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

NCT05047445 | Unknown Phase 1

• 1 other identifier: COVIDITY-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this study are to assess the safety, tolerability and immunogenicity of the candidate SARS-CoV-2 vaccine, COVIDITY, when administered using a needle-free ID or IM injection device.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (48)

• Safety and tolerability of COVIDITY as assessed by the recording of adverse events (AEs)

  National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events; CTCAE v5.0.

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by the recording of vital signs

  Oral temperature (°C)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by the recording of vital signs

  Pulse (beats per minute)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by the recording of vital signs

  Respiratory rate (breaths per minute)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by the recording of vital signs

  Systolic and diastolic blood pressure (mm Hg)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by a physical examination of the participant

  Physical examination findings (binary classification: normal or abnormal)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Albumin (g/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Alanine aminotransferase (IU/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Alkaline phosphatase (IU/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Aspartate aminotransferase (IU/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Bicarbonate (mmol/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Corrected Calcium (mmol/L).

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Chloride (mmol/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Creatinine (μmol/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Creatine kinase (IU/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Total bilirubin (and direct if clinically indicated; μmol/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Gamma glutamyl transferase (IU/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Lactate dehydrogenase (IU/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Random glucose (mmol/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Phosphorus (measured as phosphate; mmol/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Potassium (mmol/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Sodium (mmol/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Uric acid (urate; mmol/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by serum chemistry

  Total protein (g/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by haematology

  Haemoglobin (g/dL)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by haematology

  Haematocrit (L/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by haematology

  Mean corpuscular volume (fL)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by haematology

  Mean corpuscular haemoglobin concentration (g/dL)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by haematology

  Platelet count (cells x 10\^9/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by haematology

  Red blood cell count (cells x 10\^12/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by haematology

  White blood cell count (cells x 10\^9/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by haematology

  White blood cell differential (cells x 10\^9/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers

  International normalised ratio (no units)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers

  Activated partial prothrombin time (sec)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers

  Fibrinogen (g/L)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers

  D-dimer (ng/mL)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by urinalysis

  Glucose (negative, 100/250/500/1000/2000+ mg/dL)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by urinalysis

  Ketones (negative, trace/small/moderate/large, 5/15/40/80/160 mg/dL)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by urinalysis

  Blood (negative, trace, non-haemolysed trace/moderate, haemolysed trace/+/++/+++)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by urinalysis

  Leucocytes (negative, trace/+/++/+++)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by urinalysis

  Bilirubin (negative, +/++/+++)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by urinalysis

  pH (5.0/5.5/6.0/6.5/7.0/7.5/8.0/8.5 pH units)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by urinalysis

  Specific gravity (1.000/1.004/1.005/1.010/1.015/1.020/1.025/1.030 \[no units\])

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by urinalysis

  Protein (negative, trace/+/++/+++/++++)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by urinalysis

  Microscopy (if clinically indicated only) examination for bacteria, red blood cells, white blood cells, casts, and crystals (binary classification: absent or present)

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by 12-lead electrocardiogram (ECG)

  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

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by local and systemic reactogenicity events

  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.

  From enrolment through end of study; approximately 6 to 26 weeks

• Safety and tolerability of COVIDITY as assessed by the onset of any new chronic medical conditions

  From enrolment through end of study; approximately 6 to 26 weeks

Secondary Outcomes (3)

• The immunogenicity of COVIDITY as assessed by antibody response

  From enrolment through end of study; approximately 6 to 26 weeks

• The immunogenicity of COVIDITY as assessed by seroconversion and/or increase in antibody titre

  From enrolment through end of study; approximately 6 to 26 weeks

• The immunogenicity of COVIDITY as assessed by T cell response

  From enrolment through end of study; approximately 6 to 26 weeks

Other Outcomes (3)

• Exploratory: The proportion of participants who remain COVID-19 free throughout the study

  From enrolment through end of study; approximately 6 to 26 weeks

• Exploratory: The induction of a functional humoral immune response by COVIDITY

  From enrolment through end of study; approximately 6 to 26 weeks

• Exploratory: The induction of a functional humoral immune response by COVIDITY

  From enrolment through end of study; approximately 6 to 26 weeks

Study Arms (2)

