INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees

Ebola Virus Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04906629
• Other study ID #: 2020-02774
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2021
• Est. completion date: May 11, 2022

Study information

• Verified date: May 2022
• Source: University of Geneva, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 11, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Has provided written informed consent prior to screening

2. Males and females = 18 years old

3. 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

4. Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening

5. Has an acceptable site for ID electroporation considering the deltoid and anterolateral quadriceps muscles

6. 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:

1. Female volunteers who are pregnant or breastfeeding at screening or prior to dosing

2. Administration of an investigational compound either currently or within 30 days of Day 0

3. Prisoner or volunteers who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness

4. Active drug or alcohol or substance abuse or dependence

5. Planned administration of another Ebola vaccine (including rVSV-ZEBOV and Ad26/MVA-BN-Filo vaccines) during the study period

6. Administration of a live vaccine in the 21 days or an inactivated vaccine in the 14 days before planned injection

7. 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:

1. Acute disease at the time of randomization

2. Active skin lesions at the potential injection site

3. Temperature =38.0°C at the time of randomization

4. Recent receipt of a SARS-CoV-2 vaccine with final dose <4 weeks prior

Related Conditions & MeSH terms

• Ebola Virus Disease
• Hemorrhagic Fever, Ebola
• Virus Diseases

Intervention

Biological:
• INO-4201
One dose of 1 mg of INO-4201 in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000
• Placebo
One dose of normal saline in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (4)

Lead Sponsor	Collaborator
University of Geneva, Switzerland	Defense Advanced Research Projects Agency, Global Urgent and Advanced Research and Development (GuardRX), Inovio Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Days 0 - 14
Primary	Quantitative EBOV-GP-binding IgG antibody responses (GMTs as measured by ELISA) at 4 weeks after injection	Primary immunogenicity outcome	Days 0 - 28
Secondary	Occurrence of solicited local and systemic reactogenicity signs and symptoms	Secondary safety outcome	Days 0 - 14
Secondary	Occurrence of unsolicited adverse events	Secondary safety outcome	Days 0 - 28
Secondary	Occurrence of serious adverse events (SAE)	Secondary safety outcome	Days 0 - 168
Secondary	GMTs of EBOV-GP-binding antibodies as measured by ELISA	Secondary immunogenicity outcome	Weeks 2, 12, 24
Secondary	GMTs of neutralizing antibodies	Secondary immunogenicity outcome	Weeks 2, 4, 12, 24