SafetyPhase 1NCT05171946
Phase-I Study to Evaluate the Safety and Immunogenicity of a Prophylactic pDNA Vaccine Candidate Against COVID-19 in Healthy Adults
A Phase 1 study testing S.opt.FL COVID-19 pDNA vaccine in people with Safety and Vaccine Reaction, run by Iman Almansour.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Vaccine Reaction, Vaccine Adverse Reaction
- What is being tested?
- S.opt.FL COVID-19 pDNA vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2022to 1 Jul 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read more
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.).
Read the 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")
- Being tested
- S.opt.FL COVID-19 pDNA vaccine
- Keywords
- Vaccine, COVID-19, SARS-CoV-2, pDNA vaccine, Phase-I, Prophylactic, Safety, Immunogenicity
- Medical subject headings
- Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S.opt.FL COVID-19 pDNA vaccineDrug
Also called Almansour-001
Low-Dose: (1mg) level
S.opt.FL COVID-19 pDNA vaccineDrug
Also called Almansour-001
Mid-Dose: (2mg) level
S.opt.FL COVID-19 pDNA vaccineDrug
Also called Almansour-001
High-Dose: (4mg) level
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Low-Dose, 1mg, 3 doses 21 days apart Receives: Drug: S.opt.FL COVID-19 pDNA vaccine |
| Cohort 2 | Experimental | Mid-Dose, 2 mg, 2 doses 21 days apart Receives: Drug: S.opt.FL COVID-19 pDNA vaccine |
| Cohort 3 | Experimental | High-Dose, 4 mg, 2 doses 21 days apart Receives: Drug: S.opt.FL COVID-19 pDNA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage and frequency of study subjects reporting local reaction
Measured: Through 10 days after receiving each dose
The percentage of study subjects reporting systematic reaction
Measured: Through 30 days after receiving each dose
The percentage and frequency of study subjects reporting adverse events (AE)
Measured: From dose 1 through six months after last dose
The percentage and frequency of study subjects reporting systemic events (SAE)
Measured: From dose 1 through six months after last dose
GMT of the serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti-RBD)
Measured: At baseline (pre-vaccination) and one month after last dose
Proportion of subjects with four folds increase in serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti- RBD)
Measured: At baseline (pre-vaccination) and one month after last dose
GMT of the serum SARS-CoV-2 S neutralizing antibodies
Measured: At baseline (pre-vaccination) and one month after last dose
Proportion of subjects with four folds increase in serum SARS-CoV-2 neutralizing antibodies
Measured: At baseline (pre-vaccination) and one month after last dose
Secondary outcomes (4)
GMT of the serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti-RBD)
Measured: At baseline (pre-vaccination), three weeks after dose 1, three weeks after dose 2, one month after dose 3
Proportion of subjects with four folds increase in serum SARS-CoV-2 binding antibodies (anti-S, anti S1, and anti- RBD)
Measured: At baseline (pre-vaccination), three weeks after dose 1, three weeks after dose 2, one month after dose 3
GMT of the serum SARS-CoV-2 neutralizing antibodies
Measured: At baseline (pre-vaccination), three weeks after dose 1, three weeks after dose 2, one month after dose 3
Proportion of subjects with four folds increase in serum SARS-CoV-2 neutralizing antibodies
Measured: At baseline (pre-vaccination), three weeks after dose 1, three weeks after dose 2, one month after dose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start20 Nov 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for SafetyStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iman Almansour
- Sponsor type
- University, hospital or other
- Collaborators
- ICON plc
- Responsible party
- Sponsor-investigator, Iman Almansour, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171946
- Sponsor's protocol ID
- IAU-1-001-2021
- Status last verified
- Oct 2022
- First submitted
- 7 Dec 2021
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Viner RM, Ward JL, Hudson LD, Ashe M, Patel SV, Hargreaves D, Whittaker E. Systematic review of reviews of symptoms and signs of COVID-19 in children and adolescents. Arch Dis Child. 2021 Jul 19;106(8):802-807. doi: 10.1136/archdischild-2020-320972.
