“As Ministry of Health, we are excited that we are trying to explore the possibility of another component to our menu in our immunisation schedule when this study proves what we are trying to follow through. We are excited because we know that children are not only the future leaders of this country, but the social economic development of this country depends on its human capital and you cannot talk of human capital when you neglect children. That’s why you see us excited when we go into partnerships especially those targeting children as this study is bringing to the table”.
Ministry of Health (MOH) Permanent Secretary for Technical Services, Dr Kennedy Malama said during the official launch of the Centre for Infectious Disease Research in Zambia (CIDRZ) ETVAX Vaccine Study, a Phase 1 age descending placebo controlled clinical trial to examine the safety, tolerability, and immunogenicity of an oral inactivated Enterotoxigenic Escherichoia Coli (ETEC) Vaccine (ETVAX®) with dmLT adjuvant in healthy adults and children in Zambia.
The study is funded by the European Research and Innovation Programme (Horizon 2020) and will be conducted over a period of 12 months in Lusaka.
Dr Malama explained that “this is a signature study for Zambia, which requires no justification because one of the commonest conditions we see in our people particularly children is diarrhea and we have evidence that vaccines do work when they go through rigorously testing as we are launching today. For Zambia our memories are still fresh because not long ago, we had the rotavirus vaccine included to our immunization schedule and as health workers can attest, since the vaccine was introduced, there are reduced cases of diarrhea. In Zambia, diarrhea remains one of the causes of death and illnesses among children below the age of five with the majority of diarrhea cases ending up in death occurring in children below the age of two years. It is important that we invest in appropriate technology, high impact innovations like vaccinations to protect these children because the long-term effects of diarrhea on the health of our children cannot be overemphasized as their growth becomes stunted and their mental development impaired”.
He added that, “this study speaks to the Zambian government’s aspirations of attaining universal health coverage by strengthening health systems. Government takes CIDRZ as a strategic ally for the role you have continued to play in many areas in our health sector such research where a lot of research topics have been explored with findings that have informed policy shift and decision making in our country”.
Speaking earlier, CIDRZ Chief Executive Officer (CEO) Dr Izukanji Sikazwe said, “we are pleased to be tackling ETEC diarrhea as it is a major public health issue and is one of the priority pathogens identified by the World Health Organisation (WHO) as requiring vaccine development. I am proud to be leading an organization that is responding to globally pressing problems, but which are also locally relevant to the public health in Zambia. Our Enteric Disease and Vaccine Research Group started off a few years ago with a focus on rotavirus, in which field we have made remarkable contributions in this country. But we soon learned that diarrhea is a very complex syndrome with very many causative pathogens. Indeed, our recent work published last year confirmed that ETEC is among the top 5 causes of diarrhea in Zambian. To this end, I am happy to confirm that our research teams are steadily attempting to understand all these top causes of diarrhea in Zambia. As an example, we are presently evaluating a PCR based technology called Loop Isothermal Amplified (LAMP) method to explore practical utilization of the rapid diagnostic in the clinical setting to support clinicians detect ETEC and Shigella”.
And National Health Research Authority (NHRA) CEO, Professor Godfrey Biemba said NHRA has in line with MOH strategic mission to prioritize studies that deal with promotion of health and prevention of diseases and vaccine studies like the one we are launching now are aimed at preventing disease and therefore of high priority to Zambia.
“Some of the vaccines we have prioritized are HIV, TB and malaria vaccines. I am happy to note that CIDRZ is conducting research at least in two of those that is TB vaccine and HIV vaccine. Because of the work that CIDRZ has been doing, NHRA has decided to nominate CIDRZ as one of the centres of excellence for research in traditional medicines. NHRA has developed guidelines for research in traditional medicines because there is great potential. I am aware that you may not have the capacity to do pre-clinical studies, but you have the capacity to carry out clinical trials. NHRA is committed to support CIDRZ in this study, particularly to ensure that the evidence generated in this research is relevant to inform policy and contribute to the improvement of child health services in the country”.
And Swedish Ambassador to Zambia, Henrik Cederin said it was nice to see a Swedish Company, Scandinavian Biopharma and Swedish University of Gothenburg playing key roles in setting up the study with CIDRZ in Zambia. “The Swedish government is always committed to research especially in this area and helping out in the efforts in a country like Zambia and putting a strong foundation for the healthy development of children”.
Scandinavian Biopharma CEO, Björn Sjöstrand said, “the vaccine ETVAX is a very safe vaccine and promotes 80 % to 90% of all clinical ETEC rates. Even though we are talking of a phase one trial here, we have already demonstrated this in separate studies in Europe, Asia and now Africa that the vaccine is safe in both adults and infants as young as six months. Today’s kick off meeting here in Zambia is a very important milestone in the development of the first ETVAX vaccine and we are thankful to CIDRZ because we see that you are experts in the field and dedicated in what you do”.