Vaccine Clinical Trials

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1 Vaccine Clinical Trials Simon Agwale, PhD CEO Innovative Biotech Ltd, Keffi, Nigeria Chair, Developing countries Coordinating Committee (DCCC)-European and Developing Countries Clinical Trials Partnership (EDCTP)

2 Vaccines and Disease Eradication Definition: Eradication can be defined as "permanent reduction to zero of the worldwide incidence of infection caused by a specific agent, as a result of deliberate efforts, such that intervention measures are no longer needed after a decade-long campaign, smallpox was the first disease to be eradicated from such a worldwide effort.

3 Facts Over 17 million people die each year from infectious diseases, many of which are classified as emerging or neglected. HIV/AIDS, together with the other global priority diseases, tuberculosis (TB) and malaria, account for over 300 million illnesses and more than 5 million deaths each year. Today in Sub-Saharan Saharan Africa a 15-year year-old girl has a 52% chance of reaching age 60. By 2010 she will have about a 30% chance. With this kind of outlook for African youth, investment in education, careers and economic advancement becomes almost irrelevant. In South Africa, there is currently a 2.6% annual decline in enrolment and rising pupil absenteeism.

4 AIDS in Africa confirmed that when infectious diseases prevail, average life expectancy decreases dramatically

5 Benefits of Disease Eradication Populations have much better biological production. Absence of disease aids production and development. Increases general welfare.

6 Portugal: A Case Study In the 19th and early 20th centuries, Portugal, like most of southern Europe, suffered major malaria epidemics, with over cases a year. Eradication was finally and successfully achieved in After that date, the country saw a surge of economic growth associated with increased foreign investment and tourism.

7 Problem of Disease Eradication Sustainability of Health System: The sustainability of health systems can be defined as the ability to deliver an appropriate level of benefits for an extended period of time after major financial and technical donor assistance has been terminated. A problem in developing countries.

8 Possible solution Conduct clinical trials where the product would eventually be used. Establish Biotechnology which will encourage local production, distribution and therefore availability of medical products to the population.

9 Why Conduct Clinical Trials in Developing Countries? Developed countries account for over 95% of basic scientific research, command 85% of the world s economic resources and act as home to only 18% of the world s s population. - In disease eradication focus will be on their primary population first. National needs differ A vaccine against a particular disease may be vital in one country but marginal in another. Highly cost-effective vaccines against diseases in developed countries may be of limited significance in developing countries. Conversely, a major killer in a developing country may be unimportant elsewhere.

10 Rotavirus (differing national needs). A rotavirus vaccine based on a live attenuated virus was licensed in the United States in July 1999, soon after the vaccine was introduced, 15 vaccinated infants had developed an uncommon but potentially life-threatening form of intestinal obstruction called intussusception. The vaccine was therefore withdrawn from the market and the company abandoned work on it.

11 Rotavirus Cont d In India, rotavirus infection in the young is commonly fatal. About children and infants die annually from it, times more than in any developed country- Thailand 18%, Nepal 21%, Zimbabwe 31%, Tanzania 38%). A vaccine is badly needed. The withdrawn rotavirus vaccine was never tested in India or in any of these countries. It is possible that the side effects suspected in the United States may not have occurred in an Indian or African population Merck s RotaTeq approved by regulators in Europe and the US. February 2006-GSK GSK s Rotarix approved in Europe.

12 The international community has come to recognise the urgency of this issue, and a strong international consensus has been developing on the need to address inefficiencies in global health research for infectious diseases, the barriers to effective R&D and market failure.

13 Indigenous needs We need to identify areas where action is lacking or insufficiently known. We need to better understand the factors that motivate R&D decisions, how to focus a research agenda to meet domestic health needs and what policy mechanisms might successfully act as incentives to bring R&D capacity to bear. The solution has been for India and other highly affected developing countries to develop a vaccine in their own facilities at their own expense. Novel vaccines from other manufacturers, including Indian producers, are presently in clinical trials.

