A Phase 1/2 Study to Determine Safety and Immunogenicity of Two COVID 19 Vaccines VB10.2129 (RBD Candidate) and VB10.2210 (T Cell Candidate) Previously Vaccinated in Healthy Adult Volunteers : A Phase 1/2, Open Label, Dose Escalation Study to Determine Safety and Immunogenicity of Two (Prophylactic) COVID 19 DNA Vaccine Candidates (VB10.2129 [C1], a RBD Candidate and VB10.2210 [C2], a T Cell Candidate), in Healthy Adult Volunteers
This is an open label, dose escalation, and dose expansion study designed to evaluate the safety, reactogenicity and immunogenicity of two SARS-CoV-2 or COVID-19 DNA plasmid vaccine candidates, VB10.2129 (C1) and VB10.2210 (C2).Part 1 is a dose escalation phase and Part 2 is a dose expansion phase and both vaccine candidates, ie, VB10.2129 (C1) and VB10.2210 (C2) will be tested.Part 1 consist of two arms: one arm with each vaccine candidate and each arm investigating three escalating dose levels.10 subjects previously vaccinated with an mRNA vaccine will be enrolled at each dose level. Each subject will receive two vaccinations 21 days apart (Day 0 and Day 21).In Part 2 is a dose expansion phase with one arm for each candidate; VB10.2129 and VB10.2210, in previously vaccinated healthy subjects only. The dose to be investigated will be selected based on safety and inital immune response data from Part 1. All subjects will be folowed for up to 1 year after the first vaccination..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 11. Apr. 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: October 6, 2021, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024 |
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| Study ID: |
NCT05069623 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG007924100 |
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| 245 | 1 | 0 | |a A Phase 1/2 Study to Determine Safety and Immunogenicity of Two COVID 19 Vaccines VB10.2129 (RBD Candidate) and VB10.2210 (T Cell Candidate) Previously Vaccinated in Healthy Adult Volunteers |b A Phase 1/2, Open Label, Dose Escalation Study to Determine Safety and Immunogenicity of Two (Prophylactic) COVID 19 DNA Vaccine Candidates (VB10.2129 [C1], a RBD Candidate and VB10.2210 [C2], a T Cell Candidate), in Healthy Adult Volunteers |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: October 6, 2021, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024 | ||
| 520 | |a This is an open label, dose escalation, and dose expansion study designed to evaluate the safety, reactogenicity and immunogenicity of two SARS-CoV-2 or COVID-19 DNA plasmid vaccine candidates, VB10.2129 (C1) and VB10.2210 (C2).Part 1 is a dose escalation phase and Part 2 is a dose expansion phase and both vaccine candidates, ie, VB10.2129 (C1) and VB10.2210 (C2) will be tested.Part 1 consist of two arms: one arm with each vaccine candidate and each arm investigating three escalating dose levels.10 subjects previously vaccinated with an mRNA vaccine will be enrolled at each dose level. Each subject will receive two vaccinations 21 days apart (Day 0 and Day 21).In Part 2 is a dose expansion phase with one arm for each candidate; VB10.2129 and VB10.2210, in previously vaccinated healthy subjects only. The dose to be investigated will be selected based on safety and inital immune response data from Part 1. All subjects will be folowed for up to 1 year after the first vaccination. | ||
| 650 | 2 | |a Infections | |
| 650 | 2 | |a Communicable Diseases | |
| 650 | 2 | |a COVID-19 | |
| 650 | 2 | |a Virus Diseases | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Completed | |
| 650 | 4 | |a Phase: Phase 1, Phase 2 | |
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