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A First Time in Human Phase 1 Open-Label Study of the COVIDITY Vaccine Administered by Needle-free Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05047445
Recruitment Status : Recruiting
First Posted : September 17, 2021
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Scancell Ltd

Brief Summary:
The main objectives of this study are to assess the safety, tolerability and immunogenicity of the candidate SARS-CoV-2 vaccines, COVIDITY, when administered using a needle-free injection device.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: COVIDITY administered via needle-free injection (PharmaJet Tropis®; intradermal injection). Biological: COVIDITY administered via needle-free injection (PharmaJet Stratis®; intramuscular injection). Phase 1

Detailed Description:

This is an open label, two-arm Phase 1 study to determine the safety, tolerability and immunogenicity of the SARS-CoV-2 COVIDITY vaccine, when administered using a needle-free injection device.

COVIDITY consists of two doses of the plasmid DNA vaccine SCOV1 (administered on Day 1 and Day 29), followed by two doses of the plasmid DNA vaccine SCOV2 (not before Days 113 and 141 [doses 4 weeks apart]). A final end of study assessment will then be performed 6 weeks after last dose of study vaccine (Day 183 [earliest]).

SCOV1 is expected to be active against the original SARS-CoV-2 strain and the B.1.1.7 (Alpha) variant, and to a slightly lesser extent against the B.1.351 (Beta) and P.1 (Gamma) variants. SCOV2 is expected to boost the effects of SCOV1 while providing further enhanced protection against the B.1.351 (Beta) and P.1 (Gamma) variants.

Each dose of SCOV1 or SCOV2 will be administered via needle-free injection, either intradermally (0.2 mg doses; study Arm 1; PharmaJet Tropis® device) or intramuscularly (1.0 mg doses; study Arm 2; PharmaJet Stratis® device). Eligible injection sites include the outer aspect of the upper left or right arm (medial deltoid muscle) or the left or right outer thigh (lateralis muscle) for intradermal administration (Arm 1), and the outer aspect of the upper left or right arm (medial deltoid muscle) for intramuscular administration (Arm 2).

This study is expected to enrol 40 participants (20 per study arm) at one study centre in South Africa. At least 15 participants in each arm should be negative for antibodies against SARS-CoV-2 upon entry into the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label, uncontrolled study.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A First Time in Human Phase 1 Open-Label Study of the Safety, Tolerability, and Immunogenicity of COVIDITY Vaccine Administered by Needle-free Intradermal Injection or Needle-free Intramuscular Injection in Healthy Adults (COVIDITY-001)
Actual Study Start Date : September 30, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COVIDITY administered via needle-free injection (intradermal). Biological: COVIDITY administered via needle-free injection (PharmaJet Tropis®; intradermal injection).
COVIDITY (intradermal) consists of two 0.2 mg doses of the plasmid DNA vaccine SCOV1 (administered on Day 1 and Day 29), followed by two 0.2 mg doses of the plasmid DNA vaccine SCOV2 (not before Days 113 and 141 [doses 4 weeks apart]).

Experimental: COVIDITY administered via needle-free injection (intramuscular). Biological: COVIDITY administered via needle-free injection (PharmaJet Stratis®; intramuscular injection).
COVIDITY (intramuscular) consists of two 1.0 mg doses of the plasmid DNA vaccine SCOV1 (administered on Day 1 and Day 29), followed by two 1.0 mg doses of the plasmid DNA vaccine SCOV2 (not before Days 113 and 141 [doses 4 weeks apart]).




Primary Outcome Measures :
  1. Safety and tolerability of COVIDITY as assessed by the recording of adverse events (AEs) [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events; CTCAE v5.0.

  2. Safety and tolerability of COVIDITY as assessed by the recording of vital signs [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Oral temperature (°C).

  3. Safety and tolerability of COVIDITY as assessed by the recording of vital signs [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Pulse (beats per minute).

  4. Safety and tolerability of COVIDITY as assessed by the recording of vital signs [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Respiratory rate (breaths per minute).

