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Phase-I Study to Evaluate the Safety and Immunogenicity of a Prophylactic pDNA Vaccine Candidate Against COVID-19 in Healthy Adults

Primary Purpose

Safety, Vaccine Reaction, Vaccine Adverse Reaction

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

S.opt.FL COVID-19 pDNA vaccine

About this trial

This is an interventional prevention trial for Safety focused on measuring Vaccine, COVID-19, SARS-CoV-2, pDNA vaccine, Phase-I, Prophylactic, Safety, Immunogenicity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

Study participants should meet ALL the below inclusion criteria to be eligible for the study:

Male or female participants between the age of 18 to 55 years (inclusive) at the time of enrollment.
Healthy participants as determined by the medical history, physical examination, clinical verification by the investigator.
Participant who are committed to comply with planned scheduled visits, vaccination, laboratory tests, and any other procedures.
Participants who received 2 doses of an approved mRNA COVID-19 vaccine at least 4 months prior to enrollment.
Female subjects must have used an acceptable contraceptive method for at least 60 days prior to receiving the first dose of the investigational vaccine and should continue using contraception for at least 1 month after receiving the last dose of the investigational vaccine.
Male subjects able to father children, and sexually active with a female partner who is able to bear children must be willing to use (or have his female partner use) an acceptable contraceptive method from the time they receive the first dose of the study vaccine until at least 1 month after the last dose of study vaccine.
Willing to sign the informed consent which includes all the requirements and restrictions listed in the informed consent and the protocol.

Exclusion criteria

Study participants should meet NONE of the exclusion criteria listed below:

Participant with known infection with Hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV).
Individuals with current infection and diagnosis with COVID-19 documented by PCR nasal swab test.
Individuals who received an authorized mRNA COVID-19 vaccine within the past 4 months of first study drug administration.
Individuals who received only one dose of a COVID-19 vaccine.
Individuals working in facility with high probability of infection with SARS-CoV-2 such as health workers in hospitals.
History of adverse reaction associated with vaccines and/or severe allergic reaction to any component of the study intervention.
Individuals under immunosuppressive therapy.
Individuals receiving treatment or medications that can adherently affect the immune system in the last 90 days, including but not limited to: interferon, immunoglobin, immunomodulators, epinephrine injector, cytotoxic drug.
Individuals diagnosed any diseases that is/are associated with sever COVID-19, including the following factors:
- Diabetes
- Hypertension
- Asthma
- BMI more than 30 kg/m2
- Pregnant or lactating women.
- Chronic pulmonary disease
- Chronic liver diseases
- Chronic renal diseases
Individuals with known or suspected immunological disorders, including, autoimmune disease and diabetes mellitus.
Individuals with current or previous neurological disorders, such as seizure or Gillian-Barre syndrome.
Individuals with psychiatric disorder or cognitive impairment.
Individuals with bleeding disorder or other conditions associated with prolonged bleeding time.
Individuals with clinically significant abnormal safety laboratory results at screening in the opinion of the investigator.
Individuals receiving or planning to receive non-study vaccine 30 days prior to study enrollment.
Individuals receiving or donating blood or blood components 60 days prior to study enrollment.
Individuals participating in a clinical trial with an investigational vaccine, treatment, or device 30 days prior to study enrollment.
Individuals intending to participate in another clinical trial while being enrolled in this study.
Individuals with history of alcohol or drug addiction.
Individual with other condition that may interfere with the health or the participants or that interfere with study's primary or secondary objectives.
Female participants who are pregnant, plan to get pregnant or are breast feeding.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Low-Dose, 1mg, 3 doses 21 days apart

Mid-Dose, 2 mg, 2 doses 21 days apart

High-Dose, 4 mg, 2 doses 21 days apart

Outcomes

Primary Outcome Measures

The percentage and frequency of study subjects reporting local reaction

The percentage of study subjects reporting systematic reaction

The percentage and frequency of study subjects reporting adverse events (AE)

The percentage and frequency of study subjects reporting systemic events (SAE)

GMT of the serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti-RBD)

Proportion of subjects with four folds increase in serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti- RBD)

GMT of the serum SARS-CoV-2 S neutralizing antibodies

Proportion of subjects with four folds increase in serum SARS-CoV-2 neutralizing antibodies

Secondary Outcome Measures

GMT of the serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti-RBD)

Proportion of subjects with four folds increase in serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti- RBD)

GMT of the serum SARS-CoV-2 neutralizing antibodies

Proportion of subjects with four folds increase in serum SARS-CoV-2 neutralizing antibodies

Full Information

NCT ID

NCT05171946

First Posted

December 7, 2021

Last Updated

October 16, 2022

Sponsor

Iman Almansour

Collaborators

ICON plc

1. Study Identification

Unique Protocol Identification Number

NCT05171946

Brief Title

Phase-I Study to Evaluate the Safety and Immunogenicity of a Prophylactic pDNA Vaccine Candidate Against COVID-19 in Healthy Adults

Official Title

Phase-I, Single Center, Randomized, Dosage Finding Study, to Evaluate the Safety, Tolerability, and Immunogenicity of a Prophylactic COVID-19 pDNA Vaccine After Multiple Ascending Doses in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 20, 2022 (Anticipated)

Primary Completion Date

March 1, 2023 (Anticipated)

Study Completion Date

July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Iman Almansour

Collaborators

ICON plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A pneumonia of unknown cause detected in Wuhan, China, was first reported in December 2019. On 08 January 2020, the pathogen causing this outbreak was identified as a novel coronavirus 2019. The outbreak was declared a Public Health Emergency of International Concern on 30 January 2020. On 12 February 2020, the virus was officially named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the WHO officially named the disease caused by SARS-CoV-2 as coronavirus disease 2019 (COVID-19). On 11 March 2020, the WHO upgraded the status of the COVID-19 outbreak from epidemic to pandemic, which is now spreading globally at high speed. There are currently few licensed vaccines to prevent infection with SARS-CoV-2 or COVID-19 and the duration of response is unknown. Given the rapid transmission of COVID-19 and incidence of disease on a worldwide basis, the rapid development of effective vaccines with sufficient protection and duration of response is of utmost importance. IAU has developed a thermally stable plasmid DNA (pDNA)-based vaccine candidate using a platform approach that enables the rapid development of vaccines against emerging viral diseases, including SARS-CoV-2. The pDNA vaccine developed by IAU is a synthetic, codon-optimized, encode either the full-length Spike (S) gene or S1 domain of SARS-CoV-2 as genes of interest. Here, we aim to test a synthetic, codon optimized pDNA encoding S.opt.FL as vaccine candidate against COVID-19. A key advantage of pDNA vaccine is that multiple immunization can be used without the limitations of anti-vector responses. This study is intended to investigate the safety, immunogenicity, and tolerbilty of this prophylactic vaccine against COVID-19 administered as intramuscular immunization (i.m.).

Detailed Description

Sever Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) is a newly emerging coronavirus that is known to cause worldwide public health crisis and an ongoing pandemic since February 2020 with 219 million cases and 4.5 million deaths as of September 2021 (1). The World Health Organization (WHO) has given the term Coronavirus Diseases 19 (COVID-19) to indicate the illness caused by SARS-CoV-2. Individuals infected SARS-CoV-2 can have wide ranges of symptoms that varies between mild to very severe (1,2). Despite the existence of several COVID-19 vaccine that are approved under emergency use by EMA and FDA (2,3,4,5,6,7), there is a global demand for the manufacturing of sufficient vaccine to control the COVID-19 worldwide. In addition, there is a demand for the development and deployment of new COVID-19 vaccine that is generic and thermally stable for which the vaccine can be stored for a longer period, especially in countries that lacks the infrastructure capabilities to store the vaccine under freezing temperature. Imam Abdulrahman Bin Faisal University (IAU) has developed an investigational prophylactic COVID-1 pDNA vaccine using a codon optimized spike gene of the SARS-CoV-2 (S.opt.FL). The developed pDNA vaccine possess several advantages; Unlike with mRNA vaccine platforms, pDNA is more stable. Therefore, cold-chain shipment and storage is not needed. Also, the chance for anti-vector immunity generated after immunization viral vector vaccine platform is omitted in pDNA vaccine platform. Importantly, the pDNA can stimulate humoral and cellular immune responses (9,10,11). IAU COVID-19 vaccine Almansour-001 consists of a plasmid DNA (pDNA) carrying a synthetic, codon-optimized, gene insert that encodes spike (S) gene of COVID-19. The pDNA included in the study is (pVAX-1), an FDA approved plasmid for the application in clinical trials. Preclinical study conducted at Imam Abdulrahman Bin Faisal University (IAU) have demonstrated that S.opt.FL and S1.opt are immunogenic in mice (8). The study investigated 3 doses versus 4 doses of DNA vaccine. The study demonstrated three doses S1.opt.FL elicited high bAB and nAB responses (8) as well as interferon-Gamma as an indicator of cellular immunity. Previous work on pDNA vaccines encoding the S gene of SARS-CoV, MERS-CoV, and SARS-CoV-2 have demonstrated that pDNA vaccine is safe and well tolerated (12,13,14,15). The purpose of this clinical trial is to evaluate the safety and immunogenicity of 2 or 3 dose regimen of investigational pDNA vaccine encoding S.opt.FL gene inserted into pVAX1 plasmid (Almansour-001). Here, in this phase-I study, the pDNA vaccine candidate is administered intramuscularly (IM) by immunizing healthy adults (18-55 years). The S.opt.FL pDNA vaccine is evaluated in dose wise manner in three different cohorts (cohort 1: low dosage of pDNA vaccine "1 mg", cohort 2: middle dosage of pDNA vaccine "2 mg", cohort 3: high dosage of pDNA vaccine "4 mg")

