Immunogenicity and safety of a two‐dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation
Identifieur interne : 001E05 ( Main/Exploration ); précédent : 001E04; suivant : 001E06Immunogenicity and safety of a two‐dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation
Auteurs : J. Sasadeusz [Australie] ; H. M. Prince [Australie] ; A. Schwarer [Australie] ; J. Szer [Australie] ; A. Stork [Australie] ; H. L. Bock [Singapour] ; M. Povey [Belgique] ; O. Nicholson [États-Unis] ; B. L. Innis [États-Unis]Source :
- Transplant Infectious Disease [ 1398-2273 ] ; 2014-12.
Abstract
Background: Immunogenicity and safety of varicella vaccine (Varilrix™ [Oka‐RIT]; GlaxoSmithKline Vaccines) in adults who had undergone autologous hematopoietic stem cell transplantation (HSCT) were assessed (September 2003 to September 2007; NCT00792623). Methods: Two Oka‐RIT doses were given at 4.5 and 6.5 months post transplantation. Humoral immune responses were assessed using an immunofluorescence assay (anti‐varicella zoster virus [VZV] antibody; cutoff 1:4) after each vaccine dose. Solicited local (8 day) and general (43 day), unsolicited (until day 43) adverse events (AEs) after each vaccine dose and serious adverse events (SAEs) (until 17.5 months post dose 2) were recorded. Results: Of 45 patients, 19 were included in the according to protocol cohort for immunogenicity; 15 patients had pre‐ and post‐vaccination serum samples positive for anti‐VZV antibodies. Vaccine responses (anti‐VZV antibody titer ≥1:4 in seronegative patients, and ≥4‐fold increase in anti‐VZV antibody titer in seropositive patients) were elicited by only 2 patients 2 months post dose 1, and by a single patient 1.5 months post dose 2. Although no major safety signals were detected, any and Grade 3 solicited AEs that were causally related to vaccination were reported by 44.8% and 10.3% patients, respectively. During the 43‐day follow‐up period, 3 patients developed varicella‐like rash (1 vaccine‐type VZV). Beyond 43 days, herpes zoster was reported in 2 patients and wild‐type varicella infection in 2 patients (1 was breakthrough infection). Four non‐fatal SAEs were reported by patients and considered causally unrelated to vaccination. Conclusion: Oka‐RIT was poorly immunogenic but safe when given to adults up to 6 months post autologous HSCT, and alternative strategies are required to prevent VZV‐associated complications in these populations.
Url:
DOI: 10.1111/tid.12295
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 001341
- to stream Istex, to step Curation: 001341
- to stream Istex, to step Checkpoint: 000189
- to stream Main, to step Merge: 001E20
- to stream Main, to step Curation: 001E05
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Immunogenicity and safety of a two‐dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation</title><author><name sortKey="Sasadeusz, J" sort="Sasadeusz, J" uniqKey="Sasadeusz J" first="J." last="Sasadeusz">J. Sasadeusz</name></author><author><name sortKey="Prince, H M" sort="Prince, H M" uniqKey="Prince H" first="H. M." last="Prince">H. M. Prince</name></author><author><name sortKey="Schwarer, A" sort="Schwarer, A" uniqKey="Schwarer A" first="A." last="Schwarer">A. Schwarer</name></author><author><name sortKey="Szer, J" sort="Szer, J" uniqKey="Szer J" first="J." last="Szer">J. Szer</name></author><author><name sortKey="Stork, A" sort="Stork, A" uniqKey="Stork A" first="A." last="Stork">A. Stork</name></author><author><name sortKey="Bock, H L" sort="Bock, H L" uniqKey="Bock H" first="H. L." last="Bock">H. L. Bock</name></author><author><name sortKey="Povey, M" sort="Povey, M" uniqKey="Povey M" first="M." last="Povey">M. Povey</name></author><author><name sortKey="Nicholson, O" sort="Nicholson, O" uniqKey="Nicholson O" first="O." last="Nicholson">O. Nicholson</name></author><author><name sortKey="Innis, B L" sort="Innis, B L" uniqKey="Innis B" first="B. L." last="Innis">B. L. Innis</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:0D3B03BA41EE3A660444EC176EB323285E17868F</idno><date when="2014" year="2014">2014</date><idno type="doi">10.1111/tid.12295</idno><idno type="url">https://api.istex.fr/ark:/67375/WNG-Z1P8QKC2-H/fulltext.pdf</idno><idno type="wicri:Area/Istex/Corpus">001341</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001341</idno><idno type="wicri:Area/Istex/Curation">001341</idno><idno type="wicri:Area/Istex/Checkpoint">000189</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Checkpoint">000189</idno><idno