  5. Safety and tolerability of COVIDITY as assessed by the recording of vital signs [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Systolic and diastolic blood pressure (mm Hg).

  6. Safety and tolerability of COVIDITY as assessed by a physical examination of the participant [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Physical examination findings (binary classification: normal or abnormal).

  7. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Albumin (g/L).

  8. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Alanine aminotransferase (IU/L).

  9. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Alkaline phosphatase (IU/L).

  10. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Aspartate aminotransferase (IU/L).

  11. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Bicarbonate (mmol/L).

  12. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Calcium (mmol/L).

  13. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Chloride (mmol/L).

  14. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Creatinine (μmol/L).

  15. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Creatine kinase (IU/L).

  16. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Total bilirubin (and direct if clinically indicated; μmol/L).

  17. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Gamma glutamyl transferase (IU/L).

  18. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Lactate dehydrogenase (IU/L).

  19. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Non-fasting glucose (mmol/L).

  20. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Phosphorus (measured as phosphate; mmol/L).

  21. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Potassium (mmol/L).

  22. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Sodium (mmol/L).

  23. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Uric acid (urate; mmol/L).

  24. Safety and tolerability of COVIDITY as assessed by serum chemistry [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Total protein (g/L).

  25. Safety and tolerability of COVIDITY as assessed by haematology [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Haemoglobin (g/dL).

  26. Safety and tolerability of COVIDITY as assessed by haematology [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Haematocrit (L/L).

  27. Safety and tolerability of COVIDITY as assessed by haematology [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Mean corpuscular volume (fL).

  28. Safety and tolerability of COVIDITY as assessed by haematology [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Mean corpuscular haemoglobin concentration (g/dL).

  29. Safety and tolerability of COVIDITY as assessed by haematology [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Platelet count (cells x 10^9/L).

  30. Safety and tolerability of COVIDITY as assessed by haematology [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Red blood cell count (cells x 10^12/L).

  31. Safety and tolerability of COVIDITY as assessed by haematology [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    White blood cell count (cells x 10^9/L).

  32. Safety and tolerability of COVIDITY as assessed by haematology [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    White blood cell differential (cells x 10^9/L).

  33. Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    International normalised ratio (no units).

  34. Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Activated partial prothrombin time (sec).

  35. Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Fibrinogen (g/L).

  36. Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    D-Dimer (μg/mL).

  37. Safety and tolerability of COVIDITY as assessed by urinalysis [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Glucose (negative, 0.1/0.25/0.5/1.0/2.0+ g/dL).

  38. Safety and tolerability of COVIDITY as assessed by urinalysis [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Ketones (negative, 5/15/40/80/160 mg/dL).

  39. Safety and tolerability of COVIDITY as assessed by urinalysis [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Blood (negative, non-haemolysed trace/moderate, haemolysed trace/small+/moderate++/large+++).

  40. Safety and tolerability of COVIDITY as assessed by urinalysis [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Leucocytes (negative, trace/small+/moderate++/large+++).

  41. Safety and tolerability of COVIDITY as assessed by urinalysis [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Bilirubin (negative, small+/moderate++/large+++).

  42. Safety and tolerability of COVIDITY as assessed by urinalysis [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    pH (5.0/6.0/6.5/7.0/7.5/8.0/8.5 pH units).

  43. Safety and tolerability of COVIDITY as assessed by urinalysis [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Specific gravity (1.000/1.005/1.010/1.015/1.020/1.025/1.030 [no units]).

  44. Safety and tolerability of COVIDITY as assessed by urinalysis [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Protein (negative, trace/30/100/300/2000+ mg/dL).

  45. Safety and tolerability of COVIDITY as assessed by urinalysis [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Microscopy (if clinically indicated only) examination for bacteria, red blood cells, white blood cells, casts, and crystals (binary classification: positive or negative).

