani da Qdenga, wanda Kamfanin Jafananci Takeda Pharmaceutical Company ya haɓaka, ya mai da shi kawai maganin da aka amince da shi a yau. don yaƙar dengue a Argentina .  An yi amfani da shi a cikin 2024 annoba ta dengue . 

A cikin Yuli 2023, Takeda ya janye aikace-aikacensa na Qdenga a gaban FDA, yana ambaton buƙatun FDA don ƙarin bayanan da ba a kama su ba a cikin karatun kashi na III. 

 Ilimin tattalin arziki 
A Indonesiya, Dengvaxia ya kai kimanin  don shawarwarin allurai guda uku kamar na 2016.  Indonesiya ita ce ƙasa ta farko da ta amince da Qdenga, a ƙarshen 2022.

 Rigingimu 

 Philippines 
Rigimar rigakafin dengue na 2017 a cikin Philippines ta ƙunshi shirin rigakafin da Ma'aikatar Lafiya ta Philippines (DOH) ke gudanarwa.  DOH ta yiwa yaran makaranta alurar riga kafi da Sanofi Pasteur's CYD-TDV (Dengvaxia) rigakafin dengue. Wasu daga cikin yaran da suka karɓi maganin ba su taɓa kamuwa da cutar dengue ba a baya. An dakatar da shirin ne a lokacin da Sanofi Pasteur ya shawarci gwamnati cewa rigakafin na iya jefa mutanen da ba su kamu da cutar a baya cikin wani dan karamin hadarin kamuwa da cutar zazzabin dengue.  Takaddama ta siyasa ta barke kan ko an gudanar da shirin da isasshiyar kulawa da kuma wanda ya kamata a dora wa alhakin cutar da yaran da aka yi wa allurar. 

 Hanyoyin haɗi na waje 


 Dengue Vaccines at the U.S. National Library of Medicine Medical Subject Headings (MeSH)

 Manazarta 
Rukuni:Rigakafi
Rukuni:Shafuka masu fassarorin da ba'a duba ba