PubMed 33334728Chen X, Laurent S, Onur OA, Kleineberg NN, Fink GR, Schweitzer F, Warnke C. A systematic review of neurological symptoms and complications of COVID-19. J Neurol. 2021 Feb;268(2):392-402. doi: 10.1007/s00415-020-10067-3. Epub 2020 Jul 20.
PubMed 32691236Oliver SE, Gargano JW, Marin M, Wallace M, Curran KG, Chamberland M, McClung N, Campos-Outcalt D, Morgan RL, Mbaeyi S, Romero JR, Talbot HK, Lee GM, Bell BP, Dooling K. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine - United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021 Jan 1;69(5152):1653-1656. doi: 10.15585/mmwr.mm695152e1.
PubMed 33382675Oliver SE, Gargano JW, Marin M, Wallace M, Curran KG, Chamberland M, McClung N, Campos-Outcalt D, Morgan RL, Mbaeyi S, Romero JR, Talbot HK, Lee GM, Bell BP, Dooling K. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020 Dec 18;69(50):1922-1924. doi: 10.15585/mmwr.mm6950e2.
PubMed 33332292Roncati L, Roncati M. Emergency use authorization (EUA), conditional marketing authorization (CMA), and the precautionary principle at the time of COVID-19 pandemic. J Public Health Policy. 2021 Sep;42(3):518-521. doi: 10.1057/s41271-021-00299-6. Epub 2021 Jul 27. No abstract available.
PubMed 34316006MacNeil JR, Su JR, Broder KR, Guh AY, Gargano JW, Wallace M, Hadler SC, Scobie HM, Blain AE, Moulia D, Daley MF, McNally VV, Romero JR, Talbot HK, Lee GM, Bell BP, Oliver SE. Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients - United States, April 2021. MMWR Morb Mortal Wkly Rep. 2021 Apr 30;70(17):651-656. doi: 10.15585/mmwr.mm7017e4.
PubMed 33914723Krause PR, Gruber MF. Emergency Use Authorization of Covid Vaccines - Safety and Efficacy Follow-up Considerations. N Engl J Med. 2020 Nov 5;383(19):e107. doi: 10.1056/NEJMp2031373. Epub 2020 Oct 16. No abstract available.
PubMed 33064383Almansour I, Macadato NC, Alshammari T. Immunogenicity of Multiple Doses of pDNA Vaccines against SARS-CoV-2. Pharmaceuticals (Basel). 2021 Jan 6;14(1):39. doi: 10.3390/ph14010039.
PubMed 33419184Yang B, Jeang J, Yang A, Wu TC, Hung CF. DNA vaccine for cancer immunotherapy. Hum Vaccin Immunother. 2014;10(11):3153-64. doi: 10.4161/21645515.2014.980686.
PubMed 25625927Liu MA. A Comparison of Plasmid DNA and mRNA as Vaccine Technologies. Vaccines (Basel). 2019 Apr 24;7(2):37. doi: 10.3390/vaccines7020037.
PubMed 31022829Lee LYY, Izzard L, Hurt AC. A Review of DNA Vaccines Against Influenza. Front Immunol. 2018 Jul 9;9:1568. doi: 10.3389/fimmu.2018.01568. eCollection 2018.
PubMed 30038621Modjarrad K, Roberts CC, Mills KT, Castellano AR, Paolino K, Muthumani K, Reuschel EL, Robb ML, Racine T, Oh MD, Lamarre C, Zaidi FI, Boyer J, Kudchodkar SB, Jeong M, Darden JM, Park YK, Scott PT, Remigio C, Parikh AP, Wise MC, Patel A, Duperret EK, Kim KY, Choi H, White S, Bagarazzi M, May JM, Kane D, Lee H, Kobinger G, Michael NL, Weiner DB, Thomas SJ, Maslow JN. Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial. Lancet Infect Dis. 2019 Sep;19(9):1013-1022. doi: 10.1016/S1473-3099(19)30266-X. Epub 2019 Jul 24.
