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  1. Article ; Online: Recombinant full-length Plasmodium falciparum circumsporozoite protein-based vaccine adjuvanted with GLA-LSQ: Results of Phase 1 testing with malaria challenge.

    Friedman-Klabanoff, DeAnna J / Berry, Andrea A / Travassos, Mark A / Shriver, Mallory / Cox, Catherine / Butts, Jessica / Lundeen, Jordan S / Strauss, Kathleen A / Joshi, Sudhaunshu / Shrestha, Biraj / Mo, Annie X / Nomicos, Effie Y H / Deye, Gregory A / Regules, Jason A / Bergmann-Leitner, Elke S / Pasetti, Marcela F / Laurens, Matthew B

    The Journal of infectious diseases

    2024  

    Abstract: Introduction: Malaria is preventable yet causes >600,000 deaths annually. RTS, S, the first marketed malaria vaccine, has modest efficacy, but improvements are needed for eradication.: Methods: We conducted an open-label, dose escalation Phase 1 ... ...

    Abstract Introduction: Malaria is preventable yet causes >600,000 deaths annually. RTS, S, the first marketed malaria vaccine, has modest efficacy, but improvements are needed for eradication.
    Methods: We conducted an open-label, dose escalation Phase 1 study of a recombinant, full-length circumsporozoite protein vaccine (rCSP) administered with adjuvant GLA-LSQ on days 1, 29, and 85 or 1 and 490 to healthy, malaria-naïve adults. Primary endpoints were safety and reactogenicity. Secondary endpoints were antibody responses and Plasmodium falciparum parasitemia after homologous controlled human malaria infection (CHMI).
    Results: Participants were enrolled into four groups receiving rCSP/GLA-LSQ: 10 µg x 3 (n = 20), 30 µg x 3 (n = 10), 60 µg x 3 (n = 10) or 60 µg x 2 (n = 9); ten participants received 30 µg rCSP alone x 3; and six infectivity controls. Participants experienced no serious adverse events. Rates of solicited and unsolicited adverse events were similar among groups. All 26 participants who underwent CHMI 28 days after final vaccinations developed malaria. Increasing vaccine doses induced higher IgG titers, but did not achieve previously established RTS, S benchmarks.
    Conclusions: rCSP/GLA-LSQ had favorable safety results. However, tested regimens did not induce protective immunity. Further investigation could assess if adjuvant or schedule adjustments improve efficacy.
    Trial registration: ClinicalTrials.gov Identifier NCT03589794.
    Language English
    Publishing date 2024-02-08
    Publishing country United States
    Document type Journal Article
    ZDB-ID 3019-3
    ISSN 1537-6613 ; 0022-1899
    ISSN (online) 1537-6613
    ISSN 0022-1899
    DOI 10.1093/infdis/jiae062
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Myrrh: medical marvel or myth of the Magi?

    Nomicos, Effie Y H

    Holistic nursing practice

    2007  Volume 21, Issue 6, Page(s) 308–323

    Abstract: Since antiquity, the genus Commiphora is composed of more than 200 species, and has been exploited as a natural drug to treat pain, skin infections, inflammatory conditions, diarrhea, and periodontal diseases. In more recent history, products derived ... ...

    Abstract Since antiquity, the genus Commiphora is composed of more than 200 species, and has been exploited as a natural drug to treat pain, skin infections, inflammatory conditions, diarrhea, and periodontal diseases. In more recent history, products derived from Commiphora myrrha and various other species of Commiphora are becoming recognized to possess significant antiseptic, anesthetic, and antitumor properties. Traditional practice and evidence-based research have supported that these properties are directly attributable to terpenoids (especially furanosesquiterpenes), the active compounds present in myrrh essential oil. More recently, current studies have focused on applying clinical trial methodologies to validate its use as an antineoplastic, an antiparasitic agent, and as an adjunct in healing wounds.
    MeSH term(s) Anesthetics/therapeutic use ; Anti-Infective Agents, Local/therapeutic use ; Antineoplastic Agents/therapeutic use ; Commiphora/chemistry ; Drug Interactions ; Evidence-Based Medicine ; Humans ; Marketing of Health Services ; Oils, Volatile/chemistry ; Oils, Volatile/pharmacology ; Oils, Volatile/therapeutic use ; Phytotherapy/methods ; Phytotherapy/trends ; Plant Oils/chemistry ; Plant Oils/pharmacology ; Plant Oils/therapeutic use ; Resins, Plant/chemistry ; Resins, Plant/pharmacology ; Resins, Plant/therapeutic use ; Sesquiterpenes/therapeutic use ; Terpenes/chemistry ; Terpenes/pharmacology ; Terpenes/therapeutic use
    Chemical Substances Anesthetics ; Anti-Infective Agents, Local ; Antineoplastic Agents ; Oils, Volatile ; Plant Oils ; Resins, Plant ; Sesquiterpenes ; Terpenes ; myrrh oil (H74221J5J4)
    Language English
    Publishing date 2007-11
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 639032-8
    ISSN 0887-9311
    ISSN 0887-9311
    DOI 10.1097/01.HNP.0000298616.32846.34
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Low dose recombinant full-length circumsporozoite protein-based Plasmodium falciparum vaccine is well-tolerated and highly immunogenic in phase 1 first-in-human clinical testing.

