NDV-3, a recombinant alum-adjuvanted vaccine for Candida and Staphylococcus aureus, is safe and immunogenic in healthy adults
► NDV-3 is safe and generally well-tolerated in healthy adults. ► NDV-3 elicits quick and robust B- and T-cell immune responses. ► A single dose induces an anamnestic rather than priming immune response. ► T-cell response includes increases in PBMCs producing IFN-γ and/or IL-17A. ► A second dose fur...
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| Published in | Vaccine Vol. 30; no. 52; pp. 7594 - 7600 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier Ltd
14.12.2012
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| Subjects | |
| Online Access | Get full text |
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| Abstract | ► NDV-3 is safe and generally well-tolerated in healthy adults. ► NDV-3 elicits quick and robust B- and T-cell immune responses. ► A single dose induces an anamnestic rather than priming immune response. ► T-cell response includes increases in PBMCs producing IFN-γ and/or IL-17A. ► A second dose further enhances the B- and T-cell immune response.
The investigational vaccine, NDV-3, contains the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p) formulated with an aluminum hydroxide adjuvant in phosphate-buffered saline. Preclinical studies demonstrated that the Als3p vaccine antigen protects mice from oropharyngeal, vaginal and intravenous challenge with C. albicans and other selected species of Candida as well as both intravenous challenge and skin and soft tissue infection with Staphylococcus aureus. The objectives of this first-in-human Phase I clinical trial were to evaluate the safety, tolerability and immunogenicity of NDV-3 at two different antigen levels compared to a saline placebo. Forty healthy, adult subjects were randomized to receive one dose of NDV-3 containing either 30 or 300μg of Als3p, or placebo. NDV-3 at both dose levels was safe and generally well-tolerated. Anti-Als3p total IgG and IgA1 levels for both doses reached peak levels by day 14 post vaccination, with 100% seroconversion of all vaccinated subjects. On average, NDV-3 stimulated peripheral blood mononuclear cell (PBMC) production of both IFN-γ and IL-17A, which peaked at day 7 for subjects receiving the 300μg dose and at day 28 for those receiving the 30μg dose. Six months after receiving the first dose of NDV-3, nineteen subjects received a second dose of NDV-3 identical to their first dose to evaluate memory B- and T-cell immune responses. The second dose resulted in a significant boost of IgG and IgA1 titers in >70% of subjects, with the biggest impact in those receiving the 30μg dose. A memory T-cell response was also noted for IFN-γ in almost all subjects and for IL-17A in the majority of subjects. These data support the continued investigation of NDV-3 as a vaccine candidate against Candida and S. aureus infections. |
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| AbstractList | The investigational vaccine, NDV-3, contains the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p) formulated with an aluminum hydroxide adjuvant in phosphate-buffered saline. Preclinical studies demonstrated that the Als3p vaccine antigen protects mice from oropharyngeal, vaginal and intravenous challenge with C. albicans and other selected species of Candida as well as both intravenous challenge and skin and soft tissue infection with Staphylococcus aureus. The objectives of this first-in-human Phase I clinical trial were to evaluate the safety, tolerability and immunogenicity of NDV-3 at two different antigen levels compared to a saline placebo. Forty healthy, adult subjects were randomized to receive one dose of NDV-3 containing either 30 or 300 μg of Als3p, or placebo. NDV-3 at both dose levels was safe and generally well-tolerated. Anti-Als3p total IgG and IgA1 levels for both doses reached peak levels by day 14 post vaccination, with 100% seroconversion of all vaccinated subjects. On average, NDV-3 stimulated peripheral blood mononuclear cell (PBMC) production of both IFN-γ and IL-17A, which peaked at day 7 for subjects receiving the 300 μg dose and at day 28 for those receiving the 30 μg dose. Six months after receiving the first dose of NDV-3, nineteen subjects received a second dose of NDV-3 identical to their first dose to evaluate memory B- and T-cell immune responses. The second dose resulted in a significant boost of IgG and IgA1 titers in >70% of subjects, with the biggest impact in those