Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa.
Identifieur interne : 000845 ( PubMed/Corpus ); précédent : 000844; suivant : 000846Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa.
Auteurs : 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 R. Feikin ; John C. Victor ; Max Ciarlet ; Kathleen M. Neuzil ; A Duncan SteeleSource :
- Vaccine [ 1873-2518 ] ; 2012.
English descriptors
- KwdEn :
- Administration, Oral, Africa South of the Sahara (epidemiology), Double-Blind Method, Female, Gastroenteritis (epidemiology), Gastroenteritis (pathology), Gastroenteritis (prevention & control), Humans, Infant, Male, Placebos (administration & dosage), Rotavirus Infections (epidemiology), Rotavirus Infections (pathology), Rotavirus Infections (prevention & control), Rotavirus Vaccines (administration & dosage), Rotavirus Vaccines (immunology), Severity of Illness Index, Vaccination (methods), Vaccines, Attenuated (administration & dosage), Vaccines, Attenuated (immunology).
- MESH :
- chemical , administration & dosage : Placebos, Rotavirus Vaccines, Vaccines, Attenuated.
- geographic , epidemiology : Africa South of the Sahara.
- epidemiology : Gastroenteritis, Rotavirus Infections.
- chemical , immunology : Rotavirus Vaccines, Vaccines, Attenuated.
- methods : Vaccination.
- pathology : Gastroenteritis, Rotavirus Infections.
- prevention & control : Gastroenteritis, Rotavirus Infections.
- Administration, Oral, Double-Blind Method, Female, Humans, Infant, Male, Severity of Illness Index.
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.
DOI: 10.1016/j.vaccine.2012.01.022
PubMed: 22520141
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pubmed:22520141Le document en format XML
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Dallas</name></author><author><name sortKey="Lewis, Kristen D C" sort="Lewis, Kristen D C" uniqKey="Lewis K" first="Kristen D C" last="Lewis">Kristen D C. Lewis</name></author><author><name sortKey="Sow, Samba O" sort="Sow, Samba O" uniqKey="Sow S" first="Samba O" last="Sow">Samba O. Sow</name></author><author><name sortKey="Rivers, Stephen B" sort="Rivers, Stephen B" uniqKey="Rivers S" first="Stephen B" last="Rivers">Stephen B. Rivers</name></author><author><name sortKey="Levine, Myron M" sort="Levine, Myron M" uniqKey="Levine M" first="Myron M" last="Levine">Myron M. Levine</name></author><author><name sortKey="Laserson, Kayla F" sort="Laserson, Kayla F" uniqKey="Laserson K" first="Kayla F" last="Laserson">Kayla F. Laserson</name></author><author><name sortKey="Feikin, Daniel R" sort="Feikin, Daniel R" uniqKey="Feikin D" first="Daniel R" last="Feikin">Daniel R. 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Neuzil</name></author><author><name sortKey="Steele, A Duncan" sort="Steele, A Duncan" uniqKey="Steele A" first="A Duncan" last="Steele">A Duncan Steele</name></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2012" type="published">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Africa South of the Sahara (epidemiology)</term><term>Double-Blind Method</term><term>Female</term><term>Gastroenteritis (epidemiology)</term><term>Gastroenteritis (pathology)</term><term>Gastroenteritis (prevention & control)</term><term>Humans</term><term>Infant</term><term>Male</term><term>Placebos (administration & dosage)</term><term>Rotavirus Infections (epidemiology)</term><term>Rotavirus Infections (pathology)</term><term>Rotavirus Infections (prevention & control)</term><term>Rotavirus Vaccines (administration & dosage)</term><term>Rotavirus Vaccines (immunology)</term><term>Severity of Illness Index</term><term>Vaccination (methods)</term><term>Vaccines, Attenuated (administration & dosage)</term><term>Vaccines, Attenuated (immunology)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Placebos</term><term>Rotavirus Vaccines</term><term>Vaccines, Attenuated</term></keywords><keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>Africa South of the Sahara</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Gastroenteritis</term><term>Rotavirus Infections</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Rotavirus Vaccines</term><term>Vaccines, Attenuated</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Vaccination</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Gastroenteritis</term><term>Rotavirus Infections</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Gastroenteritis</term><term>Rotavirus Infections</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Infant</term><term>Male</term><term>Severity of Illness Index</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">22520141</PMID><DateCreated><Year>2012</Year><Month>04</Month><Day>23</Day></DateCreated><DateCompleted><Year>2012</Year><Month>08</Month><Day>08</Day></DateCompleted><DateRevised><Year>2012</Year><Month>04</Month><Day>23</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>30 Suppl 1</Volume><PubDate><Year>2012</Year><Month>Apr</Month><Day>27</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa.