Phase II AIDS vaccine trial begins in South Africa
A clinical trial evaluating the safety and immune responses generated by a candidate AIDS vaccine known as tgAAC09 recently began at three sites in South Africa, including clinics in Soweto, Cape Town, and Medunsa. This is the country's first Phase II AIDS vaccine trial and investigators will enroll and follow 78 volunteers over a period of 18 months.
The vaccine candidate uses an adeno-associated virus vector to deliver HIV fragments from subtype C, the most common subtype of HIV in southern and eastern Africa, into the body. Phase I trials with tgAAC09 were conducted in Belgium, Germany, and India. Other arms of this Phase II trial will occur in Zambia and Uganda, after receiving regulatory approval in these countries.
The candidate was developed and manufactured by Targeted Genetics Corporation in Seattle based on work by Philip Johnson when he was a researcher at the Children's Hospital in Ohio. The South African trial is collaboration between Targeted Genetics and IAVI and is an important advancement in a country where 25 million people are estimated to be HIV infected.
South Africa is also hosting another important HIV prevention trial involving the microbicide candidate PRO 2000, a vaginal gel consisting of a synthetic compound that binds to HIV and may prevent it from infecting target cells. This Phase III trial will enroll over 10,000 women volunteers in South Africa, Uganda, Tanzania, and Zambia, making it the largest microbicide trial to date. This trial is being coordinated by the UK Medical Research Council.