COVIDITY administered via needle-free intradermal injection (PharmaJet Tropis)

EXPERIMENTAL

Biological: COVIDITY (SCOV1 and SCOV2) administered via needle-free intradermal injection; Biological: COVIDITY (SCOV2 only) administered via needle-free intradermal injection to vaccine naive and/or previously vaccinated participants; Biological: COVIDITY (SCOV2 only) administered via needle-free intradermal injection to previously infected participants

COVIDITY administered via needle-free intramuscular injection (PharmaJet Stratis)

EXPERIMENTAL

Biological: COVIDITY (SCOV1 and SCOV2) administered via needle-free intramuscular injection; Biological: COVIDITY (SCOV2 only) administered via needle-free intramuscular injection to vaccine naive and/or previously vaccinated participants; Biological: COVIDITY (SCOV2 only) administered via needle-free intramuscular injection to previously infected participants

Interventions

COVIDITY (SCOV1 and SCOV2) administered via needle-free intradermal injection BIOLOGICAL

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 \[doses 4 weeks apart\]).

COVIDITY administered via needle-free intradermal injection (PharmaJet Tropis)

COVIDITY (SCOV1 and SCOV2) administered via needle-free intramuscular injection BIOLOGICAL

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 \[doses 4 weeks apart\]).

COVIDITY administered via needle-free intramuscular injection (PharmaJet Stratis)

COVIDITY (SCOV2 only) administered via needle-free intradermal injection to vaccine naive and/or previously vaccinated participants BIOLOGICAL

Two 0.8 mg doses of the plasmid DNA vaccine SCOV2 administered on Day 1 and Day 29

COVIDITY administered via needle-free intradermal injection (PharmaJet Tropis)

COVIDITY (SCOV2 only) administered via needle-free intramuscular injection to vaccine naive and/or previously vaccinated participants BIOLOGICAL

Two 4.0 mg doses of the plasmid DNA vaccine SCOV2 administered on Day 1 and Day 29

COVIDITY administered via needle-free intramuscular injection (PharmaJet Stratis)

COVIDITY (SCOV2 only) administered via needle-free intradermal injection to previously infected participants BIOLOGICAL

A single 0.8 mg dose of the plasmid DNA vaccine SCOV2 administered on Day 1

COVIDITY administered via needle-free intradermal injection (PharmaJet Tropis)

COVIDITY (SCOV2 only) administered via needle-free intramuscular injection to previously infected participants BIOLOGICAL

A single 4.0 mg dose of the plasmid DNA vaccine SCOV2 administered on Day 1

COVIDITY administered via needle-free intramuscular injection (PharmaJet Stratis)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 within 48 hours prior to the first study vaccination administration.
• 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 of study vaccine, 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 oC at screening and prior to dosing.
• Participant has a screening electrocardiogram (ECG) with none of the following clinically significant findings:
• PR-interval \>210 msec
• QRS-duration \>120 msec
• QT-interval \>500 msec
• Corrected QT-interval by Fridericia (QTcF)-interval \>450 msec (males), \>470 msec (females)
• Pathologic Q wave

You may not qualify if:

• Participant has a history of proven infection with SARS-CoV-2 during the 28 days prior to the first planned administration of COVIDITY.
• Participant has received a COVID-19 or other vaccination or booster during the 28 days prior to the first planned administration of COVIDITY.
• 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).
• History of strenuous exercise (e.g., heavy lifting, weight, or fitness training) within 96 hours (4 days) prior to administration of the first study vaccination.
• 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 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 urine drugs of abuse at screening or prior to the first study vaccine administration (Day 1) with the exception of cannabis for which a positive result is acceptable if the participant confirms recreational use, and this information is considered to be reliable in the opinion of the Investigator.

Sponsors & Collaborators

• Scancell Ltd: lead

Study Sites (1)

University of Cape Town Lung Institute, Centre for TB Research Innovation

Cape Town, Western Cape, 7700, South Africa

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rodney Dawson, MD

  University of Cape Town Lung Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, uncontrolled study.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 17, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)