receiving the 30 μg dose. A memory T-cell response was also noted for IFN-γ in almost all subjects and for IL-17A in the majority of subjects. These data support the continued investigation of NDV-3 as a vaccine candidate against Candida and S. aureus infections.The investigational vaccine, NDV-3, contains the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p) formulated with an aluminum hydroxide adjuvant in phosphate-buffered saline. Preclinical studies demonstrated that the Als3p vaccine antigen protects mice from oropharyngeal, vaginal and intravenous challenge with C. albicans and other selected species of Candida as well as both intravenous challenge and skin and soft tissue infection with Staphylococcus aureus. The objectives of this first-in-human Phase I clinical trial were to evaluate the safety, tolerability and immunogenicity of NDV-3 at two different antigen levels compared to a saline placebo. Forty healthy, adult subjects were randomized to receive one dose of NDV-3 containing either 30 or 300 μg of Als3p, or placebo. NDV-3 at both dose levels was safe and generally well-tolerated. Anti-Als3p total IgG and IgA1 levels for both doses reached peak levels by day 14 post vaccination, with 100% seroconversion of all vaccinated subjects. On average, NDV-3 stimulated peripheral blood mononuclear cell (PBMC) production of both IFN-γ and IL-17A, which peaked at day 7 for subjects receiving the 300 μg dose and at day 28 for those receiving the 30 μg dose. Six months after receiving the first dose of NDV-3, nineteen subjects received a second dose of NDV-3 identical to their first dose to evaluate memory B- and T-cell immune responses. The second dose resulted in a significant boost of IgG and IgA1 titers in >70% of subjects, with the biggest impact in those receiving the 30 μg dose. A memory T-cell response was also noted for IFN-γ in almost all subjects and for IL-17A in the majority of subjects. These data support the continued investigation of NDV-3 as a vaccine candidate against Candida and S. aureus infections. The investigational vaccine, NDV-3, contains the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p) formulated with an aluminum hydroxide adjuvant in phosphate-buffered saline. Preclinical studies demonstrated that the Als3p vaccine antigen protects mice from oropharyngeal, vaginal and intravenous challenge with C. albicans and other selected species of Candida as well as both intravenous challenge and skin and soft tissue infection with Staphylococcus aureus. The objectives of this first-in-human Phase I clinical trial were to evaluate the safety, tolerability and immunogenicity of NDV-3 at two different antigen levels compared to a saline placebo. Forty healthy, adult subjects were randomized to receive one dose of NDV-3 containing either 30 or 300μg of Als3p, or placebo. NDV-3 at both dose levels was safe and generally well-tolerated. Anti-Als3p total IgG and IgA1 levels for both doses reached peak levels by day 14 post vaccination, with 100% seroconversion of all vaccinated subjects. On average, NDV-3 stimulated peripheral blood mononuclear cell (PBMC) production of both IFN-γ and IL-17A, which peaked at day 7 for subjects receiving the 300μg dose and at day 28 for those receiving the 30μg dose. Six months after receiving the first dose of NDV-3, nineteen subjects received a second dose of NDV-3 identical to their first dose to evaluate memory B- and T-cell immune responses. The second dose resulted in a significant boost of IgG and IgA1 titers in >70% of subjects, with the biggest impact in those receiving the 30μg dose. A memory T-cell response was also noted for IFN-γ in almost all subjects and for IL-17A in the majority of subjects. These data support the continued investigation of NDV-3 as a vaccine candidate against Candida and S. aureus infections. The investigational vaccine, NDV-3, contains the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p) formulated with an aluminum hydroxide adjuvant in phosphate-buffered saline. Preclinical studies demonstrated that the Als3p vaccine antigen protects mice from oropharyngeal, vaginal and intravenous challenge with C. albicans and other selected species of Candida as well as both intravenous challenge and skin and soft tissue infection with Staphylococcus aureus. The objectives of this first-in-human Phase I clinical trial were to evaluate the safety, tolerability and immunogenicity of NDV-3 at two different antigen levels compared to a saline placebo. Forty healthy, adult