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Feasibility of Hepatitis B Vaccination by Microneedle Patch: Cellular and Humoral Immunity Studies in Rhesus Macaques.

Abstract

BACKGROUND

Dissolvable microneedle patches (dMNPs) provide ease of deployment and eliminate need for hypodermic needle disposal after conventional vaccinations. In this study, immunogenicity of dMNP delivery of adjuvant-free monovalent hepatitis B surface antigen (HBsAg) vaccine (AFV) to standard intramuscular (IM) injection of monovalent aluminum-adjuvanted monovalent hepatitis B vaccine (AAV) were compared in rhesus macaques.

METHODS

Sixteen macaques were immunized twice in 4 groups: dMNP delivery of 24 ± 8µg (n=4) or 48 ± 14µg (n=4) AFV; IM injection of 10µg AFV (IM AFV, n=4); and IM injection of 10µg AAV (IM AAV, n=4). Levels of hepatitis B surface antibody 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, IFN-γ, IL-2, and IL-4 production by HBsAg-specific T-cells were detected. A statistically significant positive correlation was detected between anti-HBs levels and HBsAg-specific IFN-γ and IL-2 (Th1-type cytokine) and IL-4 (Th2-type cytokine) producing cells in all anti-HBs positive animals.

CONCLUSIONS

dMNP delivery of AFV can elicit seroprotective anti-HBs levels in rhesus macaques that correlate in human seroprotection, and could be particularly promising for hepatitis B vaccine birth dose delivery in resource-constrained regions.

Authors+Show Affiliations

Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention , US Centers for Disease Control and Prevention (CDC), Atlanta, GA.School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, Georgia.Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention , US Centers for Disease Control and Prevention (CDC), Atlanta, GA.Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention , US Centers for Disease Control and Prevention (CDC), Atlanta, GA.School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, Georgia.Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention , US Centers for Disease Control and Prevention (CDC), Atlanta, GA.Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention , US Centers for Disease Control and Prevention (CDC), Atlanta, GA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31408163

Citation

Choi, Youkyung H., et al. "Feasibility of Hepatitis B Vaccination By Microneedle Patch: Cellular and Humoral Immunity Studies in Rhesus Macaques." The Journal of Infectious Diseases, 2019.
Choi YH, Perez-Cuevas MB, Kodani M, et al. Feasibility of Hepatitis B Vaccination by Microneedle Patch: Cellular and Humoral Immunity Studies in Rhesus Macaques. J Infect Dis. 2019.
Choi, Y. H., Perez-Cuevas, M. B., Kodani, M., Zhang, X., Prausnitz, M. R., Kamili, S., & O'Connor, S. M. (2019). Feasibility of Hepatitis B Vaccination by Microneedle Patch: Cellular and Humoral Immunity Studies in Rhesus Macaques. The Journal of Infectious Diseases, doi:10.1093/infdis/jiz399.
Choi YH, et al. Feasibility of Hepatitis B Vaccination By Microneedle Patch: Cellular and Humoral Immunity Studies in Rhesus Macaques. J Infect Dis. 2019 Aug 13; PubMed PMID: 31408163.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Feasibility of Hepatitis B Vaccination by Microneedle Patch: Cellular and Humoral Immunity Studies in Rhesus Macaques. AU - Choi,Youkyung H, AU - Perez-Cuevas,Monica B, AU - Kodani,Maja, AU - Zhang,Xiugen, AU - Prausnitz,Mark R, AU - Kamili,Saleem, AU - O'Connor,Siobhan M, Y1 - 2019/08/13/ PY - 2019/01/11/received PY - 2019/8/14/entrez KW - adaptive immune response KW - cellular immune response KW - hepatitis B vaccine KW - hepatitis B virus KW - microneedle patch KW - rhesus macaques KW - skin vaccination JF - The Journal of infectious diseases JO - J. Infect. Dis. N2 - BACKGROUND: Dissolvable microneedle patches (dMNPs) provide ease of deployment and eliminate need for hypodermic needle disposal after conventional vaccinations. In this study, immunogenicity of dMNP delivery of adjuvant-free monovalent hepatitis B surface antigen (HBsAg) vaccine (AFV) to standard intramuscular (IM) injection of monovalent aluminum-adjuvanted monovalent hepatitis B vaccine (AAV) were compared in rhesus macaques. METHODS: Sixteen macaques were immunized twice in 4 groups: dMNP delivery of 24 ± 8µg (n=4) or 48 ± 14µg (n=4) AFV; IM injection of 10µg AFV (IM AFV, n=4); and IM injection of 10µg AAV (IM AAV, n=4). Levels of hepatitis B surface antibody 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, IFN-γ, IL-2, and IL-4 production by HBsAg-specific T-cells were detected. A statistically significant positive correlation was detected between anti-HBs levels and HBsAg-specific IFN-γ and IL-2 (Th1-type cytokine) and IL-4 (Th2-type cytokine) producing cells in all anti-HBs positive animals. CONCLUSIONS: dMNP delivery of AFV can elicit seroprotective anti-HBs levels in rhesus macaques that correlate in human seroprotection, and could be particularly promising for hepatitis B vaccine birth dose delivery in resource-constrained regions. SN - 1537-6613 UR - https://www.unboundmedicine.com/medline/citation/31408163/Feasibility_of_Hepatitis_B_Vaccination_by_Microneedle_Patch:_Cellular_and_Humoral_Immunity_Studies_in_Rhesus_Macaques L2 - https://academic.oup.com/jid/article-lookup/doi/10.1093/infdis/jiz399 DB - PRIME DP - Unbound Medicine ER -