Immunogenicity and safety of the influenza A HINIv 2009 vaccine in cancer patients treated with cytotoxic chemotherapy and/or targeted therapy: the VACANCE study
Identifieur interne : 000631 ( France/Analysis ); précédent : 000630; suivant : 000632Immunogenicity and safety of the influenza A HINIv 2009 vaccine in cancer patients treated with cytotoxic chemotherapy and/or targeted therapy: the VACANCE study
Auteurs : B. Rousseau [France] ; P. Loulergue [France] ; O. Mir [France] ; A. Krivine [France] ; S. Kotti [France] ; E. Viel [France] ; T. Simon [France] ; A. De Gramont [France] ; F. Goldwasser [France] ; O. Launay [France] ; C. Tournigand [France]Source :
- Annals of oncology [ 0923-7534 ] ; 2012.
Descripteurs français
- Pascal (Inist)
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English descriptors
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Abstract
Background: Influenza vaccination is recommended to cancer patients undergoing chemotherapy, but vaccine coverage remains low. During the 2009 influenza pandemic, French recommendations were to vaccinate immunocompromised patients with two doses of adjuvanted vaccine. This study aimed to evaluate vaccine immunogenicity in cancer patients receiving chemotherapy. Patients and methods: VACANCE is a prospective open-label study that evaluated the immunogenicity and safety of two doses of AS03A-adjuvanted H1N1v vaccine in cancer patients receiving cytotoxic and/or targeted therapies. Serum haemagglutination-inhibited antibody titres against influenza A H1 N1 v were measured at days 1,21, and 42, to estimate the proportion of participants with antibody titres ≥1: 40 [seroprotection rate (SPR)], the efficacy of seroconversion, and factors that increased the geometric mean titre. Results: Sixty-five patients were included. At baseline, 5% of patients had vaccine strain titres of specific haemagglutination inhibition antibodies that were ≥1: 40. After one and two doses of vaccine, SPRs were48% and 73%, respectively, and seroconversion rates were 44% and 73%, respectively. Vaccine-related adverse events were mild to moderate. Conclusions: A single dose of AS03-adjuvanted A/H1N1 vaccine triggered a low immune response in cancer patients on chemotherapy depending on their treatment type and frequency. Two doses are needed for these cancer patients.
Affiliations:
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Rousseau</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Oncology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="Loulergue, P" sort="Loulergue, P" uniqKey="Loulergue P" first="P." last="Loulergue">P. Loulergue</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Centre d'Investigation Clinique de Vaccinologie Cochin-Pasteur, Groupe Hospitalier Cochin-Broca-Hôtel Dieu, Assistance Publique Hôpitaux de Paris, Université Paris Descartes, Inserm CIC BT505</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Mir, O" sort="Mir, O" uniqKey="Mir O" first="O." last="Mir">O. Mir</name><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Medical Oncology Unit, Université Paris Descartes</s1><s2>Paris;</s2><s3>FRA</s3><sZ>3 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Krivine, A" sort="Krivine, A" uniqKey="Krivine A" first="A." last="Krivine">A. Krivine</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Department of Virology, Groupe Hospitalier Cochin-Broca-Hotel Dieu, Assistance Publique Hôpitaux de Paris, Université Paris Descartes</s1><s2>Paris;</s2><s3>FRA</s3><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Kotti, S" sort="Kotti, S" uniqKey="Kotti S" first="S." last="Kotti">S. Kotti</name><affiliation wicri:level="4"><inist:fA14 i1="05"><s1>Clinical Pharmacology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>5 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="Viel, E" sort="Viel, E" uniqKey="Viel E" first="E." last="Viel">E. Viel</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Oncology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="Simon, T" sort="Simon, T" uniqKey="Simon T" first="T." last="Simon">T. Simon</name><affiliation wicri:level="4"><inist:fA14 i1="05"><s1>Clinical Pharmacology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>5 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="De Gramont, A" sort="De Gramont, A" uniqKey="De Gramont A" first="A." last="De Gramont">A. De