Phase I, Placebo-Controlled, Double-Blind Study To Evaluate The Safety, Tolerability, AND Immunogenicity Of GLS-5700, Administered ID Followed By Electroporation In Dengue Virus-Seropositive Adults
Latest Information Update: 21 Jan 2022
At a glance
- Drugs GLS 5700 (Primary)
- Indications Zika virus infection
- Focus Adverse reactions
- Sponsors GeneOne Life Science
- 12 Mar 2019 According to an Inovio Pharmaceuticals media release, the company expects to have clinical data from several Phase 1 vaccine programs published multiple publications in 2019: Ebola vaccine; MERS vaccine; HIV; and ZIka vaccine study in Puerto Rico.
- 12 Mar 2019 According to an Inovio Pharmaceuticals media release,the company announced that all patient samples have been collected for this trial. Inovio's partner GeneOne is analyzing all samples blindly and will report safety, immune responses and infection rate data from this study in 2019.
- 04 Dec 2018 Status changed from active, no longer recruiting to completed.
Most Recent Events
Trial Overview
Purpose
This trial is evaluating the safety, tolerability, and immunogenicity of GLS-5700. GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus.
Primary Endpoints
Mean change from baseline in safety laboratory measures
safety_issue: Yes
time_frame: Day 0 through Week 24
Incidence of solicited adverse events after vaccination
safety_issue: Yes
time_frame: Day 0 through Week 24
Incidence of unsolicited adverse events after vaccination
safety_issue: Yes
time_frame: Day 0 through Week 24
Incidence of serious adverse events
safety_issue: Yes
time_frame: Day 0 through Week 24
Other Endpoints
Binding antibody titers to Zika envelope
safety_issue: No
time_frame: Day 0 through Week 60 following first dose
Neutralizing antibody response against Zika virus
safety_issue: No
time_frame: Day 0 through Week 60 following first dose
T cell response
safety_issue: No
time_frame: Day 0 through Week 60 following first dose
Mean change from baseline for safety measures and adverse events
safety_issue: No
time_frame: Day 0 through Week 60 [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
Zika virus infection | prevention | - |
Subjects
- Subject Type volunteers
-
Number
Planned: 160
Actual: 160
- Sex male & female
- Age Group 18-65 years; adult
Patient Inclusion Criteria
- Age 18-65 years; - Able to provide consent to participate and having signed an Informed Consent Form (ICF); - Able and willing to comply with all study procedures; - Women of child-bearing potential agree to use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile from enrollment to 3 months following the last injection, or have a partner who is medically unable to induce pregnancy. - Sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception during the study, and agree to continue the use for at least 3 months following the last injection, or have a partner who is permanently sterile or medically unable to become pregnant; - Seropositive for dengue virus infection. - Normal screening ECG or screening ECG with no clinically significant findings; - Screening labs must be within normal limits or have only Grade 0-1 findings, except that creatinine may grade 2 at baseline; - No history of clinically significant immunosuppressive or autoimmune disease. - No history of dengue virus vaccination; no history of yellow fever vaccination - Not currently or within the previous 4 weeks taking immunosuppressive agents (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose less than 10 mg/day, or steroid equivalent).
Patient Exclusion Criteria
- Administration of an investigational compound either currently or within 30 days of first dose; - Previous receipt of an investigational product for the treatment or prevention of Zika virus infection except if subject is verified to have received placebo; - Administration of any vaccine within 4 weeks of first dose; - Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose - Administration of any blood product within 3 months of first dose; - Pregnancy or breast feeding or have plans to become pregnant during the course of the study; - Negative serologic result for dengue virus (any serotype) or history of receipt of either dengue virus or yellow fever virus vaccination at any time in the past; - Positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor; - Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response); - Baseline evidence of kidney disease as measured by creatinine greater than 1.5 (CKD Stage II or greater); - Baseline screening lab(s) with Grade 2 or higher abnormality; - Chronic liver disease or cirrhosis; - Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation; - Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose equal to or greater than 10 mg/day, or steroid equivalent); - Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept; - Prior major surgery or any radiation therapy within 4 weeks of group assignment; - Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome; - Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD) - Metal implants within 20 cm of the planned site(s) of injection; - Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection. - Prisoner or subjects who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness; - Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or - Not willing to allow storage and future use of samples for Zika virus related research - Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT02887482 | ClinicalTrials.gov: US National Institutes of Health |
Zika002 | - |
Organisations
- Sponsors GeneOne Life Science
- Affiliations GeneOne Life Science; Inovio Pharmaceuticals
Trial Dates
-
Initiation Dates
Actual : 01 Aug 2016
-
Primary Completion Dates
Planned : 01 Oct 2017
Actual : 01 Oct 2017
-
End Dates
Planned : 01 Jun 2018
Actual : 01 Jun 2018
Other Details
- Design double-blind; parallel; prospective; randomised
- Phase of Trial Phase I
- Location Puerto Rico
- Focus Adverse reactions
Interventions
Drugs | Route | Formulation |
---|---|---|
GLS 5700Primary Drug | Intradermal |
-
|
GLS-5700
GLS 5700 at 2 mg DNA/dose. GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
Biological: GLS-5700 (GLS 5700 at 2 mg DNA/dose)
Placebo
Placebo at 0 mg DNA/dose
Biological: Placebo
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Celine Remigio, DPT, RN
215-703-5843 cremigio@geneonels-us.com
show details
|
-
|
|
Ileana Boneta
787-767-9192
show details
|
University of Puerto Rico | Puerto-Rico |
Joel Maslow, MD
215-703-5843 jmaslow@geneonels-us.com
show details
|
-
|
|
Michelle Echeandia
787-722-1248
show details
|
Fundacion De Investigation | Puerto-Rico |
Monica Rodriguez
787-592-7018
show details
|
Clinical Research of Puerto Rico | Puerto-Rico |
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
- |
-
|
-
|
Clinical Research of Puerto Rico | Guyama | Puerto-Rico |
Fundacion De Investigation | San Juan | Puerto-Rico |
GeneOne Life Science, Inc. |
-
|
-
|
Inovio Pharmaceuticals |
-
|
-
|
University of Puerto Rico | San Juan | Puerto-Rico |
Trial History
Event Date | Event Type | Comment |
---|---|---|
21 Jan 2022 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 21 Jan 2022 |
12 Mar 2019 | Other trial event | According to an Inovio Pharmaceuticals media release, the company expects to have clinical data from several Phase 1 vaccine programs published multiple publications in 2019: Ebola vaccine; MERS vaccine; HIV; and ZIka vaccine study in Puerto Rico. Updated 19 Mar 2019 |
12 Mar 2019 | Other trial event | According to an Inovio Pharmaceuticals media release,the company announced that all patient samples have been collected for this trial. Inovio's partner GeneOne is analyzing all samples blindly and will report safety, immune responses and infection rate data from this study in 2019. Updated 19 Mar 2019 |
04 Dec 2018 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 12 Dec 2018 |
13 Jun 2017 | Completion date | Planned End Date changed from 1 May 2018 to 1 Jun 2018. Updated 19 Jun 2017 |
13 Jun 2017 | Other trial event | Planned primary completion date changed from 1 Jun 2017 to 1 Oct 2017. Updated 19 Jun 2017 |
13 Jun 2017 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 19 Jun 2017 |
10 May 2017 | Other trial event | According to an Inovio Pharmaceuticals media release, enrollment in this trial is expected to complete by 2Q 2017. Updated 18 May 2017 |
21 Dec 2016 | Other trial event | According to an Inovio Pharmaceuticals media release, based on this and other study (Zika001), company plans to meet with regulators to map out the most efficient path forward to bring our Zika vaccine to patients and help mitigate this widespread Zika outbreak that has expanded into the continental United States. Updated 27 Dec 2016 |
21 Dec 2016 | Other trial event | According to an Inovio Pharmaceuticals media release, results from this study is expected next year. Updated 27 Dec 2016 |
26 Sep 2016 | Other trial event | New source identified and integrated (ClinicalTrials.gov NCT02887482). Updated 26 Sep 2016 |
19 Sep 2016 | New trial record | New trial record Updated 19 Sep 2016 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Inovio Pharmaceuticals. Inovio Pharmaceuticals Reports 2018 Fourth Quarter and Year-End Financial Results. Media-Rel 2019;.
Media Release -
Inovio Pharmaceuticals. Inovio Launches Zika Vaccine Trial in Midst of Puerto Rico Epidemic to Explore Early Signals of Vaccine Efficacy. Media-Rel 2016;.
Media Release -
Inovio Pharmaceuticals. Inovio Pharmaceuticals Reports 2017 First Quarter Financial Results. Media-Rel 2017;.
Media Release -
Inovio Pharmaceuticals. Inovios Zika VaccineGenerates Robust Immune Responses in First Human Study. Media-Rel 2016;.
Media Release
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG