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Mtafiti mkuu wa hapa nchini ni Dkt Anthony Etyang: barua pepe Aetyang@kemri-wellcome.org Simu +254 722 417507
Utafiti huu umeidhinishwa na mamlaka za uthibiti hapa Kenya na unatarajiwa kuanza kusajili watu hapo mwezzi wa 10, 2020. Ufuatilizi wa washiriki unatarajiwa kukamilika kufikia mwezi wa Tatu,2021 na majibu yachapishwe muda mfupi baadaye.
Utafiti huu unaweza kuonyesha manufaa ya matumizi ya hydroxychloroquine ambayo yataokoa maisha ya watu wengi, au kinyume na hivi, inaweza kuonyesha kwamba kinga ya hydroxychloroquine haifanyi kazi kwa hivyo majaribio yataweza kwenda kwa kutathmini mbinu nyengine ziwezekanazo.
Kuna manufaa yanayoweza kupatikana ya kupata kinga dhidi ya maambukizi ya kirusi cha korona iwapo dawa itafanya kazi kwa wale walio kwenye kundi la kupata hydroxychloroquine. Wale watakaokuwa kwenye kundi la kulinganisha pia wanaweza kunufaika kutokana na kukingwa ambako si kwa moja kwa moja yaani kupitia kwa kupungua kwa uwezo wa kusambaa kwa maambukizi.
Hatari zinazohusiana na hydroxychloroquine ziko chini sana, kando na utangazaji mbaya ambao hivi karibuni dawa hiyo umeipokea. Mambo ya kiusalama yamejadiliwa sana na wathibiti wa hapa Kenya na wa kimataifa na mbinu kadhaa zimewekwa kuhakikisha usalama wa washiriki wa majaribio haya.
Washiriki watajibu maswali kadhaa kuhusu historia yao ya kimatibabu, wapeane mililita 25 za damu kwa ajili ya vipimo, watumie dawa (tembe) (hydroxychloroquine au kilinganishi) na waweke rekodi ya joto na dalili za matatizo ya kupumua kupitia njia ya simu ya rununu.
Washiriki watatumia dawa za utafiti kwa muda wa siku 90. Wataombwa waje katika kliniki ya utafiti katika siku ya 30, 60 na ya 90, na ziara ya mwisho ifanywe baada ya miezi 5.
Wale watakaotoa ripoti ya dalili za matatizo ya kupumua wakati wa utafiti, sampuli itokanayo na kupangusa ndani ya pua na kooni itachukuliwa kwa ajili ya vipimo vya uwepo wa virusi vya matatizo ya kupumua.
Utafiti unafanywa katika nchi kadhaa huko Asia, Ulaya na Afrika. Tunatumai kusajili wahudumu wa afya wasiozidi 40,000 dunia nzima.
Kwa sasa kuna vituo 4 vya utafiti huu hapa Kenya; Kilifi, Mombasa, Nairobi na Kisumu. Tunalenga kusajili angalau washiriki 800 na wasiozidi 1,600 katika vituo vyote.
Tutasajili wahudumu wa afya ambao wako kwenye hatari zaidi ya kupata maambukizi ya SARS-CoV-2.
Tunafanya utafiti kujua ikiwa dawa ya hydroxychloroquine inaweza kukinga ugonjwa wa kirusi cha korona. Chloroquine, dawa inayofanana na hydroxychloroquine, ilitumika kwingi katika kukinga na kutibu malaria kwa zaidi ya miaka 50 na pia kutibu maumivu ya viungo (rheumatoid arthritis). Watu wamekuwa wakiitumia kwa miaka mingi. Inaonekana kuwa salama sana, na inaweza kufanya kazi dhidi ya kirusi hiki.
Tungependa kujua ikiwa hydroxychloroquine inapunguza dalili kwa wale wanaopata maambukizi ya kirusi cha korona wakati wanaitumia.
