A pilot clinical trial of a near‐infrared laser vaccine adjuvant: safety, tolerability, and cutaneous immune cell trafficking
ABSTRACT Many vaccines require adjuvants to enhance immunogenicity, but there are few safe and effective intradermal (i.d.) adjuvants. Murine studies have validated the potency of laser illumination of skin as an adjuvant for i.d. vaccination with advantages over traditional adjuvants. We report a p...
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| Veröffentlicht in: | The FASEB journal 2019-02, Vol.33 (2), p.3074-3081 |
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| creator | Gelfand, Jeffrey A. Nazarian, Rosalynn M. Kashiwagi, Satoshi Brauns, Timothy Martin, Brent Kimizuka, Yoshifumi Korek, Skylar Botvinick, Elliot Elkins, Kristen Thomas, Logan Locascio, Joseph Parry, Blair Kelly, Kristen M. Poznansky, Mark C. |
| description | ABSTRACT
Many vaccines require adjuvants to enhance immunogenicity, but there are few safe and effective intradermal (i.d.) adjuvants. Murine studies have validated the potency of laser illumination of skin as an adjuvant for i.d. vaccination with advantages over traditional adjuvants. We report a pilot clinical trial of low‐power, continuous‐wave, near‐infrared laser adjuvant treatment, representing the first human trial of the safety, tolerability, and cutaneous immune cell trafficking changes produced by the laser adjuvant. In this trial we demonstrated a maximum tolerable energy dose of 300 J/cm2 to a spot on the lower back. The irradiated spot was biopsied 4 h later, as was a control spot. Paired biopsies were submitted for histomorphologic and immunohistochemical evaluation in a blinded fashion as well as quantitative PCR analysis for chemokines and cytokines. Similar to prior murine studies, highly significant reductions in CD1a+ Langerhans cells in the dermis and CD11c+ dermal dendritic cells were observed, corresponding to the increased migratory activity of these cells; changes in the epidermis were not significant. There was no evidence of skin damage. The laser adjuvant is a safe, well‐tolerated adjuvant for i.d. vaccination in humans and results in significant cutaneous immune cell trafficking.—Gelfand, J. A., Nazarian, R. M., Kashiwagi, S., Brauns, T., Martin, B., Kimizuka, Y., Korek, S., Botvinick, E., Elkins, K., Thomas, L., Locascio, J., Parry, B., Kelly, K.M., Poznansky, M.C. A pilot clinical trial of a near‐infrared laser vaccine adjuvant: safety, tolerability, and cutaneous immune cell trafficking. FASEB J. 33, 3074–3081 (2019). www.fasebj.org |
| doi_str_mv | 10.1096/fj.201801095R |
| format | Article |
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Many vaccines require adjuvants to enhance immunogenicity, but there are few safe and effective intradermal (i.d.) adjuvants. Murine studies have validated the potency of laser illumination of skin as an adjuvant for i.d. vaccination with advantages over traditional adjuvants. We report a pilot clinical trial of low‐power, continuous‐wave, near‐infrared laser adjuvant treatment, representing the first human trial of the safety, tolerability, and cutaneous immune cell trafficking changes produced by the laser adjuvant. In this trial we demonstrated a maximum tolerable energy dose of 300 J/cm2 to a spot on the lower back. The irradiated spot was biopsied 4 h later, as was a control spot. Paired biopsies were submitted for histomorphologic and immunohistochemical evaluation in a blinded fashion as well as quantitative PCR analysis for chemokines and cytokines. Similar to prior murine studies, highly significant reductions in CD1a+ Langerhans cells in the dermis and CD11c+ dermal dendritic cells were observed, corresponding to the increased migratory activity of these cells; changes in the epidermis were not significant. There was no evidence of skin damage. The laser adjuvant is a safe, well‐tolerated adjuvant for i.d. vaccination in humans and results in significant cutaneous immune cell trafficking.