The Centre for Infectious Disease Research in Zambia (CIDRZ) is hosting an engagement workshop aimed at deliberating the ethical and regulatory framework needed to conduct Human Infection Studies (HIS) in Zambia.
The workshop that has drawn participants from Kenya, Malawi and Zambia seeks to introduce HIS to stakeholders, document concerns and issues that may arise in conducting HIS in Zambia
, develop a framework to inform future HIS in Zambia and publish the workshop findings.
CIDRZ Chief Scientific Officer, Dr. Roma Chilengi told participants that “the workshop is intended to facilitate engagement of key players in clinical studies who have oversight in research conduct.
Given our understanding as CIDRZ, this concept of HIS is relatively new to Zambia and we are hoping to initiate conversations with regard to this area of research. This workshop is designed to talk about issues related to HIS and so we hope that we have created an environment free enough to give your perspectives from your respective institutional mandates that have allowed you to come but also for your individual perspectives”.
When giving a historical perspective of HIS, Dr. Chilengi said new vaccines were needed and while the classical way of evaluating these vaccines was sufficient, they took long and required a lot of participants, and some designs may no longer be justified.
He said human infection challenge models have not been widely used and accepted in low middle income countries even though there were scientific and ethical merits of considering the unique opportunity this methodology offers.
And CIDRZ Research Fellow, Michelo Simuyandi said the CIDRZ Enteric Disease and Vaccines Research Unit, borne out of the Programme for Awareness and Elimination of Diarrhoea (PAED) that was aimed at introducing the rotavirus vaccine, caregivers and community education targeted at behaviour change and improving clinical case management of under-five diarrhoea management has conducted several studies to evaluate and understand low vaccine efficacy in Zambia. “While the PAED programme had a huge impact in reducing both all cause diarrhea and rotavirus specific severe gastroenteritis, there was still a huge residual burden, no clear correlate of protection and other hurdles to oral vaccines such as enteric dysfunction, malnutrition and maternal antibodies among others”.
He added that it was for this reason that CIDRZ was considering conducting HIS in in enteric diseases (i.e. cholera, shigella, rotavirus and salmonella) to evaluate candidate vaccines, understand natural immunity and disease pathogenesis which are crucial to infectious disease control.