Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers

Summary

Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting for 45% of severe diarrhea disease in both developed and developing countries. Annually, rotavirus causes approximately 111 million episodes of gastroenteritis requiring home care, 25 million clinic visits, 2 million hospitalizations, and approximately 440,000 deaths in children less than 5 years of age, of which approximately 90% of hospitalizations and 99% of deaths occur in developing countries. Although rotavirus infection is not more common in HIV-infected children, it complicates their care and interferes with their nutrition. Chances of death by these infections can be greater in HIV-infected children when they also suffer from wasting, malnutrition, and/or opportunistic infections. The primary purpose of this study was to evaluate the safety and immunogenicity of the Rotavirus vaccine candidate, RotaTeq, in HIV-infected and uninfected children born to HIV-infected mothers.

Timeline

Start

2009-12

Primary completion

2014-01

Completion

2014-01

Publications

• Background Committee on Infectious Diseases; American Academy of Pediatrics. Prevention of rotavirus disease: updated guidelines for use of rotavirus vaccine. Pediatrics. 2009 May;123(5):1412-20. doi: 10.1542/peds.2009-0466. Epub 2009 Mar 30.
• Background Kiulia NM, Nyaundi JK, Peenze I, Nyachieo A, Musoke RN, Steele AD, Mwenda JM. Rotavirus infections among HIV-infected children in Nairobi, Kenya. J Trop Pediatr. 2009 Oct;55(5):318-23. doi: 10.1093/tropej/fmp016. Epub 2009 Mar 10.
• Background Parashar UD, Glass RI. Rotavirus vaccines--early success, remaining questions. N Engl J Med. 2009 Mar 12;360(11):1063-5. doi: 10.1056/NEJMp0810154. No abstract available.
• Levin MJ, Lindsey JC, Kaplan SS, Schimana W, Lawrence J, McNeal MM, Bwakura-Dangarembizi M, Ogwu A, Mpabalwani EM, Sato P, Siberry G, Nelson M, Hille D, Weinberg GA, Weinberg A. Safety and immunogenicity of a live attenuated pentavalent rotavirus vaccine in HIV-exposed infants with or without HIV infection in Africa. AIDS. 2017 Jan 2;31(1):49-59. doi: 10.1097/QAD.0000000000001258.

Drugs

Indications