The UK will launch the world’s first coronavirus human challenge study which is set to start in the next few weeks.
The news was announced by the UK’s Department for Business, Energy and Industrial Strategy (BEIS) after the study was given the approval from the country’s clinical trials ethics body.
Researchers have called on all healthy, young people between the ages of 18 and 30 to take part in the study, which will play a major role in helping the development of effective Covid-19 treatments and vaccines.
The study which is being backed by a UK government investment of £33.6 million, will be the first-of-its-kind. It will see up to 90 carefully selected human adult volunteers, being exposed to the Covid-19 virus in a controlled and safe environment.
The initial trial will involve establishing the lowest amount of the virus that is needed to cause infection, probe the body’s immune response and explore how the virus is passed from person to person.
It will also help doctors understand how the immune system reacts to the virus and recognise factors that influence how Covid is transmitted, including how a person who is infected could transmit the infectious virus into the environment.
All of this information will give doctors a much greater understanding of the disease and therefore help in aiding the future development of treatment and vaccines.
Participants will be very closely monitored, with medics and scientists being on hand 24 hours a day to look after them. The team added that for the safety of the volunteers, the virus that will be used will be the variant that has been circulating in the UK since March 2020, not one of the newer mutant strains.
Once the initial trials are completed, the study will move on to expose participants that have already received a Covid vaccination.
The business secretary, Kwasi Kwarteng, said the study was an important element in efforts to tackle Covid.
“While there has been very positive progress in vaccine development, we want to find the best and most effective vaccines for use over the longer term,” he said.
“These human challenge studies will take place here in the UK and will help accelerate scientists’ knowledge of how coronavirus affects people and could eventually further the rapid development of vaccines.”
The study’s chief investigator, Dr Chris Chiu from Imperial College London, said: “We are asking for volunteers aged between 18 and 30 to join this research endeavour and help us to understand how the virus infects people and how it passes so successfully between us.
“Our eventual aim is to establish which vaccines and treatments work best in beating this disease, but we need volunteers to support us in this work.”
Human challenge trials are not new. Over many decades, these studies have been carried out safely and have played a very important role in accelerating the development of treatments for diseases such as Typhoid, Flu, Malaria, Cholera and Norovirus.
These trials have also aided researchers to establish which vaccine is most likely to succeed in the phase 3 trials that would follow and usually involve thousands of volunteers.
The Human Challenge study is being carried out by a partnership between the government’s Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and the industry-leading clinical company hVIVO, which has pioneered viral human challenge models.
Interim Chair of the Vaccines Taskforce Clive Dix said: “We have secured a number of safe and effective vaccines for the UK, but it is essential that we continue to develop new vaccines and treatments for Covid-19. We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection.”
Chief Scientific Officer at hVIVO, Dr Andrew Catchpole said: “Ethical review of the research plan is a crucial part of conducting clinical studies and approval from the Ethics Committee represents a very important milestone in the development of the Covid-19 challenge model. COVID-19 Human Challenge studies have the potential to play an important role in providing data and information that will help continue to develop vaccines to control the pandemic.
"This study is a key enabling study to establish the Covid-19 challenge model and determine the lowest possible dose of virus required. Data from the study will immediately facilitate the challenge model to be used for vaccine efficacy testing as well as to answer a wide range of fundamental scientific questions that are not feasible with traditional field trials, such as exactly what type of immunological response is required to confer protection from re-infection.”
