Creating a national enabling environment for AIDS vaccine trials - China Interview with Dr Joan Kaufman

1. HDN: China is an important player in the global effort to find an AIDS vaccine. The second phase I AIDS vaccine trial was launched in 2005 in China. What lessons have been learnt and what have been the results of the trial?

JK: The trial was launched in Nanning, capital of Guangxi Zhuang Autonomous Region, in March 2005 in China. The clinical trial indicated that the vaccine is safe. But there will be further testing with this product to determine its immunological effect and ultimately its efficacy. The vaccine trial was conducted under the guidance of the local provincial CDC in Guangxi; this was a wholly owned Chinese venture. The trial created an understanding around issues relating to safety and recruiting of volunteers for AIDS vaccine trials in China.

2: HDN: Community Advisory Boards (CABs) play a significant role in linking communities and researchers to help facilitate the introduction of education and prevention programs. What is the role of the CAB in China to inform and educate volunteers, and to link the community and science?

JK: The development of AIDS vaccines depends on community participation and advocacy. There is a general enthusiasm for activities such as developing vaccine education materials, organizing ethics committees, and CAB development. While the concept is similar, CABs in China are not necessarily constructed in the same way that CABs are constructed in other countries.

IAVI is in the process of working with its partners in China to foster a more meaningful CAB process. IAVI plans to conduct a CAB assessment in some of the key sites for AIDS vaccine trials. We also plan to hold a workshop later this year regarding CAB efforts in China.

3. HDN: There may be concerns about ethical issues in AIDS vaccine research, such as standards of care, informed consent, risks and benefits to participants and communities, and issues relating to women, adolescents and other vulnerable groups. What steps are in place to ensure that the trials are conducted in an ethical manner and how is the community informed?

JK: We have played a role in vaccine preparedness program in China and we are working with local partners to introduce state of the art international understanding of ethics in AIDS vaccine research to the Chinese research community. We are doing this through a number of different mechanisms. We have translated IAVI's AIDS vaccine literacy materials into Chinese. A number of other publications focusing on ethics in AIDS vaccine research has been translated and widely disseminated to our partner organizations.

A one day satellite meeting on ethics in AIDS vaccine clinical research was held in 2006 at the International Bio-Ethics conference in Beijing, during which we translated a great deal of material for. Chinese speakers.

International experts including Ruth Macklin from Albert Einstein College of Medicine, Ezekiel Emmanuel from the US NIH, and Solomon Benatar from South Africa, discussed issues around the conduct of ethical research related to AIDS vaccines internationally and in China, standards of care and adequate volunteer protection. The report of that meeting will be published shortly.

4. HDN: What is the role of the national government in vaccine research and development? Are there specific political commitments laid out in the by the Chinese government for AIDS vaccine research? Is the level of co-ordination between local governments and healthcare providers satisfactory?

JK: The Chinese government is very committed to AIDS vaccines and they are putting significant resources into research. For example, the new 15 year science and technology development plan includes a large provision for AIDS vaccine research. Some of the provincial governments, such as the Guangdong province, have invested heavily in attracting leading Chinese AIDS vaccine researchers to work locally in state-of-the-art labs

Regarding the link between government and healthcare providers, it is too preliminary right now to say whether it is satisfactory. I can tell you that one identified need in AIDS vaccine clinical trials is for a higher level of understanding among the local healthcare providers. Given the strengthening of the government's response, it seems the link to healthcare providers should be a priority.

5. HDN: The draft blueprint for AIDS Vaccine Preparedness was generated by participants of the CAMS-IAVI AIDS Vaccine Network Meeting in Beijing in February 2006. What are the priority areas of action laid out in the blueprint?

JK: We drafted the blueprint based on the input of the participants in the Network meeting, which included the scientific community members and others working on AIDS vaccine research and vaccine preparedness issues in China.

Based on consensus of the discussion, we laid out an action plan of priority activities. Activities were proposed in five key areas: Community Relations; Stakeholder Outreach; Ethical Issues including Standards of Care; Policy Advocacy; Communicating and Networking. This was made widely available to all the stakeholders, and IAVI is now trying to interest other stakeholders to take on board the recommendations from the blueprint.

There are a number of science groups working on different vaccine candidates, and IAVI has been taking the lead in pushing preparedness issues for the field, such as the CAB process and the national ethics symposium described previously, and a follow-up meeting to provide scientific updates.

IAVI is also supporting a website to provide updates on AIDS vaccine trials in China, and is facilitating translation and dissemination of vaccine literary materials.

Ishdeep Kohli-CNS