Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Rotavirus vaccine developed in India demonstrates strong efficacy

14.05.2013
Public-private partnership announces phase III clinical trial results at conference in Delhi

New Delhi, India—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.

"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.

"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.

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.

Infants enrolled in the study received ROTAVAC® and the Universal Immunization Programme (UIP) vaccines, including oral polio vaccine (OPV). When the immune responses to OPV were tested, the result showed that infants receiving OPV at the same time as ROTAVAC® generated comparable immune responses to all three polio serotypes as the infants receiving OPV without ROTAVAC®; this result supports the concurrent administration of OPV and ROTAVAC®.

"Vaccines work to save and protect children from diseases like rotavirus for a lifetime," said Bill Gates, Co-Chair of the Bill & Melinda Gates Foundation. "This public-private partnership is an exemplary model of how to develop affordable technologies that save lives."

The vaccine development partnership was supported by DBT, the Bill & Melinda Gates Foundation, the Research Council of Norway, and the UK Department for International Development. Bharat Biotech invested important technical, manufacturing, and financial resources towards vaccine development. ROTAVAC® is an oral vaccine and is administered to infants in a three-dose course at the ages of 6, 10, and 14 weeks. It is given alongside routine immunizations in the UIP vaccines recommended at these ages.

"ROTAVAC® represents the successful research and development of a novel vaccine from the developing world with global standards," said Dr Krishna M. Ella, Chairman and Managing Director of Bharat Biotech. "ROTAVAC® is a testament of our strong vision and commitment to develop affordable health care solutions for infectious diseases—we are proud, yet humbled by our contribution to this social innovation project and global public health priority. We are thankful to all the partners in the Rotavirus Vaccine Development Project—DBT, the Indian Council of Medical Research, PATH, the Bill & Melinda Gates Foundation, NIH , CDC, and Stanford University—for their valuable support in this unique international public-private partnership."

Prior to conducting the study, the investigators received approvals from the DCGI, the Institutional Review Board for DBT, and the ethics review committees of each study site. The study partners also consulted with the State Governments of Delhi, Maharashtra, and Tamil Nadu, as well as the Ministry of Health and Family Welfare. In addition, the study was approved by the Western Institutional Review Board in the United States and met the highest international clinical trial standards. The DSMB strictly monitored the trial throughout for adherence to these standards and protocols. The trial design included a strong safety net to identify and treat illnesses, especially gastroenteritis, among study infants as early as possible. All of the infants enrolled in the trial received high-quality medical and emergency care during the trial period.

The support laboratory was the Translational Health Science and Technology Institute with Dr Sudhanshu Vrati as the lead. Quintiles was responsible for several aspects of the trial including medical monitoring, data management, site monitoring, pharmacovigilance, and biostatistics. Good Clinical Practice compliance of the clinical trials was audited by ANTHA Clinical Quality Assurance.

Additional resources for media:

Description of the social innovation partnership that developed ROTAVAC®
Fact sheet on rotavirus disease burden in India
Fact sheet on efficacy and impact of rotavirus vaccines
Additional quotes and media statements from experts
This document is available online in English, Hindi, Tamil, Telegu, and Marathi: http://www.defeatdd.org/rotavac-clinical-trial-results

DBT website: http://dbtindia.nic.in

Bharat Biotech website: http://www.bharatbiotech.com

Media contacts:

For DBT:
Dr T.S. Rao, +91 98-7348-3538, tsrao@dbt.nic.in
For Bharat Biotech:
Sheela Panicker, EnRight PR, +91 98-4980-9594, Sheela@enrightpr.com
Muralidharan, EnRight PR, +91 98-8510-9594, Murali@enrightpr.com
For PATH (and to reach US NIH and CDC experts):
Sushmita Malaviya, +91 97-1724-3131, smalaviya@path.org
Global media can contact:
Guillermo Meneses, GMMB, +1-202-445-1570, Guillermo.Meneses@gmmb.com
Allison Clifford, PATH, +1-202-669-7238, aclifford@path.org

Allison Clifford | EurekAlert!
Further information:
http://www.path.org

More articles from Health and Medicine:

nachricht Improving memory with magnets
28.03.2017 | McGill University

nachricht Graphene-based neural probes probe brain activity in high resolution
28.03.2017 | Graphene Flagship

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: A Challenging European Research Project to Develop New Tiny Microscopes

The Institute of Semiconductor Technology and the Institute of Physical and Theoretical Chemistry, both members of the Laboratory for Emerging Nanometrology (LENA), at Technische Universität Braunschweig are partners in a new European research project entitled ChipScope, which aims to develop a completely new and extremely small optical microscope capable of observing the interior of living cells in real time. A consortium of 7 partners from 5 countries will tackle this issue with very ambitious objectives during a four-year research program.

To demonstrate the usefulness of this new scientific tool, at the end of the project the developed chip-sized microscope will be used to observe in real-time...

Im Focus: Giant Magnetic Fields in the Universe

Astronomers from Bonn and Tautenburg in Thuringia (Germany) used the 100-m radio telescope at Effelsberg to observe several galaxy clusters. At the edges of these large accumulations of dark matter, stellar systems (galaxies), hot gas, and charged particles, they found magnetic fields that are exceptionally ordered over distances of many million light years. This makes them the most extended magnetic fields in the universe known so far.

The results will be published on March 22 in the journal „Astronomy & Astrophysics“.

Galaxy clusters are the largest gravitationally bound structures in the universe. With a typical extent of about 10 million light years, i.e. 100 times the...

Im Focus: Tracing down linear ubiquitination

Researchers at the Goethe University Frankfurt, together with partners from the University of Tübingen in Germany and Queen Mary University as well as Francis Crick Institute from London (UK) have developed a novel technology to decipher the secret ubiquitin code.

Ubiquitin is a small protein that can be linked to other cellular proteins, thereby controlling and modulating their functions. The attachment occurs in many...

Im Focus: Perovskite edges can be tuned for optoelectronic performance

Layered 2D material improves efficiency for solar cells and LEDs

In the eternal search for next generation high-efficiency solar cells and LEDs, scientists at Los Alamos National Laboratory and their partners are creating...

Im Focus: Polymer-coated silicon nanosheets as alternative to graphene: A perfect team for nanoelectronics

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are less stable. Now researchers at the Technical University of Munich (TUM) have, for the first time ever, produced a composite material combining silicon nanosheets and a polymer that is both UV-resistant and easy to process. This brings the scientists a significant step closer to industrial applications like flexible displays and photosensors.

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

International Land Use Symposium ILUS 2017: Call for Abstracts and Registration open

20.03.2017 | Event News

CONNECT 2017: International congress on connective tissue

14.03.2017 | Event News

ICTM Conference: Turbine Construction between Big Data and Additive Manufacturing

07.03.2017 | Event News

 
Latest News

Transport of molecular motors into cilia

28.03.2017 | Life Sciences

A novel hybrid UAV that may change the way people operate drones

28.03.2017 | Information Technology

NASA spacecraft investigate clues in radiation belts

28.03.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>