Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa

Milagritos D. Tapia, George Armah, Robert F. Breiman, Michael J. Dallas, Kristen D C Lewis, Samba O. Sow, Stephen B. Rivers, Myron M. Levine, Kayla F. Laserson, Daniel Feikin, John C. Victor, Max Ciarlet, Kathleen M. Neuzil, A. Duncan Steele

Research output: Contribution to journalArticle

Abstract

The efficacy of the pentavalent rotavirus vaccine (PRV), RotaTeq®, was evaluated in a double-blind, placebo-controlled, multicenter Phase III clinical trial conducted (April 2007-March 2009) in 3 low-income countries in Africa: Ghana, Kenya, and Mali. In total, 5468 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age; concomitant administration with routine EPI vaccines, including OPV, was allowed. HIV-infected infants were not excluded. The primary endpoint, vaccine efficacy (VE) against severe-rotavirus gastroenteritis (RVGE), as measured by Vesikari scoring system (VSS, score ≥11), from ≥14 days following Dose 3 through a follow-up period of nearly 2 years in the combined 3 African countries, and secondary endpoints by total follow-up period have been previously reported. In this study, we report post hoc subgroup analyses on secondary endpoints of public health importance. VE against RVGE of any severity was 49.2% (95%CI: 29.9, 63.5) through the first year of life and 30.5% (95%CI: 16.7, 42.2) through the complete follow-up period. VE against severe-gastroenteritis of any etiology was 21.5% (95%CI: <0, 38.4) through the first year of life and 10.6% (95%CI: <0, 24.9) through the complete follow-up period. Through the complete follow-up period, VE against severe-RVGE caused by (i) vaccine-contained G and P types (G1-G4, P1A[8]), (ii) non-vaccine G types (G8, G9, G10), and (iii) non-vaccine P types (P1B[4], P2A[6]) was 34.0% (95%CI:11.2, 51.2), 81.8% (95%CI:16.5, 98.0) and 40.7% (95%CI:8.4, 62.1), respectively. There was a trend towards higher VE with higher disease severity, although in some cases the numbers were small. In African countries with high under-5 mortality rates, PRV significantly reduced RVGE through nearly 2 years of follow-up; more modest reductions were observed against gastroenteritis of any etiology. PRV provides protection against severe-RVGE caused by diverse rotavirus genotypes, including those not contained in the vaccine.

Original languageEnglish (US)
JournalVaccine
Volume30
Issue numberSUPPL. 1
DOIs
StatePublished - Apr 27 2012
Externally publishedYes

Fingerprint

Rotavirus Vaccines
Africa South of the Sahara
gastroenteritis
Rotavirus
Gastroenteritis
Sub-Saharan Africa
endpoints
Vaccines
vaccines
Placebos
Mali
Phase III Clinical Trials
Ghana
placebos
etiology
Kenya
Public Health
Genotype
HIV
dosage

Keywords

  • G genotype
  • Gastroenteritis
  • P genotype
  • Rotavirus
  • Vaccine efficacy

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Tapia, M. D., Armah, G., Breiman, R. F., Dallas, M. J., Lewis, K. D. C., Sow, S. O., ... Steele, A. D. (2012). Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa. Vaccine, 30(SUPPL. 1). https://doi.org/10.1016/j.vaccine.2012.01.022

Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa. / Tapia, Milagritos D.; Armah, George; Breiman, Robert F.; Dallas, Michael J.; Lewis, Kristen D C; Sow, Samba O.; Rivers, Stephen B.; Levine, Myron M.; Laserson, Kayla F.; Feikin, Daniel; Victor, John C.; Ciarlet, Max; Neuzil, Kathleen M.; Steele, A. Duncan.

In: Vaccine, Vol. 30, No. SUPPL. 1, 27.04.2012.