  46. Safety and tolerability of COVIDITY as assessed by 12-lead electrocardiogram (ECG) [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Heart rate, PR-interval, QRS-duration, QT-interval, corrected QT-interval by Fridericia (QTcF), general morphology, and the interpretation of the ECG by the Investigator or designee.

  47. Safety and tolerability of COVIDITY as assessed by local and systemic reactogenicity events [ Time Frame: From enrolment through end of study; approximately 26 weeks ]

    Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (US FDA 2007).

    Local reactogenicity events will be measured for the injection site using a 4-point scale where 1 = 'mild' and 4 = 'potentially life-threatening'.

    Systemic reactogenicity events of interest include fever, chills, headache, myalgia, arthralgia, fatigue, nausea, vomiting, diarrhoea, rhinorrhoea, wheezing, general feeling of being unwell, and loss of appetite.


  48. Safety and tolerability of COVIDITY as assessed by the onset of any new chronic medical conditions [ Time Frame: From enrolment through end of study; approximately 26 weeks ]

Secondary Outcome Measures :
  1. The immunogenicity of COVIDITY as assessed by antibody response [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Quantitative COVIDITY-specific antibody responses measured by enzyme-linked immunosorbent assay (ELISA) or using the Meso Scale Discovery (MSD) platform.

  2. The immunogenicity of COVIDITY as assessed by seroconversion [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    The proportion of participants who seroconvert (defined as a 4-fold change in COVIDITY-specific antibody titre from baseline).

  3. The immunogenicity of COVIDITY as assessed by T cell response [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    Quantitative COVIDITY-specific T cell responses measured by ELISpot assay.


Other Outcome Measures:
  1. Exploratory: The proportion of participants who remain COVID-19 free throughout the study [ Time Frame: From enrolment through end of study; approximately 26 weeks ]
    The proportion of participants that remain negative for the SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) test throughout the duration of the study.

  2. Exploratory: The induction of a functional immune response by COVIDITY [ Time Frame: From enrolment through end of study; approximately 26 weeks ]

    Pseudovirus neutralisation assay, live virus neutralisation assay, angiotensin converting enzyme 2 (ACE2) neutralisation assay.

    Analysis of immune responses in participants who are SARS-CoV-2 positive.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is able and willing to provide written informed consent prior to any study procedure.
  • Participant is 18 to 59 years of age.
  • Participant is male or non-pregnant female.
  • Participant has had no known exposure to SARS-CoV-2 virus in the last 14 days and has a negative RT-PCR SARS-CoV-2 laboratory test 24-48 hours prior to initial vaccination.
  • SARS-CoV-2 antibodies:

    • Negative for SARS-CoV-2 antibodies, or
    • Positive for SARS-CoV-2 antibodies with no known clinical history of COVID-19 infection (asymptomatic) (Note: up to a maximum of 5 such participants per treatment arm).
  • Participant is determined by the Investigator to be healthy on the basis of medical history, physical examination, vital signs, and routine laboratory tests.
  • Participant agrees to comply with study procedures, including the collection of venous blood, and to be available for all study visits.
  • Women of child-bearing potential must have a negative urine pregnancy test during screening and a negative serum pregnancy test on Day -1 (prior to the first dose) and be neither breastfeeding nor intending to become pregnant during study participation. Women of child-bearing potential must agree to use highly effective contraceptive methods at least 28 days prior to study entry, for the duration of study participation, and for 120 days after the last dose of study vaccine.
  • Men who are potentially fertile must agree to use barrier protection for the duration of their participation in the study and until 120 days after administration of the last dose of study vaccine when they engage in sexual relations with women who are of child-bearing potential, pregnant, or lactating; they also agree to request their female partners to use an effective method of contraception if they are of child-bearing potential.
  • Participant has an oral temperature of less than 37.5°C at screening and prior to dosing.
  • Participant has a screening ECG with none of the following clinically significant findings:

    • PR-interval >210 msec
    • QRS-duration >120 msec
    • QT-interval >500 msec
    • QTcF-interval >450 msec (males), >470 msec (females)
    • Pathologic Q wave
    • Significant ST-T wave changes
    • Second or third-degree atrioventricular heart block.
  • Participant agrees to refrain from donating blood or plasma, outside of the study, for the duration of study participation, and for 28 days after the last dose of study vaccine.
  • Participant agrees not to consume any alcohol within 48 hours prior to each study vaccine administration.

