NCT04642638 is a Phase 2, PHASE3 clinical trial of INO-4800 in Coronavirus Infection, sponsored by Inovio Pharmaceuticals.

Who is sponsoring NCT04642638?

NCT04642638 is sponsored by Inovio Pharmaceuticals.

What drugs are being tested in NCT04642638?

Interventions in NCT04642638: INO-4800, CELLECTRA® 2000, Placebo, CELLECTRA® 2000.

What condition does NCT04642638 study?

NCT04642638 studies Coronavirus Infection, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), COVID-19 Disease.

Is NCT04642638 still recruiting?

NCT04642638 is currently terminated. Last updated 20 December 2023.

Are results published for NCT04642638?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-12-20 · How we verify

NCT04642638

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure

Terminated Phase 2, PHASE3 Results posted Last updated 20 December 2023

What this trial tests

Phase 2, PHASE3 trial testing INO-4800 in Coronavirus Infection in 1,307 participants. Terminated before completion.

Timeline

30 November 2020

Primary endpoint
13 September 2022

13 September 2022

Quick facts

Lead sponsor	Inovio Pharmaceuticals
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	prevention
Enrollment	1,307
Start date	30 November 2020
Primary completion	13 September 2022
Estimated completion	13 September 2022
Sites	27 locations across Colombia, United States, Mexico

Drugs / interventions tested

INO-4800 — full drug profile →
CELLECTRA® 2000
Placebo
CELLECTRA® 2000

Conditions studied

Coronavirus Infection — all drugs for Coronavirus Infection →
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) — all drugs for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) →
COVID-19 Disease — all drugs for COVID-19 Disease →

Sponsor

Inovio Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Coronavirus Infection or Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay Primary · Baseline up to Week 6

Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 was measured in spot-forming units per million peripheral blood mononuclear cells (SFU/10\^6, PBMC) using ELISpot. No samples collected after Week 6 were analyzed.

Baseline

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	0.00	0.0 – 90.0
Phase 2: INO-4800 Dose Group 2	2.20	0.0 – 115.6
Phase 2: Placebo Dose Group 1	0.00	0.0 – 25.6
Phase 2: Placebo Dose Group 2	0.00	0.0 – 95.6

Change From Baseline at Week 6

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	6.70	0.0 – 245.6
Phase 2: INO-4800 Dose Group 2	13.30	0.0 – 311.1
Phase 2: Placebo Dose Group 1	0.00	0.0 – 81.1
Phase 2: Placebo Dose Group 2	0.00	0.0 – 54.4

Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay Primary · Baseline up to Week 6

The immune responses to INO-4800 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial timepoints. No samples collected after Week 6 were analyzed.

Baseline

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	34.8	± 0.42
Phase 2: INO-4800 Dose Group 2	40.6	± 0.52
Phase 2: Placebo Dose Group 1	30.2	± 0.40
Phase 2: Placebo Dose Group 2	38.0	± 0.45

Change From Baseline at Week 6

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	3.1	± 0.49
Phase 2: INO-4800 Dose Group 2	4.6	± 0.52
Phase 2: Placebo Dose Group 1	1.2	± 0.39
Phase 2: Placebo Dose Group 2	1.2	± 0.49

Phase 2 and 3: Percentage of Participants With Solicited Injection Site Reactions Secondary · 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35)

Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' (Food and Drug Administration \[FDA\] Guidance for Industry, September 2007). Participants were provided a diary to record the solicited injection site reactions. Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were recorded. Injection site react

Injection Site Pain

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	27.2
Phase 2: INO-4800 Dose Group 2	36.1
Phase 2: Placebo Dose Group 1	20.0
Phase 2: Placebo Dose Group 2	23.5
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	19.1
Phase 3: Placebo Dose Group	21.2

Injection Site Tenderness

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	1.9
Phase 2: INO-4800 Dose Group 2	5.4
Phase 2: Placebo Dose Group 1	2.0
Phase 2: Placebo Dose Group 2	3.9
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	0
Phase 3: Placebo Dose Group	0

Injection Site Erythema

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	17.9
Phase 2: INO-4800 Dose Group 2	25.2
Phase 2: Placebo Dose Group 1	18.0
Phase 2: Placebo Dose Group 2	7.8
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	6.8
Phase 3: Placebo Dose Group	6.0

