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Hum Vaccin Immunother. 2017 Apr 10:1-10. doi: 10.1080/21645515.2017.1299300. [Epub ahead of print]
Establishment of a cohort for deep phenotyping of the immune response to influenza vaccination among elderly individuals recruited from the general population.
Akmatov MK1,2,3, Riese P4, May M5, Jentsch L1, Ahmed MW1, Werner D1, R?sel A1, Tyler M5, Pessler K1, Prokein J6, Bernemann I6, Klopp N6, Prochnow B4, Trittel S4, Tallam A1, Illig T6, Schindler C5, Guzm?n CA3,4, Pessler F1,2,3.
Author information
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.
KEYWORDS:
Germany; elderly; feasibility; influenza vaccination; nonresponse bias; pilot study; population-based study; response rate; vaccinomics
PMID: 28394705 DOI: 10.1080/21645515.2017.1299300
Establishment of a cohort for deep phenotyping of the immune response to influenza vaccination among elderly individuals recruited from the general population.
Akmatov MK1,2,3, Riese P4, May M5, Jentsch L1, Ahmed MW1, Werner D1, R?sel A1, Tyler M5, Pessler K1, Prokein J6, Bernemann I6, Klopp N6, Prochnow B4, Trittel S4, Tallam A1, Illig T6, Schindler C5, Guzm?n CA3,4, Pessler F1,2,3.
Author information
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.
KEYWORDS:
Germany; elderly; feasibility; influenza vaccination; nonresponse bias; pilot study; population-based study; response rate; vaccinomics
PMID: 28394705 DOI: 10.1080/21645515.2017.1299300