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    Home > Medical News > Medical Research Articles > China's AIDS vaccine into phase II clinical trials

    China's AIDS vaccine into phase II clinical trials

    • Last Update: 2020-04-03
    • Source: Internet
    • Author: User
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    On August 14, the AIDS vaccine, supported by major national science and technology projects and with independent intellectual property rights, officially entered phase II clinical trials The first 15 volunteers were vaccinated in Beijing You'an Hospital Shao Yiming, a researcher at the China Center for Disease Control and prevention, who led the major special study, said the main objective of the clinical trial was to further evaluate the safety and immunogenicity of the vaccine and determine its immune procedures, so as to prepare for the clinical trial of large-scale test of vaccine effectiveness It is reported that this is the first time in the world that the HIV vaccine developed with the replication type live virus vector has entered phase II clinical trials According to reports, the vaccine, jointly developed by China Center for Disease Control and prevention and Beijing Institute of Biological Products Co., Ltd., is for the joint use of HIV nucleic acid vaccine and HIV recombinant Tiantan vaccinia The former is the initial immunization, while the latter is to strengthen the immunization The vaccine is different from the international technical route of using non replicating virus vector, but it is developed with the vaccine of eliminating smallpox in China - replicating vaccinia virus Tiantan strain as the carrier In recent years, a number of European and American R & D teams have begun to develop HIV vaccine with replication virus carriers, and two teams are carrying out phase I clinical trials After the clinical trials of phase IA and phase IB, 46 volunteers were observed The results showed that the vaccine had good safety and immunogenicity, and could induce the anti HIV humoral and cellular immune responses The research team put forward the phase II clinical trial application in 2011 and obtained the approval of the State Food and Drug Administration in late March this year The two R & D units and the clinical research team composed of Beijing You'an Hospital, Peking University Clinical Research Institute, China food and Drug Control Research Institute jointly carried out program optimization, ethical review, trial preparation and volunteer recruitment As of August 9, a total of 42 volunteers were screened and 29 qualified volunteers were selected At present, recruitment is still in progress According to reports, this year, the research team will vaccinate 150 volunteers in stages and batches, and carry out phase IIa clinical trial observation to prepare for the future phase IIB clinical trial.
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