subjects were randomized to receive one dose of NDV-3 containing either 30 or 300 mu g of Als3p, or placebo. NDV-3 at both dose levels was safe and generally well-tolerated. Anti-Als3p total IgG and IgA1 levels for both doses reached peak levels by day 14 post vaccination, with 100% seroconversion of all vaccinated subjects. On average, NDV-3 stimulated peripheral blood mononuclear cell (PBMC) production of both IFN-[gamma] and IL-17A, which peaked at day 7 for subjects receiving the 300 mu g dose and at day 28 for those receiving the 30 mu g dose. Six months after receiving the first dose of NDV-3, nineteen subjects received a second dose of NDV-3 identical to their first dose to evaluate memory B- and T-cell immune responses. The second dose resulted in a significant boost of IgG and IgA1 titers in >70% of subjects, with the biggest impact in those receiving the 30 mu g dose. A memory T-cell response was also noted for IFN-[gamma] in almost all subjects and for IL-17A in the majority of subjects. These data support the continued investigation of NDV-3 as a vaccine candidate against Candida and S. aureus infections. ► NDV-3 is safe and generally well-tolerated in healthy adults. ► NDV-3 elicits quick and robust B- and T-cell immune responses. ► A single dose induces an anamnestic rather than priming immune response. ► T-cell response includes increases in PBMCs producing IFN-γ and/or IL-17A. ► A second dose further enhances the B- and T-cell immune response. The investigational vaccine, NDV-3, contains the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p) formulated with an aluminum hydroxide adjuvant in phosphate-buffered saline. Preclinical studies demonstrated that the Als3p vaccine antigen protects mice from oropharyngeal, vaginal and intravenous challenge with C. albicans and other selected species of Candida as well as both intravenous challenge and skin and soft tissue infection with Staphylococcus aureus. The objectives of this first-in-human Phase I clinical trial were to evaluate the safety, tolerability and immunogenicity of NDV-3 at two different antigen levels compared to a saline placebo. Forty healthy, adult subjects were randomized to receive one dose of NDV-3 containing either 30 or 300μg of Als3p, or placebo. NDV-3 at both dose levels was safe and generally well-tolerated. Anti-Als3p total IgG and IgA1 levels for both doses reached peak levels by day 14 post vaccination, with 100% seroconversion of all vaccinated subjects. On average, NDV-3 stimulated peripheral blood mononuclear cell (PBMC) production of both IFN-γ and IL-17A, which peaked at day 7 for subjects receiving the 300μg dose and at day 28 for those receiving the 30μg dose. Six months after receiving the first dose of NDV-3, nineteen subjects received a second dose of NDV-3 identical to their first dose to evaluate memory B- and T-cell immune responses. The second dose resulted in a significant boost of IgG and IgA1 titers in >70% of subjects, with the biggest impact in those receiving the 30μg dose. A memory T-cell response was also noted for IFN-γ in almost all subjects and for IL-17A in the majority of subjects. These data support the continued investigation of NDV-3 as a vaccine candidate against Candida and S. aureus infections. The investigational vaccine, NDV-3, contains the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p) formulated with an aluminum hydroxide adjuvant in phosphate-buffered saline. Preclinical studies demonstrated that the Als3p vaccine antigen protects mice from oropharyngeal, vaginal and intravenous challenge with C. albicans and other selected species of Candida as well as both intravenous challenge and skin and soft tissue infection with Staphylococcus aureus. The objectives of this first-in-human Phase I clinical trial were to evaluate the safety, tolerability and immunogenicity of NDV-3 at two different antigen levels compared to a saline placebo. Forty healthy, adult subjects were randomized to receive one dose of NDV-3 containing either 30 or 300 μg of Als3p, or placebo. NDV-3 at both dose levels was safe and generally well-tolerated. Anti-Als3p total IgG and IgA1 levels for both doses reached peak levels by day 14 post vaccination, with 100% seroconversion of all vaccinated subjects. On average, NDV-3 stimulated peripheral blood mononuclear cell (PBMC) production of both IFN-γ and IL-17A, which peaked at day 7 for subjects receiving the 300 μg dose and at day 28 for those receiving the 30 μg dose. Six months after receiving the