Ugonjwa wa virusi vya korona (COVID-19), unaosababishwa na kirusi kinachoitwa SARS-CoV-2, uliripotiwa mara ya kwanza huko Wuhan China Disemba, 2019 na kufikia sasa umeathiri zaidi ya watu milioni 2 duniani na umetangazwa kama janga la dunia nzima na Shirika la Afya Duniani [World Health Organisation (WHO)]
Hakuna dawa ya kukinga au hata chanjo iliyothibitishwa. Kufikia tarehe 22/9/2020, kulikuwa na vifo zaidi ya 500,000 duniani na kati ya hivi 34,077 vilikuwa Afrika. Tuko mbioni kutafuta matibabu mwafaka na njia za kukinga kadri janga linavyokua.
Kuna wasiwasi mkubwa kwamba ugonjwa wa COVID-19 unaweza kulemea/kuharibu mataifa yenye uwezo mdogo wa kutibu na wa kuwatenga wale walioambukizwa, na unaweza kulemea mifumo ya afya ambayo tayari ni dhaifu. Hatari kwa wahudumu wa afya, kama ilivyoonekana na SARS-CoV hapo nyuma, na sasa katika mataifa mengi na COVID-19, inaweza kuwa tishio kubwa kwa shughuli za utoaji wa huduma kwa jumla.
Watu wanaowahudumia wagonjwa wenye maambukizi ya COVID-19 wako katika hatari kubwa zaidi ya maambukizi. Kuna uhitaji wa dharura wa kutambua dawa zinazoweza kukinga usambazaji wa maambukizi lakini pia zinazoweza kukinga makundi yaliyo kwenye hatari zaidi, kama wale wanaofanya kazi kwenye vituo vya afya, kutokana na kupata maambukizi, ili waweze kuendelea kuhudumia wagonjwa na kulinda familia zao.
The study has been approved by regulatory authorities in Kenya and is expected to start recruitment in October 2020. Participant follow up is expected to be completed by March 2021 and results published shortly thereafter.
The study may show a benefit of using hydroxychloroquine which would save many lives around the world, or alternatively may show hydroxychloroquine prophylaxis is ineffective so trials can move on to evaluate other possible interventions.
There is a potential benefit of direct protection from corona virus infection if the drug works for those who are in the hydroxychloroquine arm. Individuals in the placebo arm may also benefit from indirect protection through decreased ability of the infection to spread.
Risks related to hydroxychloroquine are very low, despite the recent negative publicity that it has received. Safety issues have been discussed extensively with both local and international regulators and several measures have been put in place to ensure safety of trial participants.
Participants will answer some questions about their medical history, provide 25 ml of blood for testing, take study tablets (hydroxychloroquine or placebo) and record temperature and respiratory symptoms via mobile phone.
Participants will take the study tablets for 90 days. They will be requested to come to the study clinic on days 30,60 and 90, plus a final visit being conducted at 5 months.
Those reporting respiratory symptoms during the course of the study will have nasal and throat swabs collected for testing for the presence of respiratory viruses.
The study is being conducted in multiple countries in Asia, Europe and Africa. We hope to recruit up to 40,000 health care workers worldwide.
There are currently four study sites in Kenya; Kilifi, Mombasa, Nairobi, and Kisumu. We aim to recruit a minimum of 800 and a maximum of 1,600 participants across all sites.
We will enroll health care workers who are at high risk of exposure to SARS-CoV-2 infection.
We are conducting a study to find out whether hydroxychloroquine may prevent development of coronavirus illness. Chloroquine, the medicine very similar to hydroxychloroquine, was used very widely for the prevention and treatment of malaria for over 50 years and also to treat rheumatoid arthritis. People have taken it for many years at a time. It is considered very safe, and it may have effects against the virus.
We would also like to find out if hydroxychloroquine lessens the symptoms for those who do get corona virus infection while taking it.
Coronavirus disease (COVID-19), which is caused by the virus known as SARS-CoV-2, was first reported in Wuhan China in December 2019 and has so far affected over 2 million people globally and has been declared a global pandemic by the World Health Organisation (WHO).
There is no proven effective prophylaxis and no vaccine. As of 22 Sept 2020, there are more than 500,000 deaths globally with 34,077 in Africa. We are in a race against time to find effective treatments and preventive measures as the pandemic grows.
