Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine : Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of the Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine
Study Description: This is a randomized, double-blinded, placebo-controlled, single-center, phase 1 clinical trial of beta-propiolactone (BPL)- inactivated quadruple influenza virus cocktail vaccine (BPL-1357) administered intramuscularly (IM) or intranasally (IN) in 2 doses 28 days apart. Participants will be randomized to one of three groups for treatment assignment. The primary hypothesis is that IN and IM BPL-1357 will be well tolerated.Objectives:Primary Objective:1. To assess the safety of BPL-1357 given IM or IN, compared to placebo.Secondary Objective:To further assess the safety of BPL-1357 given IM or IN, compared to placebo.To assess the immunogenicity of BPL-1357 given IM or IN, compared to placebo.Tertiary Objective:To characterize the systemic and mucosal humoral immune responses induced by BPL-1357 given IM or IN, compared to placebo.To further characterize the immune response induced by BPL-1357 given IM or IN through variable, diversity, and joining (VDJ) gene repertoire analysis, cytokine analysis, cytometry, transcriptomics, and assessment of T-cell responses.To assess the rates of influenza disease among groups given IM or IN BPL-1357 compared to placebo.Endpoints:Primary Endpoints:Type and severity (by grading) of adverse events (AEs) through vaccine 2 (V2) day 28 (D28) [28 days after vaccine dose 2].Type of serious adverse events (SAEs) through V2D28 [28 days after vaccine dose 2].Secondary Endpoints:SafetyType and severity (by grading) of AEs through V2D182 [182 days after vaccine dose 2].Type of SAEs through V2D182 [182 days after vaccine dose 2].ImmunogenicityAntibodies against H1, H3, H5, and H7 head and stalk as measured by hemagglutination inhibition (HAI) or enzyme-linked immunosorbent assay (ELISA) from blood and mucosal samples at V2D28.Antibodies against N1, N3, N8, and N9 as measured by neuraminidase inhibition (NAI) or ELISA from blood and mucosal samples at V2D28.Tertiary Endpoints:Additional antibody titer characterization via:Antibodies against H1, H3, H5, and H7 head and stalk as measured by HAI or ELISA from blood and mucosal samples at V1D7, V1D14, V1D28, V2D7, V2D14, V2D56, and V2D182.Antibodies against N1, N3, N8, and N9 as measured by NAI or ELISA from blood and mucosal samples at V1D7, V1D14, V1D28, V2D7, V2D14, V2D56, and V2D182.Additional immune response characterization via:VDJ gene repertoire analysis.Cytokine analysis.Flow cytometric phenotyping of lymphocytes.Transcriptomic gene expression.T-cell responses.Influenza disease.
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 21. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: August 31, 2021, Last downloaded: ClinicalTrials.gov processed this data on March 27, 2024, Last updated: March 27, 2024 |
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| Study ID: |
NCT05027932 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG000146552 |
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| 245 | 1 | 0 | |a Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine |b Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of the Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine |
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| 520 | |a Study Description: This is a randomized, double-blinded, placebo-controlled, single-center, phase 1 clinical trial of beta-propiolactone (BPL)- inactivated quadruple influenza virus cocktail vaccine (BPL-1357) administered intramuscularly (IM) or intranasally (IN) in 2 doses 28 days apart. Participants will be randomized to one of three groups for treatment assignment. The primary hypothesis is that IN and IM BPL-1357 will be well tolerated.Objectives:Primary Objective:1. To assess the safety of BPL-1357 given IM or IN, compared to placebo.Secondary Objective:To further assess the safety of BPL-1357 given IM or IN, compared to placebo.To assess the immunogenicity of BPL-1357 given IM or IN, compared to placebo.Tertiary Objective:To characterize the systemic and mucosal humoral immune responses induced by BPL-1357 given IM or IN, compared to placebo.To further characterize the immune response induced by BPL-1357 given IM or IN through variable, diversity, and joining (VDJ) gene repertoire analysis, cytokine analysis, cytometry, transcriptomics, and assessment of T-cell responses.To assess the rates of influenza disease among groups given IM or IN BPL-1357 compared to placebo.Endpoints:Primary Endpoints:Type and severity (by grading) of adverse events (AEs) through vaccine 2 (V2) day 28 (D28) [28 days after vaccine dose 2].Type of serious adverse events (SAEs) through V2D28 [28 days after vaccine dose 2].Secondary Endpoints:SafetyType and severity (by grading) of AEs through V2D182 [182 days after vaccine dose 2].Type of SAEs through V2D182 [182 days after vaccine dose 2].ImmunogenicityAntibodies against H1, H3, H5, and H7 head and stalk as measured by hemagglutination inhibition (HAI) or enzyme-linked immunosorbent assay (ELISA) from blood and mucosal samples at V2D28.Antibodies against N1, N3, N8, and N9 as measured by neuraminidase inhibition (NAI) or ELISA from blood and mucosal samples at V2D28.Tertiary Endpoints:Additional antibody titer characterization via:Antibodies against H1, H3, H5, and H7 head and stalk as measured by HAI or ELISA from blood and mucosal samples at V1D7, V1D14, V1D28, V2D7, V2D14, V2D56, and V2D182.Antibodies against N1, N3, N8, and N9 as measured by NAI or ELISA from blood and mucosal samples at V1D7, V1D14, V1D28, V2D7, V2D14, V2D56, and V2D182.Additional immune response characterization via:VDJ gene repertoire analysis.Cytokine analysis.Flow cytometric phenotyping of lymphocytes.Transcriptomic gene expression.T-cell responses.Influenza disease | ||
| 650 | 2 | |a Influenza, Human | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Completed | |
| 650 | 4 | |a Phase: Phase 1 | |
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