first dose of NDV-3, nineteen subjects received a second dose of NDV-3 identical to their first dose to evaluate memory B- and T-cell immune responses. The second dose resulted in a significant boost of IgG and IgA1 titers in >70% of subjects, with the biggest impact in those receiving the 30 μg dose. A memory T-cell response was also noted for IFN-γ in almost all subjects and for IL-17A in the majority of subjects. These data support the continued investigation of NDV-3 as a vaccine candidate against Candida and S. aureus infections. The investigational vaccine, NDV-3, contains the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p) formulated with an aluminum hydroxide adjuvant in phosphate-buffered saline. Preclinical studies demonstrated that the Als3p vaccine antigen protects mice from oropharyngeal, vaginal and intravenous challenge with C. albicans and other selected species of Candida as well as both intravenous challenge and skin and soft tissue infection with Staphylococcus aureus. The objectives of this first-in-human Phase I clinical trial were to evaluate the safety, tolerability and immunogenicity of NDV-3 at two different antigen levels compared to a saline placebo. Forty healthy, adult subjects were randomized to receive one dose of NDV-3 containing either 30 or 300 μg of Als3p, or placebo. NDV-3 at both dose levels was safe and generally well-tolerated. Anti-Als3p total IgG and IgA1 levels for both doses reached peak levels by day 14 post vaccination, with 100% seroconversion of all vaccinated subjects. On average, NDV-3 stimulated peripheral blood mononuclear cell (PBMC) production of both IFN-γ and IL-17A, which peaked at day 7 for subjects receiving the 300 μg dose and at day 28 for those receiving the 30 μg dose. Six months after receiving the first dose of NDV-3, nineteen subjects received a second dose of NDV-3 identical to their first dose to evaluate memory B- and T-cell immune responses. The second dose resulted in a significant boost of IgG and IgA1 titers in >70% of subjects, with the biggest impact in those receiving the 30 μg dose. A memory T-cell response was also noted for IFN-γ in almost all subjects and for IL-17A in the majority of subjects. These data support the continued investigation of NDV-3 as a vaccine candidate against Candida and S. aureus infections. Highlights► NDV-3 is safe and generally well-tolerated in healthy adults. ► NDV-3 elicits quick and robust B- and T-cell immune responses. ► A single dose induces an anamnestic rather than priming immune response. ► T-cell response includes increases in PBMCs producing IFN-γ and/or IL-17A. ► A second dose further enhances the B- and T-cell immune response. |
| Author | Yeaman, Michael R. Fu, Yue Edwards Jr, John E. Schmidt, Clint S. Ibrahim, Ashraf S. Filler, Scott G. Hennessey Jr, John P. White, C. Jo |
| AuthorAffiliation | f The David Geffen School of Medicine at UCLA, Los Angeles CA 90024 USA b CJW Consulting, Ambler PA, USA c The Division of Infectious Diseases, Department of Medicine, Harbor-University of California at Los Angeles (UCLA) Medical Center, 1000 West Carson St., Torrance CA 90502, USA a NovaDigm Therapeutics, Inc., 4201 James Ray Drive, Suite 2200, REAC 1 Building, Grand Forks ND 58202, USA d The Division of Molecular Medicine, Department of Medicine, Harbor-University of California at Los Angeles (UCLA) Medical Center, 1000 West Carson St., Torrance CA 90502, USA e Los Angeles Biomedical Research Institute at Harbor-University of California at Los Angeles (UCLA) Medical Center, 1124 West Carson St. Torrance CA 90502 USA |
| AuthorAffiliation_xml | – name: a NovaDigm Therapeutics, Inc., 4201 James Ray Drive, Suite 2200, REAC 1 Building, Grand Forks ND 58202, USA – name: e Los Angeles Biomedical Research Institute at Harbor-University of California at Los Angeles (UCLA) Medical Center, 1124 West Carson St. Torrance CA 90502 USA – name: c The Division of Infectious Diseases, Department of Medicine, Harbor-University of California at Los Angeles (UCLA) Medical Center, 1000 West Carson St., Torrance CA 90502, USA – name: b CJW Consulting, Ambler PA, USA – name: d The Division of Molecular Medicine, Department of Medicine, Harbor-University of California at Los Angeles (UCLA) Medical Center, 1000 West Carson St., Torrance CA 90502, USA – name: f The David Geffen School of Medicine at UCLA, Los Angeles CA 90024 USA |
