Rotavirus

Wednesday 6 February 2019 - Updated on Wednesday 6 November 2019
A major cause of diarrhea-related deaths in children

Acute diarrhea remains one of the major causes of morbidity and mortality among children, accounting for an estimated 11% of child deaths worldwide. Rotavirus is the leading cause of acute diarrhea, or severe gastroenteritis, in children and is responsible for about 450,000 deaths per year.

A preventable cause of severe gastroenteritis

Acute diarrhea is rapidly dehydrating and can be life-threatening unless fluid therapy is initiated quickly. Treating severe rotavirus gastroenteritis involves hospitalization and rehydration therapy. In countries with rapid access to high-quality of care, children are taken under charge and almost always survive the infection. In the areas where Médecins Sans Frontières (MSF) works, however, diarrhea remains one of the major causes of childhood morbidity and mortality. Rotavirus is a major cause of diarrheal disease that can be prevented with a vaccine.

Developing a vaccine for difficult settings

Adapting to the context

Child receives oral vaccine against rotavirus, Niger.
Légende
Child receives oral vaccine against rotavirus, Niger.

Until recently there were only two prequalified rotavirus vaccines, but they are not adapted to the settings where MSF works due to the logistical challenges of the large storage footprint and cold chain requirements.  Epicentre has focused on research and development of a rotavirus vaccine that can be brought to the infants that need it most: a new vaccine that is easy-to-use and an affordable option for developing countries.

 

Proven efficacy

The vaccine tested by Epicentre is called Rotasill and is manufactured by the Serum Institute of India Pvt Ltd.  Although there are several other potential candidate vaccines that could expand access and respond to the needs, this vaccine was selected as the most promising. This vaccine is based on existing vaccines, and its proven safety track record minimizes risk.

Heat-stable, easy to transport and affordable

Rotasiil has several other properties that make it especially suitable for use in sub-Saharan Africa: it is heat stable and does not require a cold chain, this makes it suitable for places where maintaining the cold chain is a challenge. Less packaging and easier transport
are additional advantages. Last, but not least, this is an affordable vaccine.

Epicentre’s field and clinical trials

In 2017, we showed the efficacy of this vaccine to prevent severe gastroenteritis among infants in Niger.  The results published in the New England Journal of Medicine show that the vaccine has no safety concerns with an efficacy of 66.8% in preventing severe gastroenteritis caused by rotavirus. It means that 6 children in 10 receiving the vaccine did not develop severe gastroenteritis.  This is  more promising than the efficacy of existing rotavirus vaccines which were previously tested in Sub-Saharan Africa.

Prequalification

Rotasill vaccine was prequalified by WHO in 2018.  This means it can now can be purchased by UN agencies and governments. Prequalification is a big step to ensure that this vaccine can be rolled out quickly in sub-Saharan Africa.  MSF's aim is to ensure access to vaccines that require minimal logistics and that can be made available to populations in greatest need. This clinical trial has made a significant contribution to making that possible.

Selected publications

Safety of a heat-stable rotavirus vaccine among children in Niger: Data from a phase 3, randomized, double-blind, placebo-controlled trial.

Journal Reference: Vaccine 2018 06 14; 36(25); 3674-3680. doi: 10.1016/j.vaccine.2018.05.023. Epub 2018 05 08

Improving rotavirus vaccine coverage: Can newer-generation and locally produced vaccines help?

Journal Reference: Human vaccines & immunotherapeutics 2018 02 01; 14(2); 495-499. doi: 10.1080/21645515.2017.1403705. Epub 2017 12 21

Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger.

Journal Reference: The New England journal of medicine 2017 03 23; 376(12); 1121-1130. doi: 10.1056/NEJMoa1609462. Epub 2017 04 28

Rotavirus surveillance in urban and rural areas of Niger, April 2010-March 2012.

Journal Reference: Emerging infectious diseases 2014 Apr ; 20(4); 573-80. doi: 10.3201/eid2004.131328. Epub 2014 12 16
See all

Image
Mother and child participate in the rotavirus clinical trial, Niger
Légende
Mother and child participate in the rotavirus clinical trial, Niger
Image
 Samples from the rotavirus vaccine clinical trial in Niger Zone de texte libre
Légende
Samples from the rotavirus vaccine clinical trial in Niger
Image
Children hospitalized with gastroenteritis infections.
Légende
Children hospitalized with gastroenteritis infections.
Image
Running the rotavirus clinical trial at Epicentre in Maradi, Niger.
Légende
Running the rotavirus clinical trial at Epicentre in Maradi, Niger.
Image
Processing samples from the rotavirus clinical trial in Niger.
Légende
Processing samples from the rotavirus clinical trial in Niger.