A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection
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ClinicalTrials.gov Identifier: NCT04639466 |
Recruitment Status :
Active, not recruiting
First Posted : November 20, 2020
Last Update Posted : November 7, 2023
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 4, 2020 | ||||||
First Posted Date ICMJE | November 20, 2020 | ||||||
Last Update Posted Date | November 7, 2023 | ||||||
Actual Study Start Date ICMJE | November 19, 2020 | ||||||
Estimated Primary Completion Date | November 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Incidence of adverse events [ Time Frame: Up to 365 days ] Evaluated based on the Division of Microbiology and Infectious Diseases criteria.
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||||
Brief Title ICMJE | A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection | ||||||
Official Title ICMJE | Phase 1/2 Dose Escalation Study To Evaluate the Safety and Biologically Effective Dose of GEO-CM04S1, a Synthetic MVA-based SARS-CoV-2 Vaccine, Administered as One or Two Injections or as a Booster to Healthy Adult Volunteers | ||||||
Brief Summary | This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. GEO-CM04S1 was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) into synthetic MVA, which may be able to induce immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The purpose of the Phase 1 study is to determine the safety and the optimal dose of the GEO-CM04S1 vaccine. The Phase 2 study is designed as a multi-center, double-blind, randomized, parallel, study to evaluate the safety profile of 2 dose levels of GEO-CM04S1 as a single booster shot to assess the immune response measured by the fold-increase in antibody against SARS-CoV-2 Spike protein at day 28 post-injection among healthy adult volunteers. |
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Detailed Description | PRIMARY OBJECTIVE: I. Safety and tolerability of the synthetic MVA-based SARS-CoV-2 vaccine GEO-CM04S1 vaccine at three different dose levels (DL): 1.0x10^7 plaque-forming unit (PFU)/dose, 1.0x10^8 PFU/dose, and 2.5x10^8 PFU/dose. (Phase I) II. Evaluate the safety profile of a single-dose vaccine boost at day 7 post-injection of GEO-CM04S1. (Phase II) III. Determine whether the GEO-CM04S1 dose levels tested (1.0x10^7 or 1.0x10^8) generate promising immune responses (>5-fold increase of Spike IgG over baseline) after single-dose booster injection, and select a promising dose to use for further study. (Phase II) SECONDARY OBJECTIVES: I. Longitudinal evaluation of humoral immunity. (Phase I) II. Quality and properties of cellular and humoral immunity elicited as a result of the vaccination. (Phase I) III. Explore the role of two injections versus one injection, and evaluate a placebo group. (Phase I) III. Evaluate T cell-based antigen-specific immune responses at day 28 post-injection of single-dose GEO-CM04S1 vaccine boost. (Phase II) IV. Evaluate SARS-CoV-2 S and N-specific Th1 vs Th2 polarization. (Phase II) V. Assess levels of SARS-CoV-2 neutralizing antibodies and their activity against variants of concern (VOC) or variants of high consequence (VHC). (Phase II) VI. Estimate the durability of antibody-based immune responses in a 12-month time period. (Phase II) VII. Estimate the durability of T-cell-based immune responses in a 12-month time period. (Phase II) VIII. Estimate the incidence of COVID-19 Moderate and Severe disease during follow-up (12 months). (Phase II) IX. Evaluate the potential relationship between duration of immunity and COVID infection (incidence) over the 12-month study period. (Phase II) X. Summarize outcomes, primary and secondary endpoints, based on pre-study mRNA vaccine received. (Phase II) EXPLORATORY OBJECTIVES: I. Surveillance for incidental coronavirus disease 2019 (COVID-19) infection during follow-up (1 year). (Phase I) II. Quality and properties of cellular and humoral immunity elicited as a result of the vaccination. (Phase I) III. Evaluate activated/cycling, cytotoxic/helper, and memory phenotype markers. (Phase II) IV. Estimate SARS-CoV-2-specfic serum IgA and IgG over time. (Phase II) OUTLINE: This is a dose-escalation study. PHASE I: Participants are randomized to 1 of 3 arms. ARM I: Participants receive GEO-CM04S1 intramuscularly (IM) in the non-dominant upper arm on day 0 and day 28 in the absence of unacceptable toxicity. ARM II: Participants receive GEO-CM04S1 IM in the non-dominant upper arm on day 0 and placebo IM in the non-dominant upper arm on day 28 in the absence of unacceptable toxicity. ARM III: Participants receive placebo IM in the non-dominant upper arm on day 0 and day 28 in the absence of unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 arms. ARM I: Participants receive low dose GEO-CM04S1 booster IM in non-dominant upper arm on day 1 in the absence of unacceptable toxicity. ARM II: Participants receive high dose GEO-CM04S1 booster IM in non-dominant upper arm on day 1 in the absence of unacceptable toxicity. During Phase 1, participants are followed up at 7, 14, 28, 35, 42, 56, 90, 120, 180, 270, and 365 days. During Phase 2, participants are followed up at 7, 14, 28, 80, and 365 days. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | COVID-19 Infection | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Estimated Enrollment ICMJE |
189 | ||||||
Original Estimated Enrollment ICMJE |
129 | ||||||
Estimated Study Completion Date ICMJE | September 2024 | ||||||
Estimated Primary Completion Date | November 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Noncompliance
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
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Administrative Information | |||||||
NCT Number ICMJE | NCT04639466 | ||||||
Other Study ID Numbers ICMJE | 20447 NCI-2020-08335 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 20447 ( Other Identifier: City of Hope Medical Center ) P30CA033572 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | GeoVax, Inc. | ||||||
Original Responsible Party | City of Hope Medical Center | ||||||
Current Study Sponsor ICMJE | GeoVax, Inc. | ||||||
Original Study Sponsor ICMJE | City of Hope Medical Center | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | GeoVax, Inc. | ||||||
Verification Date | November 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |