NCT05085639

Brief Summary

Phase I study of the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2 (COVID-19)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Nov 2021

Typical duration for phase_1 covid19

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

December 23, 2020

Last Update Submit

October 18, 2021

Conditions

Covid19Healthy

Keywords

VaccineDNA

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events

    solicited/unsolicited local and systemic AEs

    Through 56 weeks post vaccination

  • Geometric mean titer (GMT) of antigen specific antibody titers

    Endpoint titer of binding antibody in serum

    Through 56 weeks post vaccination

Secondary Outcomes (2)

  • Evaluation of positive response rate of T cell responses induced by GLS-5310

    Through 56 weeks post vaccination

  • Geometric mean titer (GMT) of neutralizing antibody titers

    Through 56 weeks post vaccination

Other Outcomes (2)

  • Determine IgG antibody responses after a single dose of GLS-5310 related to treatment arm

    Through 56 weeks post vaccination

  • Determine IgA antibody responses following vaccination of GLS-5310 related to treatment arm

    Through 56 weeks post vaccination

Study Arms (4)

GLS-5310 1.2 mg (Group 1)

EXPERIMENTAL

GLS-5310 1.2 mg (ID + Gene-Derm) at Day 0 and Week 8

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

Biological: GLS-5130

GLS-5310 1.2 mg (Group 3)

EXPERIMENTAL

GLS-5310 1.2 mg ID at Day 0 and Week 8

Biological: GLS-5130

Placebo (Group 4)

PLACEBO COMPARATOR

Placebo (ID + Gene-Derm) at Day 0 and Week 8

Biological: Placebo

Interventions

GLS-5130BIOLOGICAL

GLS-5310 DNA plasmid vaccine

GLS-5310 1.2 mg (Group 1)GLS-5310 1.2 mg (Group 3)GLS-5310 2.4 mg (Group 2)
PlaceboBIOLOGICAL

Placebo

Placebo (Group 4)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Research Puerto Rico

San Juan, PR, 00909, Puerto Rico

Location

University of Puerto Rico

San Juan, 00963, Puerto Rico

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Medical Monitor

CONTACT

610-707-5671jmaslow@genels.us

Project Manager

CONTACT

914-606-1199dkane@genels.us

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2020

First Posted

October 20, 2021

Study Start

November 1, 2021

Primary Completion

April 1, 2022

Study Completion

December 1, 2022

Last Updated

October 20, 2021

Record last verified: 2021-10

Locations

PR(2)