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INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees (Boost-EBOV)

Primary Purpose

Ebola Virus Disease

Status

Completed

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

INO-4201

Placebo

About this trial

This is an interventional prevention trial for Ebola Virus Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Has provided written informed consent prior to screening
Males and females ≥ 18 years old
Previously vaccinated with a single dose of VSV-ZEBOV at any dose between 10^5 and 10^8 pfu more than 6 months prior to inclusion
Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening
Has an acceptable site for ID electroporation considering the deltoid and anterolateral quadriceps muscles
Is post-menopausal, or surgically sterile, or has a partner who is sterile, or uses a medically effective contraception with a failure rate of <1% per year when used consistently and correctly from screening until 6 months following last dose.

Exclusion Criteria:

Female volunteers who are pregnant or breastfeeding at screening or prior to dosing
Administration of an investigational compound either currently or within 30 days of Day 0
Prisoner or volunteers who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness
Active drug or alcohol or substance abuse or dependence
Planned administration of another Ebola vaccine (including rVSV-ZEBOV and Ad26/MVA-BN-Filo vaccines) during the study period
Administration of a live vaccine in the 21 days or an inactivated vaccine in the 14 days before planned injection
Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, or low-dose methotrexate). Systemic corticosteroids must be discontinued at least 4 weeks prior to first dose.

Temporary exclusion criteria:

Acute disease at the time of randomization
Active skin lesions at the potential injection site
Temperature ≥38.0°C at the time of randomization
Recent receipt of a SARS-CoV-2 vaccine with final dose <4 weeks prior

Sites / Locations

Geneva University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

INO-4201

Placebo

Arm Description

One intradermal injection of INO-4201 followed by electroporation

One intradermal injection of normal saline followed by electroporation

Outcomes

Primary Outcome Measures

Incidence of adverse events by systemic organ class, preferred term, severity and relationship to investigational product INO-4201 from day 0 to day 14.

Primary safety outcome

Quantitative EBOV-GP-binding IgG antibody responses (GMTs as measured by ELISA) at 4 weeks after injection

Primary immunogenicity outcome

Secondary Outcome Measures

Occurrence of solicited local and systemic reactogenicity signs and symptoms

Secondary safety outcome

Occurrence of unsolicited adverse events

Secondary safety outcome

Occurrence of serious adverse events (SAE)

Secondary safety outcome

GMTs of EBOV-GP-binding antibodies as measured by ELISA

Secondary immunogenicity outcome

GMTs of neutralizing antibodies

Secondary immunogenicity outcome

Full Information

NCT ID

NCT04906629

First Posted

May 25, 2021

Last Updated

May 22, 2022

Sponsor

University of Geneva, Switzerland

Collaborators

Defense Advanced Research Projects Agency, Global Urgent and Advanced Research and Development (GuardRX), Inovio Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04906629

Brief Title

INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees

Acronym

Boost-EBOV

Official Title

Phase Ib, Placebo-controlled Randomized Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of INO-4201 Followed by Electroporation as a Booster Vaccination in Healthy Volunteers Who Have Previously Received the VSV-ZEBOV Vaccine

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

January 5, 2022 (Actual)

Study Completion Date

May 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Geneva, Switzerland

Collaborators

Defense Advanced Research Projects Agency, Global Urgent and Advanced Research and Development (GuardRX), Inovio Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Ebola virus disease (EVD) is a serious illness with a high fatality rate. Currently only one vaccine is available, VSV-ZEBOV/Ervebo; this vaccine is clinically effective and has been deployed as a preventive measure during recent Ebola outbreaks. The durability of protection afforded by this vaccine is unknown, however, and it is thought that a booster vaccination may be required to maintain immune responses. Recently, a synthetic DNA vaccine, INO-4201, was tested in humans and showed good immunogenicity and an enhanced safety profile. This study aims to test whether the DNA-based candidate INO-4201 can be used as a booster in healthy volunteers previously vaccinated with VSV-ZEBOV.

