The Minister of Health, Mr . Alex Segbefia earlier called for an immediate suspension of the proposed Ebola vaccine trial, explaining that Ghanaians are not psychologically ready to undergo the clinical test.
Parliament also ordered that the trial be suspended following growing concerns raised by some Civil Society Organizations (CSOs), the Volta Regional branch of the National Democratic Congress (NDC) and some members of Parliament (MPs).
There are however many reasons why need a vaccine
1.Why do we need a vaccine?
The following are some of the reasons:
• The current epidemic continues to have devastating effects in Guinea, Liberia and Sierra Leone.
• This epidemic is not over, and as long as new cases continue to appear, people remain at risk of spread of the Ebola infection.
• It is vital that we work together to accelerate the development of an effective vaccine, to protect people from this and future Ebola outbreaks.
• ¬ Protecting frontline health workers and stopping spread of this disease with a preventive vaccine is critical.
• New Ebola outbreaks will almost certainly occur and this is an opportunity to ensure that this is the last such epidemic at a time when the only tools available to control it are isolation and quarantine.
Is there a vaccine to protect against Ebola virus disease?
- At this time, there are no vaccines to protect against EVD licensed for use in humans.
- How are Vaccine clinical trials conducted?
Pre-clinical trials (Animal studies)
Pre-clinical trials are carried out in laboratories and animals and aim to: 1) determine whether the vaccine works as intended and 2) to identify any harmful effects. In the proposed vaccine trials, animal studies have already been conducted and found to be safe and indeed efficacious in chimpanzee.
Clinical trials (Human trials)
Human trials are conducted in a chronological order from Phase I to phase IV
Phase I trials involve 20 to a few hundred healthy individuals and examine safety and immune response. They also identify commonly occurring adverse reactions. Phase 1 trials are first conducted in the countries where the vaccines are developed and subsequently in other countries. The first trial to be conducted in Hohoe is a Phase 1 trial.
Phase II trials involve several hundred to a few thousand people and seeks to determine the optimum vaccine composition for achieving immunity while ensuring safety. Phase II trials also involve healthy adults and then healthy children only after the vaccine is found to be safe in adults. Phase II trials of GSKs anti Ebola vaccine will be conducted in Kintampo and Hohoe.
Phase III trials involve thousands to tens of thousands of people and examine the vaccine’s ability to prevent a disease as intended. They also provide further safety information. Phase III studies of an anti Ebola vaccine can only be conducted when there is an outbreak of a disease, therefore a Phase III trial will not be conducted in Ghana.
Phase IV trials are conducted after the vaccine if found by regulatory authorities to be safe and can prevent diseases in Phase III trial. Phase IV trials include surveillance activities to identify rare adverse events that may not have been identified in Phase I-III trials. There adverse events are reported through spontaneous reporting systems to health authorities for decision making.
- What are scientists/researchers planning to do in Ghana?
In Ghana, scientists/researchers/ planning to do a Phase l for the Johnson & Johnson in Hohoe and Phase ll for the GSK vaccine in Hohoe and Kintampo .
- Why are the trials going to be conducted in Ghana and not in the Ebola affected countries?
Ghana was selected to take part in this multi-country study through a competitive process. This shows the high regard the global health community has for Ghana for her science and capacity to carry out quality clinical trials. This is why the Government of Ghana and leading experts in the country are taking part in this global effort to find a preventive vaccine against the Ebola Virus Disease. The trials in Ghana seek to assess how well the body builds up immunity after an injection with the anti Ebola vaccine.
Vaccine trials are being conducted in Guinea where there was an outbreak, but there is a scientific rationale to determine how safe the vaccine is and how will it builds up immunity in individuals who have not been exposed to an Ebola outbreak. Other anti Ebola vaccine trials are being conducted in Kenya and Tanzania. Nigeria, Burkina Faso and other West African Countries will start soon.
4.1. Why Hohoe was selected?
The Oncho research center at Hohoe was started in 1986 by WHO. For nearly 30 years now, over 30 clinical trials including phase l, ll, lll studies of onchocerchiasis drugs, malaria drugs and others have been conducted according to internationally recognized standards at the Hohoe Centre.
The use of Ivermectin and other combinations of drugs recommended by World Health Organisation (WHO) for all the Onchocerchiasis affected countries was developed following trials at Hohoe. The Research Center has collaborated with more than 20 reputable institutions including the WHO, UNICEF, The Noguchi Memorial Institute for Medical Research in Accra, The University of Ibadan, The National Institute of Health in Maryland, The Liverpool School of Tropical Medicine and the Center for Global Health & Diseases, Case Western Reserve University (USA). Hohoe is an internationally recognized name in clinical research.