There is major concern that COVID-19 could devastate countries with limited capacity for testing and case isolation, and overwhelm their fragile healthcare systems. The high risk to healthcare workers, as seen with SARS-CoV previously, and now in many countries with COVID-19, could be a major threat to healthcare operations overall.
People who look after patients with COVID-19 infections are at increased risk of infection. There is an urgent need to identify drugs which can prevent the spread of infection but also that prevent high-risk groups, like those working in healthcare facilities, from getting the infection, so they can continue to care for patients and protect their families.
Tayari tuko na habari nyingi kuhusu usalama na ubora wa utendajikazi wa chanjo hii, hatuwezi kujua ni lini tutakapoweza kuamua ikiwa chanjo inakinga ugonjwa. Hii itategemea janga, pale wagonjwa wanapopungua, ni vigumu kujua ikiwa chanjo inakinga ugonjwa.
Majaribio haya yamefadhiliwa na Wellcome Trust na chuo kikuu cha Oxford.
Watafiti wa KWTRP wamefanya majaribio makubwa ya chanjo ndani ya muda wa miaka zaidi ya ishirini kama vile majaribio ya chanjo ya malaria ya RTSS na majaribio ya chanjo ya Ebola
Habari kwa muhtasari za matokeo ya majaribio zitapeanwa katika mikutano ya wanajamii katika maeneo ambayo washiriki walisajiliwa. Pia, habari kwa washikadau wote zitapeanwa kupitia njia mwafaka za mawasiliano na za ujumuishaji wa watu.
Chanjo hii imetengenezwa na watafiti kutika chuo kikuu cha Oxford, Uingereza, wakishirikiana na AstraZeneca.
Iwapo habari/data kote ulimwenguni zitaonyesha usalama na utendajikazi wa chanjo hii ya majaribio, kundi la kudhibiti litakalopokea chanjo ya kichaa cha mbwa litapewa chanjo ya ChAdOx1 nCoV-19, mara tu muongozo unaofaa utakapokuwa umefuatiliwa.
Washiriki watanufaika na ufahamu wa hali yao ya afya kwa jumla, ikijumuisha ikiwa wameambukizwa na SARS-CoV-2 (kirusi kinachosababisha COVID-19)
Watu watakaokubali kujitolea kushiriki kwenye majaribio haya wataregeshewa gharama zao za kushiriki kama vile tikiti. Pia watapewa fidia ya gharama nyengine zinazohusiana na utafiti ambazo wanaweza kuzipata, kwa kiwango maalum kama kilivyowekwa kwenye muongozo wetu wa malipo. Kulipa gharama za washiriki ni jambo la kimaadili linalohitajika katika utafiti.
Washiriki watafuatiliwa kwa ukaribu wakati wa majaribio haya kuhakikisha wako na afya nzuri, na madhara yoyote ya chanjo hii yanashuhulikiwa. Watafuatiliwa kwa muda usiozidi miezi 12 baada ya kupata chanjo ya majaribio.
Hii ni kamati huru ya wataalam wa maswala ya utafiti wa kimatibabu. Wanakamati ni wa kutoka sehemu mbali mbali za dunia. Kazi yao ni kufuatilia kwa ukaribu habari za usalama zinazotoka kwa majaribio ya dawa/chanjo. DSMB ya majaribio ya chanjo hii inajumuisha wanasayansi wenye utaalam kutoka Kenya. Mamlaka zinazoidhinisha za Kenya zinaendelea kupewa habari punde zinapotokea zinazohusu mambo yote ya usalama katika majaribio ya kimataifa.
Kufuatia ukaguzi ulio huru wa kilichosababisha ugonjwa wa mshiriki wa majaribio haya, na kutambua kwamba inawezekana haikuhuisana na chanjo ya majaribio, bodi ya kufuatilia habari za usalama [Data Safety and Monitoring Board (DSMB)], imeruhusu majaribio yaendelee.
