印度本土轮状病毒疫苗ROTAVAC III期临床取得积极数据

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印度生物技术部（DBT）和Bharat生物技术公司今天宣布，在印度本土开发和生产的轮状病毒疫苗在III期临床试验中取得积极数据。该试验数据已提交至今天举行的轮状病毒疫苗国际研讨会（International Symposium on Rotavirus Vaccines for India—The Evidence and the Promise），数据显示ROTAVAC具有出色的安全性和有效性属性。
  本文来自织梦

该项临床研究首次证明，印度本土开发的轮状病毒疫苗ROTAVAC能够有效地预防严重轮状病毒腹泻。ROTAVAC将第一年中严重轮状病毒腹泻减少了56%，且该保护作用可以持续至第二年。此外，该疫苗也能作用于其他任何因素引起的严重腹泻。

“这是在抗轮状病毒感染中取得的一个非常重要的科学突破。在印度，每年约有10万儿童死于轮状病毒感染。该疫苗若获得批准，每年将能够挽救数以千计儿童的生命，”DBT司长Vijay Raghavan博士说道。

ROTAVAC最初源于1985-86年在印度新德里全印医学科学研究所治疗的一名儿童体内分离的一株并经减毒（弱化）的轮状病毒，该疫苗通过一个独特的社会创新合作伙伴关系开发，汇集了印度和国际研究人员以及公共和私营部门的经验和专长。

英文原文：INDIAN ROTAVIRUS VACCINE DEMONSTRATES STRONG EFFICACY

The Government of India’s Department of Biotechnology (DBT) and Bharat Biotech announced positive results from a Phase III clinical trial of a rotavirus vaccine developed and manufactured in India. Data from the trial, presented today at the International Symposium on Rotavirus Vaccines for India—The Evidence and the Promise, showed ROTAVAC? to have an excellent safety and efficacy profile.

The clinical study demonstrates for the first time that the India-developed rotavirus vaccine ROTAVAC? is efficacious in preventing severe rotavirus diarrhoea in low-resource settings in India. ROTAVAC? significantly reduced severe rotavirus diarrhoea by more than half—56 percent during the first year of life, with protection continuing into the second year of life. Moreover, the vaccine also showed impact against severe diarrhoea of any cause. 本文来自织梦

“This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 100,000 deaths of small children in India each year,” said DBT Secretary Dr K. VijayRaghavan. “The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India.”

The vaccine was developed through a unique social innovation partnership that brought together the experience and expertise of Indian and international researchers as well as the public and private sectors. The vaccine originated from an attenuated (weakened) strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in 1985-86. Since then, partners have included DBT, Bharat Biotech, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and the nongovernmental organization, PATH. Dr M.K. Bhan, who recently completed his service as DBT Secretary, was tireless in fostering the social innovation partnership and ensuring the highest standards for the vaccine.

The randomized, double-blind, placebo-controlled Phase III clinical trial enrolled 6,799 infants in India (aged six to seven weeks at the time of enrolment) at three sites—the Centre for Health Research and Development, Society for Applied Studies (SAS) in New Delhi; Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre in Vadu, Pune; and Christian Medical College (CMC) in Vellore. The Clinical Operations Management Unit headed by Dr Nita Bhandari at SAS oversaw the day-to-day coordination and logistical complexities of this multi-site study and played a pivotal role in the conduct of this trial. The Principal Investigators were Dr Temsunaro Rongsen-Chandola at SAS, Dr Ashish Bavdekar at KEM, and Dr Gagandeep Kang at CMC.

The Data Safety Monitoring Board (DSMB), an independent group of experts established to protect the participating infants’ rights and needs during the Phase III trial, determined that the trial met the highest standards for ethics and patient care and complied with international standards for good clinical practices.

Bharat Biotech previously announced a price of US$ 1.00/dose (or approximately INR 54/dose) for ROTAVAC? and will soon file for registration of the vaccine in India. If licensed by the Drugs Controller General of India (DCGI), the vaccine will be a more affordable alternative to the rotavirus vaccines already on the market. 织梦内容管理系统

“With its low price and strong efficacy, ROTAVAC? has the potential to significantly reduce the incidence of severe diarrhoea due to rotavirus among children in India,” said Dr M.K. Bhan, Advisor to the Indian Academy of Pediatrics and former DBT Secretary. 织梦好，好织梦

The vaccine efficacy compares favourably with the efficacy of the currently licensed rotavirus vaccines in low-resource countries. The study results showed clear evidence of protection across different rotavirus strains and continued efficacy in the second year of life.