title: Immunogenicity and safety of the influenza A H1N1v 2009 vaccine in cancer patients treated with cytotoxic chemotherapy and/or targeted therapy: the VACANCE study.
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.
  
  
  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 H1N1v 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 were 48% 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.
authors.affiliation: Oncology Unit, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France.
authors.forename: B
authors.initials: B
authors.lastname: Rousseau
authors.forename: P
authors.initials: P
authors.lastname: Loulergue
authors.forename: O
authors.initials: O
authors.lastname: Mir
authors.forename: A
authors.initials: A
authors.lastname: Krivine
authors.forename: S
authors.initials: S
authors.lastname: Kotti
authors.forename: E
authors.initials: E
authors.lastname: Viel
authors.forename: T
authors.initials: T
authors.lastname: Simon
authors.forename: A
authors.initials: A
authors.lastname: de Gramont
authors.forename: F
authors.initials: F
authors.lastname: Goldwasser
authors.forename: O
authors.initials: O
authors.lastname: Launay
authors.forename: C
authors.initials: C
authors.lastname: Tournigand
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D007252:Influenza Vaccines / Q000276:immunology* / Q000627:therapeutic use; D007251:Influenza, Human / Q000150:complications / Q000517:prevention & control* / Q000821:virology; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000276:immunology / Q000628:therapy*; D011446:Prospective Studies
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D007252:Influenza Vaccines