Majaribio yalisitishwa kwa muda mfupi wakati mshiriki mmoja alipata ugonjwa usiotarajiwa. Kusitishwa kwa majaribio ni utaratibu wa kawaida unaoruhusu kundi la watu huru kufanya uchunguzi wa kilichosababisha ugonjwa fulani ambao umetokea kwa mshiriki wa majaribio. Wakati majaribio yalipositishwa, usajili wa washiriki haukuwa unaendelea hapa Kenya.
Athari inayoweza kutokea kwa washiriki iko chini sana, na hasa inahusiana na kuchukua kwa sampuli ya damu na kudungwa chanjo.
Chanjo hii ya majaribio kufikia sasa imepeanwa kwa washiriki zaidi ya 8,000 huko Uingereza, Afrika Kusini na Brazil, na hakuna wasiwasi mkubwa wa usalama ulioonekana.
Utafiti huu unahusisha awamu mbili. Katika awamu ya kwanza, washiriki 40 watasajiliwa; na kufuatwa na washiriki 360 watakaosajiliwa katika awamu ya pili ya utafiti huu
Majaribio haya yatajumuisha watu ambao kazi zao zinawalazimu kutangamana na watu mara kwa mara katika maeneo yanayotoa huduma muhimu kama vile wahudumu wa afya, madereva wa magari ya mizigo, wafanyikazi wa mambo ya usalama miongoni mwa watu wengine, wenye umri wa zaidi ya miaka 18
Jumla ya watu wazima 400 waliojitolea watasajiliwa kwa awamu ya 1b na ya 2.
Ufuatilizi unaofaa ni muhimu sana katika majaribio ya awamu ya 1 na ya 2, na ufuatilizi huu unafanyika kwa urahisi katika maeneo yaliyo na mfumo wa ufuatilizi wa idadi ya watu.
Kituo cha kwanza cha usajili kitakuwa Kilifi na usajili nje ya kaunti ya Kilifi utakuwa kulingana na janga litakavyokuwa linaendelea na unaweza kujumuisha Mombasa.
Chanjo inayofanya kazi katika jamii moja sio kwamba itafanya kazi katika jamii zote, kwa hivyo, ni muhimu kujua ikiwa chanjo hii ya majaribio inafanya kazi katika jamii za Kenya kuhakikisha kwamba waKenya wanaweza kunufaika na chanjo hiyo iwapo itaonekana kuwa na ufanisi.
Baada ya kuanza, majaribio yatafanyika kwa muda wa miezi 24.
Majaribio haya yanalenga kutathmini ikiwa chanjo ya ChAdOx1 nCOV-19 ni salama, inafanya kazi na inapeana kinga dhidi ya COVID-19 kwa watu wazima wenye umri wa miaka 18 na zaidi
We already have a lot of information on safety and how well the vaccine works, it’s unclear when we will determine if the vaccine prevents disease. This will depend on the pandemic, as cases fall it’s harder to demonstrate that the vaccine prevents disease.
The trial is being funded by the Wellcome Trust and Oxford University as the sponsor.
The compensation is fixed so that volunteers are not out of pocket as a result of their participation. The rate is dependent on various factors including transportation, the time required to participate, and other expenses incurred by the volunteer.
As is standard practice in conduct of all clinical trials (not just this trial)– we are bound by various regulatory policies, guidelines and requirements in the various stages of development and conduct of clinical trials. These requirements include publicity and information sharing both to the general public and to potential (and actual study) participants. Part of the publicity and information sharing (required) includes publishing the protocol when it is being submitted for review – and updating the published version every time amendments are done. We have continued to do this and in addition, updating the highlights on our website and social media platforms. We shall continue providing information through our website and social media updates throughout the trial.
The knowledge gained from this clinical trial will be relevant in informing us how this vaccine performs in our population. This is the main reason for clinical trials, to use the knowledge for the improvement of new and existing health interventions.
The vaccine candidate under trial in the UK, Brazil, and South Africa is the same as what will be used in Kenya and is the same currently in use in the phase III trials in South Africa.
