Feasibility of Hepatitis B Vaccination by Microneedle Patch: Cellular and Humoral Immunity Studies in Rhesus Macaques. (13th August 2019)

• Record Type: Journal Article
• Authors: Choi, Youkyung H; Perez-Cuevas, Monica B; Kodani, Maja; Zhang, Xiugen; Prausnitz, Mark R; Kamili, Saleem; O'Connor, Siobhan M
• Is Part Of: Journal of infectious diseases. Volume 220:Number 12(2019)
• Page Start: 1926
• Page End: 1934
• Publication Date: 2019-08-13
• Subjects: hepatitis B virus -- hepatitis B vaccine -- microneedle patch -- skin vaccination -- cellular immune response -- adaptive immune response -- rhesus macaques; Communicable diseases -- Periodicals; Diseases -- Causes and theories of causation -- Periodicals; Medicine -- Periodicals; Communicable Diseases -- Periodicals; Electronic journals; 616.9
• DOI: 10.1093/infdis/jiz399
• Languages: English
• ISSNs: 0022-1899

Abstract

Abstract: Background: This study evaluated dissolvable microneedle patch (dMNP) delivery of hepatitis B vaccine in rhesus macaques and provides evidence that dMNP delivery elicits seroprotective anti-HBs levels comparable with human seroprotection, potentially useful for hepatitis B birth dose vaccination in resource-constrained regions. Methods: Sixteen macaques were each vaccinated twice; they were treated in 4 groups, with dMNP delivery of AFV at 24 ± 8 µg (n = 4) or 48 ± 14 µg (n = 4), intramuscular injection of AFV (10 µg; n = 4), or intramuscular injection of AAV (10 µg; n = 4). Levels of antibody to hepatitis B surface antigen (HBsAg) (anti-HBs) and HBsAg-specific T-cell responses were analyzed. Results: Six of 8 animals with dMNP delivery of AFV had anti-HBs levels ≥10 mIU/mL after the first vaccine dose. After dMNP delivery of AFV, interferon γ, interleukin 2, and interleukin 4 production by HBsAg-specific T cells was detected. A statistically significant positive correlation was detected between anti-HBs levels and cells producing HBsAg-specific interferon γ and interleukin 2 (T-helper 1–type cytokine) and interleukin 4 (T-helper 2–type cytokine) in all anti-HBs–positive animals. Conclusions: dMNP delivery of AFV can elicit seroprotective anti-HBs levels in rhesus macaques that are correlated with human seroprotection, and it could be particularly promising for birth dose delivery of hepatitis B vaccine in resource-constrained regions.