Safety, reactogenicity, and immunogenicity of human rotavirus vaccine RIX4414 in human immunodeficiency virus-positive infants in South Africa

Pediatric Infectious Disease Journal

Volumn 30, Issue 2, 2011, Pages 125-130

  Steele, Andrew Duncan ^a,b   Madhi, Shabir Ahmed ^c   Louw, Cheryl Emily ^d   Bos, Pieter ^b   Tumbo, John M ^b   Werner, Corne M ^d   Bicer, Ceyhun ^e   De Vos, Beatrice ^f   Delem, Andree ^f   Han, Htay Htay ^f  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

^b UNIVERSITY OF LIMPOPO   (South Africa)

^c UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^d MCR (Madibeng Centre for Research)   (South Africa)

^e BICER Consulting and Research   (Belgium)

^f GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

Author keywords

HIV positive infants; RIX4414; rotavirus vaccine; South Africa

Indexed keywords

IMMUNOGLOBULIN A ANTIBODY; PLACEBO; ROTAVIRUS VACCINE; VIRUS ANTIBODY;

ARTICLE; BRONCHOPNEUMONIA; CD4+ T LYMPHOCYTE; COUGHING; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; FECES ANALYSIS; FEMALE; FEVER; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE DEFICIENCY; IMMUNOGENICITY; INFANT; IRRITABILITY; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; ROTAVIRUS; ROTAVIRUS INFECTION; SEROCONVERSION; SIDE EFFECT; SOUTH AFRICA; THRUSH; VIRUS LOAD; VOMITING;

EID: 79551583117     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e3181f42db9     Document Type: Article

References (28)

1. Reither K, Ignatius R, Weitzel T, et al. Acute childhood diarrhea in northern Ghana: epidemiological, clinical and microbiological characteristics. BMC Infect Dis. 2007;7:104.
2. Boscho-Pinto C, Velebit L, Shibuya K. Estimating child mortality due to diarrhea in developing countries: a meta-analysis review. Bull World Health Organ. 2008;86:710-717.
3. Bryce J, Boschi-Pinto C, Shibuya K, et al. the WHO Child Health Epidemiology Reference Group. WHO estimates of the causes of death in children. Lancet. 2005;365:1147-1152.
4. Centers for Disease Control and Prevention. Rotavirus Surveillance- Worldwide, 2001-2008. Morb Mortal Wkly Rep. 2008;57:1255-1257.
5. Parashar UD, Burton A, Lanata C, et al. Global mortality associated with rotavirus disease among children in 2004. J Infect Dis. 2009;200:S9-S15.
6. Steele AD, Cunliffe NA, Tumbo JM, et al. A review of rotavirus infection in, and vaccination of, HIV-infected children. J Infect Dis. 2009;200:S57-S62.
7. WHO. Meeting of the immunization Strategic Advisory Group of Experts, April 2009- conclusions and recommendations. Wkly Epidemiol Rec. 2009;84:220-235.
8. Cunliffe N, Gondwe J, Kirkwood C, et al. Effect of concomitant HIV infection on presentation and outcome of rotavirus gastroenteritis in Malaw-ian children. Lancet. 2001;358:550-555.
9. Jere C, Cunliffe NA, Hoffman IF, et al. Plasma HIV burden in Malawian children co-infected with rotavirus. AIDS. 2001;15:1439-1442.
10. WHO. Guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines (oral). World Health Organ Tech Rep Ser. 2007; 941:133-188.
11. Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomized, double-blind controlled study. Lancet. 2007; 370:1757-1763.
12. Linhares AC, Velázquez FR, Schael IP, et al. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomized, double-blind, placebo-controlled phase III study. Lancet. 2008;371:1181-1189.
13. Ruiz-Palacios GM, Schael IP, Velázquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006;354:11-22.
14. Madhi SA, Cunliffe NA, Steele AD, et al. Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med. 2010;362:289-298.
15. Steele AD, De Vos B, Tumbo J, et al. Co-administration study in South African infants of a new live-attenuated oral rotavirus vaccine (RIX4414) and poliovi-rus vaccines. Vaccine. In press. doi: 10.1016/j.vaccine.2008.08.034.
16. Steele AD, Tumbo J, Reynders J, et al. Comparison of 2 different regimens of reactogenicity, safety and immunogenicity of the live attenuated oral rotavirus vaccine RIX4414 co-administered with oral polio vaccine in South African infants. J Infect Dis. 2010;202:S93-S100.
17. Steele AD, Tumbo J, Armah G, et al. Concomitant administration of a live attenuated oral rotavirus vaccine (Rix4414) with poliovirus vaccines in African infants. In: The annual Meeting of the European Society of Paediatric Infectious Diseases; May 18-20, 2005; Valencia, Spain.
18. World Health Organization. Interim WHO clinical staging of HIV/AIDS and HIV/AIDS case definitions for surveillance. African region. WHO/ HIV/2005.02. Geneva: World Health Organization.
19. Bernstein DI, Smith VE, Sherwood JR, et al. Safety and immunogenicity of a live attenuated human rotavirus 89-12 vaccine. Vaccine. 1998;16:381-387.
20. Bernstein DI, Sack DA, Rothstein E, et al. Efficacy of live attenuated human rotavirus vaccine 89-12 in infants: a randomized placebo-controlled trial. Lancet. 1999;354:287-290.
21. Gouvea V, Glass RI, Woods P, et al. Polymerase chain reaction amplification and typing of rotavirus nucleic acid from stool specimens. J Clin Microbiol. 1990;28:276-282.
22. van Doorn LJ, Kleter B, Hoefnagel E, et al. Detection and genotyping of human rotavirus VP4 and VP7 genes by reverse transcriptase PCR and reverse hybridization. J Clin Microbiol. 2009;47:2704-2712.
23. Glencross D, Scott LE, Jani IV, et al. CD45-assisted PanLeucogating for accurate, cost-effective dual-platform CD4+ T-cell enumeration. Cytometry. 2002;50:69-77.
24. Centers for Disease Control and Prevention 1994 Revised classification system for human immunodeficiency virus infection in children less than 13 years of age; Official authorized addenda: human immunodeficiency virus infection codes and official guidelines for coding and reporting ICD-9-CM. Morb Mortal Wkly Rep 1994; 43: 1-7.
25. UNAIDS. Status of the global HIV epidemic. 2008 Report on the global AIDS epidemic. Geneva: UNAIDS; 2008.
26. Moss WJ, Clements CJ, Halsey NA. Immunization of children at risk of infection with human immunodeficiency virus. Bull World Health Organ. 2003;81:61-70.
27. Phua KB, Quak SH, Lee BW, et al. Evaluation of RIX4414, a live, attenuated rotavirus vaccine, in a randomized, double-blind, placebo-controlled phase 2 trial involving 2464 Singaporean infants. J Infect Dis. 2005;192:S6-S16.
28. World Health Organization. Rotavirus vaccines. WHO position paper. Wkly Epidemiol Rec. 2007;82:285-296.