PubMed 31351922Tebas P, Kraynyak KA, Patel A, Maslow JN, Morrow MP, Sylvester AJ, Knoblock D, Gillespie E, Amante D, Racine T, McMullan T, Jeong M, Roberts CC, Park YK, Boyer J, Broderick KE, Kobinger GP, Bagarazzi M, Weiner DB, Sardesai NY, White SM. Intradermal SynCon(R) Ebola GP DNA Vaccine Is Temperature Stable and Safely Demonstrates Cellular and Humoral Immunogenicity Advantages in Healthy Volunteers. J Infect Dis. 2019 Jul 2;220(3):400-410. doi: 10.1093/infdis/jiz132.
PubMed 30891607Muthumani K, Falzarano D, Reuschel EL, Tingey C, Flingai S, Villarreal DO, Wise M, Patel A, Izmirly A, Aljuaid A, Seliga AM, Soule G, Morrow M, Kraynyak KA, Khan AS, Scott DP, Feldmann F, LaCasse R, Meade-White K, Okumura A, Ugen KE, Sardesai NY, Kim JJ, Kobinger G, Feldmann H, Weiner DB. A synthetic consensus anti-spike protein DNA vaccine induces protective immunity against Middle East respiratory syndrome coronavirus in nonhuman primates. Sci Transl Med. 2015 Aug 19;7(301):301ra132. doi: 10.1126/scitranslmed.aac7462.
PubMed 26290414
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05171946
- Acronym / sponsor ID
- IAU-1-001-2021
- Keywords
- Vaccine, COVID-19, SARS-CoV-2, pDNA vaccine, Phase-I, Prophylactic, Safety, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Iman AlmansourUniversity, hospital or other
- Collaborators
- ICON plc
- Study start
- 20 Nov 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 29 Dec 2021 (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.
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")
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: S.opt.FL COVID-19 pDNA vaccineLow-Dose, 1mg, 3 doses 21 days apart |
| Cohort 2 | Experimental | Drug: S.opt.FL COVID-19 pDNA vaccineMid-Dose, 2 mg, 2 doses 21 days apart |
| Cohort 3 | Experimental | Drug: S.opt.FL COVID-19 pDNA vaccineHigh-Dose, 4 mg, 2 doses 21 days apart |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
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 |
|---|---|---|
| S.opt.FL COVID-19 pDNA vaccineAlso: Almansour-001Low-Dose: (1mg) level | Drug | Cohort 1 |
| S.opt.FL COVID-19 pDNA vaccineAlso: Almansour-001Mid-Dose: (2mg) level | Drug | Cohort 2 |
| S.opt.FL COVID-19 pDNA vaccineAlso: Almansour-001High-Dose: (4mg) level | Drug | Cohort 3 |
Primary outcome
The percentage and frequency of study subjects reporting local reaction
Time frame: Through 10 days after receiving each dose
The percentage of study subjects reporting systematic reaction
Time frame: Through 30 days after receiving each dose
The percentage and frequency of study subjects reporting adverse events (AE)
Time frame: From dose 1 through six months after last dose
The percentage and frequency of study subjects reporting systemic events (SAE)
Time frame: From dose 1 through six months after last dose
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
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
GMT of the serum SARS-CoV-2 S neutralizing antibodies
Time frame: At baseline (pre-vaccination) and one month after last dose
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
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Background: PubMed 33334728Viner RM, Ward JL, Hudson LD, Ashe M, Patel SV, Hargreaves D, Whittaker E. Systematic review of reviews of symptoms and signs of COVID-19 in children and adolescents. Arch Dis Child. 2021 Jul 19;106(8):802-807. doi: 10.1136/archdischild-2020-320972.
- Background: PubMed 32691236Chen X, Laurent S, Onur OA, Kleineberg NN, Fink GR, Schweitzer F, Warnke C. A systematic review of neurological symptoms and complications of COVID-19. J Neurol. 2021 Feb;268(2):392-402. doi: 10.1007/s00415-020-10067-3. Epub 2020 Jul 20.
