Covid19Phase 1NCT05085639
GLS-5310 Vaccine in Healthy Volunteers for the Prevention of SARS-CoV-2 (COVID-19)
A Phase 1 study testing GLS-5130 in people with Covid19 and Healthy, run by GeneOne Life Science, Inc. at 2 sites in Puerto Rico.
Trial summary
Phase I study of the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2 (COVID-19) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- GLS-5130
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesPuerto Rico
- Study dates
- Nov 2021to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years of age
- Able to provide informed consent
- Able and willing to comply with study procedures
- For women of childbearing potential, able and willing to use an approved form of pregnancy prevention during the study
- Negative test result for the presence of SARS-CoV-2 IgM and IgG antibodies, which indicate recent or prior infection
Who cannot join
- Persons involved in the care of patients with COVID-19 and health care workers considered, in the opinion of the investigator, to be at increased risk of infection from SARS-CoV-2
- Persons with symptoms in the past 2 weeks consistent with possible acute SARS-CoV-2 infection to include fever, loss of smell or taste
- Persons diagnosis of type 2 diabetes mellitus
- Persons with a diagnosis of chronic kidney disease
- Persons with a diagnosis of chronic obstructive pulmonary disease (COPD)
- Persons with a diagnosis of heart conditions to include heart failure, coronary artery disease, prior heart attack, cardiomyopathy
Show all 33Show fewer
- Obesity (BMI of 30 kg/m2 or greater)
- Sickle cell disease
- Current or former smoker
- Current or planned pregnancy during the study
- Currently breastfeeding
- Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study, or receipt of a SARS-CoV-2 vaccine that has been approved by the FDA, including vaccines that have received Emergency Use Authorization (EUA)
- Administration of an investigational agent within 90 days of the 1st dose
- Administration of a vaccine within 2 weeks prior to the 1st dose
- Administration of immune globulin within 6 months of enrollment
- Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 6 months from enrollment
- Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater; or the equivalent dose of other systemic corticosteroids
- Treatment within the four weeks prior to enrollment with any drug intended for the prophylaxis or treatment of COVID-19
- Any prior treatment with an anti-SARS-CoV-2 monoclonal antibody or immune serum
- Prior treatment with an anti-IL-6 inhibitor, anti-IL-1 inhibitor, anti-TNF monoclonal antibody, or anti-JAK inhibitor (see Appendix B exclusionary period for specific drugs)
- History of malignancy
- History of transplantation (any organ or bone marrow)
- Current or planned chemotherapy treatment for hematologic or solid tumor during study period
- History of other congenital or acquired immunodeficiency, excluding those with HIV infection who are taking highly active antiretroviral therapy and who have documentation of undetectable serum viral load
- History of PCR-confirmed infection with SARS-CoV-2
- Not willing to allow storage and future use of samples for SARS-CoV-2 related research and who have a CD4 count > 200 cells/µL on two measures at least 3 months apart
- Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness
- Any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint
- History of chronic rhinosinusitis
- History of nasal septal defect or deviated nasal septum
- History of cleft palate
- History of nasal polyps
- History of other disorders that, in the opinion of the investigator, may adversely affect administration of intranasal vaccine
Trial locations and contacts
2 sites in 1 country.
Puerto Rico2 sites
Clinical Research Puerto Rico
San Juan, PR, 00909
Javier Morales, MD
University of Puerto Rico
San Juan, 00963
Ileana Boneta, 787-767-9192
Jorge Santana, MD
About this study
Official title: Phase I Study of the Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Against SARS-CoV-2
Phase I study of the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2 (COVID-19)
Read the detailed description
This Phase I, randomized, placebo-controlled, dose-ranging, single-blind study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration of GLS-5310. Vaccine delivered ID will either be performed by Mantoux injection and followed by suction applied to the skin surface using the Gene-Derm device or Mantous injection alone without applied suction. Vaccine delivered IN will be administered using the MAD300 atomizer.