type="wicri:doubleKey">1398-2273:2014:Sasadeusz J:immunogenicity:and:safety</idno><idno type="wicri:Area/Main/Merge">001E20</idno><idno type="wicri:Area/Main/Curation">001E05</idno><idno type="wicri:Area/Main/Exploration">001E05</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main">Immunogenicity and safety of a two‐dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation</title><author><name sortKey="Sasadeusz, J" sort="Sasadeusz, J" uniqKey="Sasadeusz J" first="J." last="Sasadeusz">J. Sasadeusz</name><affiliation wicri:level="3"><country xml:lang="fr">Australie</country><wicri:regionArea>Victorian Infectious Disease Service, Royal Melbourne Hospital, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation></affiliation><affiliation wicri:level="1"><country wicri:rule="url">Australie</country></affiliation></author><author><name sortKey="Prince, H M" sort="Prince, H M" uniqKey="Prince H" first="H. M." last="Prince">H. M. Prince</name><affiliation wicri:level="3"><country xml:lang="fr">Australie</country><wicri:regionArea>Haematology Department, Peter MacCallum Centre, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Medicine, University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Schwarer, A" sort="Schwarer, A" uniqKey="Schwarer A" first="A." last="Schwarer">A. Schwarer</name><affiliation wicri:level="3"><country xml:lang="fr">Australie</country><wicri:regionArea>Malignant Haematology and Stem Cell Transplant Service, The Alfred Hospital, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Szer, J" sort="Szer, J" uniqKey="Szer J" first="J." last="Szer">J. Szer</name><affiliation wicri:level="3"><country xml:lang="fr">Australie</country><wicri:regionArea>Victorian Infectious Disease Service, Royal Melbourne Hospital, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Medicine, University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Stork, A" sort="Stork, A" uniqKey="Stork A" first="A." last="Stork">A. Stork</name><affiliation wicri:level="3"><country xml:lang="fr">Australie</country><wicri:regionArea>Medical Department, Ipsen Pty Ltd, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="3"><country xml:lang="fr">Australie</country><wicri:regionArea>Current Address: Clinical Research and Development, GlaxoSmithKline Pty Ltd, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Bock, H L" sort="Bock, H L" uniqKey="Bock H" first="H. L." last="Bock">H. L. Bock</name><affiliation wicri:level="1"><country xml:lang="fr">Singapour</country><wicri:regionArea>Development, Novartis Vaccines</wicri:regionArea><wicri:noRegion>Novartis Vaccines</wicri:noRegion></affiliation><affiliation wicri:level="1"><country xml:lang="fr">Singapour</country><wicri:regionArea>Current Address: Clinical R&D and Medical Affairs, GlaxoSmithKline Vaccines</wicri:regionArea><wicri:noRegion>GlaxoSmithKline Vaccines</wicri:noRegion></affiliation></author><author><name sortKey="Povey, M" sort="Povey, M" uniqKey="Povey M" first="M." last="Povey">M. Povey</name><affiliation wicri:level="1"><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Statistics, GlaxoSmithKline Vaccines, Wavre</wicri:regionArea><wicri:noRegion>Wavre</wicri:noRegion></affiliation></author><author><name sortKey="Nicholson, O" sort="Nicholson, O" uniqKey="Nicholson O" first="O." last="Nicholson">O. Nicholson</name><affiliation wicri:level="1"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Vaccine Discovery and Development, GlaxoSmithKline Vaccines, Pennsylvania, King of Prussia</wicri:regionArea><wicri:noRegion>King of Prussia</wicri:noRegion></affiliation></author><author><name sortKey="Innis, B L" sort="Innis, B L" uniqKey="Innis B" first="B. L." last="Innis">B. L. Innis</name><affiliation wicri:level="1"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Vaccine Discovery and Development, GlaxoSmithKline Vaccines, Pennsylvania, King of Prussia</wicri:regionArea><wicri:noRegion>King of Prussia</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Transplant Infectious Disease</title><title level="j" type="alt">TRANSPLANT INFECTIOUS DISEASE</title><idno type="ISSN">1398-2273</idno><idno type="eISSN">1399-3062</idno><imprint><biblScope unit="vol">16</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="1024">1024</biblScope><biblScope unit="page" to="1031">1031</biblScope><biblScope unit="page-count">8</biblScope><date type="published" when="2014-12">2014-12</date></imprint><idno