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. 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.
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.
RCT Entities:
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.
Authors: Oluwaseun Egunsola; Fiona Clement; John Taplin; Liza Mastikhina; Joyce W Li; Diane L Lorenzetti; Laura E Dowsett; Tom Noseworthy Journal: JAMA Netw Open Date: 2021-02-01