Lassa FeverPhase 1NCT04093076
Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
A Phase 1 study testing INO-4500 and CELLECTRA™ 2000 in people with Lassa Fever, run by Inovio Pharmaceuticals at 1 site in Ghana.
Trial summary
This is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana. 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
- 220 participants
- Where
- 1 siteGhana
- Study dates
- 27 Jan 2021to 14 Oct 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 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);
- Must meet one of the following criteria with respect to reproductive capacity: Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, participants should wait six (6) months post-vasectomy prior to enrolling. Women who are post-menopausal as defined by absence of menstruation for ≥ 12 months. Use of medically effective contraception when used consistently and correctly from Screening until three (3) months following last dose.
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 three (3) months following last dose;
- Positive serum pregnancy test during Screening or positive urine pregnancy test prior to any dosing;
- 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;
- Audiometry testing that demonstrates a hearing level threshold greater than 30 dB for any frequency tested between 500 Hz - 8000 Hz;
- Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
- Current or anticipated concomitant immunosuppressive therapy;
- Fever with or without cough or any other concurrent illness which the principal investigator feels is contraindicated to clinical trial participation.
Trial locations and contacts
1 site in 1 country.
Ghana1 site
Noguchi Memorial Institute for Medical Research, University of Ghana
Legon, Accra
About this study
Official title: Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana
This is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.
- Conditions
- Lassa Fever
- Being tested
- INO-4500, CELLECTRA™ 2000, Placebo
- 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.
CELLECTRA™ 2000Device
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.
PlaceboDrug
Also called SSC-0001
Placebo will be administered ID on Day 0 and Week 4.
| 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 |
| 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 in two acceptable locations in two different limbs at each dosing visit. Receives: Drug: INO-4500; Device: CELLECTRA™ 2000 |
| Placebo Group C | Placebo comparator | Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device. Receives: Device: CELLECTRA™ 2000; Drug: Placebo |
| Placebo Group D | Placebo comparator | Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.. Receives: Device: CELLECTRA™ 2000; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
Measured: Baseline up to Week 48
Number of Participants with Injection Site Reactions
Measured: Day 0 up to Week 48
Number of Participants with Adverse Events of Special Interest (AESIs)
Measured: Baseline up to Week 48
Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies
Measured: Day 0 up to Week 48
Change from Baseline in Lassa virus (LASV) Neutralization Assays
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 posted17 Sep 2019
- Study start27 Jan 2021
- Primary completion14 Oct 2022
- Study completion14 Oct 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 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 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
- Bonaventure Orizu, MD, Study director, Inovio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093076
- Sponsor's protocol ID
- LSV-002
- Status last verified
- Nov 2022
- First submitted
- 16 Sep 2019
- Last updated
- 21 Nov 2022
- 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.
Publications
Koram KA, Walker KA, Orizu B, Marrero I, Boyer J, Yang S, Broderick KE, Kusi KA, Kyei-Baafour E, Ofori EA, Pobee A, Adu-Amankwah S, Amoakoh-Coleman M, Amoakoh HB, Abuaku B, Badji E, Ntiri M, Quaye L, Morrow MP, Sylvester AJ, Reuschel EL, Gillespie E, Liebowitz D, Humeau LM. Safety, tolerability, and immunogenicity of INO-4500, a synthetic DNA-based vaccine against Lassa virus, in a phase 1b clinical trial in healthy Ghanaian adults. Front Immunol. 2025 Oct 24;16:1658549. doi: 10.3389/fimmu.2025.1658549. eCollection 2025.
PubMed 41208990
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana
- ClinicalTrials.gov ID
- NCT04093076
- Acronym / sponsor ID
- LSV-002
- Conditions
- Lassa Fever
- Keywords
- Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Coalition for Epidemic Preparedness Innovations
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 17 Sep 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, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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. |
| 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 in two acceptable locations in two different limbs at each dosing visit. |
| Placebo Group C | Placebo comparator | Device: CELLECTRA™ 2000, Drug: PlaceboParticipants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device. |
| Placebo Group D | Placebo comparator | Device: CELLECTRA™ 2000, Drug: PlaceboParticipants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.. |
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);
- Must meet one of the following criteria with respect to reproductive capacity: Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, participants should wait six (6) months post-vasectomy prior to enrolling. Women who are post-menopausal as defined by absence of menstruation for ≥ 12 months. Use of medically effective contraception when used consistently and correctly from Screening until three (3) months following last dose.
Key exclusion criteria (8 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 three (3) months following last dose;
- Positive serum pregnancy test during Screening or positive urine pregnancy test prior to any dosing;
- 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;
- Audiometry testing that demonstrates a hearing level threshold greater than 30 dB for any frequency tested between 500 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 |
| CELLECTRA™ 2000EP using the CELLECTRA™ 2000 device will be administered following ID drug administration. | Device | INO-4500 Group A, INO-4500 Group B, Placebo Group C, Placebo Group D |
| PlaceboAlso: SSC-0001Placebo will be administered ID on Day 0 and Week 4. | Drug | Placebo Group C, Placebo Group D |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Baseline up to Week 48
Number of Participants with Injection Site Reactions
Time frame: Day 0 up to Week 48
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Baseline up to Week 48
Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies
Time frame: Day 0 up to Week 48
Change from Baseline in Lassa virus (LASV) Neutralization Assays
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 21 Nov 2022.
- Derived from this study: PubMed 41208990Koram KA, Walker KA, Orizu B, Marrero I, Boyer J, Yang S, Broderick KE, Kusi KA, Kyei-Baafour E, Ofori EA, Pobee A, Adu-Amankwah S, Amoakoh-Coleman M, Amoakoh HB, Abuaku B, Badji E, Ntiri M, Quaye L, Morrow MP, Sylvester AJ, Reuschel EL, Gillespie E, Liebowitz D, Humeau LM. Safety, tolerability, and immunogenicity of INO-4500, a synthetic DNA-based vaccine against Lassa virus, in a phase 1b clinical trial in healthy Ghanaian adults. Front Immunol. 2025 Oct 24;16:1658549. doi: 10.3389/fimmu.2025.1658549. eCollection 2025.
- Individual participant dataSharing planned: Yes. Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
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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.
Bonaventure Orizu, MD 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 Ghana.
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 8 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 21 Nov 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 Ghana. 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?
Number of Participants with Adverse Events (AEs) (time frame: Baseline up to Week 48). The study lists 6 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 NCT04093076, 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 21 Nov 2022.