title: Establishment of a cohort for deep phenotyping of the immune response to influenza vaccination among elderly individuals recruited from the general population.
abstract: Elderly individuals have the highest burden of disease from influenza infection but also the lowest immune response to influenza vaccination. A better understanding of the host response to influenza vaccination in the elderly is therefore urgently needed. We conducted a biphasic prospective, population-based study from Dec. 2014 to May 2015 (pilot study) and Sept. 2015 to May 2016 (main study). Individuals 65-80 y of age were randomly selected from the residents' registration office in Hannover, Germany, for the pilot (n = 34) and main study (n = 200). The pilot study tested recruitment for study arms featuring 2, 4, or 5 visits/blood draws. The 5-visit (day 0, 1/3, 7, 21, 70 with respect to vaccination) study arm was selected for the main study. Both studies featured vaccination with Fluad™ (Novartis, Italy), a detailed medical history, a physical exam, recording of adverse events, completion of a questionnaire on common infections and an end-of-study questionnaire, and blood samples. Response rates in the pilot and main studies were 3.7% and 4.0%, respectively. Willingness to participate did not differ among the study arms (Fisher's exact test, p = 0.44). In both studies, there were no losses to follow-up. Compliance with study visits, blood sampling and completion of the questionnaires was very high (100%, >97%, 100%, respectively), as were participants' acceptance of and satisfaction with both phases of the study. The low response rates indicate the need for optimized recruitment strategies if the study population is to be representative of the general population. Nonetheless, the complex prospective study design proved to be highly feasible.
authors.affiliation: a TWINCORE, Centre for Experimental and Clinical Infection Research , Hannover , Germany.|b Helmholtz Centre for Infection Research , Braunschweig , Germany.|c Centre for Individualized Infection Medicine , Hannover , Germany.
authors.forename: Manas K
authors.initials: MK
authors.lastname: Akmatov
authors.affiliation: d Department of Vaccinology and Applied Microbiology , Helmholtz Centre for Infection Research , Braunschweig , Germany.
authors.forename: Peggy
authors.initials: P
authors.lastname: Riese
authors.affiliation: e Clinical Research Center Hannover , Hannover Medical School , Hannover , Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: May
authors.affiliation: a TWINCORE, Centre for Experimental and Clinical Infection Research , Hannover , Germany.
authors.forename: Leonhard
authors.initials: L
authors.lastname: Jentsch
authors.affiliation: a TWINCORE, Centre for Experimental and Clinical Infection Research , Hannover , Germany.
authors.forename: Malik W
authors.initials: MW
authors.lastname: Ahmed
authors.affiliation: a TWINCORE, Centre for Experimental and Clinical Infection Research , Hannover , Germany.
authors.forename: Damaris
authors.initials: D
authors.lastname: Werner
authors.affiliation: a TWINCORE, Centre for Experimental and Clinical Infection Research , Hannover , Germany.
authors.forename: Anja
authors.initials: A
authors.lastname: Rösel
authors.affiliation: e Clinical Research Center Hannover , Hannover Medical School , Hannover , Germany.
authors.forename: Megan
authors.initials: M
authors.lastname: Tyler
authors.affiliation: a TWINCORE, Centre for Experimental and Clinical Infection Research , Hannover , Germany.
authors.forename: Kevin
authors.initials: K
authors.lastname: Pessler
authors.affiliation: f Hannover Unified Biobank , Hannover Medical School , Hannover , Germany.
authors.forename: Jana
authors.initials: J
authors.lastname: Prokein
authors.affiliation: f Hannover Unified Biobank , Hannover Medical School , Hannover , Germany.
authors.forename: Inga
authors.initials: I
authors.lastname: Bernemann
authors.affiliation: f Hannover Unified Biobank , Hannover Medical School , Hannover , Germany.
authors.forename: Norman
authors.initials: N
authors.lastname: Klopp
authors.affiliation: d Department of Vaccinology and Applied Microbiology , Helmholtz Centre for Infection Research , Braunschweig , Germany.
authors.forename: Blair
authors.initials: B
authors.lastname: Prochnow
authors.affiliation: d Department of Vaccinology and Applied Microbiology , Helmholtz Centre for Infection Research , Braunschweig , Germany.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Trittel
authors.affiliation: a TWINCORE, Centre for Experimental and Clinical Infection Research , Hannover , Germany.
authors.forename: Aravind
authors.initials: A
authors.lastname: Tallam
authors.affiliation: f Hannover Unified Biobank , Hannover Medical School , Hannover , Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Illig
authors.affiliation: e Clinical Research Center Hannover , Hannover Medical School , Hannover , Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Schindler
authors.affiliation: c Centre for Individualized Infection Medicine , Hannover , Germany.|d Department of Vaccinology and Applied Microbiology , Helmholtz Centre for Infection Research , Braunschweig , Germany.
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Guzmán
authors.affiliation: a TWINCORE, Centre for Experimental and Clinical Infection Research , Hannover , Germany.|b Helmholtz Centre for Infection Research , Braunschweig , Germany.|c Centre for Individualized Infection Medicine , Hannover , Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Pessler
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D005858:Germany; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D018579:Patient Selection; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D007252:Influenza Vaccines; C478243:fluad vaccine
keywords: Germany; elderly; feasibility; influenza vaccination; nonresponse bias; pilot study; population-based study; response rate; vaccinomics