Immunogenicity and safety of intradermal trivalent influenza vaccination in nursing home older adults: a randomized controlled trial

Tuen-Ching Chan; Ivan Fan-Ngai Hung; Kwok-Hung Chan; Clara Pui-Yan Li; Patrick Tsz-Wai Li; James Ka-Hay Luk; Leung-Wing Chu; Felix Hon-Wai Chan

doi:10.1016/j.jamda.2014.05.002

Immunogenicity and safety of intradermal trivalent influenza vaccination in nursing home older adults: a randomized controlled trial

J Am Med Dir Assoc. 2014 Aug;15(8):607.e5-12. doi: 10.1016/j.jamda.2014.05.002. Epub 2014 Jun 21.

Authors

Tuen-Ching Chan¹, Ivan Fan-Ngai Hung², Kwok-Hung Chan³, Clara Pui-Yan Li³, Patrick Tsz-Wai Li³, James Ka-Hay Luk⁴, Leung-Wing Chu⁵, Felix Hon-Wai Chan⁴

Affiliations

¹ Department of Medicine and Geriatrics, TWGHs Fung Yiu King Hospital, Hong Kong SAR, China; Division of Geriatrics, Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China. Electronic address: tuenching@yahoo.com.hk.
² Division of Infectious Disease, Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
³ Department of Microbiology, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
⁴ Department of Medicine and Geriatrics, TWGHs Fung Yiu King Hospital, Hong Kong SAR, China.
⁵ Division of Geriatrics, Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.

PMID: 24957950
DOI: 10.1016/j.jamda.2014.05.002

Abstract

Objective: To compare the immunogenicity and safety between full-dose (15 μg) intramuscular (i.m.) and full-dose (15 μg) intradermal (i.d.) immunization of the trivalent influenza vaccine in nursing home older adults.

Design: A single-center, randomized, controlled, open-label, parallel group trial from October 2013 to April 2014.

Setting: Nine nursing homes in Hong Kong.

Participants: Hundred nursing home older adults (mean age: 82.9 ± 7.4 years).

Intervention: Fifty received i.d. (Intanza) and 50 received i.m. (Vaxigrip) vaccination.

Measurements: Baseline measurements included demographics, comorbidity, frailty and nutritional status. Day 21 and day 180 immunogenicity (seroconversion rate, seroprotection rate, geometric mean titer [GMT] fold increase in antibody titer) using hemagglutination-inhibition and adverse events were measured. Noninferiority and superiority of i.d. compared with i.m. vaccination in immunogenicity were analyzed. The study was registered on ClinicalTrials.gov; identifier: NCT 01967368.

Results: At day 21, noninferiority in immunogenicity of the i.d. vaccination was demonstrated. The seroconversion rate of the H1N1 strain was significantly higher in the i.d. group. At day 180, immunogenicity of both groups fell but the GMT of all strains in i.d. group was higher and the difference was significant for H3N2 strain. The seroconversion rate and GMT fold increase of H3N2 strain was significantly higher in the i.d. group. Local adverse events was significantly more in i.d. group, but they were mild and resolved in 72 hours.

Conclusions: I.d. vaccination is noninferior, and even superior in some parts of immunogenicity assessment, to i.m. vaccination without compromising safety in nursing home older adults. I.d. vaccination is a good alternative to i.m. vaccination in this population.

Trial registration: ClinicalTrials.gov NCT01967368.

Keywords: Influenza vaccination; immunogenicity; intradermal vaccination; nursing home older adults; randomized controlled trial; safety.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged, 80 and over
Female
Hong Kong
Humans
Influenza A Virus, H1N1 Subtype
Influenza A Virus, H3N2 Subtype
Influenza Vaccines / administration & dosage*
Influenza Vaccines / immunology*
Influenza, Human / prevention & control*
Influenza, Human / virology
Injections, Intradermal
Injections, Intramuscular
Male
Nursing Homes*
Patient Safety*

Substances

Influenza Vaccines

Associated data

ClinicalTrials.gov/NCT01967368