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Safety, Vaccine Reaction, Vaccine Adverse Reaction, Immunization; Infection

Keywords

Vaccine, COVID-19, SARS-CoV-2, pDNA vaccine, Phase-I, Prophylactic, Safety, Immunogenicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Low-Dose, 1mg, 3 doses 21 days apart

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Mid-Dose, 2 mg, 2 doses 21 days apart

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

High-Dose, 4 mg, 2 doses 21 days apart

Intervention Type

Drug

Intervention Name(s)

S.opt.FL COVID-19 pDNA vaccine

Other Intervention Name(s)

Almansour-001

Intervention Description

Low-Dose: (1mg) level

Intervention Type

Drug

Intervention Name(s)

S.opt.FL COVID-19 pDNA vaccine

Other Intervention Name(s)

Almansour-001

Intervention Description

Mid-Dose: (2mg) level

Intervention Type

Drug

Intervention Name(s)

S.opt.FL COVID-19 pDNA vaccine

Other Intervention Name(s)

Almansour-001

Intervention Description

High-Dose: (4mg) level

Primary Outcome Measure Information:

Title

The percentage and frequency of study subjects reporting local reaction

Time Frame

Through 10 days after receiving each dose

Title

The percentage of study subjects reporting systematic reaction

Time Frame

Through 30 days after receiving each dose

Title

The percentage and frequency of study subjects reporting adverse events (AE)

Time Frame

From dose 1 through six months after last dose

Title

The percentage and frequency of study subjects reporting systemic events (SAE)

Time Frame

From dose 1 through six months after last dose

Title

GMT of the serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti-RBD)

Time Frame

At baseline (pre-vaccination) and one month after last dose

Title

Proportion of subjects with four folds increase in serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti- RBD)

Time Frame

At baseline (pre-vaccination) and one month after last dose

Title

GMT of the serum SARS-CoV-2 S neutralizing antibodies

Time Frame

At baseline (pre-vaccination) and one month after last dose

Title

Proportion of subjects with four folds increase in serum SARS-CoV-2 neutralizing antibodies

Time Frame

At baseline (pre-vaccination) and one month after last dose

Secondary Outcome Measure Information:

Title

GMT of the serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti-RBD)

Time Frame

At baseline (pre-vaccination), three weeks after dose 1, three weeks after dose 2, one month after dose 3

Title

Proportion of subjects with four folds increase in serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti- RBD)

Time Frame

At baseline (pre-vaccination), three weeks after dose 1, three weeks after dose 2, one month after dose 3

Title

GMT of the serum SARS-CoV-2 neutralizing antibodies

Time Frame

At baseline (pre-vaccination), three weeks after dose 1, three weeks after dose 2, one month after dose 3

Title

Proportion of subjects with four folds increase in serum SARS-CoV-2 neutralizing antibodies

Time Frame

At baseline (pre-vaccination), three weeks after dose 1, three weeks after dose 2, one month after dose 3