Gramont</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Oncology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="Goldwasser, F" sort="Goldwasser, F" uniqKey="Goldwasser F" first="F." last="Goldwasser">F. Goldwasser</name><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Medical Oncology Unit, Université Paris Descartes</s1><s2>Paris;</s2><s3>FRA</s3><sZ>3 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Launay, O" sort="Launay, O" uniqKey="Launay O" first="O." last="Launay">O. Launay</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Centre d'Investigation Clinique de Vaccinologie Cochin-Pasteur, Groupe Hospitalier Cochin-Broca-Hôtel Dieu, Assistance Publique Hôpitaux de Paris, Université Paris Descartes, Inserm CIC BT505</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Tournigand, C" sort="Tournigand, C" uniqKey="Tournigand C" first="C." last="Tournigand">C. Tournigand</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Oncology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">12-0135710</idno><date when="2012">2012</date><idno type="stanalyst">PASCAL 12-0135710 INIST</idno><idno type="RBID">Pascal:12-0135710</idno><idno type="wicri:Area/PascalFrancis/Corpus">000746</idno><idno type="wicri:Area/PascalFrancis/Curation">001690</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000599</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000599</idno><idno type="wicri:doubleKey">0923-7534:2012:Rousseau B:immunogenicity:and:safety</idno><idno type="wicri:Area/Main/Merge">002135</idno><idno type="wicri:Area/Main/Curation">002077</idno><idno type="wicri:Area/Main/Exploration">002077</idno><idno type="wicri:Area/France/Extraction">000631</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Immunogenicity and safety of the influenza A HINIv 2009 vaccine in cancer patients treated with cytotoxic chemotherapy and/or targeted therapy: the VACANCE study</title><author><name sortKey="Rousseau, B" sort="Rousseau, B" uniqKey="Rousseau B" first="B." last="Rousseau">B. Rousseau</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Oncology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="Loulergue, P" sort="Loulergue, P" uniqKey="Loulergue P" first="P." last="Loulergue">P. Loulergue</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Centre d'Investigation Clinique de Vaccinologie Cochin-Pasteur, Groupe Hospitalier Cochin-Broca-Hôtel Dieu, Assistance Publique Hôpitaux de Paris, Université Paris Descartes, Inserm CIC BT505</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Mir, O" sort="Mir, O" uniqKey="Mir O" first="O." last="Mir">O. Mir</name><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Medical Oncology Unit, Université Paris Descartes</s1><s2>Paris;</s2><s3>FRA</s3><sZ>3 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Krivine, A" sort="Krivine, A" uniqKey="Krivine A" first="A." last="Krivine">A. Krivine</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Department of Virology, Groupe Hospitalier Cochin-Broca-Hotel Dieu, Assistance Publique Hôpitaux de Paris, Université Paris Descartes</s1><s2>Paris;</s2><s3>FRA</s3><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Kotti, S" sort="Kotti, S" uniqKey="Kotti S" first="S." last="Kotti">S. Kotti</name><affiliation wicri:level="4"><inist:fA14 i1="05"><s1>Clinical Pharmacology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>5 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="Viel, E" sort="Viel, E" uniqKey="Viel E" first="E." last="Viel">E. Viel</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Oncology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="Simon, T" sort="Simon, T" uniqKey="Simon T" first="T." last="Simon">T. Simon</name><affiliation wicri:level="4"><inist:fA14 i1="05"><s1>Clinical Pharmacology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>5 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="De Gramont, A" sort="De Gramont, A" uniqKey="De Gramont A" first="A." last="De Gramont">A. De Gramont</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Oncology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="Goldwasser, F" sort="Goldwasser, F" uniqKey="Goldwasser F" first="F." last="Goldwasser">F. Goldwasser</name><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Medical Oncology Unit, Université Paris Descartes</s1><s2>Paris;</s2><s3>FRA</s3><sZ>3 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Launay, O" sort="Launay, O" uniqKey="Launay