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

Sponsor

Inovio Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05430958

Collaborator

(none)

160

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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 months prior to the booster dose.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection	Drug: INO-4800 Drug: INO-9112 Device: CELLECTRA® 2000	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Single injection of 0.8 mg of INO-4800 followed by EP administered at Day 0	Drug: INO-4800 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. Device: CELLECTRA® 2000 Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.
Experimental: Group 2 Single injection of 0.8 mg of INO-4800 plus 0.05 mg of INO-9112 followed by EP administered at Day 0	Drug: INO-4800 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. Drug: INO-9112 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. Device: CELLECTRA® 2000 Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.
Experimental: Group 3 Single injection of 0.8 mg of INO-4800 plus 0.10 mg of INO-9112 followed by EP administered at Day 0	Drug: INO-4800 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. Drug: INO-9112 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. Device: CELLECTRA® 2000 Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.
Experimental: Group 4 Single injection of 0.8 mg of INO-4800 plus 0.20 mg of INO-9112 followed by EP administered at Day 0	Drug: INO-4800 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. Drug: INO-9112 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. Device: CELLECTRA® 2000 Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.
Experimental: Group 5 Two injections of 0.8 mg (1.6 mg total) of INO-4800 followed by EP administered at Day 0	Drug: INO-4800 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. Device: CELLECTRA® 2000 Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.
Experimental: Group 6 Two 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	Drug: INO-4800 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. Drug: INO-9112 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. Device: CELLECTRA® 2000 Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.
Experimental: Group 7 Two 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	Drug: INO-4800 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. Drug: INO-9112 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. Device: CELLECTRA® 2000 Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.
Experimental: Group 8 Two 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	Drug: INO-4800 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. Drug: INO-9112 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. Device: CELLECTRA® 2000 Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.

Outcome Measures

Primary Outcome Measures

Percentage of Participants with Solicited Local and Systemic Adverse Events (AEs) [Baseline up to Day 7]
Percentage of Participants with Adverse Events (AEs) [Baseline up to Day 28]
Percentage of Participants with Serious Adverse Events (SAEs) [Baseline up to week 52]
Percentage of Participants with Adverse Events of Special Interest (AESIs) [Baseline up to week 52]
Percentage of Participants with Incidence of medically attended AEs (MAAEs) [Baseline up to week 52]
Percentage of Participants with Change in SARS-CoV-2 pseudovirus neutralizing titers [Baseline up to day 28]

Secondary Outcome Measures

Number of Participants with a Change in SARS-CoV-2 pseudovirus neutralizing titers [Baseline, Day 7, 14, 84, 180, 224, 280 and 365 post-booster]
Number of Participants with SARS-CoV-2 pseudovirus neutralizing titers [Days 7, 14, 28, 84, 180, 224, 280 and 365 post-booster]
Number of Participants with ARS-CoV-2 Spike binding IgG and change in SARS-CoV-2 Spike binding IgG [Days 7, 14, 28, 84, 180 and 365 post-booster]
Number of Participants with SARS-CoV-2 cellular immune response as measured by IFN-gamma ELISpot [Day 14 post-booster]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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);
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Inovio Pharmaceuticals

Investigators

Study Director: Jose Suaya, MD, Inovio Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Inovio Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT05430958

Other Study ID Numbers:

COVID19-131

First Posted:

Jun 24, 2022

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Inovio Pharmaceuticals

DNA vaccine

Coronavirus Infection

SARS-CoV-2

COVID19

Additional relevant MeSH terms:

Coronavirus Infections

Study Results

No Results Posted as of Aug 22, 2022