Immunogenicity and Safety of Influenza Vaccine in Inflammatory Bowel Disease Patients Treated or not with Immunomodulators and/or Biologics: A Two-year Prospective Study.
OBJECTIVE
Data on the efficacy and safety of seasonal influenza vaccines in patients with inflammatory bowel disease (IBD) remain scarce. The aim of the study was to evaluate the impact of immunosuppressive (IS) therapeutics on serological response to 2-year influenza vaccination in IBD adults.


METHODS
A multicentre prospective study performed in 255 IBD adults (18-64 years) receiving the trivalent influenza vaccine in the years 2009-2010 and 2010-2011. Haemagglutination inhibition (HI) titres were assessed before and 3 weeks and 6 months after vaccination.


RESULTS
At inclusion, 31 patients were receiving no IS treatment (Group A), 77 were receiving IS treatment without anti-TNF (Group B) and 117 were receiving anti-tumour necrosis factor (TNF) treatment with or without IS treatment (Group C). Three weeks after the first vaccination, rates of seroprotection were 77, 75 and 66% for strain A/H1N12007 (p = 0.35), 77, 68 and 52% for strain A/H3N2 (p = 0.014) and 97, 96 and 95% for strain B (p = 0.99) in Groups A, B and C, respectively. Seroconversion rates for A/H1N12007 (67, 64 and 54%; p = 0.28), A/H3N2 (63, 50 and 41%; p = 0.074) and strain B (63, 76 and 60%; p = 0.078) were not significantly different among treatment groups. At 6 months after vaccination, seroprotection rates were lower in Group C compared with Groups A and B. Comparable results were observed for the second year of vaccination. No impact on Harvey-Bradshaw and Mayo scores was detected.


CONCLUSIONS
Influenza vaccine yielded high seroprotection rates in IBD patients. Persistence of seroprotection was lower in patients with anti-TNF treatment. ClinicalTrials.gov, number NCT01022749.
Université Paris Descartes, Sorbonne Paris Cité, Paris, France Assistance Publique Hôpitaux de Paris (AP-HP), Hôpital Cochin, CIC Cochin-Pasteur, Paris, France INSERM, CIC 1417, Paris, France INSERM, F-CRIN, Innovative clinical research network in vaccinology (I-REIVAC), Paris, France odile.launay@cch.aphp.fr.
Odile
O
Launay
AP-HP, Hôpital Cochin, Service de gastro-entérologie, Paris, France.
Vered
V
Abitbol
AP-HP, Hôpital Cochin, Service de virologie, Paris, France.
Anne
A
Krivine
Assistance Publique Hôpitaux de Paris (AP-HP), Hôpital Cochin, CIC Cochin-Pasteur, Paris, France.
Lilia Ben
LB
Slama
CHU Nantes, Hôtel Dieu, Nantes, France.
Arnaud
A
Bourreille
Service d'Hépatogastroentérologie, Hôpital Nord, Amiens, France.
Jean Louis
JL
Dupas
Hôpital de l'Archet, Fédération d'Hépatogastroentérologie et de nutrition clinique, Nice, France.
Xavier
X
Hébuterne
Service Hépatogastroentérologie et Nutrition, Hôpital Charles Nicolle, Rouen, France.
Guillaume
G
Savoye
INSERM, F-CRIN, Innovative clinical research network in vaccinology (I-REIVAC), Paris, France INSERM-CHRU de Lille, CIC 1403, Lille, France.
Dominique
D
Deplanque
Hôpital Beaujon, Service de Gastroentérologie et Assistance Nutritive, Clichy, France.
Yoram
Y
Bouhnik
Service de Gastroentérologie, Hôpital Bichat Claude Bernard, Paris, France.
Anne Laure
AL
Pelletier
INSERM, F-CRIN, Innovative clinical research network in vaccinology (I-REIVAC), Paris, France INSERM, CIC de Montpellier, Hôpital Saint Eloi, Montpellier, France.
Florence
F
Galtier
Service d'Hépatogastroentérologie, Hôpital Haut-Lévêque, Pessac, France.
David
D
Laharie
Service de Gastroentérologie, CHU Jean Minjoz, Besançon, and Service d'Hépatogastroentérologie, Hôpital Claude Huriez, Lille, France.
Maria
M
Nachury
Service d'Hépato-gastroentérologie, Hôpital Saint-André, Bordeaux, France.
Frank
F
Zerbib
Service de Gastroentérologie, AP-HP, Hôpital Saint-Louis, Paris, France.
Mathieu
M
Allez
Service de Médecine Digestive et Hépatobiliaire, CHU Estaing, Clermont-Ferrand, France.
Gilles
G
Bommelaer
Hôpitaux Universitaires de Strasbourg, Service d'Hépato gastroentérologie, Hôpital de Hautepierre, INSERM U1113, Strasbourg, France.
Bernard
B
Duclos
INSERM, F-CRIN, Innovative clinical research network in vaccinology (I-REIVAC), Paris, France CHU Saint Etienne, Service des Maladies Infectieuses et tropicales, Saint Etienne, France.
Frederic
F
Lucht
INSERM, F-CRIN, Innovative clinical research network in vaccinology (I-REIVAC), Paris, France Antiviral Immunity, Biotherapy and Vaccine Unit, Infection and Epidemiology Department, Institut Pasteur, Paris, France.
Marie-Lise
ML
Gougeon
Université Paris Descartes, Sorbonne Paris Cité, Paris, France INSERM, F-CRIN, Innovative clinical research network in vaccinology (I-REIVAC), Paris, France Hôpital Européen Georges Pompidou, Service d'Immunologie Biologique, INSERM, UMR_S 970, PARCC, Paris, France.
Eric
E
Tartour
Université Paris Descartes, Sorbonne Paris Cité, Paris, France AP-HP, Hôpital Cochin, Service de virologie, Paris, France.
Flore
F
Rozenberg
Service de médecine interne, AP-HP; Hôpital Ambroise Paré, Université de Versailles Saint-Quentin-en-Yvelines, Boulogne-Billancourt, France.
Thomas
T
Hanslik
Service de Gastroentérologie, AP-HP, Hôpital Saint-Antoine et INSERM/UMRS 7203, UPMC Université de Paris VI, Paris, France.
Laurent
L
Beaugerie
Département de santé publique, AP-HP, Hôpital Saint-Antoine, Paris, France Université Pierre et Marie Curie, UMR-S 1136, Paris, France INSERM, U1136, Paris, France.
Fabrice
F
Carrat
D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D007252:Influenza Vaccines
Vaccine immune response; anti-TNF; safety