Safety of and Immune Response to a Pneumococcal Vaccine (PncCV) in HIV Infected and Uninfected Children

Summary

Infection by Streptococcal pneumoniae is a common invasive bacterial infection in HIV infected children. The purpose of this study is to determine the safety of and immune response to a pneumococcal polysaccharide-protein conjugate vaccine (PncCV) in HIV infected and uninfected children. The study will also determine the safety of and immune response to Haemophilus influenzae vaccine (HibCV) in these children. Recruitment for this study will occur at two hospitals in South Africa, and all HIV infected infants participating in this study must also be coenrolled in the CIPRA SA-Project 2 study.

Timeline

Start

2005-04

Primary completion

2013-12

Completion

2014-06

Publications

• Background Klugman KP, Madhi SA, Huebner RE, Kohberger R, Mbelle N, Pierce N; Vaccine Trialists Group. A trial of a 9-valent pneumococcal conjugate vaccine in children with and those without HIV infection. N Engl J Med. 2003 Oct 2;349(14):1341-8. doi: 10.1056/NEJMoa035060.
• Background Madhi SA, Kuwanda L, Cutland C, Holm A, Kayhty H, Klugman KP. Quantitative and qualitative antibody response to pneumococcal conjugate vaccine among African human immunodeficiency virus-infected and uninfected children. Pediatr Infect Dis J. 2005 May;24(5):410-6. doi: 10.1097/01.inf.0000160942.84169.14.
• Background Madhi SA, Petersen K, Madhi A, Khoosal M, Klugman KP. Increased disease burden and antibiotic resistance of bacteria causing severe community-acquired lower respiratory tract infections in human immunodeficiency virus type 1-infected children. Clin Infect Dis. 2000 Jul;31(1):170-6. doi: 10.1086/313925. Epub 2000 Jul 25.
• Background Nachman S, Kim S, King J, Abrams EJ, Margolis D, Petru A, Shearer W, Smith E, Moye J, Blanchard S, Hawkins E, Bouquin P, Vink P, Benson M, Estep S, Malinoski F; Pediatric AIDS Clinical Trials Group Study 292 Team. Safety and immunogenicity of a heptavalent pneumococcal conjugate vaccine in infants with human immunodeficiency virus type 1 infection. Pediatrics. 2003 Jul;112(1 Pt 1):66-73. doi: 10.1542/peds.112.1.66.
• Background Pai VB, Heyneman CA, Erramouspe J. Conjugated heptavalent pneumococcal vaccine. Ann Pharmacother. 2002 Sep;36(9):1403-13. doi: 10.1345/aph.1A048.
• Mutsaerts EAML, Nunes MC, van Rijswijk MN, Klipstein-Grobusch K, Otwombe K, Cotton MF, Violari A, Madhi SA. Measles Immunity at 4.5 Years of Age Following Vaccination at 9 and 15-18 Months of Age Among Human Immunodeficiency Virus (HIV)-infected, HIV-exposed-uninfected, and HIV-unexposed Children. Clin Infect Dis. 2019 Aug 1;69(4):687-696. doi: 10.1093/cid/ciy964.
• Madhi SA, Izu A, Nunes MC, Violari A, Cotton MF, Jean-Philippe P, Klugman KP, von Gottberg A, van Niekerk N, Adrian PV; CIPRA 4 team. Longitudinal study on Streptococcus pneumoniae, Haemophilus influenzae and Staphylococcus aureus nasopharyngeal colonization in HIV-infected and -uninfected infants vaccinated with pneumococcal conjugate vaccine. Vaccine. 2015 May 28;33(23):2662-9. doi: 10.1016/j.vaccine.2015.04.024. Epub 2015 Apr 21.

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