Uingereza ina mpango wa kuanzisha utafiti wa kwanza wa changamoto ya binadamu ya coronavirus, ambao utaanza wiki chache zijazo. Utafiti huo ulitangazwa na Idara ya Biashara, Nishati na Mkakati wa Viwanda (BEIS) nchini Uingereza baada ya utafiti huo kuidhinishwa na shirika la maadili la majaribio ya kliniki nchini humo. Watafiti wamewataka vijana wote wenye afya wenye umri wa kati ya miaka 18 na 30 kushiriki katika utafiti huo ambao utachangia sana katika kuendeleza matibabu na chanjo za COVID-19. Utafiti huo, ambao unasaidiwa na uwekezaji wa serikali ya Uingereza wa £ 33.6 milioni, utakuwa wa kwanza wa aina yake. "Kama ilivyoelezwa hapo juu, ""waajiri 90 waliochaguliwa kwa uangalifu watakuwa na maambukizi ya virusi vya COVID-19 katika mazingira ya kudhibitiwa na salama.""" Majaribio ya kwanza yatahusisha kuanzisha kiasi cha chini cha virusi vinavyohitajika kusababisha maambukizi, kuchunguza majibu ya kinga ya mwili na kuchunguza jinsi virusi vinavyopitishwa kutoka kwa mtu mmoja hadi mwingine. Pia itasaidia madaktari kuelewa jinsi mfumo wa kinga unavyoitikia virusi na kutambua mambo yanayoathiri jinsi Covid inavyoambukizwa, ikiwa ni pamoja na jinsi mtu aliyeambukizwa anaweza kuambukiza virusi vya kuambukiza katika mazingira. Habari hizi zote zitawapa madaktari uelewa mkubwa zaidi wa ugonjwa na hivyo kusaidia katika maendeleo ya baadaye ya matibabu na chanjo. Washiriki watakuwa chini ya uangalizi wa karibu, na madaktari na wanasayansi watakuwa karibu masaa 24 kwa siku kuwatunza. "Timu hiyo iliongeza kuwa kwa usalama wa kujitolea, virusi vinavyotumiwa vitakuwa ""tofauti ambayo imekuwa ikizunguka Uingereza tangu Machi 2020,"" sio moja ya aina mpya za mutant." Baada ya majaribio ya kwanza kukamilika, utafiti utaendelea na washiriki ambao tayari wamepokea chanjo ya COVID-19. Katibu wa biashara, Kwasi Kwarteng, alisema utafiti huo ulikuwa kipengele muhimu katika juhudi za kukabiliana na Covid. "Wakati ambapo kumekuwa na maendeleo mazuri sana katika maendeleo ya chanjo, tunataka kupata chanjo bora na zenye ufanisi zaidi kwa matumizi ya muda mrefu", alisema. "Utafiti huo wa ""Human Challenge"" utafanyika hapa Uingereza na utasaidia kuharakisha maarifa ya wanasayansi juu ya jinsi coronavirus inavyoathiri watu na hatimaye inaweza kuendeleza maendeleo ya haraka ya chanjo, ""Mtafiti mkuu wa utafiti, Dk Chris Chiu kutoka Chuo Kikuu cha Imperial London, alisema, ""Tunaomba wajitolea wenye umri wa kati ya 18 na 30 kujiunga na juhudi hii ya utafiti na kutusaidia kuelewa jinsi virusi vinavyowaambukiza watu na jinsi inavyoweza kupita kati yetu." "Lengo letu la mwisho ni kuanzisha chanjo na matibabu ambayo yanafanya kazi bora katika kushinda ugonjwa huu, lakini tunahitaji wajitoleaji kutusaidia katika kazi hii. "" Majaribio ya changamoto ya binadamu si mpya." Kwa miongo mingi, utafiti huu umefanywa kwa usalama na umekuwa na jukumu muhimu sana katika kuharakisha maendeleo ya matibabu ya magonjwa kama vile homa ya kawaida, homa, malaria, kolera na norovirus. Majaribio hayo pia yamesaidia watafiti kuamua ni chanjo gani inayoweza kufanikiwa katika majaribio ya awamu ya tatu ambayo hufuatia na kwa kawaida huhusisha maelfu ya wajitoleaji. Utafiti wa Human Challenge unafanywa na ushirikiano kati ya Serikali ya Vaccine Taskforce, Imperial College London, Royal Free London NHS Foundation Trust na kampuni ya kliniki inayoongoza ya hVIVO, ambayo imesababisha mifano ya changamoto ya binadamu ya virusi. "Mkurugenzi wa muda wa Kikosi cha Kazi cha Chanjo Clive Dix alisema: ""Tumehifadhi chanjo kadhaa salama na zenye ufanisi kwa Uingereza, lakini ni muhimu kwamba tuendelee kuendeleza chanjo mpya na matibabu ya COVID-19." "Tunatarajia masomo haya yatatoa ufahamu wa kipekee juu ya jinsi virusi vinavyofanya kazi na kutusaidia kuelewa ni chanjo gani zenye kuahidi zinazotoa nafasi bora ya kuzuia maambukizo. ""Mkurugenzi Mkuu wa Sayansi katika hVIVO, Dk Andrew Catchpole alisema: ""Mapitio ya maadili ya mpango wa utafiti ni sehemu muhimu ya kufanya masomo ya kliniki na idhini kutoka Kamati ya Maadili inawakilisha hatua muhimu sana katika maendeleo ya mfano wa changamoto ya COVID-19." "Utafiti wa ""Covid-19 Human Challenge"" una uwezo wa kucheza jukumu muhimu katika kutoa data na habari ambayo itasaidia kuendelea kuendeleza chanjo za kudhibiti janga hilo." "Utafiti huu ni utafiti muhimu wa kuwezesha kuanzisha mfano wa changamoto ya COVID-19 na kuamua kipimo cha chini zaidi cha virusi vinavyohitajika.""" Takwimu kutoka kwa utafiti huo zitasaidia mara moja mfano wa changamoto kutumika kwa majaribio ya ufanisi wa chanjo na pia kujibu maswali mengi ya kisayansi ya msingi ambayo hayawezekani na majaribio ya kawaida ya uwanja, kama vile ni aina gani ya majibu ya kinga inahitajika kutoa ulinzi dhidi ya maambukizi ya mara kwa mara.