Research output: Contribution to journalArticle

Tapia, MD, Armah, G, Breiman, RF, Dallas, MJ, Lewis, KDC, Sow, SO, Rivers, SB, Levine, MM, Laserson, KF, Feikin, D, Victor, JC, Ciarlet, M, Neuzil, KM & Steele, AD 2012, 'Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa', Vaccine, vol. 30, no. SUPPL. 1. https://doi.org/10.1016/j.vaccine.2012.01.022
Tapia, Milagritos D. ; Armah, George ; Breiman, Robert F. ; Dallas, Michael J. ; Lewis, Kristen D C ; Sow, Samba O. ; Rivers, Stephen B. ; Levine, Myron M. ; Laserson, Kayla F. ; Feikin, Daniel ; Victor, John C. ; Ciarlet, Max ; Neuzil, Kathleen M. ; Steele, A. Duncan. / Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa. In: Vaccine. 2012 ; Vol. 30, No. SUPPL. 1.
@article{a14302b264e24adb8b9ede236ea17e8a,
title = "Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa",
abstract = "The efficacy of the pentavalent rotavirus vaccine (PRV), RotaTeq{\circledR}, was evaluated in a double-blind, placebo-controlled, multicenter Phase III clinical trial conducted (April 2007-March 2009) in 3 low-income countries in Africa: Ghana, Kenya, and Mali. In total, 5468 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age; concomitant administration with routine EPI vaccines, including OPV, was allowed. HIV-infected infants were not excluded. The primary endpoint, vaccine efficacy (VE) against severe-rotavirus gastroenteritis (RVGE), as measured by Vesikari scoring system (VSS, score ≥11), from ≥14 days following Dose 3 through a follow-up period of nearly 2 years in the combined 3 African countries, and secondary endpoints by total follow-up period have been previously reported. In this study, we report post hoc subgroup analyses on secondary endpoints of public health importance. VE against RVGE of any severity was 49.2{\%} (95{\%}CI: 29.9, 63.5) through the first year of life and 30.5{\%} (95{\%}CI: 16.7, 42.2) through the complete follow-up period. VE against severe-gastroenteritis of any etiology was 21.5{\%} (95{\%}CI: <0, 38.4) through the first year of life and 10.6{\%} (95{\%}CI: <0, 24.9) through the complete follow-up period. Through the complete follow-up period, VE against severe-RVGE caused by (i) vaccine-contained G and P types (G1-G4, P1A[8]), (ii) non-vaccine G types (G8, G9, G10), and (iii) non-vaccine P types (P1B[4], P2A[6]) was 34.0{\%} (95{\%}CI:11.2, 51.2), 81.8{\%} (95{\%}CI:16.5, 98.0) and 40.7{\%} (95{\%}CI:8.4, 62.1), respectively. There was a trend towards higher VE with higher disease severity, although in some cases the numbers were small. In African countries with high under-5 mortality rates, PRV significantly reduced RVGE through nearly 2 years of follow-up; more modest reductions were observed against gastroenteritis of any etiology. PRV provides protection against severe-RVGE caused by diverse rotavirus genotypes, including those not contained in the vaccine.",
keywords = "G genotype, Gastroenteritis, P genotype, Rotavirus, Vaccine efficacy",
author = "Tapia, {Milagritos D.} and George Armah and Breiman, {Robert F.} and Dallas, {Michael J.} and Lewis, {Kristen D C} and Sow, {Samba O.} and Rivers, {Stephen B.} and Levine, {Myron M.} and Laserson, {Kayla F.} and Daniel Feikin and Victor, {John C.} and Max Ciarlet and Neuzil, {Kathleen M.} and Steele, {A. Duncan}",
year = "2012",
month = "4",
day = "27",
doi = "10.1016/j.vaccine.2012.01.022",
language = "English (US)",
volume = "30",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "SUPPL. 1",

}

TY - JOUR

T1 - Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa

AU - Tapia, Milagritos D.

AU - Armah, George

AU - Breiman, Robert F.

AU - Dallas, Michael J.

AU - Lewis, Kristen D C

AU - Sow, Samba O.

AU - Rivers, Stephen B.

AU - Levine, Myron M.

AU - Laserson, Kayla F.

AU - Feikin, Daniel

AU - Victor, John C.

AU - Ciarlet, Max

AU - Neuzil, Kathleen M.

