In a development that is likely to turn around the country’s fight against HIV and Aids, a consortium of research organisations will embark on clinical trials of an HIV vaccine, starting with 24 volunteers this coming November.

Announcing the landmark research, Dr Lynda Stranix-Chibanda, who is leading the research team, said the clinical trials will be conducted at Seke South Clinic and will involve 24 volunteers. If all the regulatory approvals are achieved, the trials will begin as soon as November, she said.

“The research protocol is currently under review by the regulatory authorities that govern medical research in Zimbabwe, such as the Medical Research Council of Zimbabwe, Medicines Control Authority of Zimbabwe, and National Biotechnology Authority of Zimbabwe,” she said.

“This review will possibly be completed towards November 2015. In the meantime, the research team continues to prepare the clinic and an intense training course, interacting with regional colleagues who will also conduct the trial and learning best practice from the more experienced vaccine trial sites.

“The trial will be conducted in Zimbabwe at Seke South Clinic. We will recruit from the surrounding community, following information and education sessions for various groups in the area,” she explained.

The trials, to be run under the name HVTN 107, will be rolled out in phases over the next five to 10 years with the initial phase expected to last about three years.

“This is an early phase trial for very few people. Only 24 people will be recruited in Zimbabwe, although we may need to screen three times as many as that to get the 24 people who qualify to enter.”

Dr Stranix-Chibanda went on to say there is need to make sure that the volunteers truly understand the study and the commitment required and willingly give consent to join.

She added that although the vaccine is safe for humans they will screen the health of volunteers to make sure they have no condition that would make it risky to receive new drugs.

“HIV vaccine studies have been happening for about 20 years already, not just in Zimbabwe. This particular kind of vaccine has been used before in humans in the RV144 trial in Thailand where over 16 000 adults received the vaccine safely.

“The Thai vaccine was modified to better suit the kind of HIV strain circulating in Southern Africa – clade C. The vaccines have already passed the pre-clinical phase, being tested in laboratory animals, and are now ready for human trials.”

Vaccination has, in recent history, been one of the most important shields of humans against infectious diseases such as polio, measles and yellow fever. As such, the development of vaccines that prevent these diseases has helped reduce mortality rates by significant margins worldwide.

Sadly, there is yet to be a cure or a vaccine for the endemic HIV virus, which is arguably the deadliest virus of the 21st century. Drugs such as antiretrovirals (ARVs) have been developed to reduce the effects of HIV but the virus remains prevalent in the world and Zimbabwe in particular.

Statistics show that about 15 percent of Zimbabwe’s population is living with HIV while 35 million people in the world have succumbed to Aids-related illnesses so far.

The multi-organisational group that is spearheading the research in HIV vaccines, the HIV Vaccines Trial Network (HVTN), has made inroads in their researches and say the first and much-awaited clinical trial of a possible vaccine in Zimbabwe by November will give hope to many as it brings the world a step closer to finding an effective vaccine. The trial will be conducted by the University of Zimbabwe in partnership with the University of San Francisco.

The vaccine which will be tested in Zimbabwe is an improvement of the Thai vaccine, which after being tested in about 16 000 people in Thailand, reduced the risk of contracting HIV by almost 31 percent. In Thailand, the trial was hailed by researchers as successful since its results gave the first supporting evidence of any vaccine being effective in lowering the risk of contracting HIV.

According to online references a total of 16 402 volunteers aged between 18 and 30 were recruited to participate in the trial in Thailand. The volunteers were randomly placed in double-blind study groups, with those in the experimental group receiving a phase III prime-boost HIV vaccine.

Volunteers were only eligible to participate in the study on the basis that they were HIV-negative prior to enrolment.

After being vaccinated, volunteers were asked to receive HIV testing every six months for three years, as well as receive additional risk-behaviour counselling at every testing visit. During the study, 125 of the 16 402 participants contracted HIV through behaviour unrelated to their study participation.

Immediately after the release of the results, there was controversy and dispute over the significance of these results raised by several researchers, who also questioned the unusual strategy of pre-releasing the conclusion of vaccine efficacy to the Press before publication of the actual data in a peer-reviewed scientific journal.

Chief Executive Officer and Registrar of the National Biotechnology Authority (NBA), Dr Jonathan Mufandaedza, said his organisation is still scrutinising the research protocol adding that the authority’s mandate is to ensure that the trials are safe.

“NBA is one of the regulators that will be involved in the trial to ensure that biosafety procedures are followed before, during and after the trial,” he said.

“To this end, NBA has been working with the researchers to ensure that all bio safety guidelines are being followed. This includes formulation of an Institutional Biosafety Committee as stipulated in the NBA Act.

“NBA has already done preliminary inspections of the trial site (Seke South Clinic) and records. Throughout the trial, the researchers will have to submit progress reports and the NBA will ensure that safety standards are being adhered to.”

Dr Mufandaedza said the vaccine to be used in the HVNT107 study is not the virulent HIV but rather a pox protein engineered vaccine that can elicit an immunological response when injected into a healthy being.

He said timing and completion of the review process is dependent upon the researchers meeting the biosafety and other regulatory requirements.

Efforts to get a comment from the other regulators were not successful as some said they were not aware of the research while others requested questions to which they had not responded to by the time of going to print.

Public health research expert with National University of Science and Technology, Nomathemba Ndiweni, says while it is plausible to receive funding to carry out such trials in Africa, scientists carrying such studies must have deep knowledge and be skilled in HIV/Aids.

“The general problem and failure of most clinical studies in Africa is that they are being carried out by scientists with little capacity in terms of knowledge and experience in the research fields.”

How will it work?

While the prospect of having HIV vaccine clinical trial being done in Zimbabwe for the first time has excited many, the million dollar question has been how the vaccine’s ability to prevent HIV infection will be tested.

Will participants be injected with the virus, to test their immune systems? Will they be “ordered” to engage in risky sexual behaviour? Will one test positive after taking the vaccines? These are just some of the questions that easily come to mind when talk of an HIV vaccine is made. Head of the research team, Dr Lynda Stranix Chibanda, explained that volunteers will not be at risk of being infected with HIV, because the virus will be simulated.

“The virus is not injected but pieces of the viral DNA and protein are given. These pieces cannot cause HIV infection but the body recognises that they come from HIV.

“For the dose or strength of the vaccine – that’s one of the questions to be addressed in our studies.

“The DNA and protein are parts of the virus and are sufficient for the body to recognise which virus they come from and to set off an immune response to attack it.”

According to HIV Vaccine Trials Network (HVTN) one can test positive as result of the vaccines while they are actually not infected with the actual HIV virus.

“Yes, the study vaccines may cause you to test positive on some types of HIV tests. If a participant gets an HIV study vaccine, their body may make antibodies to HIV. Standard HIV tests search for HIV antibodies as a sign of infection.

“Because of this, a person could have a positive HIV test result even if they are not infected with HIV. This is called a vaccine-induced seropositive (VISP) test result.

HVTN says no health problems are associated with a VISP test result but can hamper one’s ambitions to secure insurance or join the military.

“But VISP test results may cause problems in several areas such as medical or dental care, employment, insurance, a visa for traveling, or entry into the military. You might not be allowed to donate blood or other organs. If you are planning to apply for insurance, employment, or the military, one has to inform the study site from the onset. The insurance company, employer, or military agency may not accept HIV test results from the HVTN.

“However, the HVTN can work with them to ensure the right test is done that will show the true HIV status.”