Exclusion Criteria:

  • Participant has a history of chronic respiratory disease, hypertension, significant cardiovascular disease, autoimmune disease (including hypothyroidism without defined non-autoimmune cause), immunodeficiency, clotting disorder, history of thrombosis, or malignancy (except for adequately treated malignancies with an expected 5-year survival rate of >90%, e.g., carcinoma in-situ of the breast or cervix, squamous or basal cell carcinoma of the skin).
  • Participant has any medical disease or condition, or psychiatric condition, which in the opinion of the Investigator would preclude study participation (would place the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or may interfere with the evaluation of responses).
  • Participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
  • Alcohol consumption of >21 units per week (males) or >14 units per week (females) (1 unit of alcohol equals 1/2 pint [285 mL] of beer or lager, 1 glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits).
  • Strenuous exercise (e.g., heavy lifting, weight, or fitness training) within 96 hours (4 days) of screening and the first dosing visit.
  • Participant has participated in another investigational study involving an investigational product within 30 days, or 5 half-lives, whichever is longer, before the first study vaccine administration in the current study.
  • Participant is currently enrolled in, or plans to participate in, another clinical trial with an investigational product that will be received during the study-reporting period.
  • Participant has a history of any vaccine or drug hypersensitivity reactions (including skin reactions or anaphylaxis), or other known clinically significant allergies.
  • Participant has a history of chronic use (>14 continuous days in the 6 months preceding screening) of any medications that may be associated with impaired immune responsiveness including, but not limited to: systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other immuno-suppressive drugs. The use of low dose topical, ophthalmic, inhaled, and intranasal steroid preparations is permitted (not more than the equivalent of 10 mg prednisone a day).
  • Use of any prescription medications within 14 days or 5 half-lives (whichever is longer) of first study vaccine administration (Day 1), use of over-the-counter medications, or herbal supplements within 7 days. The use of occasional paracetamol (up to 4 g per day) and hormone replacement therapy, oral, implantable, transdermal injectable, or intrauterine contraceptives is permitted. Nutritional supplements may be permitted but must be discussed with the Sponsor's medical monitor prior to participant enrolment.
  • Participant has received immunoglobulins and/or any blood or blood products within 90 days before the first study vaccine administration (Day 1) or at any time during the study.
  • Participant has received a vaccine within 28 days of the first dose of study vaccine administration.
  • Participant has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before the first study vaccine administration.
  • Participant has a positive result for the urine drugs of abuse test at screening or prior to the first study vaccine administration (Day 1).
  • Participant has received any other SARS-CoV-2 vaccine or experimental coronavirus vaccine at any time prior to the study.
  • Participant is pregnant, lactating, or is expecting to conceive/father children during the study.
  • Participant has any clinically significant abnormal findings on screening biochemistry, haematology blood tests, or urinalysis; participants with Gilbert's syndrome will be permitted to enter the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05047445


Contacts
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Contact: Robert Miller +44 (0)1865 582 690 info@scancell.co.uk

Locations
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South Africa
University of Cape Town Lung Institute, Centre for TB Research Innovation Recruiting
Cape Town, Western Cape, South Africa, 7700
Contact: Rodney Dawson, MD         
Principal Investigator: Rodney Dawson, MD         
Sponsors and Collaborators
Scancell Ltd
Investigators
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Principal Investigator: Rodney Dawson, MD University of Cape Town Lung Institute
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Responsible Party: Scancell Ltd
ClinicalTrials.gov Identifier: NCT05047445    
Other Study ID Numbers: COVIDITY-001
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual patient data available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No