A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection

NCT04639466 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: 20447NCI-2020-08335P30CA033572
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19 Infection

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events (Phase I)

  Evaluated based on the Division of Microbiology and Infectious Diseases criteria.

  Up to 365 days

• Incidence of adverse events (Phase II)

  Evaluated based on the Division of Microbiology and Infectious Diseases criteria.

  Within the first 7 days following booster injection

• Antibody levels to SARS CoV-2 Spike protein (Phase II)

  Assessed by Ortho VITROS Anti-SARS-CoV-2 IgG Quantitative assay.

  Up to 365 days

• Fold increase of Spike IgG levels (Phase II)

  At 28 days post-injection

Secondary Outcomes (14)

• Humoral immunity (Phase I)

  During 1 year of observation

• Level of SARS-CoV-2-specfic neutralizing antibodies (Phase I)

  Up to 365 days

• Th1 vs Th2 polarization (Phase I)

  Up to 365 days

• SARS-CoV-2- antigen specific T cell responses to the COH04S1 vaccine (Phase I)

  Up to 365 days

• Evolution of activated/cycling and memory phenotype markers on the surface of SARS-CoV-2- specific T cells elicited as a result of the COH04S1 vaccination (Phase I)

  Up to 365 days

Other Outcomes (7)

• Incidence of coronavirus 2019 (COVID-19) infection (Phase I)

  Up to 365 days

• Severity of COVID-19 and resolution (Phase I)

  Up to 365 days

• Incidence of COVID-19 in placebo group (Phase I)

  Up to 365 days

Study Arms (5)

Phase I Arm I (COH04S1)

EXPERIMENTAL

Participants receive COH04S1 IM in the non-dominant upper arm on day 0 and day 28 in the absence of unacceptable toxicity.

Biological: Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1

Phase I Arm II (COH04S1, placebo)

ACTIVE COMPARATOR

Participants receive COH04S1 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.

Drug: Placebo Administration; Biological: Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1

Phase I Arm III (placebo)

PLACEBO COMPARATOR

Participants receive placebo IM in the non-dominant upper arm on day 0 and day 28 in the absence of unacceptable toxicity.

Drug: Placebo Administration

Phase II Arm I (low dose COH04S1 booster)

EXPERIMENTAL

Participants receive low dose COH04S1 booster IM in non-dominant upper arm on day 1 in the absence of unacceptable toxicity.

Biological: Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1

Phase II Arm II (high dose COH04S1 booster)

EXPERIMENTAL

Participants receive high dose COH04S1 booster IM in non-dominant upper arm on day 1 in the absence of unacceptable toxicity.

Biological: Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1

Interventions

Placebo Administration DRUG

Given IM in the non-dominant upper arm

Phase I Arm II (COH04S1, placebo); Phase I Arm III (placebo)

Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1 BIOLOGICAL

Given IM in the non-dominant upper arm

Also known as: COH04S1, SARS-CoV-2 Vaccine COH04S1, sMVA-based SARS-CoV-2 Vaccine COH04S1, GEO-CM04S1

Phase I Arm I (COH04S1); Phase I Arm II (COH04S1, placebo); Phase II Arm I (low dose COH04S1 booster); Phase II Arm II (high dose COH04S1 booster)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• PHASE I: Documented informed consent of the participant
• PHASE I: Age: \>= 18 years and \< 55 years
• PHASE I: Ability to read and understand English, Spanish, or Mandarin for consenting
• PHASE I: Platelets \>= 100,000/mm\^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• PHASE I: White blood cells (WBCs) 3,600-10,100/mm\^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• PHASE I: Total bilirubin \< 1.1 x upper limit of normal (ULN) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• PHASE I: Aspartate aminotransferase (AST) \< 1.5 x ULN (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• PHASE I: Alanine aminotransferase (ALT) \< 1.5 x ULN (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• PHASE I: Alkaline phosphatase (AP) \< 1.1 x ULN (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• PHASE I: Blood urea nitrogen (BUN) \< 1.25 x ULN (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• PHASE I: Creatinine less than or equal to the ULN (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• PHASE I: Sodium 137-145 mEq/L (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• PHASE I: Potassium 3.5-5.1 mEq/L (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• PHASE I: Carbon dioxide 22-30 mmol/L (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• PHASE I: Glucose 80-128 mg/dL (within 30 days prior to day 0 of protocol therapy unless otherwise stated)

You may not qualify if:

• PHASE I: Participants at increased risk of exposure to SARS-CoV-2, such as patient-facing health care workers and emergency responders are excluded
• PHASE I: Participants who would be at higher risk for severe COVID-19 according to known risk factors are excluded e.g. type 2 diabetes, obesity (body mass index \[BMI\] \>= 35), congestive heart failure (New York Heart Association class \>= I), history of coronary artery disease, or chronic obstructive pulmonary disease
• PHASE I: Participants using investigational or licensed agents that may prevent or treat SARS-CoV-2 are excluded
• PHASE I: Participants are excluded, who have any history of allergic diatheses as defined by a history of asthma, anaphylaxis, or generalized urticaria, or by daily use of antihistamines, episodic (more than once in past 3 months) inhalational medications including steroidal agents, non-steroidal agents, or cromolyn sodium
• PHASE I: Any previous condition, or one that becomes known during the screening period, which would suggest that the technicians and health professionals involved in the study would be exposed to specific infectious risk
• PHASE I: Surgery in past 6 months that required general anesthesia. Minor procedures, such as dental surgery and superficial diagnostic biopsies, are permitted
• PHASE I: Taking daily medications for chronic or intercurrent illness. Medications excluded from this rule are: thyroid replacement, estrogen replacement, dietary vitamins and protein supplements, mild anti-depressant and anxiety medication, and any medication not known or likely to be immunosuppressive, as determined by the P.I.
• PHASE I: Participants who have had a live vaccine =\< 30 days prior to administration of study vaccine or subjects who are =\< 2 weeks within administration of inactivated vaccines (e.g. influenza vaccine). Flu shots are allowed \> 2 weeks before the first injection and \> 2 weeks post 2nd injection
• PHASE I: Treatment with medication for high cholesterol or other lipid abnormality. Prophylactic medication is acceptable
• PHASE I: History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
• PHASE I: History of adverse event with a prior smallpox vaccination
• PHASE I: Participants are excluded who have history of cancer other than basal cell skin cancer, or any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc. as determined by the P.I.)
• PHASE I: Participants with severe migraine headaches (more than one per month on average in the past 6 months or requiring preventive medication) are excluded but those on effective medication (less than one migraine per month) are allowed to enroll
• PHASE I: History of heart disease, e.g. previous treated arrhythmia or myocardial infarction
• PHASE I: Horizontal positioning- induced or activities of normal living exercise-induced shortness of breath

Sponsors & Collaborators

• GeoVax, Inc.: lead

Study Sites (3)

EmVenio Research

Claremont, California, 91711, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Millennium Clinical Trials

Thousand Oaks, California, 91360, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

COH04S1 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chief Medical Officer

  GeoVax, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 20, 2020
• Study Start: November 19, 2020
• Primary Completion: October 31, 2025
• Study Completion: December 3, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (3)