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Malawi will in May be one of the three countries in southern Africa to start testing an HIV vaccine as part of the urgent global effort to find a cure for HIV/Aids..
The experimental vaccine called MRKAd5-HIV-1 gag will be put on trial for the first time in Malawi to see if it can fight HIV-1, a strain that has affected about a million people in the country and reduced life expectancy from 56 years to 37 years.
Study Coordinator and Investigator of Record at John Hopkins Project in Blantyre, Dr Jane Mallewa, said the vaccine will be put on trial in three phases.
“The objective will be to first find out the safety of the vaccine and its immunogenicity—to see if it can cause the body to mount an immune response—and its efficacy to see if it is effective in protecting against acquisition of HIV,” she said.
Mallewa said the first phase will have 435 participants worldwide and Malawi will get between 40-44 participants to enrol in the first phase.
“We are asking for volunteers, who are HIV negative and have no history of any chronic disease like diabetes,” she said.
Mallewa said the volunteers are expected to be at low risk of naturally acquiring HIV infection, able to consent freely, be able to use acceptable contraceptives for the first year of the study and be able to commit to a five-year follow-up.
“We expect the volunteers to be able not to move out of the country for the first five years,” she said.
The study will be done in three stages. The first one, according to Dr Mallewa, will be a low dosage of vaccine versus placebo—a substance with no physical effect. Stage two will have fresh participants and a high dosage will be given and the final stage will have both the low and high dose and placebo.
The doctor said the first pilot tests were done in the USA on humans in which low and high dosages were used and resulted in no long or short term side effects.
Dr Newton Kumwenda, Field director of the project, said in all these pilot tests in the USA, the drug was found to be safe for humans.
“Now the advantages for Malawi to get involved in the research trials are that Malawi will have the priority of getting the vaccine earlier than other countries that are not participating if the vaccine proves to be effective at preventing HIV infection,” Dr Kumwenda said.
Dr Mallewa explained research of vaccines can take 50 years “but in this case because of the urgency we are looking at 15 to 20 years because all products are being tested at once.”
The research has been made possible by the National Institute of Health of USA through the HIV Vaccine Trial Network (HVTN).
Since the first Aids case was reported in 1985, the social consequences of HIV/Aids in Malawi have been enormous.
Latest National Aids Commission figures show that Aids has left 400,000 orphans, with 15 percent of persons between 15 and 49 years old HIV positive which has created child-headed households and weakened support structures for the very young and the elderly.
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