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Rotavirus vaccine phase 3 trial

May 14, 2013

Here’s great news, live from the Rotavirus meeting at Delhi. A terrific example of collaboration and staying power for an important cause: Reducing childhood mortality due to diarrhoea.
Nita Bhandari talks about her team. This is hot off the press and more details in due course.
K, VijayRaghavan

Dr. Nita Bhandari
Society for Applied Studies
Rotavirus Vaccine Developed in India Is a Major Breakthrough

Today we celebrate a wonderful breakthrough for Indian researchers, but most importantly for India’s children. Each year, over 1 lakh Indian children die from the most common and severe cause of diarrhoea: rotavirus.

I was thrilled to be part of history today as we announced positive results from a clinical study of the first indigenous rotavirus vaccine. This rotavirus vaccine was developed from an Indian strain by an Indian company, and tested by Indian investigators in an effort led by the Indian government and supported by several national and global partners.

The rotavirus vaccine we studied (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. The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India.

I am proud to have led an extraordinary team of clinical investigators at three sites across India for this pivotal clinical study—the Centre for Health Research and Development, Society for Applied Studies (CHRD-SAS) in New Delhi; Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre in Vadu, Pune; and Christian Medical College (CMC) in Vellore. The Principal Investigators were Dr Temsunaro Rongsen-Chandola at CHRD-SAS, Dr Ashish Bavdekar at KEM, and Dr Gagandeep Kang at CMC. I was supported by Kalpana Antony and Sunita Taneja.

The experience, expertise, and excellence of the investigators ensured that this trial met the highest standards for ethics and patient care and complied with international standards for good clinical practices. In particular, we had in place a strong safety net to identify and treat illnesses, especially gastroenteritis, among study infants as early as possible. We gave mobile phones to the mothers of all of the infants enrolled in the study to ensure that the children received high-quality medical and emergency care during the study period.

For the first time, we have taken a vaccine from the earliest discovery through every stage of development. This major contribution to public health is thanks to the knowledge and dedication of our national researchers, and I am proud and humbled to have been a part of this unique collaboration.

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One Comment
  1. Fantastic news! Truly a cause for celebration. Let’s keep our fingers crossed for the phase 3 trial.

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