Paula M Frew1, Michele Bennett Paine2, Nadine Rouphael2, Jay Schamel3, Yunmi Chung3, Mark J Mulligan4, Mark R Prausnitz5. 1. The University of Nevada, Las Vegas, School of Public Health, United States; UNLV Population Health & Health Equity Initiative, United States. Electronic address: paula.frew@unlv.edu. 2. Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States; The Hope Clinic of the Emory Vaccine Center, United States. 3. Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States. 4. NYU Langone Health, Division of Infectious Diseases and Immunology, United States. 5. Georgia Institute of Technology, School of Chemical and Biomolecular Engineering, United States.
Abstract
OBJECTIVE: This study sought to evaluate the acceptability of inactivated influenza vaccine delivered by microneedle patch (MNP) in comparison to inactivated influenza vaccine (IIV) delivered by hypodermic needle. DESIGN, SETTING, AND PARTICIPANTS: From the general population of Atlanta, Georgia, we screened 112 and enrolled 100 healthy adult subjects ages 18 to 49 years. Main Outcome(s) and Measure(s). Our participants were randomized to 4 groups of 25 per arm: (1) IIV by MNP administered by healthcare worker (HCW), (2) IIV by MNP self-administered by study participants, (3) IIV by intramuscular (IM) injection administered by HCW or (4) placebo by MNP administered by HCW. We administered four questionnaires: at Day 0 before and after study product delivery, and at Days 8 and 28. RESULTS: At baseline, 98.6% of participants receiving MNP vaccination reported an overall positive experience with MNPs, compared to 86.4% for participants receiving IM vaccination. For future influenza vaccination, study participants (N = 99) preferred MNP (n = 65, 69.9%) to injections or nasal spray (n = 20, 21.5%), and the preference for MNP increased from Day 0 to Day 28. Factor analyses resulted in two scaled measures including MNP Use Perceptions (a = 0.799, n = 5 items) and MNP Perceived Convenience (a = 0.844, n = 4 items) that were included in longitudinal assessments; while findings reflect significant differences across treatment groups on mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge, all groups reported their belief that influenza vaccination by MNP would be reliable and protective, as well as easy-to-use and convenient. CONCLUSIONS AND RELEVANCE: Most participants were accepting of IIV vaccination by MNP and preferred it to injection. Delivery of IIV by MNP may help increase vaccination coverage.
RCT Entities:
OBJECTIVE: This study sought to evaluate the acceptability of inactivated influenza vaccine delivered by microneedle patch (MNP) in comparison to inactivated influenza vaccine (IIV) delivered by hypodermic needle. DESIGN, SETTING, AND PARTICIPANTS: From the general population of Atlanta, Georgia, we screened 112 and enrolled 100 healthy adult subjects ages 18 to 49 years. Main Outcome(s) and Measure(s). Our participants were randomized to 4 groups of 25 per arm: (1) IIV by MNP administered by healthcare worker (HCW), (2) IIV by MNP self-administered by study participants, (3) IIV by intramuscular (IM) injection administered by HCW or (4) placebo by MNP administered by HCW. We administered four questionnaires: at Day 0 before and after study product delivery, and at Days 8 and 28. RESULTS: At baseline, 98.6% of participants receiving MNP vaccination reported an overall positive experience with MNPs, compared to 86.4% for participants receiving IM vaccination. For future influenza vaccination, study participants (N = 99) preferred MNP (n = 65, 69.9%) to injections or nasal spray (n = 20, 21.5%), and the preference for MNP increased from Day 0 to Day 28. Factor analyses resulted in two scaled measures including MNP Use Perceptions (a = 0.799, n = 5 items) and MNP Perceived Convenience (a = 0.844, n = 4 items) that were included in longitudinal assessments; while findings reflect significant differences across treatment groups on mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge, all groups reported their belief that influenza vaccination by MNP would be reliable and protective, as well as easy-to-use and convenient. CONCLUSIONS AND RELEVANCE: Most participants were accepting of IIV vaccination by MNP and preferred it to injection. Delivery of IIV by MNP may help increase vaccination coverage.
Authors: Yoo Chun Kim; Jeong Woo Lee; E Stein Esser; Haripriya Kalluri; Jessica C Joyce; Richard W Compans; Ioanna Skountzou; Mark R Prausnitz Journal: Drug Deliv Transl Res Date: 2021-02-15 Impact factor: 4.617
Authors: Emrullah Korkmaz; Stephen C Balmert; Tina L Sumpter; Cara Donahue Carey; Geza Erdos; Louis D Falo Journal: Adv Drug Deliv Rev Date: 2021-02-02 Impact factor: 17.873