Ebola Virus DiseasePhase 1Boost-EBOVNCT04906629
INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees
A Phase 1 study testing INO-4201 in people with Ebola Virus Disease, run by University of Geneva, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- INO-4201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2021to 11 May 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Ebola Virus Disease
- Being tested
- INO-4201, Placebo
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-4201Biological
One dose of 1 mg of INO-4201 in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000
PlaceboBiological
One dose of normal saline in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000
| Study group | Role | What they receive |
|---|---|---|
| INO-4201 | Experimental | One intradermal injection of INO-4201 followed by electroporation Receives: Biological: INO-4201 |
| Placebo | Placebo comparator | One intradermal injection of normal saline followed by electroporation Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Days 0 - 14
Quantitative EBOV-GP-binding IgG antibody responses (GMTs as measured by ELISA) at 4 weeks after injection
Primary immunogenicity outcome
Measured: Days 0 - 28
Secondary outcomes (5)
Occurrence of solicited local and systemic reactogenicity signs and symptoms
Secondary safety outcome
Measured: Days 0 - 14
Occurrence of unsolicited adverse events
Secondary safety outcome
Measured: Days 0 - 28
Occurrence of serious adverse events (SAE)
Secondary safety outcome
Measured: Days 0 - 168
GMTs of EBOV-GP-binding antibodies as measured by ELISA
Secondary immunogenicity outcome
Measured: Weeks 2, 12, 24
GMTs of neutralizing antibodies
Secondary immunogenicity outcome
Measured: Weeks 2, 4, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Sep 2021
- Primary completion5 Jan 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Defense Advanced Research Projects Agency, Global Urgent and Advanced Research and Development (GuardRX), Inovio Pharmaceuticals
- Responsible party
- Principal investigator, Angela HUTTNER, University of Geneva, Switzerland
- Investigators
- Angela Huttner, MD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906629
- Sponsor's protocol ID
- 2020-02774
- Acronym
- Boost-EBOV
- Status last verified
- May 2022
- First submitted
- 25 May 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Huttner A, de La Vega MA, Boehm-Bosmani C, Boyer J, Eberhardt C, Fontannaz P, Gillespie E, Lemeille S, Morrow MP, Nepveu-Traversy ME, Orizu B, Reuschel EL, Roth R, Sharkhith H, Sylvester AJ, Vetter P, Humeau LM, Pignac-Kobinger J, Liebowitz D, Didierlaurent AM, Siegrist CA, Kobinger GP. A phase Ib, placebo-controlled randomized clinical trial of the Ebolavirus DNA vaccine candidate INO-4201 followed by electroporation as booster vaccination in healthy, rVSVDeltaG-ZEBOV-GP-primed volunteers (Boost-EBOV). Clin Microbiol Infect. 2026 Jul;32(7):1158-1164. doi: 10.1016/j.cmi.2026.01.019. Epub 2026 Jan 27.
PubMed 41610955
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04906629
- Acronym / sponsor ID
- Boost-EBOV / 2020-02774
- Conditions
- Ebola Virus Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- Defense Advanced Research Projects Agency, Global Urgent and Advanced Research and Development (GuardRX), Inovio Pharmaceuticals
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INO-4201 | Experimental | Biological: INO-4201One intradermal injection of INO-4201 followed by electroporation |
| Placebo | Placebo comparator | Biological: PlaceboOne intradermal injection of normal saline followed by electroporation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INO-4201One dose of 1 mg of INO-4201 in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000 | Biological | INO-4201 |
| PlaceboOne dose of normal saline in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000 | Biological | Placebo |
Primary outcome
Incidence of adverse events by systemic organ class, preferred term, severity and relationship to investigational product INO-4201 from day 0 to day 14.
Time frame: Days 0 - 14
Primary safety outcome
Quantitative EBOV-GP-binding IgG antibody responses (GMTs as measured by ELISA) at 4 weeks after injection
Time frame: Days 0 - 28
Primary immunogenicity outcome
5 secondary outcomes
Occurrence of solicited local and systemic reactogenicity signs and symptoms
Time frame: Days 0 - 14
Occurrence of unsolicited adverse events
Time frame: Days 0 - 28
Occurrence of serious adverse events (SAE)
Time frame: Days 0 - 168
GMTs of EBOV-GP-binding antibodies as measured by ELISA
Time frame: Weeks 2, 12, 24
GMTs of neutralizing antibodies
Time frame: Weeks 2, 4, 12, 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 41610955Huttner A, de La Vega MA, Boehm-Bosmani C, Boyer J, Eberhardt C, Fontannaz P, Gillespie E, Lemeille S, Morrow MP, Nepveu-Traversy ME, Orizu B, Reuschel EL, Roth R, Sharkhith H, Sylvester AJ, Vetter P, Humeau LM, Pignac-Kobinger J, Liebowitz D, Didierlaurent AM, Siegrist CA, Kobinger GP. A phase Ib, placebo-controlled randomized clinical trial of the Ebolavirus DNA vaccine candidate INO-4201 followed by electroporation as booster vaccination in healthy, rVSVDeltaG-ZEBOV-GP-primed volunteers (Boost-EBOV). Clin Microbiol Infect. 2026 Jul;32(7):1158-1164. doi: 10.1016/j.cmi.2026.01.019. Epub 2026 Jan 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Huttner, MD principal investigator
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INO-4201 in people with Ebola Virus Disease, run by University of Geneva, Switzerland at 1 site in Switzerland.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 by systemic organ class, preferred term, severity and relationship to investigational product INO-4201 from day 0 to day 14. (time frame: Days 0 - 14). 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 NCT04906629, which also lists 1 linked publication.
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 24 May 2022.