Kobporn Boonnak1, Jittima Dhitavat1, Narumon Thantamnu2, Nathamon Kosoltanapiwat3, Montida Auayporn4, Li Jiang5, Pilaipan Puthavathana5, Punnee Pitisuttithum6. 1. Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Thailand; Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Thailand. 2. Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Thailand. 3. Department of Microbiology and Immunology, Faculty of Tropical Medicine, Mahidol University, Thailand; Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Thailand. 4. Center of Excellence for Biomedical and Public Health Informatics, Mahidol University, Bangkok, Thailand. 5. Department of Microbiology, Siriraj Hospital, Mahidol University, Thailand. 6. Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Thailand; Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Thailand. Electronic address: punnee.pit@mahidol.ac.th.
Abstract
BACKGROUD: Influenza viruses cause substantial morbidity, especially in older age groups. Thus, they are amongst high priority groups for routine vaccination. However, vaccine-induced immune responses and effectiveness were reported as relatively low. This study aims to systemically compare the immune responses elicited by intramuscular (IM) and intradermal (ID) injections with inactivated seasonal influenza vaccine among the older age group. METHODS: A prospective, open-label, randomized study with a total of 221 adults (>60 years) were enrolled and randomized into 2 groups. Group I (n = 111) received an IM inactivated seasonal influenza vaccine while Group II (n = 110) received the same vaccine ID. Demographics and co-morbidity were collected at baseline. Safety data was collected 3 days post-vaccination using diary card. HAI, NAb and NAI titers were assessed prior to vaccination and at 30, 45, and 60 days post-vaccination. Data was analyzed using SPSS 11.5. RESULTS: Both groups had similar BMI and co-morbidity. For ID and IM groups, significant differences were observed for seroconversion rate measured using HAI against H1N1 and H3N2 (58/111 vs 44/110 and 68/111 vs 54/110, respectively) being higher for those aged 60-65 years. However, no differences in HI antibody against B/Phuket were seen. For ID route, history of hyperlipidemia and hypertension were factors associated with high seroconversion rate towards influenza A (p = .001). The seroconversion rate risk ratio were 1.31 and 1.25 (p < .05) against A/California/07/09(H1N1) and A/Songkha/308/13 (H3N2), respectively. Interestingly, the GMT (95% CI) of baseline NAI antibodies among both groups were high (56.57 and 54.01 in the ID and IM groups, respectively). A 4-fold increase measured by NAI against A/California/07/09 (H1N1) were detected in 16.67% and 20% of participants who received ID or IM vaccination, respectively. CONCLUSIONS: The seroconversion rates of HAI, NAb and NAI were modest, especially in those >65 years of age. However, it was higher in the ID group as compared to the IM group. CLINICAL TRIAL REGISTRATION: NCT02101749.
RCT Entities:
BACKGROUD: Influenza viruses cause substantial morbidity, especially in older age groups. Thus, they are amongst high priority groups for routine vaccination. However, vaccine-induced immune responses and effectiveness were reported as relatively low. This study aims to systemically compare the immune responses elicited by intramuscular (IM) and intradermal (ID) injections with inactivated seasonal influenza vaccine among the older age group. METHODS: A prospective, open-label, randomized study with a total of 221 adults (>60 years) were enrolled and randomized into 2 groups. Group I (n = 111) received an IM inactivated seasonal influenza vaccine while Group II (n = 110) received the same vaccine ID. Demographics and co-morbidity were collected at baseline. Safety data was collected 3 days post-vaccination using diary card. HAI, NAb and NAI titers were assessed prior to vaccination and at 30, 45, and 60 days post-vaccination. Data was analyzed using SPSS 11.5. RESULTS: Both groups had similar BMI and co-morbidity. For ID and IM groups, significant differences were observed for seroconversion rate measured using HAI against H1N1 and H3N2 (58/111 vs 44/110 and 68/111 vs 54/110, respectively) being higher for those aged 60-65 years. However, no differences in HI antibody against B/Phuket were seen. For ID route, history of hyperlipidemia and hypertension were factors associated with high seroconversion rate towards influenza A (p = .001). The seroconversion rate risk ratio were 1.31 and 1.25 (p < .05) against A/California/07/09(H1N1) and A/Songkha/308/13 (H3N2), respectively. Interestingly, the GMT (95% CI) of baseline NAI antibodies among both groups were high (56.57 and 54.01 in the ID and IM groups, respectively). A 4-fold increase measured by NAI against A/California/07/09 (H1N1) were detected in 16.67% and 20% of participants who received ID or IM vaccination, respectively. CONCLUSIONS: The seroconversion rates of HAI, NAb and NAI were modest, especially in those >65 years of age. However, it was higher in the ID group as compared to the IM group. CLINICAL TRIAL REGISTRATION: NCT02101749.
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