Clinical research
Current rotavirus vaccines have been shown to be safe and effective in the US, Latin America, and Europe. The next step is determining their safety and efficacy in Africa and Asia. These regions are among those where the most rotavirus deaths occur, making prevention through immunization critical.
The World Health Organization emphasized the need for these data in an update to its 2007 position paper on rotavirus vaccines. RVP is collaborating with Merck & Co., Inc., GlaxoSmithKline, and clinical research sites in several countries to collect this important information.
Clinical trials of Rotarix®, in collaboration with GlaxoSmithKline
South Africa
- Immunogenicity, dose range, age of administration, and interaction with oral polio vaccine (Phase 2; 2004–05)
Results: Immunological response after three doses was not superior to two doses; Rotarix® does not interfere with the immune response of oral polio vaccine when coadministered.
- Safety and efficacy (Phase 3; 2005-ongoing)
Interim results: Rotarix® was 83 percent efficacious in preventing severe rotavirus gastroenteritis among infants in impoverished populations of South Africa. Full results will be available in 2009. - Safety, reactogenicity, and immunogenicity in HIV-positive infants (Phase 2; 2005-ongoing)
Malawi
- Safety and efficacy (Phase 3; 2006-ongoing)
- Safety, reactogenicity, and immunogenicity in HIV-positive infants (Phase 2 2005-ongoing)
Bangladesh
- Immunogenicity, dose range, and reactogenicity (Phase 2; 2005-06)
Results: Significant immune response following two doses; coadministration with oral polio vaccine did not lower the polio immune response.
- Population effectiveness (Phase 4; 2007-ongoing)
El Salvador
- Vaccine effectiveness (2008-ongoing)
Clinical trials of RotaTeq®, in collaboration with Merck & Co., Inc.
Ghana
- Safety and efficacy (Phase 3, 2007-ongoing)
Kenya
- Safety and efficacy (Phase 3, 2007-ongoing)
Mali
- Safety and efficacy (Phase 3, 2007-ongoing)
Bangladesh
- Safety and efficacy (Phase 3, 2007-ongoing)
Vietnam
- Safety and efficacy (Phase 3, 2007-ongoing)
Nicaragua
- Vaccine effectiveness (2008-ongoing)
Addressing the knowledge gap
Our social research found that knowledge about rotavirus remains low among policymakers and providers. Additionally, the promotion of general diarrheal disease control interventions, such as oral rehydration solution and therapy (ORS/ORT), has abated.
Building on this valuable insight, we developed the Enhanced Diarrheal Disease Control Initiative (EDD), an integrated approach to diarrheal disease control aimed at raising awareness about new and improved interventions to control diarrheal disease, including rotavirus vaccines, low-osmolarity ORS, and zinc treatment. EDD also reinforces the importance of existing interventions such as ORT, breastfeeding, and improvements in hygiene and sanitation.
Top photo by Richard Lord.