Detailed Description

This randomized placebo-controlled phase 1b trial will evaluate the safety, tolerability and immunogenicity of the DNA-based vaccine candidate INO-4201 in healthy adult volunteers who previously received a single injection of VSV-ZEBOV. These participants will be randomized to either INO-4201 or placebo, injected once intradermally (ID) followed by electroporation (EP) with the CELLECTRA2000 device. Volunteers will be observed for 1 hour after vaccination and will attend follow-up visits at the Clinical Trials Unit in the 24 weeks after injection (8 visits in all). Primary outcome parameters are (i) the incidence of adverse events in relationship with INO-4201 from day 0 to 14, and (ii) geometric mean titers (GMT) of EBOV-GP-binding IgG antibodies at 4 weeks post-injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ebola Virus Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

INO-4201

Arm Type

Experimental

Arm Description

One intradermal injection of INO-4201 followed by electroporation

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

One intradermal injection of normal saline followed by electroporation

Intervention Type

Biological

Intervention Name(s)

INO-4201

Intervention Description

One dose of 1 mg of INO-4201 in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

One dose of normal saline in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000

Primary Outcome Measure Information:

Title

Incidence of adverse events by systemic organ class, preferred term, severity and relationship to investigational product INO-4201 from day 0 to day 14.

Description

Primary safety outcome

Time Frame

Days 0 - 14

Title

Quantitative EBOV-GP-binding IgG antibody responses (GMTs as measured by ELISA) at 4 weeks after injection

Description

Primary immunogenicity outcome

Time Frame

Days 0 - 28

Secondary Outcome Measure Information:

Title

Occurrence of solicited local and systemic reactogenicity signs and symptoms

Description

Secondary safety outcome

Time Frame

Days 0 - 14

Title

Occurrence of unsolicited adverse events

Description

Secondary safety outcome

Time Frame

Days 0 - 28

Title

Occurrence of serious adverse events (SAE)

Description

Secondary safety outcome

Time Frame

Days 0 - 168

Title

GMTs of EBOV-GP-binding antibodies as measured by ELISA

Description

Secondary immunogenicity outcome

Time Frame

Weeks 2, 12, 24

Title

GMTs of neutralizing antibodies

Description

Secondary immunogenicity outcome

Time Frame

Weeks 2, 4, 12, 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has provided written informed consent prior to screening Males and females ≥ 18 years old Previously vaccinated with a single dose of VSV-ZEBOV at any dose between 10^5 and 10^8 pfu more than 6 months prior to inclusion Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening Has an acceptable site for ID electroporation considering the deltoid and anterolateral quadriceps muscles Is post-menopausal, or surgically sterile, or has a partner who is sterile, or uses a medically effective contraception with a failure rate of <1% per year when used consistently and correctly from screening until 6 months following last dose. Exclusion Criteria: Female volunteers who are pregnant or breastfeeding at screening or prior to dosing Administration of an investigational compound either currently or within 30 days of Day 0 Prisoner or volunteers who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness Active drug or alcohol or substance abuse or dependence Planned administration of another Ebola vaccine (including rVSV-ZEBOV and Ad26/MVA-BN-Filo vaccines) during the study period Administration of a live vaccine in the 21 days or an inactivated vaccine in the 14 days before planned injection Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, or low-dose methotrexate). Systemic corticosteroids must be discontinued at least 4 weeks prior to first dose. Temporary exclusion criteria: Acute disease at the time of randomization Active skin lesions at the potential injection site Temperature ≥38.0°C at the time of randomization Recent receipt of a SARS-CoV-2 vaccine with final dose <4 weeks prior

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angela Huttner, MD

Organizational Affiliation

University of Geneva

Official's Role

Principal Investigator

Facility Information:

Facility Name

Geneva University Hospitals

City

Geneva

ZIP/Postal Code

1205

Country

Switzerland

12. IPD Sharing Statement

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INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees

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