Injection Site Swelling

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	11.3
Phase 2: INO-4800 Dose Group 2	16.3
Phase 2: Placebo Dose Group 1	2.0
Phase 2: Placebo Dose Group 2	2.0
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	4.2
Phase 3: Placebo Dose Group	2.6

Phase 2 and 3: Percentage of Participants With Unsolicited Injection Site Reactions Secondary · From first dose of study drug up to Day 56

Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' FDA Guidance for Industry, September 2007. Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were reported. Injection site reactions were evaluated starting 30 minutes following the injection. Unsolicited injection site reactions were recorded for

Injection Site Pain

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	27.2
Phase 2: INO-4800 Dose Group 2	36.7
Phase 2: Placebo Dose Group 1	22.0
Phase 2: Placebo Dose Group 2	23.5
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	19.3
Phase 3: Placebo Dose Group	21.5

Injection Site Tenderness

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	0.6
Phase 2: INO-4800 Dose Group 2	0
Phase 2: Placebo Dose Group 1	0
Phase 2: Placebo Dose Group 2	1.9
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	0
Phase 3: Placebo Dose Group	0

Injection Site Erythema

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	17.9
Phase 2: INO-4800 Dose Group 2	25.2
Phase 2: Placebo Dose Group 1	18.0
Phase 2: Placebo Dose Group 2	7.8
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	6.8
Phase 3: Placebo Dose Group	6.0

Injection Site Swelling

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	11.3
Phase 2: INO-4800 Dose Group 2	16.3
Phase 2: Placebo Dose Group 1	2.0
Phase 2: Placebo Dose Group 2	2.0
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	4.2
Phase 3: Placebo Dose Group	2.6

Phase 2 and 3: Percentage of Participants With Solicited Adverse Events (AEs) Secondary · 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35)

An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants were provided a diary to record the solicited systemic AEs. The solicited AEs were recorded for 7 days after each dose.

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	72.2
Phase 2: INO-4800 Dose Group 2	83.7
Phase 2: Placebo Dose Group 1	70.0
Phase 2: Placebo Dose Group 2	56.9
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	31.6
Phase 3: Placebo Dose Group	31.5

Phase 2 and 3: Percentage of Participants With Unsolicited AEs Secondary · From first dose of study drug up to Day 56

An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AEs were recorded for up to 28 days after administration of dose 2.

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	74.2
Phase 2: INO-4800 Dose Group 2	85.0
Phase 2: Placebo Dose Group 1	74.0
Phase 2: Placebo Dose Group 2	62.7
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	38.8
Phase 3: Placebo Dose Group	37.1

Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs) Secondary · Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126

An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly or birth defect.

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	2.6
Phase 2: INO-4800 Dose Group 2	1.4
Phase 2: Placebo Dose Group 1	6.0
Phase 2: Placebo Dose Group 2	3.9
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	0.7
Phase 3: Placebo Dose Group	1.3

Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs) Secondary · Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126

An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.

Group	Value	95% CI
Phase 2: INO-4800 Dose Group 1	0
Phase 2: INO-4800 Dose Group 2	0
Phase 2: Placebo Dose Group 1	0
Phase 2: Placebo Dose Group 2	2.0
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	0.3
Phase 3: Placebo Dose Group	0

Phase 3: Number of Participants With Death From All Causes Secondary · Baseline up to Day 126

Group	Value	95% CI
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)	2
Phase 3: Placebo Dose Group	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 2: INO-4800 Dose Group 1

Serious: 4/151 (3%)

Deaths: 0/151

Phase 2: INO-4800 Dose Group 2

Serious: 2/147 (1%)

Deaths: 0/147

Phase 2: Placebo Dose Group 1

Serious: 3/50 (6%)

Deaths: 1/50

Phase 2: Placebo Dose Group 2

Serious: 2/51 (4%)

Deaths: 0/51

Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)

Serious: 4/601 (1%)

Deaths: 2/601

Phase 3: Placebo Dose Group

Serious: 4/302 (1%)

Deaths: 2/302

Serious adverse events (23 terms)

