Reappraisal of the Peruvian and Brazilian lower titer tetravalent rhesus-human reassortant rotavirus vaccine efficacy trials: Analysis by severity of diarrhea

Pediatric Infectious Disease Journal

Volumn 18, Issue 11, 1999, Pages 1001-1006

  Linhares, Alexandre C ^a   Lanata, Claudio F ^b   Hausdorff, William P ^c   Gabbay, Yvone B ^a   Black, Robert E ^d  

^a INSTITUTO EVANDRO CHAGAS   (Brazil)

^b INSTITUTO DE INVESTIGACIÓN NUTRICIONAL   (Peru)

^c Wyeth Lederle Vaccines   (United States)

^d JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Brazil; Efficacy; Lower titer; Peru; Rhesus human reassortant rotavirus; Rotavirus vaccine; Severity of diarrhea

Indexed keywords

VIRUS VACCINE;

ANIMAL; ARTICLE; BRAZIL; CHILD; CLASSIFICATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; GASTROENTERITIS; GENETIC REASSORTMENT; HOSPITALIZATION; HUMAN; IMMUNOLOGY; MACACA; PERU; RANDOMIZED CONTROLLED TRIAL; REFERENCE VALUE; REPRODUCIBILITY; VIROLOGY; VIRUS INFECTION;

ANIMALS; BRAZIL; CHILD; DIARRHEA; DOSE-RESPONSE RELATIONSHIP, DRUG; GASTROENTERITIS; HUMANS; MACACA MULATTA; PERU; REASSORTANT VIRUSES; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; ROTAVIRUS INFECTIONS; SEVERITY OF ILLNESS INDEX; VIRAL VACCINES;

EID: 0033228550     PISSN: 08913668     EISSN: None     Source Type: Journal    
DOI: 10.1097/00006454-199911000-00013     Document Type: Article

References (28)

1. Kapikian AZ, Chanock RM, Rotaviruses. In: Fields BN, Knipe DM, Howley PM, eds. Fields' virology. Philadelphia: Lippincott-Raven, 1996:1657-708.
2. De Zoysa I, Feachem RV. Interventions for the control of diarrhoeal diseases among rotavirus and cholera immunization. Bull WHO 1985;63:569-83.
3. Institute of Medicine. The prospects for immunizing against rotavirus. In: New vaccine developments: establishing priorities - diseases of importance in developing countries. Washington, DC: National Academy Press, 1986:308-18.
4. Glass RI, Gentsch J, Smith JC. Rotavirus vaccine: success by reassortment? Science 1994;265:1389-90.
5. Midthun K, Kapikian AZ. Rotavirus vaccines: an overview. Clin Microbiol Rev 1996;9:423-34.
6. Vesikari T. Rotavirus vaccines against diarrhoeal disease. Lancet 1997;350:1538-41.
7. Kapikian AZ, Hoshino Y, Chanock RM, Pérez-Schael I. Efficacy of quadrivalent rhesus rotavirus-based human rotavirus vaccine aimed at preventing severe rotavirus diarrhea in infants and young children. J Infect Dis 1996;174(Suppl 1):S65-72.
8. Midthun K, Greenberg HB, Hoshino Y, Kapikian AZ, Wyatt RG, Chanock RM. Reassortant rotaviruses as potential live rotavirus candidate vaccine. J Virol 1985;53:949-54.
9. Lanata CF, Midthun K, Black RE, et al. Safety, immunogenicity, and protective efficacy of one and three doses of the tetravalent rhesus rotavirus vaccine in infants in Peru. J Infect Dis 1996;174:268-75.
10. Linhares AC, Gabbay YB, Mascarenhas JDP, et al. Immunogenicity, safety and efficacy of rhesus-human, reassortant rotavirus vaccine in Belém, Brazil. Bull WHO 1996;74:491-500.
11. Bernstein DI, Glass RI, Rodgers G, Davidson BL, Sack AD. Evaluation of rhesus rotavirus monovalent and tetravalent reassortant vaccines in US children. JAMA 1995;273:1191-3.
12. Joensuu J, Koskenniemi E, Pang XL, Vesikari T. Randomised placebo-controlled trial of rhesus-human reassortant rotavirus vaccine for prevention of severe rotavirus gastroenteritis. Lancet 1997;350:1205-9.
13. Pérez-Schael I, Guntiñas MJ, Pérez M, et al. Efficacy of the rhesus rotavirus-based quadrivalent vaccine in young children in Venezuela. N Engl J Med 1997;337:1181-7.
14. Rennels MB, Wasserman SS, Glass RI, Keane V. Comparison of immunogenicity and efficacy of rhesus rotavirus reassortant vaccines in breast-fed and non-breast-fed children. Pediatrics 1995;96:1132-6.
15. Santosham M, Moulton LW, Reid R, et al. Efficacy and safety of high-dose rhesus- human reassortant rotavirus vaccine in native American populations. J Pediatr 1997;131:632-8.
16. Glass RI, Bresee JS, Parashar U, Miller M, Gentsch JR. Rotavirus vaccines at the threshold. Nat Med 1997;3:1324-5.
17. Foster RH, Wagstaff AJ. Tetravalent human-rhesus reassortant rotavirus vaccine: a review of its immunogenicity, tolerability and protective efficacy against paediatric rotavirus gastroenteritis. Biodrugs 1998;9:155-78.
18. Flores J, Pérez-Schael I, Gonzalez M, et al. Protection against severe rotavirus diarrhoea by rhesus rotavirus vaccine in Venezuelan infants. Lancet 1987;1:882-4.
19. Ruuska T, Vesikari T. Rotavirus disease in Finnish children: use of numerical scores for clinical diarrhoeal episodes. Scand J Infect Dis 1990;22:259-67.
20. Lanata CF, Black RE. Guideline for design, conduct and analysis of community-based rotavirus vaccine field trials: Scientific Series, Publication 1. Lima, Peru: Instituto de Investigación Nutricional, 1989.
21. Linhares AC, Gabbay YB, Freitas RB, Travassos da Rosa ES, Mascarenhas JDP, Loureiro ECB. Longitudinal study of rotavirus infections among children from Belém, Brazil. Epidem Infect 1989;102:129-44.
22. Velázquez FR, Matson DO, Calva JJ, et al. Rotavirus infection in infants as protection against subsequent infections. N Engl J Med 1996;335:1022-8.
23. Perez-Schael I, Blanco M, Garcia D, et al. Evaluation of the rhesus rotavirus-based quadrivalent and the M37 rotavirus vaccine candidates. J Med Virol 1994;12:330-7.
24. Flores J, Perez-Schael I, Blanco M, et al. Comparison of reactogenicity of M37 rotavirus vaccine and rhesus-rotavirus based quadrivalent vaccine. Lancet 1990;336:330-4.
25. Perez-Schael I, Blanco M, Vilar M, et al. Clinical studies of a quadrivalent rotavirus vaccine in Venezuelan infants. J Clin Microbiol 1990;28:553-8.
26. Simasathien S, Migasena S, Samakoses R, et al. Vaccination of Thai infants with rhesus-human reassortant tetravalent oral rotavirus vaccine. Pediatr Infect Dis J 1994;13:590-6.
27. Perez-Schael I, Garcia D, Gonzalez M, et al. Prospective study of diarrheal diseases in Venezuelan children to evaluate the efficacy of rhesus rotavirus vaccine. J Med Virol 1990;30:219-29.
28. Richardson S, Grimwood, K, Gorrell R, Palombo E, Barnes G, Bishop R. Extended excretion of rotavirus after severe diarrhoea in young children. Lancet 1998;351:1844-8.