Evidence map›Paper›PMID 37179166›Full record

ArticleVaccine2023

Hepatitis B vaccine delivered by microneedle patch: Immunogenicity in mice and rhesus macaques.

Youkyung Choi, Grace Sanghee Lee, Song Li, Jeong Woo Lee, Tonya Mixson-Hayden, Jungreem Woo, Dengning Xia, Mark R Prausnitz, Saleem Kamili, Michael A Purdy and 1 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 15 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Youkyung ChoiDivision of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, US Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. Electronic address: brt5@cdc.gov.
Grace Sanghee LeeDivision of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, US Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. Electronic address: qec7@cdc.gov.
Song LiSchool of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA, USA. Electronic address: song.li@chbe.gatech.edu.
Jeong Woo LeeSchool of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA, USA. Electronic address: jwlee@gatech.edu.
Tonya Mixson-HaydenDivision of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, US Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. Electronic address: zdy0@cdc.gov.
Jungreem WooDivision of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, US Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. Electronic address: qdq9@cdc.gov.
Dengning XiaSchool of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA, USA. Electronic address: xiadn@mail.sysu.edu.cn.
Mark R PrausnitzSchool of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA, USA. Electronic address: prausnitz@gatech.edu.
Saleem KamiliDivision of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, US Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. Electronic address: sek6@cdc.gov.
Michael A PurdyDivision of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, US Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. Electronic address: mup3@cdc.gov.
Rania A TohmeGlobal Immunization Division, Centers for Global Health, CDC, Atlanta, GA, USA. Electronic address: ihb1@cdc.gov.
Georgia Institute of Technology · USCenters for Disease Control and Prevention · USNational Center for HIV/AIDS Viral Hepatitis STD and TB Prevention · USCenter for Global Health · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

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.

Indexed as

Hepatitis BHepatitis B VaccinesAdjuvants, ImmunologicAnimalsHepatitis B AntibodiesHepatitis B Surface AntigensMacaca mulattaMiceVaccinationAdjuvants, ImmunologicHepatitis B AntibodiesHepatitis B Surface AntigensHepatitis B VaccinesBirth dose vaccinationCellular and adaptive immune responsesHepatitis B vaccineHost gene expression profile to vaccinationMicroneedle patch delivery

Identifiers

PMID37179166
PMCPMC10961677
OpenAlexW4376598146

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.