Reaction	System	Phase 2: INO-4800 Dose Gro…	Phase 2: INO-4800 Dose Gro…	Phase 2: Placebo Dose Grou…	Phase 2: Placebo Dose Grou…	Phase 3: INO-4800 Dose Gro…	Phase 3: Placebo Dose Group
Gun shot wound	Injury, poisoning and procedural complications	—	—	—	—	—	—
Stab wound	Injury, poisoning and procedural complications	—	—	—	—	—	—
Clavicle fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—
Foot fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Adenocarcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Major depression	Psychiatric disorders	—	—	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—
International normalised ratio increased	Investigations	—	—	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—	—	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—	—	—	—	—
Abortion incomplete	Pregnancy, puerperium and perinatal conditions	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—
Peripheral artery thrombosis	Vascular disorders	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Rib fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—	—	—
Wrist fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Suicidal ideation	Psychiatric disorders	—	—	—	—	—	—

Other adverse events (19 terms — click to expand)

Reaction	System	Phase 2: INO-4800 Dose Gro…	Phase 2: INO-4800 Dose Gro…	Phase 2: Placebo Dose Grou…	Phase 2: Placebo Dose Grou…	Phase 3: INO-4800 Dose Gro…	Phase 3: Placebo Dose Group
Injection site pain	General disorders	—	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Injection site swelling	General disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Injection site bruising	General disorders	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—

Most-reported serious reactions: Gun shot wound, Stab wound, Clavicle fracture, Fall, Foot fracture, Adenocarcinoma of the cervix, Invasive ductal breast carcinoma, Thyroid cancer.

Data from ClinicalTrials.gov NCT04642638 adverse events section.

Sponsor's own description

This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent coronavirus disease 2019 (COVID-19) in participants at high risk of exposure to severe acute respiratory syndrome coronavirus - 2 (SARS-CoV-2). The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 7116 participants.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Viral targets for vaccines against COVID-19.
Dai L, Gao GF. · · 2021 · cited 836× · PMID 33340022 · DOI 10.1038/s41577-020-00480-0
SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates.
Kyriakidis NC, López-Cortés A, González EV, Grimaldos AB, et al · · 2021 · cited 507× · PMID 33619260 · DOI 10.1038/s41541-021-00292-w
COVID-19 vaccine development: milestones, lessons and prospects.
Li M, Wang H, Tian L, Pang Z, et al · · 2022 · cited 298× · PMID 35504917 · DOI 10.1038/s41392-022-00996-y
COVID-19 vaccines: rapid development, implications, challenges and future prospects.
Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. · · 2021 · cited 240× · PMID 33677814 · DOI 10.1007/s13577-021-00512-4
Efficacy and safety of COVID-19 vaccines.
Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
Evaluation of the safety profile of COVID-19 vaccines: a rapid review.
Wu Q, Dudley MZ, Chen X, Bai X, et al · · 2021 · cited 151× · PMID 34315454 · DOI 10.1186/s12916-021-02059-5
COVID-19: Unmasking Emerging SARS-CoV-2 Variants, Vaccines and Therapeutic Strategies.
Raman R, Patel KJ, Ranjan K. · · 2021 · cited 139× · PMID 34356617 · DOI 10.3390/biom11070993
Cancer Vaccines, Adjuvants, and Delivery Systems.
Paston SJ, Brentville VA, Symonds P, Durrant LG. · · 2021 · cited 139× · PMID 33859638 · DOI 10.3389/fimmu.2021.627932

Verify or expand the search:

Other trials of INO-4800

Trials testing the same drug.

NCT04447781 — Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19 · Phase 1, PHASE2 · completed
NCT04336410 — Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers · Phase 1 · completed

Other recruiting trials for Coronavirus Infection

Currently open trials in the same condition.

NCT04885504 — Post COVID-19 Biorepository · recruiting
NCT04445454 — Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection · Phase 1, PHASE2 · recruiting
NCT04510025 — Capturing MultiORgan Effects of COVID-19 · recruiting
NCT04376034 — Convalescent Plasma Collection and Treatment in Pediatrics and Adults · Phase 3 · recruiting

Other Inovio Pharmaceuticals trials

Trials by the same sponsor.

NCT04588428 — Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers · Phase 2 · completed
NCT04093076 — Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana · Phase 1 · completed
NCT04398433 — INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomat · Phase 1, PHASE2 · completed
NCT04336410 — Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers · Phase 1 · completed
NCT03805984 — Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04642638 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Inovio Pharmaceuticals
Last refreshed: 20 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04642638.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing