UGANDA–A total of 187 volunteers have enrolled for an HIV vaccine trial to establish the safety and effectiveness of the vaccine.
The trial is being administered on HIV negative persons between 18 and 40 years. No benefits were given to the volunteers but the organisers sensitise those involved to help them understand what they are signing up for.
PrEPVacc is an African-led and European-funded HIV prevention clinical trial conducted in four African countries from 2018 to 2022.
It is the first vaccine trial that attempts to incorporate pre-exposure prophylaxis (PrEP) in a realistic way in addition to the vaccine candidates tested; it proposes an alternative approach to design HIV vaccine trials in the era of PrEP, which has been proven effective to prevent HIV infection in itself.
Dr Eugene Ruzagira, the coordinating investigator at the Uganda Virus Research Institute (UVRI), told Daily Monitor in an interview on Wednesday that volunteers started enrolling for the trial in December last year adding that those under trial are doing well.
“We follow up our volunteers closely to monitor exactly how they are reacting to the vaccine and so all of them are doing really well and we are positive about the vaccine,” Dr Ruzagira said.
He added: “Our trial target is about 1,700 by the year 2024 and we are optimistic that with our continuous community engagement, we shall raise that number and assess the safety and effectiveness of the vaccine.”
According to Dr Ruzagira, the vaccine has been under development for the last 20 years saying it has undergone different trial stages which are recommended before it is tested on human beings.
“One regimen combines DNA with protein based vaccine, and the other combines DNA, MVA and protein based vaccine. And they have already been evaluated in clinical trials in US, Europe, and Africa and have demonstrated their safety and ability to induce immune responses,” Dr Ruzagira said.
The trial aims to assess the safety and effectiveness of two experimental vaccine candidates and remains the largest trial happening in Africa currently after promising Imbokodo study was discontinued by an independent board of scientists two weeks ago and was 25 percent effective.
The volunteers come from all across the country with the majority coming from the Greater Masaka Sub-region especially the fishing communities.
There are also a number of persons of high risk of HIV infection enrolled in the trial as well as urban dwellers. Women make up 70 percent of the volunteers while men are 30 percent.
“Although we are looking to see whether this vaccine is effective to prevent HIV, we are more interested in the safety of the vaccine. This is why once a person volunteer and has received the first shot, we give a diary book for the person to record any effects in the body be it headache, fever among others for at least seven days then return to check-ups,” Dr Ruzagira said.
The doses are administered at the UVRI offices in Masaka. The monitoring takes about 74 weeks.
How volunteers are recruited
According to Ms Sylvia Masawi, the Community Liaison Officer based at the Masaka Field Station, they are using community engagement in order to mobilise volunteers to come for the trial.
“There is a strong partnership with stakeholders at district and community level. Various community members are routinely mobilised and engaged through bodies such as the Community Advisory Board (CAB), village health teams (VHTs), local council leaders and peer educators before, during and after a study is conducted.
This level of long term collaboration has enabled the recruitment and retention of volunteers at risk of HIV acquisition for various studies at the site over the years,” Ms Masawi said.
According to the information from PrEPVACC official website; the Masaka site was able to offer community-based HIV counselling and testing (CBHCT) to 8,762 individuals.
At least 8,387 (96 per cent) tested HIV-negative and of these, 687 were referred for screening for the PrEPVacc Registration Cohort and 441 (63 percent) were enrolled over a period of about one and half years.”—Daily MonitorDaily Monitor