All the 49 Chinese volunteers who were injected with China's first AIDS vaccine are in good health and show no ill effects, clinical observation has shown.
Experts have visited seven groups of these volunteers and the visit to the last group of 15 volunteers is expected to be completed by mid-June this year, said Chen Jie, deputy head of the Disease Control Center of Guangxi Zhuang Autonomous Region in south China.
A panel of experts will make an accurate assessment of the trial outcome and decide whether to carry out the second phase of the AIDS vaccine test, Chen said.
The assessment would cover the dose and safety of the AIDS vaccine, immunization procedures and whether the safety of the experiment accords with the targets for clinical research set by the state, and whether the experiment was carried out in a strict manner, Chen said.
The Ministry of Science and Technology and the State Food and Drug Administration will decide whether to go ahead with the second phase of the test based on the assessment outcome.
The first phase of the test was launched in Nanning, capital of Guangxi, on March 12 last year, and all the 49 Chinese volunteers aged between 18 and 50 had received vaccine rejection by Oct. 20 last year.
They were divided into eight groups, six groups received a single AIDS vaccine and two other groups were injected with a combined AIDS vaccine.
If the test enters the second phase, volunteers will be recruited from larger groups, especially from the high-risk groups, Chen said.
The State Food and Drug Administration approved the first clinical phase research of the new AIDS vaccine on Nov. 25, 2004.
China currently has approximately 650,000 HIV infected people including approximately 75,000 AIDS patients, according to recent official estimates.
(Xinhua News Agency March 31, 2006)