The date provided for the start of the trial is prospective and not a definite date. It is a procedural requirement to indicate (intended) start date when developing trial/study protocols. However, the actual start date occurs only when all regulatory requirements have been obtained. Currently we have obtained regulatory approvals from the KEMRI Scientific Ethics Review committee, the Pharmacy and Poisons Board, and the National Commission for Science, Technology and Innovation (NACOSTI). We are currently awaiting additional approvals from the relevant local approving authorities at the study sites. The vaccine trial will start once these approvals are obtained, and participants are engaged/informed about the trial.
What capacity does KWTRP have to conduct this trial? KWTRP researchers have conducted large vaccine trials over the last 2 decades such as a Malaria RTSS vaccine trial and Ebola vaccine trial.
Summaries of the outcomes of the trial will be provided during community meetings in the areas from which participants are recruited. In addition, information to all stakeholders will be provided through the relevant communication and engagement channels.
The vaccine was developed by researchers at the University of Oxford, UK in partnership with AstraZeneca.
If global data demonstrates safety and efficacy of this trial vaccine, the control group that received a rabies vaccine will be offered the ChAdOx1 nCOV-19 vaccine, once all appropriate protocols have been followed.
Participants will benefit by knowledge of their general health status, including whether they are infected with SARS-CoV-2 (the virus that causes COVID-19).
Individuals who agree to volunteer in this trial will be reimbursed costs of participation such as refund of travel costs. They will also be compensated for other study related costs they may incur, on a standardized rate as outlined in our payment guidelines. Reimbursing volunteer costs is an ethical requirement in research.
Participants will be closely monitored during the trial to ensure that they are healthy, and any effects of the vaccine are addressed. They will be followed up for 12 months after getting the trial vaccine.
This is an independent committee made up of experts in biomedical research. The committee members are drawn from different parts of the world. Their work is to closely monitor safety data coming out of clinical trials. The DSBM for this Vaccine trial includes expert scientists from Kenya. The Kenyan approving authorities continue to be updated regarding all safety matters in the international trials.
Following independent reviews of the cause of the trial volunteer’s illness and finding that it may not have been related with the trial vaccine, the Data Safety and Monitoring Board (DSMB), has allowed the trial to proceed.
The trial was temporarily paused when one volunteer developed an unexpected illness. Trial pausing is a standard procedure which allows an independent body to investigate the cause of an illness that has occurred in a trial volunteer. While the trial was paused, no participant recruitment was happening in Kenya.
Potential risk to participants is low and is mainly related to collecting blood samples and vaccination.
This trial vaccine has so far been given to over 8000 volunteers in the UK, South Africa and Brazil, and no significant safety concerns have been seen.
The study involves two phases. In the first phase 40 participants will be recruited; followed by 360 volunteers recruited in the second phase of the study.
This trial will only enrol frontline workers in key service areas such as healthcare workers, truck drivers, security personnel among others, over the age of 18 years.
A total of 400 adult volunteers will be recruited for both phase 1b and phase 2.
Effective follow up is very critical in a phase 1 and 2 trial, and this follow up is easier in a Demographic Surveillance System, which we have in Kilifi.
The initial recruitment site will be Kilifi and recruitment outside Kilifi County will be responsive to the epidemic and may include Mombasa.
A vaccine which works in one population does not necessarily work in all populations, therefore it’s important to find out whether the trial vaccine works among Kenyan populations to ensure that Kenyans can benefit from the vaccine if it proves to be successful.
After starting, the trial will run for 24 months.
This trial aims to assess whether the ChAdOx1 vaccine is safe, effective and provides immunity against COVID-19 in adults aged 18 years and above
FAQs for ChAdOx1 nCoV-19 Vaccine Trial (Questions brought about by the on-going vaccine roll out by MoH)
The vaccine has been approved in very many countries across the world and is being rolled out to the general population including those with underlying conditions. As of 7th March 2021, 22,377,255 doses of at least 1 COVID-19 vaccine had been given to UK residents. This would primarily be the Oxford/Astra Zeneca Vaccine and includes individuals with underlying conditions. No safety concerns have been identified in these groups since the vaccine has been rolled out across several countries. In phase 2/3 trials in the UK, South Africa and Brazil 11,636 individuals were recruited including older adults and individuals with a range of underlying conditions (cardiovascular, respiratory and diabetes) and there were no safety concerns identified in these groups.
