PrEPVacc COVID-19 Update III – November 2020

Dr Eugene Ruzagira, PrEPVacc Trial Director

PrEPVacc Trial Director, Dr Eugene Ruzagira of MRC/UVRI and LSHTM Research Unit, gave the following update on the status of the PrEPVacc study to colleagues on 13 November:

“Following the recent Trial Management Team meeting I’m sharing an update on the status of PrEPVacc and the beginning of the clinical trial (vaccine and PrEP trial) in particular.”

“Since the 14th September, Registration Cohort activity has resumed following lifting of COVID-19 restrictions at all of our sites: in Maputo, Mbeya, Dar es Salaam, Masaka and now at Durban Verulam.”

“For the clinical trial, we have received ethics approval at Masaka and are close to getting approvals at the other sites.

“When I last wrote to you in July we had reasonable hopes that we would have begun the trial at one site by the end of August. However, COVID-19 has continued to impact on the regulatory and logistical processes that each site needs to conclude before it can begin a Site Initiation Visit (SIV) which must take place before the trial can start.

“We are therefore very pleased that the first Site Initiation Visit took place at Masaka at the end of October, and that this site now anticipates that it will begin the clinical trial by the end of November. We hope and expect that other sites will be able to undertake their SIV over the next six months.”

“Thank you once again for all your efforts to advance PrEPVacc’s progress. We are all keen to begin the next phase of this important study but above all we must continue to ensure the safety of our participants and each of us as we go about our work in our communities.”