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Coronavirus InfectionPhase 1NCT05430958

Safety, Tolerability and Immunogenicity of INO-4800 for COVID19 in Healthy Volunteers

A Phase 1 study testing INO-4800, INO-9112 and CELLECTRA® 2000 in people with Coronavirus Infection, run by Inovio Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an open label, phase 1 clinical trial of an intra-dermal booster dose of INO-4800 alone or in combination with INO-9112 followed by electroporation (EP) among healthy adults at least 18 years of age, who previously completed their primary immunization series with mRNA vaccines against SARS-CoV-2 within 6-12… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Coronavirus Infection
What is being tested?
INO-4800, INO-9112 and CELLECTRA® 2000
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2022to Mar 2024
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

  • Healthy men and non-pregnant women at least 18 years of age;
  • Able and willing to comply with all study procedures;
  • Screening laboratory results within normal limits or deemed not clinically significant by the Investigator;
  • Received full primary series doses of an approved or authorized mRNA vaccine at least 6 months but no more than 12 months prior to INO-4800 booster dose.
  • Must meet one of the following criteria with respect to reproductive capacity:
  • Women who are post-menopausal as defined by reported spontaneous amenorrhea for ≥ 12 months;
  • Surgically 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 enrollment;
  • Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until Day 28 post booster dose.

Who cannot join

  • Acute febrile illness with temperature >100.4°F (38.0°C) or acute onset of upper or lower respiratory tract symptoms (e.g., cough, shortness of breath, sore throat) within the prior 72 hours;
  • Positive SARs-CoV-2 PCR test, if results are available prior to dosing;
  • Pregnant or breastfeeding, or intending to become pregnant or intending to father children within the projected duration of the study starting from the Screening visit until Day 28 post booster dose;
  • Positive pregnancy test during screening or immediately prior to booster dose;
  • Positive HIV rapid test, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody at Screening;
  • Is currently participating or has participated in a study with an IP within 30 days preceding Day 0 (documented receipt of placebo in a previous study would be permissible for study eligibility);
Show all 22Show fewer
  • Currently participating in another study with an investigational product during the conduct of this study;
  • Previous or planned receipt of any COVID-19 booster vaccine during the trial period
  • Medical conditions as follows:
  • Respiratory diseases
  • History of hypersensitivity or severe allergic reaction
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Malignancy within the past 2 years, with the exception of superficial skin
  • History of cardiovascular disease
  • History of myocarditis or pericarditis
  • History of seizures within the past 2 years
  • Underlying immunosuppressive illness
  • Lack of acceptable sites for ID injection and EP
  • Blood donation or transfusion within 1 month prior to Day 0;
  • Reported alcohol or substance abuse/dependence or illicit drug use within the past year;
  • Any non-study vaccine (e.g., influenza vaccine) within 2 weeks prior to the dose of IP.

About this study

Official title: Phase 1 Open Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Intradermal Booster Dose of INO-4800 Alone or in Combination With INO-9112 Followed by Electroporation, in Adults Who Completed a Primary Immunization Series Against SARS-CoV-2 With mRNA Vaccines

This is an open label, phase 1 clinical trial of an intra-dermal booster dose of INO-4800 alone or in combination with INO-9112 followed by electroporation (EP) among healthy adults at least 18 years of age, who previously completed their primary immunization series with mRNA vaccines against SARS-CoV-2 within 6-12 months prior to the booster dose.

Being tested
INO-4800, INO-9112, CELLECTRA® 2000
Keywords
DNA vaccine, Coronavirus Infection, SARS-CoV-2, COVID19
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INO-4800Drug

    INO-4800 will be given at 0.8 or 1.6 mg for at least 6 months but no more than 12 months following the completion of a primary vaccination.

  • INO-9112Drug

    INO-9112 will be given in at various doses (dose of 0, 0.05, 0.10, 0.20 or 0.40 mg) in combination with INO-4800.

  • CELLECTRA® 2000Device

    Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.