    Friedman-Klabanoff, DeAnna J / Berry, Andrea A / Travassos, Mark A / Cox, Catherine / Zhou, Yingjun / Mo, Annie X / Nomicos, Effie Y H / Deye, Gregory A / Pasetti, Marcela F / Laurens, Matthew B

    Vaccine

    2021  Volume 39, Issue 8, Page(s) 1195–1200

    Abstract: Plasmodium falciparum circumsporozoite protein (CSP) is a major sporozoite surface protein and a key target of pre-erythrocytic malaria subunit vaccines. A full-length recombinant CSP (rCSP) based strategy could be advantageous, as this antigen includes ... ...

    Abstract Plasmodium falciparum circumsporozoite protein (CSP) is a major sporozoite surface protein and a key target of pre-erythrocytic malaria subunit vaccines. A full-length recombinant CSP (rCSP) based strategy could be advantageous, as this antigen includes a region critical to sporozoite cell attachment and hepatocyte invasion. The adjuvant Glucopyranosyl Lipid A-liposome Quillaja saponaria 21 (GLA-LSQ) functions as a TLR4 agonist, promotes antigen-specific T
    MeSH term(s) Animals ; Antibodies, Protozoan ; Antibody Formation ; Humans ; Malaria Vaccines ; Malaria, Falciparum/prevention & control ; Plasmodium falciparum ; Protozoan Proteins ; Vaccines, Synthetic
    Chemical Substances Antibodies, Protozoan ; Malaria Vaccines ; Protozoan Proteins ; Vaccines, Synthetic
    Language English
    Publishing date 2021-01-22
    Publishing country Netherlands
    Document type Clinical Trial, Phase I ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2020.12.023
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.MO 458: Show issues

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  4. Article ; Online: Pharmacokinetics, Safety, and Tolerability of Oxfendazole in Healthy Adults in an Open-Label Phase 1 Multiple Ascending Dose and Food Effect Study.

    Bach, Thanh / Galbiati, Shirley / Kennedy, Jessie K / Deye, Gregory / Nomicos, Effie Y H / Codd, Ellen E / Garcia, Hector H / Horton, John / Gilman, Robert H / Gonzalez, Armando E / Winokur, Patricia / An, Guohua

    Antimicrobial agents and chemotherapy

    2020  Volume 64, Issue 11

    Abstract: Neurocysticercosis and trichuriasis are difficult-to-treat parasitic infections that affect more than 1.5 billion people worldwide. Oxfendazole, a potent broad-spectrum benzimidazole anthelmintic approved for use in veterinary medicine, has shown ... ...

    Abstract Neurocysticercosis and trichuriasis are difficult-to-treat parasitic infections that affect more than 1.5 billion people worldwide. Oxfendazole, a potent broad-spectrum benzimidazole anthelmintic approved for use in veterinary medicine, has shown substantial antiparasitic activity against neurocysticercosis and intestinal helminths in preclinical studies. As part of a program to transition oxfendazole from veterinary medicine to human use, phase I multiple ascending dose and food effect studies were conducted. Thirty-six healthy adults were enrolled in an open-label study which evaluated (i) the pharmacokinetics and safety of oxfendazole following multiple ascending doses of oxfendazole oral suspension at 3, 7.5, and 15 mg/kg once daily for 5 days and (ii) the effect of food on oxfendazole pharmacokinetics and safety after a single 3-mg/kg dose administered following an overnight fast or the consumption of a fatty breakfast. Following multiple oral dose administration, the intestinal absorption of oxfendazole was rapid, with the time to maximum concentration of drug in serum (
    MeSH term(s) Administration, Oral ; Adult ; Area Under Curve ; Benzimidazoles/adverse effects ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Half-Life ; Humans ; Male
    Chemical Substances Benzimidazoles ; oxfendazole (OMP2H17F9E)
    Language English
    Publishing date 2020-10-20
    Publishing country United States
    Document type Clinical Trial, Phase I ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 217602-6
    ISSN 1098-6596 ; 0066-4804
    ISSN (online) 1098-6596
    ISSN 0066-4804
    DOI 10.1128/AAC.01018-20
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Repeated

    von Borstel, Anouk / Chevour, Priyanka / Arsovski, Daniel / Krol, Jelte M M / Howson, Lauren J / Berry, Andrea A / Day, Cheryl L / Ogongo, Paul / Ernst, Joel D / Nomicos, Effie Y H / Boddey, Justin A / Giles, Edward M / Rossjohn, Jamie / Traore, Boubacar / Lyke, Kirsten E / Williamson, Kim C / Crompton, Peter D / Davey, Martin S

    Science translational medicine

    2021  Volume 13, Issue 622, Page(s) eabe7430

    Abstract: ... ...

