8-1 Research and Development of Contraceptive Vaccine Project Scope and Relationship to China's Agenda 21 This project is designed to lead to the development of a safe, simple, effective, economical, and reversible contraceptive vaccine for women and ultimately for men as well. The project has been developed in accordance with programme area 7A of China's Agenda 21 - Population Growth Control - and will contribute to poverty alleviation and improvement of every aspect of human life and sustainable development (all chapters). 1. Background Population concerns play a decisive role in all human endeavours and are a crucial part of any strategy for achieving sustainable development. This is particularly true for China, the most populous country in the world, whose population of almost 1.2 billion constitutes 22 percent of the global total. China has made remarkable progress in family planning during the last twenty years, with the total fertility rate, birth and death rates, and average expected life span approaching the average standards of developed countries. Its population growth during the past years has been 0.2 billion less than projected. Yet even if China's long-term population control strategy is fully successful, its population will not reach a stable level until the middle of the next century, after the population has already reached 1.6 billion. Such intense population pressures will place enormous strains on every aspect of human life and development, accelerate the decline of China's limited natural resource base, and adversely affect sustainable development throughout the world. As a result, China is now seeking to develop additional methods of controlling population in a safe, effective, economic, and equitable manner. China has the ability to produce and provide most of the contraceptive agents and devices which have been marketed internationally. Yet the devices currently available in clinical practice cannot satisfy the various needs of people at different economic and education levels and with differing access to health services. Research is therefore under way at 20 different family planning institutes throughout China to develop alternative methods of fertility regulation. Yet money for such research is severely limited due to the enormous amount of funds needed to provide free family planning services to all in China. In fact, funding for research, development constitutes only 0.25 percent of the total family planning budget. China is one of only three countries in the world (along with the United States and India) now working on development of a contraceptive vaccine, a new generation method of birth control. It is expected that one dose of such a vaccine would last 1 to 1.5 years, thus proving simpler, more economical, and more effective than other alternatives, yet still reversible. Although most of the work to date has been on developing a vaccine for women, progress has also been made, and will continue on the more difficult task of isolating antigens to be used in a vaccine for men. China hopes to continue its work and eventually be able to provide these vaccines to other developing countries. The research program for a contraceptive vaccine has been included in the Seventh and Eighth Five- Year plans, as well as on a list of the Hi-Tech Research and Development Programme. Safety and toxicological studies on three kinds of contraceptive vaccines have been conducted on primates, and a phase I clinical trial is scheduled to begin next year. Yet because of the shortage of funds and lack of necessary equipment, China lags behind in such fields as the expression of glycoprotein using bioengineering technologies, the synthesis of biodegradable polymers, and pharmacological and toxicological evaluation methods. China is therefore seeking technical cooperation in research methodology as well as assistance in upgrading its equipment, instruments, and communication system. It also hopes that by building its capacity to perform research and development of alternative contraceptive methods, it will be able to attract the return home of overseas Chinese scientists who are presently training to work in this important field. 2. Objectives Long-term Objectives To promote the rapid development and availability of a safe, simple, effective, and economical contraceptive vaccine throughout China and in other countries as well. Immediate Objectives To establish a modern centre for contraceptive vaccine research and development with access to advanced technology and methods. To improve research techniques, develop and test prototype and advanced contraceptive vaccines, and establish methods for monitoring immunization efficacy and vaccine quality. To establish an industrial production centre for testing, producing and marketing a commercial contraceptive vaccine, and begin using the vaccine in family planning health services. 3. Activities 3.1 Establish a modern centre for contraceptive vaccine research and development with access to advanced technology and methods. The centre will consist of three research groups with the following targets. Establish a group for research and development at the National Research Institute for Contraceptive Planning in Beijing, responsible for coordinating all national research on contraceptive vaccines. Establish a primate study group responsible for all safety and toxicological testing of contraceptive vaccines in primates. Establish a group for monitoring, evaluation, and quality control of all contraceptive vaccines. This activity will be Implemented by the State Family Planning Commission and the State Science and Technology Commission. The duration of this activity will be three years. 3.2 Conduct phase I and II clinical trials for the prototype hCG?contraceptive vaccine. Improve the technique for high expression of the hCG?sub-unit by bioengineering methods. Establish simple methods for monitoring immunization efficacy in rural areas. This activity will be conducted by the group for contraceptive vaccine research and development under the supervision of the State Family Planning Commission. The duration of this activity will be four years. 3.3 Develop an advanced hCG?contraceptive vaccine using biodegradable polymers and other advanced technologies. Conduct phase I and II clinical trials with the advanced vaccine. This activity will be coordinated by the group for contraceptive vaccine research and development and the primate study group, under the supervision of the State Family Planning Commission. The duration of this activity will be seven years. 3.4 Create internationally accepted standards and methods for evaluating the quality of the contraceptive vaccine. This activity will be conducted by the group for contraceptive vaccine quality control and monitoring under the supervision of the State Family Planning Commission. The duration is from 1996 until the vaccine is used in clinical practice. 3.5 Develop an electronic communications network for data collection and information exchange among the study groups and internationally. This activity will be organized by the group for contraceptive vaccine research and development under the supervision of the State Family Planning Commission. The duration of this activity will be three years. 3.6 Establish an industrial production project for testing, producing, and marketing a commercial contraceptive vaccine. Conduct the phase III clinical trial and begin using the vaccine in family planning health services. This activity will be implemented by the State Family Planning Commission and the Ministry of Public Health under the supervision of the State Science and Technology Commission. The duration of this activity will be six years, and is not slated to commence until the year 2000. 4. Inputs 4.1 Personnel, Equipment, and Material Inputs Domestic inputs will be allocated to: - Purchase of equipment; - Training of personnel; - Funding for a portion of the vaccine research. International inputs will be allocated to: - Purchase of advanced equipment for research and development of contraceptive vaccine; - Training of personnel and attracting returning Chinese scientists to work in the centre; - Inviting international scientists to provide technical assistance; - Set up the electronic communication network; - Purchase some of the instruments for industrial production of the vaccine. 4.2 Budget Total funding required is US $9.25 million, including US $5.15 million in domestic funds, US $2 million in soft loans, and US $2.1 million in grant assistance. The vaccine manufacturer will be able to repay the loan after marketing the contraceptive vaccine. Budget (in million US dollars) Activity Chinese Inputs External Inputs GrantSoft-Loan Total 3.1 2.3 1.35 3.65 3.2 0.50 0.20 0.70 3.3 1.00 0.30 1.30 3.4 0.20 0.10 0.30 3.5 0.15 0.15 0.30 3.6 1.00 2.00 3.00 Total 5.15 2.102.00 9.25 5. Benefits Successful completion of the project will enable China to make available a safe, simple, effective, and economical vaccine throughout China as well as other countries. The resulting population control benefits could have widespread implications for alleviating poverty, reducing the burden on the national and global environment, and further every aspect of sustainable development. Text Browser Utilities: [Back, ACCA21 Home] For more information about ACCA21 contact: web@acca21.edu.cn Address: 109 Wanquanhe Road, Haidian District, Beijing 100089, People's Republic of China Telephone: +86-10-82636193, +86-10-82634400 Ext.2401 Fax: +86-10-82636192