—Gelfand, J. A., Nazarian, R. M., Kashiwagi, S., Brauns, T., Martin, B., Kimizuka, Y., Korek, S., Botvinick, E., Elkins, K., Thomas, L., Locascio, J., Parry, B., Kelly, K.M., Poznansky, M.C. A pilot clinical trial of a near‐infrared laser vaccine adjuvant: safety, tolerability, and cutaneous immune cell trafficking. FASEB J. 33, 3074–3081 (2019). www.fasebj.org</description><identifier>ISSN: 0892-6638</identifier><identifier>EISSN: 1530-6860</identifier><identifier>DOI: 10.1096/fj.201801095R</identifier><identifier>PMID: 30192655</identifier><language>eng</language><publisher>United States: Federation of American Societies for Experimental Biology</publisher><subject>Adjuvants, Immunologic - administration & dosage ; Adolescent ; Adult ; Cells, Cultured ; dendritic cell ; Dendritic Cells - immunology ; Dendritic Cells - radiation effects ; Female ; Humans ; Injections, Intradermal ; intradermal vaccination ; Langerhans cell ; Lasers ; Male ; Maximum Tolerated Dose ; Middle Aged ; Pilot Projects ; Skin - immunology ; Skin - radiation effects ; Vaccination ; Vaccines - administration & dosage ; Vaccines - immunology ; Young Adult</subject><ispartof>The FASEB journal, 2019-02, Vol.33 (2), p.3074-3081</ispartof><rights>FASEB</rights><rights>FASEB 2019 FASEB</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c505R-cf5ff51fcaed27af69cc10aa53cafb1c7048d05514bd29c63e6fdfe625d0c2d23</citedby><cites>FETCH-LOGICAL-c505R-cf5ff51fcaed27af69cc10aa53cafb1c7048d05514bd29c63e6fdfe625d0c2d23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1096%2Ffj.201801095R$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1096%2Ffj.201801095R$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30192655$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gelfand, Jeffrey A.</creatorcontrib><creatorcontrib>Nazarian, Rosalynn M.</creatorcontrib><creatorcontrib>Kashiwagi, Satoshi</creatorcontrib><creatorcontrib>Brauns, Timothy</creatorcontrib><creatorcontrib>Martin, Brent</creatorcontrib><creatorcontrib>Kimizuka, Yoshifumi</creatorcontrib><creatorcontrib>Korek, Skylar</creatorcontrib><creatorcontrib>Botvinick, Elliot</creatorcontrib><creatorcontrib>Elkins, Kristen</creatorcontrib><creatorcontrib>Thomas, Logan</creatorcontrib><creatorcontrib>Locascio, Joseph</creatorcontrib><creatorcontrib>Parry, Blair</creatorcontrib><creatorcontrib>Kelly, Kristen M.</creatorcontrib><creatorcontrib>Poznansky, Mark C.</creatorcontrib><title>A pilot clinical trial of a near‐infrared laser vaccine adjuvant: safety, tolerability, and cutaneous immune cell trafficking</title><title>The FASEB journal</title><addtitle>FASEB J</addtitle><description>ABSTRACT
Many vaccines require adjuvants to enhance immunogenicity, but there are few safe and effective intradermal (i.d.) adjuvants. Murine studies have validated the potency of laser illumination of skin as an adjuvant for i.d. vaccination with advantages over traditional adjuvants. We report a pilot clinical trial of low‐power, continuous‐wave, near‐infrared laser adjuvant treatment, representing the first human trial of the safety, tolerability, and cutaneous immune cell trafficking changes produced by the laser adjuvant. In this trial we demonstrated a maximum tolerable energy dose of 300 J/cm2 to a spot on the lower back. The irradiated spot was biopsied 4 h later, as was a control spot. Paired biopsies were submitted for histomorphologic and immunohistochemical evaluation in a blinded fashion as well as quantitative PCR analysis for chemokines and cytokines. Similar to prior murine studies, highly significant reductions in CD1a+ Langerhans cells in the dermis and CD11c+ dermal dendritic cells were observed, corresponding to the increased migratory activity of these cells; changes in the epidermis were not significant. There was no evidence of skin damage. The laser adjuvant is a safe, well‐tolerated adjuvant for i.d. vaccination in humans and results in significant cutaneous immune cell trafficking.—Gelfand, J. A., Nazarian, R. M., Kashiwagi, S., Brauns, T., Martin, B., Kimizuka, Y., Korek, S., Botvinick, E., Elkins, K., Thomas, L., Locascio, J., Parry, B., Kelly, K.M., Poznansky, M.C. A pilot clinical trial of a near‐infrared laser vaccine adjuvant: safety, tolerability, and cutaneous immune cell trafficking. FASEB J. 33, 3074–3081 (2019). www.fasebj.org</description><subject>Adjuvants, Immunologic - administration & dosage</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Cells, Cultured</subject><subject>dendritic cell</subject><subject>Dendritic Cells - immunology</subject><subject>Dendritic Cells - radiation effects</subject><subject>Female</subject><subject>Humans</subject><subject>Injections, Intradermal</subject><subject>intradermal vaccination</subject><subject>Langerhans