- Being tested
- GLS-5130, Placebo
- Keywords
- Vaccine, DNA
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLS-5130Biological
GLS-5310 DNA plasmid vaccine
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GLS-5310 1.2 mg (Group 1) | Experimental | GLS-5310 1.2 mg (ID + Gene-Derm) at Day 0 and Week 8 Receives: Biological: GLS-5130 |
| GLS-5310 2.4 mg (Group 2) | Experimental | GLS-5310 1.2 mg (ID + Gene-Derm) + 1.2 mg (IN) at Day 0 and Week 8 Receives: Biological: GLS-5130 |
| GLS-5310 1.2 mg (Group 3) | Experimental | GLS-5310 1.2 mg ID at Day 0 and Week 8 Receives: Biological: GLS-5130 |
| Placebo (Group 4) | Placebo comparator | Placebo (ID + Gene-Derm) at Day 0 and Week 8 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
solicited/unsolicited local and systemic AEs
Measured: Through 56 weeks post vaccination
Geometric mean titer (GMT) of antigen specific antibody titers
Endpoint titer of binding antibody in serum
Measured: Through 56 weeks post vaccination
Secondary outcomes (2)
Evaluation of positive response rate of T cell responses induced by GLS-5310
T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint
Measured: Through 56 weeks post vaccination
Geometric mean titer (GMT) of neutralizing antibody titers
Plaque-reduction neutralizing titer(PRNT) in serum at each timepoint
Measured: Through 56 weeks post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GeneOne Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085639
- Sponsor's protocol ID
- CoV2-002
- Status last verified
- Oct 2021
- First submitted
- 23 Dec 2020
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Against SARS-CoV-2
- ClinicalTrials.gov ID
- NCT05085639
- Acronym / sponsor ID
- CoV2-002
- Keywords
- Vaccine, DNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GeneOne Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I study of the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2 (COVID-19)
Detailed description
This Phase I, randomized, placebo-controlled, dose-ranging, single-blind study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration of GLS-5310. Vaccine delivered ID will either be performed by Mantoux injection and followed by suction applied to the skin surface using the Gene-Derm device or Mantous injection alone without applied suction. Vaccine delivered IN will be administered using the MAD300 atomizer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLS-5310 1.2 mg (Group 1) | Experimental | Biological: GLS-5130GLS-5310 1.2 mg (ID + Gene-Derm) at Day 0 and Week 8 |
| GLS-5310 2.4 mg (Group 2) | Experimental | Biological: GLS-5130GLS-5310 1.2 mg (ID + Gene-Derm) + 1.2 mg (IN) at Day 0 and Week 8 |
| GLS-5310 1.2 mg (Group 3) | Experimental | Biological: GLS-5130GLS-5310 1.2 mg ID at Day 0 and Week 8 |
| Placebo (Group 4) | Placebo comparator | Biological: PlaceboPlacebo (ID + Gene-Derm) at Day 0 and Week 8 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 65 years of age
- Able to provide informed consent
- Able and willing to comply with study procedures
- For women of childbearing potential, able and willing to use an approved form of pregnancy prevention during the study
- Negative test result for the presence of SARS-CoV-2 IgM and IgG antibodies, which indicate recent or prior infection
Key exclusion criteria (33 listed)
- Persons involved in the care of patients with COVID-19 and health care workers considered, in the opinion of the investigator, to be at increased risk of infection from SARS-CoV-2
- Persons with symptoms in the past 2 weeks consistent with possible acute SARS-CoV-2 infection to include fever, loss of smell or taste
- Persons diagnosis of type 2 diabetes mellitus
- Persons with a diagnosis of chronic kidney disease
- Persons with a diagnosis of chronic obstructive pulmonary disease (COPD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLS-5130GLS-5310 DNA plasmid vaccine | Biological | GLS-5310 1.2 mg (Group 1), GLS-5310 1.2 mg (Group 3), GLS-5310 2.4 mg (Group 2) |
| PlaceboPlacebo | Biological | Placebo (Group 4) |
Primary outcome
Incidence of adverse events
Time frame: Through 56 weeks post vaccination
solicited/unsolicited local and systemic AEs
Geometric mean titer (GMT) of antigen specific antibody titers
Time frame: Through 56 weeks post vaccination
Endpoint titer of binding antibody in serum
2 secondary outcomes
Evaluation of positive response rate of T cell responses induced by GLS-5310
Time frame: Through 56 weeks post vaccination
Geometric mean titer (GMT) of neutralizing antibody titers
Time frame: Through 56 weeks post vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLS-5130 in people with Covid19 and Healthy, run by GeneOne Life Science, Inc. at 2 sites in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medical Monitor (610-707-5671, jmaslow@genels.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Through 56 weeks post vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.