type="ISSN">1398-2273</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1398-2273</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">Background: Immunogenicity and safety of varicella vaccine (Varilrix™ [Oka‐RIT]; GlaxoSmithKline Vaccines) in adults who had undergone autologous hematopoietic stem cell transplantation (HSCT) were assessed (September 2003 to September 2007; NCT00792623). Methods: Two Oka‐RIT doses were given at 4.5 and 6.5 months post transplantation. Humoral immune responses were assessed using an immunofluorescence assay (anti‐varicella zoster virus [VZV] antibody; cutoff 1:4) after each vaccine dose. Solicited local (8 day) and general (43 day), unsolicited (until day 43) adverse events (AEs) after each vaccine dose and serious adverse events (SAEs) (until 17.5 months post dose 2) were recorded. Results: Of 45 patients, 19 were included in the according to protocol cohort for immunogenicity; 15 patients had pre‐ and post‐vaccination serum samples positive for anti‐VZV antibodies. Vaccine responses (anti‐VZV antibody titer ≥1:4 in seronegative patients, and ≥4‐fold increase in anti‐VZV antibody titer in seropositive patients) were elicited by only 2 patients 2 months post dose 1, and by a single patient 1.5 months post dose 2. Although no major safety signals were detected, any and Grade 3 solicited AEs that were causally related to vaccination were reported by 44.8% and 10.3% patients, respectively. During the 43‐day follow‐up period, 3 patients developed varicella‐like rash (1 vaccine‐type VZV). Beyond 43 days, herpes zoster was reported in 2 patients and wild‐type varicella infection in 2 patients (1 was breakthrough infection). Four non‐fatal SAEs were reported by patients and considered causally unrelated to vaccination. Conclusion: Oka‐RIT was poorly immunogenic but safe when given to adults up to 6 months post autologous HSCT, and alternative strategies are required to prevent VZV‐associated complications in these populations.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Belgique</li><li>Singapour</li><li>États-Unis</li></country><region><li>Victoria (État)</li></region><settlement><li>Melbourne</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><country name="Australie"><region name="Victoria (État)"><name sortKey="Sasadeusz, J" sort="Sasadeusz, J" uniqKey="Sasadeusz J" first="J." last="Sasadeusz">J. Sasadeusz</name></region><name sortKey="Prince, H M" sort="Prince, H M" uniqKey="Prince H" first="H. M." last="Prince">H. M. Prince</name><name sortKey="Prince, H M" sort="Prince, H M" uniqKey="Prince H" first="H. M." last="Prince">H. M. Prince</name><name sortKey="Sasadeusz, J" sort="Sasadeusz, J" uniqKey="Sasadeusz J" first="J." last="Sasadeusz">J. Sasadeusz</name><name sortKey="Schwarer, A" sort="Schwarer, A" uniqKey="Schwarer A" first="A." last="Schwarer">A. Schwarer</name><name sortKey="Stork, A" sort="Stork, A" uniqKey="Stork A" first="A." last="Stork">A. Stork</name><name sortKey="Stork, A" sort="Stork, A" uniqKey="Stork A" first="A." last="Stork">A. Stork</name><name sortKey="Szer, J" sort="Szer, J" uniqKey="Szer J" first="J." last="Szer">J. Szer</name><name sortKey="Szer, J" sort="Szer, J" uniqKey="Szer J" first="J." last="Szer">J. Szer</name></country><country name="Singapour"><noRegion><name sortKey="Bock, H L" sort="Bock, H L" uniqKey="Bock H" first="H. L." last="Bock">H. L. Bock</name></noRegion><name sortKey="Bock, H L" sort="Bock, H L" uniqKey="Bock H" first="H. L." last="Bock">H. L. Bock</name></country><country name="Belgique"><noRegion><name sortKey="Povey, M" sort="Povey, M" uniqKey="Povey M" first="M." last="Povey">M. Povey</name></noRegion></country><country name="États-Unis"><noRegion><name sortKey="Nicholson, O" sort="Nicholson, O" uniqKey="Nicholson O" first="O." last="Nicholson">O. Nicholson</name></noRegion><name sortKey="Innis, B L" sort="Innis, B L" uniqKey="Innis B" first="B. L." last="Innis">B. L. Innis</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/MersV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001E05 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001E05 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Sante
|area= MersV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= ISTEX:0D3B03BA41EE3A660444EC176EB323285E17868F
|texte= Immunogenicity and safety of a two‐dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation
}}
| This area was generated with Dilib version V0.6.33. |  |