O" first="O." last="Launay">O. Launay</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Centre d'Investigation Clinique de Vaccinologie Cochin-Pasteur, Groupe Hospitalier Cochin-Broca-Hôtel Dieu, Assistance Publique Hôpitaux de Paris, Université Paris Descartes, Inserm CIC BT505</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Tournigand, C" sort="Tournigand, C" uniqKey="Tournigand C" first="C." last="Tournigand">C. Tournigand</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Oncology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author></analytic><series><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Chemotherapy</term><term>Cytotoxicity</term><term>Human</term><term>Immune response</term><term>Immunogenicity</term><term>Influenza A</term><term>Malignant tumor</term><term>Pandemic</term><term>Patient</term><term>Safety</term><term>Targeted therapy</term><term>Toxicity</term><term>Treatment</term><term>Vaccine</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Immunogénicité</term><term>Réponse immune</term><term>Toxicité</term><term>Sécurité</term><term>Grippe A</term><term>Vaccin</term><term>Tumeur maligne</term><term>Homme</term><term>Malade</term><term>Traitement</term><term>Cytotoxicité</term><term>Chimiothérapie</term><term>Thérapeutique ciblée</term><term>Pandémie</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Vaccin</term><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: Influenza vaccination is recommended to cancer patients undergoing chemotherapy, but vaccine coverage remains low. During the 2009 influenza pandemic, French recommendations were to vaccinate immunocompromised patients with two doses of adjuvanted vaccine. This study aimed to evaluate vaccine immunogenicity in cancer patients receiving chemotherapy. Patients and methods: VACANCE is a prospective open-label study that evaluated the immunogenicity and safety of two doses of AS03A-adjuvanted H1N1v vaccine in cancer patients receiving cytotoxic and/or targeted therapies. Serum haemagglutination-inhibited antibody titres against influenza A H1 N1 v were measured at days 1,21, and 42, to estimate the proportion of participants with antibody titres ≥1: 40 [seroprotection rate (SPR)], the efficacy of seroconversion, and factors that increased the geometric mean titre. Results: Sixty-five patients were included. At baseline, 5% of patients had vaccine strain titres of specific haemagglutination inhibition antibodies that were ≥1: 40. After one and two doses of vaccine, SPRs were48% and 73%, respectively, and seroconversion rates were 44% and 73%, respectively. Vaccine-related adverse events were mild to moderate. Conclusions: A single dose of AS03-adjuvanted A/H1N1 vaccine triggered a low immune response in cancer patients on chemotherapy depending on their treatment type and frequency. Two doses are needed for these cancer patients.</div></front></TEI><affiliations><list><country><li>France</li></country><region><li>Île-de-France</li></region><settlement><li>Paris</li></settlement><orgName><li>Université Paris-Descartes</li><li>Université Pierre-et-Marie-Curie</li></orgName></list><tree><country name="France"><region name="Île-de-France"><name sortKey="Rousseau, B" sort="Rousseau, B" uniqKey="Rousseau B" first="B." last="Rousseau">B. Rousseau</name></region><name sortKey="De Gramont, A" sort="De Gramont, A" uniqKey="De Gramont A" first="A." last="De Gramont">A. De Gramont</name><name sortKey="Goldwasser, F" sort="Goldwasser, F" uniqKey="Goldwasser F" first="F." last="Goldwasser">F. Goldwasser</name><name sortKey="Kotti, S" sort="Kotti, S" uniqKey="Kotti S" first="S." last="Kotti">S. Kotti</name><name sortKey="Krivine, A" sort="Krivine, A" uniqKey="Krivine A" first="A." last="Krivine">A. Krivine</name><name sortKey="Launay, O" sort="Launay, O" uniqKey="Launay O" first="O." last="Launay">O. Launay</name><name sortKey="Loulergue, P" sort="Loulergue, P" uniqKey="Loulergue P" first="P." last="Loulergue">P. Loulergue</name><name sortKey="Mir, O" sort="Mir, O" uniqKey="Mir O" first="O." last="Mir">O. Mir</name><name sortKey="Simon, T" sort="Simon, T" uniqKey="Simon T" first="T." last="Simon">T. Simon</name><name sortKey="Tournigand, C" sort="Tournigand, C" uniqKey="Tournigand C" first="C." last="Tournigand">C. Tournigand</name><name sortKey="Viel, E" sort="Viel, E" uniqKey="Viel E" first="E." last="Viel">E. 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