Study groups in NCT05430958
Study groupRoleWhat they receive
Group 1ExperimentalSingle injection of 0.8 mg of INO-4800 followed by EP administered at Day 0
Receives: Drug: INO-4800; Device: CELLECTRA® 2000
Group 2ExperimentalSingle injection of 0.8 mg of INO-4800 plus 0.05 mg of INO-9112 followed by EP administered at Day 0
Receives: Drug: INO-4800; Drug: INO-9112; Device: CELLECTRA® 2000
Group 3ExperimentalSingle injection of 0.8 mg of INO-4800 plus 0.10 mg of INO-9112 followed by EP administered at Day 0
Receives: Drug: INO-4800; Drug: INO-9112; Device: CELLECTRA® 2000
Group 4ExperimentalSingle injection of 0.8 mg of INO-4800 plus 0.20 mg of INO-9112 followed by EP administered at Day 0
Receives: Drug: INO-4800; Drug: INO-9112; Device: CELLECTRA® 2000
Group 5ExperimentalTwo injections of 0.8 mg (1.6 mg total) of INO-4800 followed by EP administered at Day 0
Receives: Drug: INO-4800; Device: CELLECTRA® 2000
Group 6ExperimentalTwo injections of 0.8 mg (1.6 mg total) of INO-4800 + 0.05 mg (0.1 mg total) of INO-9112 followed by EP administered at Day 0
Receives: Drug: INO-4800; Drug: INO-9112; Device: CELLECTRA® 2000
Group 7ExperimentalTwo injections of 0.8 mg (1.6 mg total) of INO-4800 + 0.1 mg (0.20 mg total) of INO-9112 followed by EP administered at Day 0
Receives: Drug: INO-4800; Drug: INO-9112; Device: CELLECTRA® 2000
Group 8ExperimentalTwo injections of 0.8 mg (1.6 mg total) of INO-4800 + 0.20 mg (0.40 mg total) of INO-9112 followed by EP administered at Day 0
Receives: Drug: INO-4800; Drug: INO-9112; Device: CELLECTRA® 2000

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Solicited Local and Systemic Adverse Events (AEs)

    Measured: Baseline up to Day 7

  2. Percentage of Participants with Adverse Events (AEs)

    Measured: Baseline up to Day 28

  3. Percentage of Participants with Serious Adverse Events (SAEs)

    Measured: Baseline up to week 52

  4. Percentage of Participants with Adverse Events of Special Interest (AESIs)

    Measured: Baseline up to week 52

  5. Percentage of Participants with Incidence of medically attended AEs (MAAEs)

    Measured: Baseline up to week 52

  6. Percentage of Participants with Change in SARS-CoV-2 pseudovirus neutralizing titers

    Measured: Baseline up to day 28

Secondary outcomes (4)

  1. Number of Participants with a Change in SARS-CoV-2 pseudovirus neutralizing titers

    Measured: Baseline, Day 7, 14, 84, 180, 224, 280 and 365 post-booster

  2. Number of Participants with SARS-CoV-2 pseudovirus neutralizing titers

    Measured: Days 7, 14, 28, 84, 180, 224, 280 and 365 post-booster

  3. Number of Participants with ARS-CoV-2 Spike binding IgG and change in SARS-CoV-2 Spike binding IgG

    Measured: Days 7, 14, 28, 84, 180 and 365 post-booster

  4. Number of Participants with SARS-CoV-2 cellular immune response as measured by IFN-gamma ELISpot

    Measured: Day 14 post-booster

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study startOct 2022 (estimated)
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Why it stopped: Study was withdrawn due to sponsor decision.

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05430958
Sponsor's protocol ID
COVID19-131
Status last verified
Nov 2022
First submitted
21 Jun 2022
Last updated
17 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INO-4800, INO-9112 and CELLECTRA® 2000 in people with Coronavirus Infection, run by Inovio Pharmaceuticals.

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 8 inclusion and 22 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: withdrawn, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.

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 Solicited Local and Systemic Adverse Events (AEs) (time frame: Baseline up to Day 7). 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 NCT05430958.

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 17 Nov 2022.

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