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.
RVP’s support of rotavirus vaccine clinical trials in the developing world began in 2004, building off the foundation laid by the Rotavirus Action Program for Immunization and Development (RAPID), a public-private partnership involving RVP partners WHO and PATH, that initiated Phase I and II trials in South Africa and Bangladesh. These studies gathered crucial data:
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.
Rotavirus vaccine clinical studies (supported through RVP or RAPID partnerships)
K Zaman, DA Sack, SE Arifeen, et al. Future Promise of a live oral rotavirus vaccine: Trial with human strain (RIX4414). 10th Asian Conference on Diarrhoeal Diseases and Nutrition. 7-9 December 2003. Dhaka, Bangladesh
AD Steele, J Tumbo, G Armah, et al. Immunogenicity and reactogenicity of a new live attenuated oral rotavirus vaccine (RIX4414) when administered concurrently with poliovirus vaccines in African infants. International Congress of Paediatrics, 15-20 August, 2004. Cancun, Mexico
B De Vos, S Debrus, T Vesikari, et al. Interference of transplacental antibodies on immune response to Rix4414, a live attenuated human rotavirus vaccine. Frontiers in Neonatal Immunity. 18-20 March, 2005. Madrid, Spain
AD Steele, J Tumbo, G Armah, et al. Concomitant administration of a live attenuated oral rotavirus vaccine (Rix4414) with poliovirus vaccines in African infants. European Society of Paediatric Infectious Diseases, 18-20 May, 2005. Valencia, Spain.
AD Steele, J Tumbo, J Reynders, et al. Comparison of 2 different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated human rotavirus vaccine RIX4414 in South African infants. World Society of Paediatric Infectious Diseases, 1-4 September 2005. Warsaw, Poland
K Zaman, DA Sack, Md. Yunus, et al. Rotavirus vaccine trials in Bangladesh. Past, present and future. 8th Commonwealth Congress on Diarrhoea and Malnutrition, 6-8 February 2006. Dhaka, Bangladesh
AD Steele, J Tumbo, J Reynders, et al. Comparison of 2 different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated human rotavirus vaccine RIX4414 in South African infants. 11th Asian Conference on Diarrhoea Disease and Nutrition. 8-10 March, 2006. Bangkok, Thailand
SA Madhi, T Lerumo, C Louw, et al. Efficacy of Human Rotavirus Vaccine RIX4414 (Rotarix™) in South African Infants During the First Year of Life – an Interim Analysis. 8th International Rotavirus Symposium. 2-5 July, 2008. Istanbul, Turkey
AD Steele, P Bos, JM Tumbo, et al. Safety, Reactogenicity and Immunogenicity of Live Attenuated Human Rotavirus Vaccine RIX4414 in HIV+ Infants in South Africa. 48th ICAAC , October 2008. Washington DC, USA
Steele AD, et al. Co-administration study in South African infants of a live-attenuated oral human rotavirus vaccine (RIX4414) and poliovirus vaccines. Vaccine. 2008. [Epub ahead of print]
Zaman K, et al. Successful co-administration of a human rotavirus and oral poliovirus vaccines in Bangladeshi infants in a 2-dose schedule at 12 and 16 weeks of age. Vaccine. 2009. [Epub ahead of print]
Steele AD, et al. Comparison of two different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated oral rotavirus vaccine (Rix4414) in South African infants. Journal of Infectious Diseases. [in press]
Steele AD, Cunliffe NA, Tumbo JM, et al. Rotavirus immunization in HIV-infected children. Journal of Infectious Diseases. [in press]
Phase 3 safety and efficacy studies with RotaTeq® are ongoing in Bangladesh, Vietnam, Ghana, Kenya, and Mali; and with RotarixTM in South Africa and Malawi.
WHO recommendations related to rotavirus vaccines
WHO. Report of the Strategic Advisory Group of Experts. 2002. Geneva: WHO.
WHO. Recommendations from the Strategic Advisory Group of Experts to the Department of Immunization, Vaccines and Biologicals. Weekly Epidemiological Record. 2005; 80(2).
WHO. Conclusions and recommendations from the immunization Strategic Advisory Group. Weekly Epidemiological Record. 2006; 81(1) .
WHO. Evaluating clinical trial data and guiding future research for rotavirus vaccines. Weekly Epidemiological Record. 2008; 83(43).
WHO. Meeting of the immunization Strategic Advisory Group of Experts, November 2008—conclusions and recommendations. Weekly Epidemiological Record. 2009; 84(1/2).
WHO. Meeting of the Diarrheal and Enteric Vaccines Advisory Committee. Weekly Epidemiological Record. 2009; 84(4).
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.