4.2. Why Kintampo was selected?
Kintampo Health Research Center in the last decade has been undertaking vaccine trials in meningitis and malaria. It has done both phase ll and just completed a phase 3 study as part of a multi-country study, which the whole world is waiting for the results. The Center has a well-equipped clinical trial facility of an international standard and qualified biomedical scientists and clinicians for vaccine studies.
- Have the vaccines ever been tested in humans
The vaccines have been tested in humans in the USA, UK, Switzerland and Germany, Mali and Gabon. An updated list of countries currently testing the anti Ebola vaccines is available at the website of World Health Organisation. - What vaccines are being tested?
There are two vaccines to be tested in Ghana.
1) The Chad3-ZEBOV vaccine developed by GlaxoSmithkline Biologicals and
2) 2) Ad26.ZEBOV + MVA-BN-filo developed by Johnson and Johnson Pharmaceuticals.
These vaccines are constructed by using a non Ebola disease forming protein of the Ebola virus and a no disease forming flu virus. An injection with the vaccines can therefore not lead to Ebola disease or flu disease.
- What are the possible side-effects from getting the vaccine?
The side effects differ slightly from the type of vaccine being tested. Some people experience some fever, chills or headaches, or feel tired or have muscle pain. These reactions usually last no longer than a few hours and disappear with medication. Some volunteers have also experienced joint pain, beginning in the first two weeks after vaccination and generally lasting no more than a few days.
8. Who are the Potential Participants?
¬Healthy adult volunteers who meet the study’s eligibility criteria and provide full written informed consent will be the participants. A doctor will assess whether the participant is healthy or not through a physical and laboratory examination. If the vaccine is found to be safe among healthy adults, the safety of the vaccine will subsequently be assessed among healthy children. - Is this vaccine safe for children?
The safety of the vaccine in children will be assessed only after the safety profile of adults is assessed. After it is determined to be safe in adults, healthy children will be recruited into the study as per then protocol, and safety assessment will be done.
10. Why can’t pregnant women join the study?
Pregnant women will not be allowed to join the study. When vaccines are being developed and tested, pregnant women are not usually offered the vaccines until the safety in other groups has been shown. This is done to protect pregnant women and their unborn babies. Once the vaccine is shown to be safe and efficacious, later studies could also target pregnant women.
11. Do volunteers get paid for taking part in the study?
Volunteers are not paid for agreeing to take part in the study. Volunteers will be compensated for their lost time and transport each time they come to the clinic. The Ethics Committees in Ghana determines an ideal amount of compensation as part of the approval process. The details of the nature of the compensation is below:
o The compensation for each research area has been established by using fair market value schedules, which are intended to be appropriate but not coercive to study participation. In Hohoe, the ethics committee have approved for volunteers to receive 200 GHS (Ghanaian Cedi) per visit. The compensation amount for volunteers partaking in the study in Kintampo is yet to be approved and may be different from that in Hohoe.
- What are the Process of Clinical trials in Ghana?
Clinical trials scientists and their institutions are selected based on the teams qualification and experience in conducting clinical trials research. The availability of clinical trial infrastructure to recruit participants and the ability to follow up participants, while ensuring patient safety. Clinical trial documents are then filed by the sponsor with the Ghana FDA and the Ghana Health Service National Ethics Committee. Full community engagement starts after full approval by the Food and Drugs Authority.
Monitoring:
To ensure the safety and human right protection of participants, strict adherence to national regulations, clinical trials are monitored by:
• An external clinical safety monitor
• The Independent Data Safety Monitoring Committee
• The Ghana Food and Drugs Authority
• The Ghana Health Service National Ethics Committee
13. When will we know the results of the study?
• Final results from the clinical studies will be shared with the communities that participate in the clinical trials. Results will also be shared with the other organizations that have worked on the national and international Ebola response.
• We do not yet know when we will have the final results.
14. How will the results be used?
• The study results will be put together with other data that is being collected about this vaccine and together they will be submitted to regulatory authorities that will assess whether to approve the vaccine for use in the prevention of Ebola. If approved by the regulatory authorities, more of this vaccine could be made and offered to people in countries who experience an outbreak or that have experienced Ebola outbreaks in the past. It is possible that Ghana may have an outbreak in future, and then the vaccine could be offered to people in Ghana.
• Identifiable information of people participating in the clinical studies will not be shared in accordance with applicable laws and regulations
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By: Prof Fred Binka (Vice Chancellor, University of Health and Allied Sciences), Prof Kwadwo Koram (Noguchi Memorial Institute for Medical Research), Dr. Kwaku Poku Asante (Kintampo Health Research Centre) and the investigating team