The Technological, Biomedical, and Environmental Research Center (CITBM) at Lima-based San Marcos University —a member of Peru's Clinical Trials Unit network— will participate in the Ensemble trial developed by American multinational corporation
Johnson & Johnson, which seeks to test the efficacy of its COVID-19 vaccine candidate.
Dr. Javier Lama —researcher at Asociacion Civil Impacta Salud y Educacion (Impact, Health, and Education Civil Association)— confirmed the launch of the call to begin the clinical trials, which are expected to recruit 3,500 volunteers in Peru to help test the efficacy of such vaccine and prevent the development of severe or moderate type 2 coronavirus disease.
The study requires the participation of people aged 18 years and over, who are healthy or have pre-existing and controlled diseases such as diabetes, hypertension, liver illnesses, kidney diseases in general, as well as people with obesity, and the elderly; that is, some criteria that are not considered in other research studies.
This work is being implemented in Peru's Clinical Trials Unit, which is made up of five different research centers of four non-governmental organizations working in the prevention and treatment of COVID-19 in Peru.
The distinctive feature of this vaccine is that it is designed to be administered in a single dose. Besides, if it proves effective and safe, it could be included in vaccination programs implemented by developing countries, mainly where vaccination coverage is not necessarily high.
"If it (the vaccine) is effective, we could prevent the disease with a single dose," he emphasized.
Monitoring
This Phase 3 study is expected to keep track of all participants so as to assess their health conditions and see how they respond to the vaccine, but especially, to determine if the vaccine can prevent the spread of COVID-19.
This multinational study will be conducted in more than 180 research centers in eight countries,
including Peru.
(END) DOP/MVB
Published: 11/14/2020