| Author_xml | – sequence: 1 givenname: Clint S. surname: Schmidt fullname: Schmidt, Clint S. organization: NovaDigm Therapeutics, Inc., 4201 James Ray Drive, Suite 2200, REAC 1 Building, Grand Forks, ND 58202, USA – sequence: 2 givenname: C. Jo surname: White fullname: White, C. Jo organization: CJW Consulting, Ambler, PA, USA – sequence: 3 givenname: Ashraf S. surname: Ibrahim fullname: Ibrahim, Ashraf S. organization: The Division of Infectious Diseases, Department of Medicine, Harbor-University of California at Los Angeles (UCLA) Medical Center, 1000 West Carson St., Torrance, CA 90502, USA – sequence: 4 givenname: Scott G. surname: Filler fullname: Filler, Scott G. organization: The Division of Infectious Diseases, Department of Medicine, Harbor-University of California at Los Angeles (UCLA) Medical Center, 1000 West Carson St., Torrance, CA 90502, USA – sequence: 5 givenname: Yue surname: Fu fullname: Fu, Yue organization: The Division of Infectious Diseases, Department of Medicine, Harbor-University of California at Los Angeles (UCLA) Medical Center, 1000 West Carson St., Torrance, CA 90502, USA – sequence: 6 givenname: Michael R. surname: Yeaman fullname: Yeaman, Michael R. organization: The Division of Infectious Diseases, Department of Medicine, Harbor-University of California at Los Angeles (UCLA) Medical Center, 1000 West Carson St., Torrance, CA 90502, USA – sequence: 7 givenname: John E. surname: Edwards Jr fullname: Edwards Jr, John E. organization: The Division of Infectious Diseases, Department of Medicine, Harbor-University of California at Los Angeles (UCLA) Medical Center, 1000 West Carson St., Torrance, CA 90502, USA – sequence: 8 givenname: John P. surname: Hennessey Jr fullname: Hennessey Jr, John P. email: john_hennessey@novadigm.net organization: NovaDigm Therapeutics, Inc., 4201 James Ray Drive, Suite 2200, REAC 1 Building, Grand Forks, ND 58202, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/23099329$$D View this record in MEDLINE/PubMed |
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| Snippet | ► NDV-3 is safe and generally well-tolerated in healthy adults. ► NDV-3 elicits quick and robust B- and T-cell immune responses. ► A single dose induces an... Highlights► NDV-3 is safe and generally well-tolerated in healthy adults. ► NDV-3 elicits quick and robust B- and T-cell immune responses. ► A single dose... The investigational vaccine, NDV-3, contains the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p) formulated with an... The investigational vaccine, NDV-3, contains the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p) formulated with an... |
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| SubjectTerms | Adjuvants, Immunologic - administration & dosage Adjuvants, Immunologic - adverse effects Adult adults Allergy and Immunology Als3p Alum Compounds - administration & dosage Alum Compounds - adverse effects aluminum hydroxide Antibodies, Fungal - blood antigens B-Lymphocytes - immunology Candida Candida albicans Candida albicans - genetics Candida albicans - immunology clinical trials First-in-human Fungal Vaccines - administration & dosage Fungal Vaccines - adverse effects Fungal Vaccines - genetics Fungal Vaccines - immunology Humans immune response Immunoglobulin A - blood immunoglobulin G Immunoglobulin G - blood interferon-gamma Interferon-gamma - secretion interleukin-17 Interleukin-17 - secretion intravenous injection Leukocytes, Mononuclear - immunology mice Phase 1 Placebos - administration & dosage seroconversion Staphylococcal Vaccines - administration & dosage Staphylococcal Vaccines - adverse effects Staphylococcal Vaccines - genetics Staphylococcal Vaccines - immunology Staphylococcus aureus Staphylococcus aureus - genetics Staphylococcus aureus - immunology T-lymphocytes T-Lymphocytes - immunology vaccination Vaccine vaccines Vaccines, Synthetic - administration & dosage Vaccines, Synthetic - adverse effects Vaccines, Synthetic - genetics Vaccines, Synthetic - immunology |
| Title | NDV-3, a recombinant alum-adjuvanted vaccine for Candida and Staphylococcus aureus, is safe and immunogenic in healthy adults |
| URI | https://www.clinicalkey.com/#!/content/1-s2.0-S0264410X12014843 https://www.clinicalkey.es/playcontent/1-s2.0-S0264410X12014843 https://dx.doi.org/10.1016/j.vaccine.2012.10.038 https://www.ncbi.nlm.nih.gov/pubmed/23099329 https://www.proquest.com/docview/1221853936 https://www.proquest.com/docview/1348488045 https://www.proquest.com/docview/1348488461 https://www.proquest.com/docview/1686729549 https://pubmed.ncbi.nlm.nih.gov/PMC3513491 |
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