The vaccine has now received approvals from Drug Controller General of India (DCGI) for Phase I clinical trial. The Indian Council of Medical Research (ICMR) has designed a protocol for this vaccine to be tested on 120 women at All India Institute of Medical Sciences (AIIMS) and Sir Ganga Ram Hospital (SGRH) in New Delhi.
“If it passes through the human phases of clinical trials, it will be the world’s first birth control vaccine, which will temporarily protect women against pregnancy,” Dr Talwar told DNA.
The vaccine is genetically engineered and the technology has been transferred to Bharat Biotech in Hyderabad, which will manufacture it for trial on 120 women subjects, 50 in Phase-I trial and an additional 70 in Phase-II trial.
DNA accessed the clinical trial protocol, which will be used to administer the vaccine. Non-pregnant, but sexually active women, between 22 to 35 years, with two living children will be enrolled in the study. 25 women will be enrolled at AIIMS, and another 25 at SGRH. Eligible candidates are being screened for recruitment in the Gynaecology departments at these hospitals. “Five doses — 100, 200, 300, 400 and 500 mg will be administered, respectively, to ten women.
The vaccine prevents secretion of Beta Human Chorionic Gonadotrophin (HCG) hormone, which is crucial for implantation of the fertilised embryo to the uterus. If we can prevent this hormone from circulation in female’s blood, by generating antibodies through the vaccine, there will be no pregnancy,”said a senior scientist at ICMR.
The women will be monitored on a monthly basis for the levels of antibodies in their blood. The subjects will also be trained to maintain a menstrual and an intercourse diary. If all goes well, conducting Phase-I and II trials will take close to three and half years.
While initially Dr Talwar had derived the vaccine by purifying a pregnant woman’s urine, the current recombinant version is genetically engineered based on his previous vaccine research work.
While hormonal contraceptives currently in use, in the form of pills or injectibles, are steroids that have an adverse effect on the health of the woman, and other ways to halt pregnancy like Intra Uterine Devices are known to cause bleeding, this vaccine has no side-effects, he explains.
“The women will have a normal functioning sex life and menstrual cycle. She will have to take the vaccine once in close to three months for prevention of pregnancy, we pre-empt and she can simply discontinue it when she chooses to get pregnant,” said the scientist.
The vaccine has completed it’s pre-clinical toxicity studies on animals — rodents and marmosets and is showing promising results.
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