The role of monitoring vaccine serious side effects sits within Ministry of Health, through the National Vaccine Immunization Programme (NVIP), which will monitor all serious side effects following immunization. The Pharmacy and Poisons Board of Kenya is also tracking any serious side effects following immunization through reports generated at sub-county and county level.
Pregnant and breastfeeding mothers were not included in the first clinical trials done but are now being included in vaccination programmes by some countries. As clinical trials continue and more population groups are included into vaccination, data will become available. The WHO Strategic Advisory Group of Experts (SAGE) on immunization recommends vaccination for breastfeeding mothers. Additionally, pregnant women can only be considered if the benefits outweigh the risks and upon guidance by their physician. Getting vaccinated is a personal choice. If you are interested in getting vaccinated, you may first want to assess your risk of exposure to getting the virus that causes COVID-19 and talk to your healthcare provider.
Currently, the government is rolling out vaccination in three phases targeting 30% of the population. Phase 1 – Essential Frontline Workers, classified as healthcare workers (including community health workers) and other employees providing essential services, whose jobs put them at a high risk of contracting COVID-19; Phase 2 – Over 50yrs with underlying conditions; Phase 3 – 18-50yrs with Underlying conditions. These population groups were prioritized based on current (market) vaccine and funding availability. The implementation of these phases may overlap (based on vaccine availability) and the government may expand to other (targeted) population groups should more vaccines and funds be available.
In intensive vaccination campaigns following introduction of a new vaccine, it is routine for national immunization teams to report/flag any serious side effects following vaccination. This does not necessarily mean that the side effects are linked to vaccination itself, but it is good practice to investigate them. Additionally, rare side effects need to be balanced against protection from the vaccine. For example, if a vaccine has shown a one in a million risk of serious side effect, this should be compared against the high level of protection the vaccine offers against serious COVID illness. The MoH is rolling out the vaccine based on current WHO guidance. Further information can be seen through this Link.
Data from the vaccine trial are shared with the Ministry of Health, and other regulatory bodies in Kenya and internationally. This data supports the Ministry of Health to make decisions concerning the vaccine roll out. The Kenyan trial being conducted by KEMRI Kilifi is progressing well with no safety concerns.
Several factors have led to the speeding up of the COVID-19 vaccines; firstly, that there have been ongoing studies looking at the family of coronaviruses and understanding how these viruses work. Secondly, the technology used to develop this vaccine (adenoviruses) has also been assessed for many years (over 2 decades) for different diseases including malaria, RVF, MERS, Rabies, Chikungunya, TB amongst others. Thirdly, researchers and funders have been willing to work together, sharing information and new technologies such as use of adenovirus vectors to hasten vaccine development. Finally, due to the global nature of the pandemic, thousands of people have been willing to participate in trials, which has enabled quick generation of safety and efficacy data needed to inform emergency licensure of the vaccines. In all these, safety of the populations is paramount; hence a continued need for trials as well as monitoring populations receiving the vaccines.
If you have already taken part in the trial, you are still able to get the government vaccine. When you participate in the vaccine trial, you will not know whether you have been given the ChAdOx1 nCoV-19 vaccine, or the control (Rabies) vaccine. It is important to let us know if you would like to get the government vaccine; we will then inform you which vaccine you got in the trial (known as unblinding), before being given the government one. If you plan to take part in the trial at this point remember that this trial is blinded (you will not know which vaccine you received), so if you are a frontline worker or in the groups currently being targeted in the roll out we suggest you get the vaccine through the government mechanisms.
The government COVID-19 vaccine roll out is focusing on key target population groups in a phased manner. Data being generated from the ongoing trial will continue to inform long term implementation of COVID-19 vaccination in Kenya for the subsequent roll out phases.
The government, through the Ministry of Health is rolling out the AstraZeneca/Oxford vaccine (Covishield) known as the ChAdOx1 nCoV-19 Vaccine. This is the same vaccine that KEMRI Kilifi is conducting trials on.