</ArticleTitle><Pagination><MedlinePgn>A79-85</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2012.01.022</ELocationID><Abstract><AbstractText>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.</AbstractText><CopyrightInformation>Copyright © 2012 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Tapia</LastName><ForeName>Milagritos D</ForeName><Initials>MD</Initials><AffiliationInfo><Affiliation>Centre pour le Développement des Vaccins, Bamako, Mali. mtapia@medicine.umaryland.edu</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Armah</LastName><ForeName>George</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Breiman</LastName><ForeName>Robert F</ForeName><Initials>RF</Initials></Author><Author ValidYN="Y"><LastName>Dallas</LastName><ForeName>Michael J</ForeName><Initials>MJ</Initials></Author><Author ValidYN="Y"><LastName>Lewis</LastName><ForeName>Kristen D C</ForeName><Initials>KD</Initials></Author><Author ValidYN="Y"><LastName>Sow</LastName><ForeName>Samba O</ForeName><Initials>SO</Initials></Author><Author ValidYN="Y"><LastName>Rivers</LastName><ForeName>Stephen B</ForeName><Initials>SB</Initials></Author><Author ValidYN="Y"><LastName>Levine</LastName><ForeName>Myron M</ForeName><Initials>MM</Initials></Author><Author ValidYN="Y"><LastName>Laserson</LastName><ForeName>Kayla F</ForeName><Initials>KF</Initials></Author><Author ValidYN="Y"><LastName>Feikin</LastName><ForeName>Daniel R</ForeName><Initials>DR</Initials></Author><Author ValidYN="Y"><LastName>Victor</LastName><ForeName>John C</ForeName><Initials>JC</Initials></Author><Author ValidYN="Y"><LastName>Ciarlet</LastName><ForeName>Max</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Neuzil</LastName><ForeName>Kathleen M</ForeName><Initials>KM</Initials></Author><Author ValidYN="Y"><LastName>Steele</LastName><ForeName>A Duncan</ForeName><Initials>AD</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Vaccine</MedlineTA><NlmUniqueID>8406899</NlmUniqueID><ISSNLinking>0264-410X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010919">Placebos</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C492535">RotaTeq</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D022243">Rotavirus Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D014613">Vaccines, Attenuated</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000284" MajorTopicYN="N">Administration, Oral</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017954" MajorTopicYN="N" Type="Geographic">Africa South of the Sahara</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005759" MajorTopicYN="N">Gastroenteritis</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000473" MajorTopicYN="Y">pathology</QualifierName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010919" MajorTopicYN="N">Placebos</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012400" MajorTopicYN="N">Rotavirus Infections</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000473" MajorTopicYN="Y">pathology</QualifierName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D022243" MajorTopicYN="N">Rotavirus Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012720" MajorTopicYN="N">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014611" MajorTopicYN="N">Vaccination</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D014613" MajorTopicYN="N">Vaccines, Attenuated</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2011</Year><Month>08</Month><Day>12</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2011</Year><Month>12</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2012</Year><Month>01</Month><Day>06</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2012</Year><Month>4</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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