14 Research agenda is essential to expand the knowledge base. To best use what we already know about preventing diseases Need operational research To build on the current knowledge and develop better strategies Need clinical trials to test strategies and assess interventions

15 Clinical trials are conducted to Test safety and efficacy of novel vaccine in groups of individuals randomized to the new intervention vs. control But also to. Test efficacy of a known vaccine in a new population Support new indication for a known vaccine Establish new combination vaccines Overall purpose of a clinical trial therefore is to learn and not to prevent

16 How vaccines are developed? Basic research Preclinical development Laboratory in vitro & animal studies Discovery Exploration Clinical trials Human research Safety, Immunogenicity Efficacy Human trials Experiments in primates Phase I/II Phase III Vaccine concepts Safety, immunogenicity Likelihood of protection in humans 1: Recombinant Protein 2: Synthetic Peptides 3: Naked DNA 4. Live-recombinant vectors- 5: Whole inactivated virus 6: Live attenuated virus

17 Phases of Clinical Trials Phase 1-1 Safety and immunogenicity (10-100) 100) Phase II- Dose, schedule, safety, immunogenicity ( ) Phase III- Efficacy, Safety ( , 10, 000+) Phase IV- Safety (10, 000-1, 000, 000)

18 Clinical Trials leads to Capacity Development in Developing Countries First accredited laboratory in Africa-University of Nairobi, KAVI Mbeya cohort studies Project in Tanzania led to both human and infrastructural development Establishment of a standard trial site in Mali (Malaria) Establishment of new clinics in Uganda (DART Trial) Etc, etc

19 ABOUT EDCTP

20 What is EDCTP European and Developing Countries Clinical Trials Partnership Partnership of EU member states including Norway and Switzerland on one hand; and sub-saharan African states on the other The partnership was formed to accelerate the development of new clinical interventions to fight HIV/AIDS, Malaria and TB through joint conduct of clinical trials

21 Structure of EDCTP Africa DCCC Identify needs & gaps Europe ENNP Identify priorities of NP Partnership Board Reconcile & develop the strategy Secretariat Execute Assembly Decide the strategy

22 EDCTP is changing : EDCTP has adopted the Swiss principles for research in partnership 1. Decide on the objectives together 2. Build up mutual trust 3. Share information; develop networks 4. Share responsibility 5. Create transparency 6. Monitor and evaluate the collaboration 7. Disseminate the results 8. Apply the results 9. Share contributions and profits equitably 10. Increase research capacity 11. Build on achievements

23 EDCTP 7 areas of work North-North (North-South) Networking South-South Networking Clinical Trials Capacity building Advocacy and fund raising Management Information management

MAL MAL MAL MAL EDCTP EDCTP present present in in 17 17 countries countries Support Support 64 64 African

24 MAL MAL MAL MAL EDCTP EDCTP present present in in countries countries Support Support African African investigators investigators MAL MAL MAL MAL MAL MAL TB TB TB MAL MAL TB HIV TB TB MAL TB TB TB TB

25 INNOVATIVE BIOTECH (Nig) Ltd. A World-class Biotechnology Company for Nigeria

26 Opportunity Overview Background information Over $85mil vaccines imported by Govt. annually Inadequate vaccine manufacturing facilities locally Prevalence of preventable diseases continues to increase Vaccines developed for our environment Innovative Biotech mission is to be the one of the few biotech companies developing and manufacturing vaccines in Africa

27 Hepatitis B TECHNOLOGY CONSIDERATIONS Typhoid vaccine via NIH, USA HIV vaccines research ongoing Clinical trial centre

28 Conclusions Basic research, product development and clinical trials should continue. Align R & D, regulatory, and manufacturing vaccine group. Re-assess and re-define stringency of our expectations for licensing new vaccines. Maximize value of vaccines by public education. Governments need to take on their responsibility and create the market and guarantee market.

EDCTP perspective on biopreparedness and related capacity development in Africa

EDCTP perspective on biopreparedness and related capacity development in Africa Consultation workshop on Preparedness for emerging diseases Dr. Michael Makanga EDCTP Executive Director. 29 September 2016