cell</subject><subject>Lasers</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Middle Aged</subject><subject>Pilot Projects</subject><subject>Skin - immunology</subject><subject>Skin - radiation effects</subject><subject>Vaccination</subject><subject>Vaccines - administration & dosage</subject><subject>Vaccines - immunology</subject><subject>Young Adult</subject><issn>0892-6638</issn><issn>1530-6860</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kVFPFDEQgBuikQN99NX0B7jQdmnZ1cQECIcaEhOE52Zu2sGeve6lu3vmnuQn8Bv9JfZygvjiy0wm_eabZoax11IcSNGaQ5ofKCEbUQp9tcMmUteiMo0Rz9hENK2qjKmbXbbX93MhCiXNC7ZbC9kqo_WE_TzhyxC7gWMMKSBEPuRQYkccePKQf93dh0QZsnc8Qu8zXwFiSJ6Dm48rSMM73gP5Yf2WD130GWYhhk0FyXEcB0i-G3seFouxNKGPmxFAFPB7SLcv2XOC2PtXf_I-u5meX599rC6_XHw6O7msUAt9VSFpIi0JwTt1DGRaRCkAdI1AM4nH4qhxQmt5NHOqRVN7Q468UdoJVE7V--zD1rscZwvv0KfyiWiXOSwgr20Hwf77ksI3e9utrKnrpmyqCKqtAHPX99nTY68UdnMJS3P79xKFf_N04CP9sPoCvN8CP0L06__b7PTrqZp-fqL_DfrUm1I</recordid><startdate>201902</startdate><enddate>201902</enddate><creator>Gelfand, Jeffrey A.</creator><creator>Nazarian, Rosalynn M.</creator><creator>Kashiwagi, Satoshi</creator><creator>Brauns, Timothy</creator><creator>Martin, Brent</creator><creator>Kimizuka, Yoshifumi</creator><creator>Korek, Skylar</creator><creator>Botvinick, Elliot</creator><creator>Elkins, Kristen</creator><creator>Thomas, Logan</creator><creator>Locascio, Joseph</creator><creator>Parry, Blair</creator><creator>Kelly, Kristen M.</creator><creator>Poznansky, Mark C.</creator><general>Federation of American Societies for Experimental Biology</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>201902</creationdate><title>A pilot clinical trial of a near‐infrared laser vaccine adjuvant: safety, tolerability, and cutaneous immune cell trafficking</title><author>Gelfand, Jeffrey A. ; 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Many vaccines require adjuvants to enhance immunogenicity, but there are few safe and effective intradermal (i.d.) adjuvants. Murine studies have validated the potency of laser illumination of skin as an adjuvant for i.d. vaccination with advantages over traditional adjuvants. We report a pilot clinical trial of low‐power, continuous‐wave, near‐infrared laser adjuvant treatment, representing the first human trial of the safety, tolerability, and cutaneous immune cell trafficking changes produced by the laser adjuvant. In this trial we demonstrated a maximum tolerable energy dose of 300 J/cm2 to a spot on the lower back. The irradiated spot was biopsied 4 h later, as was a control spot. Paired biopsies were submitted for histomorphologic and immunohistochemical evaluation in a blinded fashion as well as quantitative PCR analysis for chemokines and cytokines. Similar to prior murine studies, highly significant reductions in CD1a+ Langerhans cells in the dermis and CD11c+ dermal dendritic cells were observed, corresponding to the increased migratory activity of these cells; changes in the epidermis were not significant. There was no evidence of skin damage. The laser adjuvant is a safe, well‐tolerated adjuvant for i.d. vaccination in humans and results in significant cutaneous immune cell trafficking.—Gelfand, J. A., Nazarian, R. M., Kashiwagi, S., Brauns, T., Martin, B., Kimizuka, Y., Korek, S., Botvinick, E., Elkins, K., Thomas, L., Locascio, J., Parry, B., Kelly, K.M., Poznansky, M.C. A pilot clinical trial of a near‐infrared laser vaccine adjuvant: safety, tolerability, and cutaneous immune cell trafficking. FASEB J. 33, 3074–3081 (2019). www.fasebj.org</abstract><cop>United States</cop><pub>Federation of American Societies for Experimental Biology</pub><pmid>30192655</pmid><doi>10.1096/fj.201801095R</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adjuvants, Immunologic - administration & dosage Adolescent Adult Cells, Cultured dendritic cell Dendritic Cells - immunology Dendritic Cells - radiation effects Female Humans Injections, Intradermal intradermal vaccination Langerhans cell Lasers Male Maximum Tolerated Dose Middle Aged Pilot Projects Skin - immunology Skin - radiation effects Vaccination Vaccines - administration & dosage Vaccines - immunology Young Adult |
| title | A pilot clinical trial of a near‐infrared laser vaccine adjuvant: safety, tolerability, and cutaneous immune cell trafficking |
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