Lassa FeverPhase 1NCT03805984
Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
A Phase 1 study testing INO-4500 and CELLECTRA® 2000 in people with Lassa Fever, run by Inovio Pharmaceuticals at 1 site in United States.
Trial summary
This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lassa Fever
- What is being tested?
- INO-4500 and CELLECTRA® 2000
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2019to 21 Oct 2020
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening;
- Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody;
- Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
- Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 6 months following last dose or be post-menopausal or be surgically sterile or have a partner who is sterile.
Who cannot join
- Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 1 month following last dose;
- Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
- Previous receipt of an investigational vaccine product for prevention of Lassa Fever;
- Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
- Audiometry testing that demonstrates a hearing level threshold of 30 dB or greater for any frequency tested between 250 Hz - 8000 Hz;
- Recent (within 6 months) or planned travel to Lassa-endemic region;
- Current or anticipated concomitant immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
About this study
Official title: Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers.
- Conditions
- Lassa Fever
- Being tested
- INO-4500, Placebo, CELLECTRA® 2000
- Keywords
- Healthy volunteer
- Medical subject headings
- Lassa Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-4500Drug
INO-4500 will be administered ID on Day 0 and Week 4.
PlaceboDrug
Also called SSC-0001
Placebo will be administered ID on Day 0 and Week 4.
CELLECTRA® 2000Device
EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
| Study group | Role | What they receive |
|---|---|---|
| INO-4500 Group A | Experimental | Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device Receives: Drug: INO-4500; Device: CELLECTRA® 2000 |
| Placebo Comparator Group A | Placebo comparator | Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device Receives: Drug: Placebo; Device: CELLECTRA® 2000 |
| INO-4500 Group B | Experimental | Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device Receives: Drug: INO-4500; Device: CELLECTRA® 2000 |
| Placebo Comparator Group B | Placebo comparator | Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device Receives: Drug: Placebo; Device: CELLECTRA® 2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs)
Measured: Baseline up to Week 48
Percentage of Participants with Injection Site Reactions
Measured: Day 0 up to Week 48
Incidence of adverse events of special interest
Measured: Baseline up to Week 48
Secondary outcomes (3)
Change from Baseline in Antigen Specific Binding Antibody titers
Measured: Day 0 up to Week 48
Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies
Measured: Day 0 up to Week 48
Change from Baseline in Interferon-Gamma Response Magnitude
Measured: Day 0 up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start9 May 2019
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lassa FeverStudies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inovio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Coalition for Epidemic Preparedness Innovations
- Responsible party
- Sponsor
- Investigators
- Mammen Mammen, MD, FACP, FIDSA, Study director, Inovio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805984
- Sponsor's protocol ID
- LSV-001
- Status last verified
- Nov 2020
- First submitted
- 14 Jan 2019
- Last updated
- 23 Nov 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03805984
- Acronym / sponsor ID
- LSV-001
- Conditions
- Lassa Fever
- Keywords
- Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Coalition for Epidemic Preparedness Innovations
- Study start
- 9 May 2019 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 16 Jan 2019 (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.
This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| INO-4500 Group A | Experimental | Drug: INO-4500, Device: CELLECTRA® 2000Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device |
| Placebo Comparator Group A | Placebo comparator | Drug: Placebo, Device: CELLECTRA® 2000Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device |
| INO-4500 Group B | Experimental | Drug: INO-4500, Device: CELLECTRA® 2000Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device |
| Placebo Comparator Group B | Placebo comparator | Drug: Placebo, Device: CELLECTRA® 2000Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening;
- Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody;
- Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
- Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 6 months following last dose or be post-menopausal or be surgically sterile or have a partner who is sterile.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 1 month following last dose;
- Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
- Previous receipt of an investigational vaccine product for prevention of Lassa Fever;
- Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
- Audiometry testing that demonstrates a hearing level threshold of 30 dB or greater for any frequency tested between 250 Hz - 8000 Hz;
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-4500INO-4500 will be administered ID on Day 0 and Week 4. | Drug | INO-4500 Group A, INO-4500 Group B |
| PlaceboAlso: SSC-0001Placebo will be administered ID on Day 0 and Week 4. | Drug | Placebo Comparator Group A, Placebo Comparator Group B |
| CELLECTRA® 2000EP using the CELLECTRA® 2000 device will be administered following ID drug administration. | Device | INO-4500 Group A, INO-4500 Group B, Placebo Comparator Group A, Placebo Comparator Group B |
Primary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: Baseline up to Week 48
Percentage of Participants with Injection Site Reactions
Time frame: Day 0 up to Week 48
Incidence of adverse events of special interest
Time frame: Baseline up to Week 48
3 secondary outcomes
Change from Baseline in Antigen Specific Binding Antibody titers
Time frame: Day 0 up to Week 48
Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies
Time frame: Day 0 up to Week 48
Change from Baseline in Interferon-Gamma Response Magnitude
Time frame: Day 0 up to Week 48
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 23 Nov 2020.
- Individual participant dataSharing planned: Yes. Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Related trials for Lassa Fever
RecruitingPhase 2
A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa
Lassa Fever
RecruitingPhase 1
A Trial to Evaluate the Safety, Immunogenicity and the Optimal Dose of MOPEVAC-Las Vaccine Candidate Against Lassa Fever
Lassa Fever
Not yet recruitingObservational study
Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - GUINEA
Ebola Hemorrhagic Fever, Lassa Hemorrhagic Fever
RecruitingPhase 2/3
ISTH/ANRS 0409s INTEGRATE Lassa Fever Study
Lassa Fever
RecruitingPhase 2
LAssa Fever Adjunct Treatment With DEXamethasone
Lassa Fever
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.
Mammen Mammen, MD, FACP, FIDSA study director
Inovio Pharmaceuticals
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-4500 and CELLECTRA® 2000 in people with Lassa Fever, run by Inovio Pharmaceuticals at 1 site in United States.
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 4 inclusion and 7 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 23 Nov 2020. 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 United States. 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?
Percentage of Participants with Adverse Events (AEs) (time frame: Baseline up to Week 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2020.