Other Pre-specified Outcome Measures:

Title

GMT of SARS-CoV-2 S specific binding antibodies against SARS-CoV-2 variants of concern (Alpha, Beta, Gamma, and Omicron)

Description

V-PLEX SARS-CoV-2 Panel 28 IgG

Time Frame

At baseline (pre-vaccination) and one month after last dose

Title

GMT of SARS-CoV-2 S specific neutralizing antibodies against SARS-CoV-2 variants of concern (Alpha, Beta, Gamma, and Omicron)

Description

V-PLEX SARS-CoV-2 Panel 28 ACE2

Time Frame

At baseline (pre-vaccination) and one month after last dose

Title

Evaluation of intracellular cytokine responses

Description

Analysis of post-culture PBMCs under 3 conditions with the following panel:IFN-Gamma, TNF, IL-2, IL-4, IL-13 (V-Plex Viral Panel human Kit)

Time Frame

At baseline (pre-vaccination), three weeks after dose 1, three weeks after dose 2, one month after dose 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Study participants should meet ALL the below inclusion criteria to be eligible for the study: Male or female participants between the age of 18 to 55 years (inclusive) at the time of enrollment. Healthy participants as determined by the medical history, physical examination, clinical verification by the investigator. Participant who are committed to comply with planned scheduled visits, vaccination, laboratory tests, and any other procedures. Participants who received 2 doses of an approved mRNA COVID-19 vaccine at least 4 months prior to enrollment. Female subjects must have used an acceptable contraceptive method for at least 60 days prior to receiving the first dose of the investigational vaccine and should continue using contraception for at least 1 month after receiving the last dose of the investigational vaccine. Male subjects able to father children, and sexually active with a female partner who is able to bear children must be willing to use (or have his female partner use) an acceptable contraceptive method from the time they receive the first dose of the study vaccine until at least 1 month after the last dose of study vaccine. Willing to sign the informed consent which includes all the requirements and restrictions listed in the informed consent and the protocol. Exclusion criteria Study participants should meet NONE of the exclusion criteria listed below: Participant with known infection with Hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Individuals with current infection and diagnosis with COVID-19 documented by PCR nasal swab test. Individuals who received an authorized mRNA COVID-19 vaccine within the past 4 months of first study drug administration. Individuals who received only one dose of a COVID-19 vaccine. Individuals working in facility with high probability of infection with SARS-CoV-2 such as health workers in hospitals. History of adverse reaction associated with vaccines and/or severe allergic reaction to any component of the study intervention. Individuals under immunosuppressive therapy. Individuals receiving treatment or medications that can adherently affect the immune system in the last 90 days, including but not limited to: interferon, immunoglobin, immunomodulators, epinephrine injector, cytotoxic drug. Individuals diagnosed any diseases that is/are associated with sever COVID-19, including the following factors: Diabetes Hypertension Asthma BMI more than 30 kg/m2 Pregnant or lactating women. Chronic pulmonary disease Chronic liver diseases Chronic renal diseases Individuals with known or suspected immunological disorders, including, autoimmune disease and diabetes mellitus. Individuals with current or previous neurological disorders, such as seizure or Gillian-Barre syndrome. Individuals with psychiatric disorder or cognitive impairment. Individuals with bleeding disorder or other conditions associated with prolonged bleeding time. Individuals with clinically significant abnormal safety laboratory results at screening in the opinion of the investigator. Individuals receiving or planning to receive non-study vaccine 30 days prior to study enrollment. Individuals receiving or donating blood or blood components 60 days prior to study enrollment. Individuals participating in a clinical trial with an investigational vaccine, treatment, or device 30 days prior to study enrollment. Individuals intending to participate in another clinical trial while being enrolled in this study. Individuals with history of alcohol or drug addiction. Individual with other condition that may interfere with the health or the participants or that interfere with study's primary or secondary objectives. Female participants who are pregnant, plan to get pregnant or are breast feeding.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Iman Almansour, Ph.D.

Phone

0534888861

ikalmansour@iau.edu.sa

12. IPD Sharing Statement

Plan to Share IPD

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Phase-I Study to Evaluate the Safety and Immunogenicity of a Prophylactic pDNA Vaccine Candidate Against COVID-19 in Healthy Adults

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