Last data update: Sep 16, 2024. (Total: 47680 publications since 2009)
Records 1-3 (of 3 Records) |
Query Trace: Lee JW [original query] |
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Hepatitis B vaccine delivered by microneedle patch: Immunogenicity in mice and rhesus macaques
Choi Y , Lee GS , Li S , Lee JW , Mixson-Hayden T , Woo J , Xia D , Prausnitz MR , Kamili S , Purdy MA , Tohme RA . Vaccine 2023 41 (24) 3663-3672 Vaccination against hepatitis B using a dissolving microneedle patch (dMNP) could increase access to the birth dose by reducing expertise needed for vaccine administration, refrigerated storage, and safe disposal of biohazardous sharps waste. In this study, we developed a dMNP to administer hepatitis B surface antigen (HBsAg) adjuvant-free monovalent vaccine (AFV) at doses of 5 µg, 10 µg, and 20 µg, and compared its immunogenicity to vaccination with 10 µg of standard monovalent HBsAg delivered by intramuscular (IM) injection either in an AFV format or as aluminum-adjuvanted vaccine (AAV). Vaccination was performed on a three dose schedule of 0, 3, and 9 weeks in mice and 0, 4, and 24 weeks in rhesus macaques. Vaccination by dMNP induced protective levels of anti-HBs antibody responses (≥10 mIU/ml) in mice and rhesus macaques at all three HBsAg doses studied. HBsAg delivered by dMNP induced higher anti-HBsAg antibody (anti-HBs) responses than the 10 µg IM AFV, but lower responses than 10 µg IM AAV, in mice and rhesus macaques. HBsAg-specific CD4+ and CD8+ T cell responses were detected in all vaccine groups. Furthermore, we analyzed differential gene expression profiles related to each vaccine delivery group and found that tissue stress, T cell receptor signaling, and NFκB signaling pathways were activated in all groups. These results suggest that HBsAg delivered by dMNP, IM AFV, and IM AAV have similar signaling pathways to induce innate and adaptive immune responses. We further demonstrated that dMNP was stable at room temperature (20 °C-25 °C) for 6 months, maintaining 67 ± 6 % HBsAg potency. This study provides evidence that delivery of 10 µg (birth dose) AFV by dMNP induced protective levels of antibody responses in mice and rhesus macaques. The dMNPs developed in this study could be used to improve hepatitis B birth dose vaccination coverage levels in resource limited regions to achieve and maintain hepatitis B elimination. |
Increased immunogenicity of avian influenza DNA vaccine delivered to the skin using a microneedle patch.
Kim YC , Song JM , Lipatov AS , Choi SO , Lee JW , Donis RO , Compans RW , Kang SM , Prausnitz MR . Eur J Pharm Biopharm 2012 81 (2) 239-47 Effective public health responses to an influenza pandemic require an effective vaccine that can be manufactured and administered to large populations in the shortest possible time. In this study, we evaluated a method for vaccination against avian influenza virus that uses a DNA vaccine for rapid manufacturing and delivered by a microneedle skin patch for simplified administration and increased immunogenicity. We prepared patches containing 700-mcm long microneedles coated with an avian H5 influenza hemagglutinin DNA vaccine from A/Viet Nam/1203/04 influenza virus. The coating DNA dose increased with DNA concentration in the coating solution and the number of dip-coating cycles. Coated DNA was released into the skin tissue by dissolution within minutes. Vaccination of mice using microneedles induced higher levels of antibody responses and hemagglutination inhibition titers, and improved protection against lethal infection with avian influenza as compared to conventional intramuscular delivery of the same dose of the DNA vaccine. Additional analysis showed that the microneedle coating solution containing carboxymethylcellulose and a surfactant may have negatively affected the immunogenicity of the DNA vaccine. Overall, this study shows that DNA vaccine delivery by microneedles can be a promising approach for improved vaccination to mitigate an influenza pandemic. |
Low-risk human papillomavirus testing and other nonrecommended human papillomavirus testing practices among U.S. health care providers
Lee JW , Berkowitz Z , Saraiya M . Obstet Gynecol 2011 118 (1) 4-13 OBJECTIVE: To assess self-reported human papillomavirus (HPV) DNA testing practices by health care providers and clinics, including nonrecommended practices such as low-risk HPV testing, HPV cotesting in women younger than age 30 years, and HPV reflex testing for high-grade abnormal Pap test results. METHODS: We analyzed responses to a cross-sectional survey of a nationally representative sample of Papanicolaou test providers administered in conjunction with the 2006 National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey. Data analysis was performed on responses from 376 office-based health care providers and 216 outpatient clinics. RESULTS: Overall, 75.5% (95% confidence interval [CI] 68.7-81.2%) of health care providers and 77.2% (95% CI 60.3-88.3%) of clinics reported ever using the HPV DNA test. Of health care providers who used HPV testing, 28.5% (95% CI 21.6-36.6%) used both high-risk and low-risk HPV tests. Most health care providers (59.6%, 95% CI 48.5-69.7%) and clinics (66.0%, 95% CI 48.0-80.3%) used HPV cotesting in women younger than age 30 years. A high percentage of health care providers and clinics performed reflex HPV testing after Pap test results of atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesions (71.4%, 95% CI 63.5-78.3% and 62.8%, 95% CI 49.0-74.9%, respectively) and high-grade squamous intraepithelial lesions (50.7%, 95% CI 42.4-58.9% and 49.0%, 95% CI 33.1-65.2%, respectively), results for which HPV testing is not recommended. CONCLUSION: Many health care providers reported inappropriate uses of HPV testing, which may lead to unnecessary follow-up and increased medical costs without added benefits. Interventions such as eliminating the low-risk HPV test from the U.S. market and educating health care providers and patients on appropriate indications for HPV testing are needed to discourage health care providers from such practices. LEVEL OF EVIDENCE: III. |
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