AU - Steele, A. Duncan

PY - 2012/4/27

Y1 - 2012/4/27

N2 - The efficacy of the pentavalent rotavirus vaccine (PRV), RotaTeq®, was evaluated in a double-blind, placebo-controlled, multicenter Phase III clinical trial conducted (April 2007-March 2009) in 3 low-income countries in Africa: Ghana, Kenya, and Mali. In total, 5468 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age; concomitant administration with routine EPI vaccines, including OPV, was allowed. HIV-infected infants were not excluded. The primary endpoint, vaccine efficacy (VE) against severe-rotavirus gastroenteritis (RVGE), as measured by Vesikari scoring system (VSS, score ≥11), from ≥14 days following Dose 3 through a follow-up period of nearly 2 years in the combined 3 African countries, and secondary endpoints by total follow-up period have been previously reported. In this study, we report post hoc subgroup analyses on secondary endpoints of public health importance. VE against RVGE of any severity was 49.2% (95%CI: 29.9, 63.5) through the first year of life and 30.5% (95%CI: 16.7, 42.2) through the complete follow-up period. VE against severe-gastroenteritis of any etiology was 21.5% (95%CI: <0, 38.4) through the first year of life and 10.6% (95%CI: <0, 24.9) through the complete follow-up period. Through the complete follow-up period, VE against severe-RVGE caused by (i) vaccine-contained G and P types (G1-G4, P1A[8]), (ii) non-vaccine G types (G8, G9, G10), and (iii) non-vaccine P types (P1B[4], P2A[6]) was 34.0% (95%CI:11.2, 51.2), 81.8% (95%CI:16.5, 98.0) and 40.7% (95%CI:8.4, 62.1), respectively. There was a trend towards higher VE with higher disease severity, although in some cases the numbers were small. In African countries with high under-5 mortality rates, PRV significantly reduced RVGE through nearly 2 years of follow-up; more modest reductions were observed against gastroenteritis of any etiology. PRV provides protection against severe-RVGE caused by diverse rotavirus genotypes, including those not contained in the vaccine.

AB - The efficacy of the pentavalent rotavirus vaccine (PRV), RotaTeq®, was evaluated in a double-blind, placebo-controlled, multicenter Phase III clinical trial conducted (April 2007-March 2009) in 3 low-income countries in Africa: Ghana, Kenya, and Mali. In total, 5468 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age; concomitant administration with routine EPI vaccines, including OPV, was allowed. HIV-infected infants were not excluded. The primary endpoint, vaccine efficacy (VE) against severe-rotavirus gastroenteritis (RVGE), as measured by Vesikari scoring system (VSS, score ≥11), from ≥14 days following Dose 3 through a follow-up period of nearly 2 years in the combined 3 African countries, and secondary endpoints by total follow-up period have been previously reported. In this study, we report post hoc subgroup analyses on secondary endpoints of public health importance. VE against RVGE of any severity was 49.2% (95%CI: 29.9, 63.5) through the first year of life and 30.5% (95%CI: 16.7, 42.2) through the complete follow-up period. VE against severe-gastroenteritis of any etiology was 21.5% (95%CI: <0, 38.4) through the first year of life and 10.6% (95%CI: <0, 24.9) through the complete follow-up period. Through the complete follow-up period, VE against severe-RVGE caused by (i) vaccine-contained G and P types (G1-G4, P1A[8]), (ii) non-vaccine G types (G8, G9, G10), and (iii) non-vaccine P types (P1B[4], P2A[6]) was 34.0% (95%CI:11.2, 51.2), 81.8% (95%CI:16.5, 98.0) and 40.7% (95%CI:8.4, 62.1), respectively. There was a trend towards higher VE with higher disease severity, although in some cases the numbers were small. In African countries with high under-5 mortality rates, PRV significantly reduced RVGE through nearly 2 years of follow-up; more modest reductions were observed against gastroenteritis of any etiology. PRV provides protection against severe-RVGE caused by diverse rotavirus genotypes, including those not contained in the vaccine.

KW - G genotype

KW - Gastroenteritis

KW - P genotype

KW - Rotavirus

KW - Vaccine efficacy

UR - http://www.scopus.com/inward/record.url?scp=84860009433&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84860009433&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2012.01.022

DO - 10.1016/j.vaccine.2012.01.022

M3 - Article

VL - 30

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - SUPPL. 1

ER -