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Efficacy and immunogenicity of two or three dose rotavirus-vaccine regimen in South African children over two consecutive rotavirus-seasons: a randomized, double-blind, placebo-controlled trial.
Vaccine. 2012 Apr 27; 30 Suppl 1:A44-51.V

Abstract

BACKGROUND

Human rotavirus vaccine (HRV; i.e., Rotarix) reduced the incidence of severe rotavirus gastroenteritis (RVGE) by 77% (95% Confidence interval: 56-88%) during the first year of life in South Africa. Persistence of HRV-derived protection against RVGE during subsequent rotavirus seasons, although evident in industrialized settings, remains to be established in African settings. This study reports on the efficacy of HRV against severe RVGE over two consecutive rotavirus seasons in South African children.

METHODS

A prospective, double-blind, placebo controlled multi-centered trial in South Africa and Malawi randomly assigned infants in a 1:1:1 ratio to receive either two (10 and 14 weeks; HRV_2D) or three (6, 10 and 14 weeks; HRV_3D) doses of HRV or placebo. The primary analysis involved pooling of HRV_2D and HRV_3D arms. Episodes of gastroenteritis caused by wild-type rotavirus were identified through active follow-up surveillance and graded by the Vesikari scale.

RESULTS

1339 infants (447 in the HRV_2D group, 447 in the HRV_3D group and 445 in the placebo group) were enrolled in Year 2 of the study, including 1035 (77.3%) who were followed up over two consecutive rotavirus seasons (i.e., Cohort 2 subjects). Rotarix was associated with ongoing protection against severe RVGE, preventing 2.5 episodes per 100 vaccinated children over two consecutive rotavirus seasons; vaccine efficacy: 59% (95% Confidence interval: 1-83%). An exploratory analysis indicated better immunogenicity (among Cohort 1 subjects) and a higher point-efficacy estimate over two seasons in the HRV_3D compared to HRV_2D arms of the study in Cohort 2 subjects.

CONCLUSION

Rotarix is associated with significant reductions in severe gastroenteritis episodes through 2 years of life among South African children. Further research is needed to determine the optimal dosing schedule of Rotarix in providing long-term protection against rotavirus illness in African children.

Authors+Show Affiliations

National Institute for Communicable Diseases, A Division of National Health Laboratory Services, Sandringham, South Africa. shabirm@nicd.ac.zaNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

22520136

Citation

Madhi, S A., et al. "Efficacy and Immunogenicity of Two or Three Dose Rotavirus-vaccine Regimen in South African Children Over Two Consecutive Rotavirus-seasons: a Randomized, Double-blind, Placebo-controlled Trial." Vaccine, vol. 30 Suppl 1, 2012, pp. A44-51.
Madhi SA, Kirsten M, Louw C, et al. Efficacy and immunogenicity of two or three dose rotavirus-vaccine regimen in South African children over two consecutive rotavirus-seasons: a randomized, double-blind, placebo-controlled trial. Vaccine. 2012;30 Suppl 1:A44-51.
Madhi, S. A., Kirsten, M., Louw, C., Bos, P., Aspinall, S., Bouckenooghe, A., Neuzil, K. M., & Steele, A. D. (2012). Efficacy and immunogenicity of two or three dose rotavirus-vaccine regimen in South African children over two consecutive rotavirus-seasons: a randomized, double-blind, placebo-controlled trial. Vaccine, 30 Suppl 1, A44-51. https://doi.org/10.1016/j.vaccine.2011.08.080
Madhi SA, et al. Efficacy and Immunogenicity of Two or Three Dose Rotavirus-vaccine Regimen in South African Children Over Two Consecutive Rotavirus-seasons: a Randomized, Double-blind, Placebo-controlled Trial. Vaccine. 2012 Apr 27;30 Suppl 1:A44-51. PubMed PMID: 22520136.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and immunogenicity of two or three dose rotavirus-vaccine regimen in South African children over two consecutive rotavirus-seasons: a randomized, double-blind, placebo-controlled trial. AU - Madhi,S A, AU - Kirsten,M, AU - Louw,C, AU - Bos,P, AU - Aspinall,S, AU - Bouckenooghe,A, AU - Neuzil,K M, AU - Steele,A D, PY - 2011/06/23/received PY - 2011/08/08/revised PY - 2011/08/15/accepted PY - 2012/4/24/entrez PY - 2012/5/2/pubmed PY - 2012/8/9/medline SP - A44 EP - 51 JF - Vaccine JO - Vaccine VL - 30 Suppl 1 N2 - BACKGROUND: Human rotavirus vaccine (HRV; i.e., Rotarix) reduced the incidence of severe rotavirus gastroenteritis (RVGE) by 77% (95% Confidence interval: 56-88%) during the first year of life in South Africa. Persistence of HRV-derived protection against RVGE during subsequent rotavirus seasons, although evident in industrialized settings, remains to be established in African settings. This study reports on the efficacy of HRV against severe RVGE over two consecutive rotavirus seasons in South African children. METHODS: A prospective, double-blind, placebo controlled multi-centered trial in South Africa and Malawi randomly assigned infants in a 1:1:1 ratio to receive either two (10 and 14 weeks; HRV_2D) or three (6, 10 and 14 weeks; HRV_3D) doses of HRV or placebo. The primary analysis involved pooling of HRV_2D and HRV_3D arms. Episodes of gastroenteritis caused by wild-type rotavirus were identified through active follow-up surveillance and graded by the Vesikari scale. RESULTS: 1339 infants (447 in the HRV_2D group, 447 in the HRV_3D group and 445 in the placebo group) were enrolled in Year 2 of the study, including 1035 (77.3%) who were followed up over two consecutive rotavirus seasons (i.e., Cohort 2 subjects). Rotarix was associated with ongoing protection against severe RVGE, preventing 2.5 episodes per 100 vaccinated children over two consecutive rotavirus seasons; vaccine efficacy: 59% (95% Confidence interval: 1-83%). An exploratory analysis indicated better immunogenicity (among Cohort 1 subjects) and a higher point-efficacy estimate over two seasons in the HRV_3D compared to HRV_2D arms of the study in Cohort 2 subjects. CONCLUSION: Rotarix is associated with significant reductions in severe gastroenteritis episodes through 2 years of life among South African children. Further research is needed to determine the optimal dosing schedule of Rotarix in providing long-term protection against rotavirus illness in African children. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22520136/Efficacy_and_immunogenicity_of_two_or_three_dose_rotavirus_vaccine_regimen_in_South_African_children_over_two_consecutive_rotavirus_seasons:_a_randomized_double_blind_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(11)01339-9 DB - PRIME DP - Unbound Medicine ER -