The Centre for Infectious Disease Research in Zambia (CIDRZ), has disseminated results for its HIV Vaccine Trial Network (HVTN) 111 study, a Phase 1/2A clinical trial. The results were disseminated to stakeholders through meetings held for three consecutive days from 17th to 19th December 2019 at the CIDRZ Clinical Research Site located at Matero Level One (1) Hospital in Lusaka.
Speaking during the meetings, CIDRZ Research Clinician Dr. Sharif Mohammad Badiozzaman said that the research study was conducted over a period of about one (1) year between June 2016 and July 2017, in three (3) different HVTN affiliated countries; Zambia, South Africa and Tanzania.
“The total number of participants for the Study in all the 3 countries was 132, out of which 28 were from the Zambia Research Site (the Matero Level One (1) Hospital – CIDRZ Clinical Research Site),” said Dr. Badiozzaman.
He said the study title was, “A phase 1 clinical trial to evaluate the safety and immunogenicity of HIV clade C DNA and of MF59-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants.”
Dr. Badiozzaman further said that the main purpose of the study was to evaluate the safety, tolerability, and immune responses generated by a candidate of the HIV vaccine. During the study, 123 out of 132 participants (93% of the participants), completed all vaccinations and follow-ups in the five (5) clinical research sites in the three (3) countries.
He explained that a needle and syringe as well as a Biojector 2000 were used to administer the study products to participants. A Biojector 2000 is a device that pushes the study product through the skin without using a needle. Participants were randomly selected to receive the study product by needle and syringe or through a Biojector.
The HVTN 111 study also attempted to answer several questions such as finding out whether or not the study vaccines caused any untold effects and were optimally safe; if the people were able to take the study vaccines without becoming too uncomfortable; how people’s immune systems respond to the study vaccine; and would the study vaccine, using the Biojector 2000 change people’s immune responses.
Dr. Badiozzaman said, “results of the study showed that all vaccines and vaccine combinations were safe and very well tolerated by participants. No serious adverse events (SAEs), related severe adverse events or severe local reactogenicity symptoms were recorded from any of the participants of the study.”
“With regards to the immune system response, the study showed that the vaccine that gave DNA and protein together showed a boost in the immune response, and is thought to help decrease the infection risk of HIV -1,” he said.
Meanwhile in the case of immune response with regards to the Biojector Vs Injection – the study showed that giving the DNA vaccine by the Biojector followed by the booster injection caused the main engines of the immune system’s fight against HIV in the body to respond more strongly than when the needle and syringe were used in this way.
However, this benefit of the Biojector was not seen when the DNA vaccine and booster injection were given at the same time.
Therefore, all the evaluated vaccination combinations were safe and look promising to advance to the next phase of trials looking at whether they would work to prevent HIV infection.
Among the Stakeholders who attended the meetings included Study Participants, Community Advisory Boards (CAB) and Neighbourhood Health Committee (NHC) and Health Providers.