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COVID-19Phase 1NCT05182567

GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19)

A Phase 1 study testing GLS-5310 (Group 1), GLS-5310 (Group 2) and GLS-5310 (Group 3) in people with COVID-19 and Healthy, run by GeneOne Life Science, Inc. at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Phase I study to assess the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine given as a booster to those previously vaccinated against SARS-CoV-2 Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, Healthy
What is being tested?
GLS-5310 (Group 1), GLS-5310 (Group 2) and GLS-5310 (Group 3)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
3 sitesin 2 countries
Study dates
23 May 2022to Dec 2023
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 and agree to refrain from obtaining a booster vaccination with a non-study vaccine through to the 1 month post-boost vaccination visit
  • For women of childbearing potential, able and willing to use an approved form of pregnancy prevention for at least 4 weeks from study drug administration
  • Completion of a prior vaccination series with either the BNT162b2, mRNA-1273, or Ad26.CoV.S vaccines, with or without subsequent booster vaccination, with most recent vaccination at least 6 months prior to study entry

Who cannot join

  • Persons with symptoms in the past 2 weeks consistent with possible acute SARS-CoV-2 infection (https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html)
  • Persons with a 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
  • Sickle cell disease
Show all 28Show fewer
  • Current or planned pregnancy during the study
  • Currently breastfeeding
  • Administration of an investigational agent within 90 days of the GLS-5310 booster dose
  • Administration of a vaccine within 2 weeks prior to the GLS-5310 booster 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 and who have a CD4 count > 200 cells/μL on two measures at least 3 months apart
  • Not willing to allow storage and future use of samples for coronavirus-related research and/or vaccine development
  • 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

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Meridian Clinical Research

    Lincoln, Nebraska, 68510

  • Meridian Clinical Research

    Rockville, Maryland, 20854

Other trials in United States

Puerto Rico1 site

  • Clinical Research Puerto Rico

    San Juan, PR, 00909

Other trials in Puerto Rico

About this study

Official title: Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Given as a Booster to Those Previously Vaccinated Against SARS-CoV-2

Phase I study to assess the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine given as a booster to those previously vaccinated against SARS-CoV-2

Read the detailed description

This Phase I, randomized, placebo-controlled study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration given as a heterologous booster dose to those previously vaccinated against SARS-CoV-2.

Conditions
COVID-19, Healthy
Being tested
GLS-5310 (Group 1), GLS-5310 (Group 2), GLS-5310 (Group 3), GLS-5310 (Group 4)
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-5310 (Group 1)Drug

    GLS-5310 DNA plasmid vaccine

  • GLS-5310 (Group 2)Drug

    GLS-5310 DNA plasmid vaccine

  • GLS-5310 (Group 3)Drug

    GLS-5310 DNA plasmid vaccine

  • GLS-5310 (Group 4)Drug

    GLS-5310 DNA plasmid vaccine

Study groups in NCT05182567
Study groupRoleWhat they receive
GLS-5310 ID + GeneDerm 65 kPa, 30 secondsExperimentalGLS-5310 ID + GeneDerm administered at Visit 1
Receives: Drug: GLS-5310 (Group 1)
GLS-5310 ID + GeneDerm 65 kPa, 30 seconds + GLS-5310 INExperimentalGLS-5310 ID + GeneDerm + GLS-5310 IN administered at Visit 1
Receives: Drug: GLS-5310 (Group 2)
GLS-5310 ID + GeneDerm 65 kPa, 15 secondsExperimentalGLS-5310 ID + GeneDerm administered at Visit 1
Receives: Drug: GLS-5310 (Group 3)
GLS-5310 ID + GeneDerm 80 kPa, 30 secondsExperimentalGLS-5310 ID + GeneDerm administered at Visit 1
Receives: Drug: GLS-5310 (Group 4)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Solicited/unsolicited local and systemic AEs after vaccination

    Measured: Through 48 weeks post vaccination

  2. Determine antibody responses after a single dose of vaccine

    The fold change of SARS-CoV-2 Spike binding antibodies 1-month post-booster

    Measured: Through 48 weeks post vaccination

Secondary outcomes (2)

  1. Evaluation of positive response rate of T cell responses induced by GLS-5310 DNA vaccine

    Measured: Through 48 weeks post vaccination

  2. Evaluation of neutralizing antibody response induced by GLS-5310 relative to treatment arm

    Measured: Through 48 weeks post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start23 May 2022
  3. Primary completion10 Jan 2023
  4. Study completionDec 2023 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05182567
Sponsor's protocol ID
CoV2-008
Status last verified
Feb 2023
First submitted
5 Jan 2022
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GLS-5310 (Group 1), GLS-5310 (Group 2) and GLS-5310 (Group 3) in people with COVID-19 and Healthy, run by GeneOne Life Science, Inc. at 3 sites in 2 countries.

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 28 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Through 48 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?

On the ClinicalTrials.gov record for NCT05182567.

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 13 Sep 2023.

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