Indian doctor's decision to "self test" AIDS vaccine decried as unethical
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《英国医生杂志》
An Indian doctor has reported that he injected himself with a candidate HIV vaccine that he had developed but which had not been approved for human use.
Dr Pradeep Seth, head of microbiology at the All India Institute of Medical Sciences, New Delhi, said that he took the vaccine—after results in mice and monkeys were encouraging—only to see how the human body would react to it.
"The test has generated data, and, even if it did nothing else, it has boosted my own confidence in the vaccine," said Dr Seth. The DNA vaccine, supported by India抯 Department of Biotechnology, does not contain HIV. However, it is constructed from select genetic sequences of HIV and is delivered with the help of a plasmid vector in the prime dose and a highly attenuated strain of vaccinia virus—modified vaccinia Ankara—as the vector in the boost dose.
Dr Seth, who injected himself with the prime and boost doses in December last year, said the experiment was driven by scientific curiosity. But colleagues and policy makers have decried the test as unethical.
"It is ethically unacceptable," said Dr Vasantha Muthuswamy, chief of the basic medical sciences division at the Indian Council of Medical Research.
"He抯 injected emotion and bravado into his project for a vaccine," said Dr Samiran Nundy, a gastrointestinal surgeon in New Delhi who is also editor of the Indian Journal of Medical Ethics and a former colleague of Dr Seth.
Government officials have said that the vaccine would need to go through another round of toxicological tests in animals before it is approved for human trials. Dr Seth has emphasised that his test had nothing to do with the long wait that India has endured for human trials of candidate HIV vaccines. "The scientific and regulatory process will go on. This was a personal decision," he said.
His DNA vaccine is the only HIV vaccine developed in India to have been tested in monkeys. But the health ministry plans to begin human trials with two other vaccines through the international AIDS vaccine initiative, both developed in the United States. Although the first trial had been expected to begin in July this year, a senior health ministry official said a realistic date would now be early 2005.
"Scientific data now suggest that a single vaccine may not be able to provide sufficient protection, and there is merit in considering a multiple candidate approach," a spokesperson for the initiative said.
The two other candidates that India is considering for human trials are a modified vaccinia Ankara vaccine developed by Therion Biologics in Cambridge, Massachusetts, and a vaccine based on an adenoassociated virus developed by Targeted Genetics in Seattle, Washington. The second vaccine is currently in the first phase of human trials in Belgium and Germany. Both vaccines are based on HIV subtype C.(New Delhi Ganapati Murdur)
Dr Pradeep Seth, head of microbiology at the All India Institute of Medical Sciences, New Delhi, said that he took the vaccine—after results in mice and monkeys were encouraging—only to see how the human body would react to it.
"The test has generated data, and, even if it did nothing else, it has boosted my own confidence in the vaccine," said Dr Seth. The DNA vaccine, supported by India抯 Department of Biotechnology, does not contain HIV. However, it is constructed from select genetic sequences of HIV and is delivered with the help of a plasmid vector in the prime dose and a highly attenuated strain of vaccinia virus—modified vaccinia Ankara—as the vector in the boost dose.
Dr Seth, who injected himself with the prime and boost doses in December last year, said the experiment was driven by scientific curiosity. But colleagues and policy makers have decried the test as unethical.
"It is ethically unacceptable," said Dr Vasantha Muthuswamy, chief of the basic medical sciences division at the Indian Council of Medical Research.
"He抯 injected emotion and bravado into his project for a vaccine," said Dr Samiran Nundy, a gastrointestinal surgeon in New Delhi who is also editor of the Indian Journal of Medical Ethics and a former colleague of Dr Seth.
Government officials have said that the vaccine would need to go through another round of toxicological tests in animals before it is approved for human trials. Dr Seth has emphasised that his test had nothing to do with the long wait that India has endured for human trials of candidate HIV vaccines. "The scientific and regulatory process will go on. This was a personal decision," he said.
His DNA vaccine is the only HIV vaccine developed in India to have been tested in monkeys. But the health ministry plans to begin human trials with two other vaccines through the international AIDS vaccine initiative, both developed in the United States. Although the first trial had been expected to begin in July this year, a senior health ministry official said a realistic date would now be early 2005.
"Scientific data now suggest that a single vaccine may not be able to provide sufficient protection, and there is merit in considering a multiple candidate approach," a spokesperson for the initiative said.
The two other candidates that India is considering for human trials are a modified vaccinia Ankara vaccine developed by Therion Biologics in Cambridge, Massachusetts, and a vaccine based on an adenoassociated virus developed by Targeted Genetics in Seattle, Washington. The second vaccine is currently in the first phase of human trials in Belgium and Germany. Both vaccines are based on HIV subtype C.(New Delhi Ganapati Murdur)