- Background: PubMed 33382675Oliver SE, Gargano JW, Marin M, Wallace M, Curran KG, Chamberland M, McClung N, Campos-Outcalt D, Morgan RL, Mbaeyi S, Romero JR, Talbot HK, Lee GM, Bell BP, Dooling K. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine - United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021 Jan 1;69(5152):1653-1656. doi: 10.15585/mmwr.mm695152e1.
- Background: PubMed 33332292Oliver SE, Gargano JW, Marin M, Wallace M, Curran KG, Chamberland M, McClung N, Campos-Outcalt D, Morgan RL, Mbaeyi S, Romero JR, Talbot HK, Lee GM, Bell BP, Dooling K. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020 Dec 18;69(50):1922-1924. doi: 10.15585/mmwr.mm6950e2.
- Background: PubMed 34316006Roncati L, Roncati M. Emergency use authorization (EUA), conditional marketing authorization (CMA), and the precautionary principle at the time of COVID-19 pandemic. J Public Health Policy. 2021 Sep;42(3):518-521. doi: 10.1057/s41271-021-00299-6. Epub 2021 Jul 27. No abstract available.
- Background: PubMed 33914723MacNeil JR, Su JR, Broder KR, Guh AY, Gargano JW, Wallace M, Hadler SC, Scobie HM, Blain AE, Moulia D, Daley MF, McNally VV, Romero JR, Talbot HK, Lee GM, Bell BP, Oliver SE. Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients - United States, April 2021. MMWR Morb Mortal Wkly Rep. 2021 Apr 30;70(17):651-656. doi: 10.15585/mmwr.mm7017e4.
- Background: PubMed 33064383Krause PR, Gruber MF. Emergency Use Authorization of Covid Vaccines - Safety and Efficacy Follow-up Considerations. N Engl J Med. 2020 Nov 5;383(19):e107. doi: 10.1056/NEJMp2031373. Epub 2020 Oct 16. No abstract available.
- Background: PubMed 33419184Almansour I, Macadato NC, Alshammari T. Immunogenicity of Multiple Doses of pDNA Vaccines against SARS-CoV-2. Pharmaceuticals (Basel). 2021 Jan 6;14(1):39. doi: 10.3390/ph14010039.
- Background: PubMed 25625927Yang B, Jeang J, Yang A, Wu TC, Hung CF. DNA vaccine for cancer immunotherapy. Hum Vaccin Immunother. 2014;10(11):3153-64. doi: 10.4161/21645515.2014.980686.
- Background: PubMed 31022829Liu MA. A Comparison of Plasmid DNA and mRNA as Vaccine Technologies. Vaccines (Basel). 2019 Apr 24;7(2):37. doi: 10.3390/vaccines7020037.
- Background: PubMed 30038621Lee LYY, Izzard L, Hurt AC. A Review of DNA Vaccines Against Influenza. Front Immunol. 2018 Jul 9;9:1568. doi: 10.3389/fimmu.2018.01568. eCollection 2018.
- Background: PubMed 31351922Modjarrad K, Roberts CC, Mills KT, Castellano AR, Paolino K, Muthumani K, Reuschel EL, Robb ML, Racine T, Oh MD, Lamarre C, Zaidi FI, Boyer J, Kudchodkar SB, Jeong M, Darden JM, Park YK, Scott PT, Remigio C, Parikh AP, Wise MC, Patel A, Duperret EK, Kim KY, Choi H, White S, Bagarazzi M, May JM, Kane D, Lee H, Kobinger G, Michael NL, Weiner DB, Thomas SJ, Maslow JN. Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial. Lancet Infect Dis. 2019 Sep;19(9):1013-1022. doi: 10.1016/S1473-3099(19)30266-X. Epub 2019 Jul 24.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S.opt.FL COVID-19 pDNA vaccine in people with Safety and Vaccine Reaction, run by Iman Almansour.
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 30 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: status not confirmed, as of the sponsor's last update on 19 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iman Almansour, Ph.D. (0534888861, ikalmansour@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage and frequency of study subjects reporting local reaction (time frame: Through 10 days after receiving each dose). The study lists 8 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 NCT05171946, which also lists 14 linked publications.
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 19 Oct 2022.