    Abstract Repeated
    MeSH term(s) Adult ; Australia ; Child ; Humans ; Malaria, Falciparum/parasitology ; Plasmodium falciparum ; Receptors, Antigen, T-Cell, gamma-delta ; T-Lymphocytes
    Chemical Substances Receptors, Antigen, T-Cell, gamma-delta
    Language English
    Publishing date 2021-12-01
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, N.I.H., Intramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2518854-9
    ISSN 1946-6242 ; 1946-6234
    ISSN (online) 1946-6242
    ISSN 1946-6234
    DOI 10.1126/scitranslmed.abe7430
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Pharmacokinetics, Safety, and Tolerability of Oxfendazole in Healthy Volunteers: a Randomized, Placebo-Controlled First-in-Human Single-Dose Escalation Study.

    An, Guohua / Murry, Daryl J / Gajurel, Kiran / Bach, Thanh / Deye, Greg / Stebounova, Larissa V / Codd, Ellen E / Horton, John / Gonzalez, Armando E / Garcia, Hector H / Ince, Dilek / Hodgson-Zingman, Denice / Nomicos, Effie Y H / Conrad, Thomas / Kennedy, Jessie / Jones, Walt / Gilman, Robert H / Winokur, Patricia

    Antimicrobial agents and chemotherapy

    2019  Volume 63, Issue 4

    Abstract: Cysticercosis is a parasitic disease that frequently involves the human central nervous system (CNS), and current treatment options are limited. Oxfendazole, a veterinary medicine belonging to the benzimidazole family of anthelmintic drugs, has ... ...

    Abstract Cysticercosis is a parasitic disease that frequently involves the human central nervous system (CNS), and current treatment options are limited. Oxfendazole, a veterinary medicine belonging to the benzimidazole family of anthelmintic drugs, has demonstrated substantial activity against the tissue stages of
    MeSH term(s) Administration, Oral ; Adolescent ; Adult ; Benzimidazoles/pharmacokinetics ; Biological Availability ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Half-Life ; Healthy Volunteers ; Humans ; Male ; Middle Aged ; Young Adult
    Chemical Substances Benzimidazoles ; benzimidazole (E24GX49LD8) ; oxfendazole (OMP2H17F9E)
    Language English
    Publishing date 2019-03-27
    Publishing country United States
    Document type Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ZDB-ID 217602-6
    ISSN 1098-6596 ; 0066-4804
    ISSN (online) 1098-6596
    ISSN 0066-4804
    DOI 10.1128/AAC.02255-18
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: Gene therapy improves immune function in preadolescents with X-linked severe combined immunodeficiency.

    Chinen, Javier / Davis, Joie / De Ravin, Suk See / Hay, Beverly N / Hsu, Amy P / Linton, Gilda F / Naumann, Nora / Nomicos, Effie Y H / Silvin, Christopher / Ulrick, Jean / Whiting-Theobald, Narda L / Malech, Harry L / Puck, Jennifer M

    Blood

    2007  Volume 110, Issue 1, Page(s) 67–73

    Abstract: Retroviral gene therapy can restore immunity to infants with X-linked severe combined immunodeficiency (XSCID) caused by mutations in the IL2RG gene encoding the common gamma chain (gammac) of receptors for interleukins 2 (IL-2), -4, -7, -9, -15, and -21. ...

    Abstract Retroviral gene therapy can restore immunity to infants with X-linked severe combined immunodeficiency (XSCID) caused by mutations in the IL2RG gene encoding the common gamma chain (gammac) of receptors for interleukins 2 (IL-2), -4, -7, -9, -15, and -21. We investigated the safety and efficacy of gene therapy as salvage treatment for older XSCID children with inadequate immune reconstitution despite prior bone marrow transplant from a parent. Subjects received retrovirus-transduced autologous peripherally mobilized CD34(+) hematopoietic cells. T-cell function significantly improved in the youngest subject (age 10 years), and multilineage retroviral marking occurred in all 3 children.
    MeSH term(s) Genetic Therapy/methods ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Immunity/drug effects ; Infant ; Mutation ; Receptors, Interleukin-2/administration & dosage ; Receptors, Interleukin-2/genetics ; Retroviridae/genetics ; T-Lymphocytes/immunology ; Transduction, Genetic ; Transplantation, Autologous ; X-Linked Combined Immunodeficiency Diseases/genetics ; X-Linked Combined Immunodeficiency Diseases/immunology ; X-Linked Combined Immunodeficiency Diseases/therapy
    Chemical Substances Receptors, Interleukin-2
    Language English
    Publishing date 2007-03-16
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Research Support, N.I.H., Intramural
    ZDB-ID 80069-7
    ISSN 1528-0020 ; 0006-4971
    ISSN (online) 1528-0020
    ISSN 0006-4971
    DOI 10.1182/blood-2006-11-058933
    Database MEDical Literature Analysis and Retrieval System OnLINE

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