COVID-19Phase 1NCT05047445
A First Time in Human Phase 1 Open-Label Study of the COVIDITY Vaccine Administered by Needle-free Injection
A Phase 1 study testing COVIDITY (SCOV1 and SCOV2) administered via needle-free intradermal injection, COVIDITY (SCOV1 and SCOV2) administered via needle-free intramuscular injection and COVIDITY (SCOV2 only) administered via needle-free intradermal injection to vaccine naive and/or previously vaccinated participants in people with COVID-19, run by Scancell Ltd at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- COVIDITY (SCOV1 and SCOV2) administered via needle-free intradermal injection, COVIDITY (SCOV1 and SCOV2) administered via needle-free intramuscular injection and COVIDITY (SCOV2 only) administered via needle-free intradermal injection to vaccine naive and/or previously vaccinated participants
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Oct 2021to Dec 2022
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Participants must meet ALL of the following Inclusion Criteria to be eligible for study entry:
- 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
- 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 and has a negative alcohol breath test prior to the first administration of the study vaccine.
Participant's meeting ANY of the following Exclusion Criteria are not eligible for study entry:
- 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.
- Participant has received an experimental SARS-CoV-2 vaccine other than SCOV1.
- Participant is pregnant, lactating, or is planning or wanting to conceive/father children during the study.
- Participant has any clinically significant abnormal findings on screening biochemistry, haematology or coagulation blood tests, or urinalysis; participants with Gilbert's syndrome will be permitted to enter the study.
- Any other reason that, in the opinion of the Investigator, may render the participant unable to participate in the study, may limit their ability to provide participant reported outcomes, or may interfere with protocol adherence.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Cape Town Lung Institute, Centre for TB Research Innovation
Cape Town, Western Cape, 7700
About this study
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)
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.
Read the detailed description
This is a first time in human (FTiH) study designed to explore the safety, tolerability, and immunogenicity of COVIDITY in healthy adults when administered by needle-free injection.
COVIDITY consists of two DNA plasmid vaccines (SCOV1 and SCOV2). 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. Antibodies induced by SCOV1 and SCOV2 also show strong binding to the B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants in nonclinical models.
When the study commenced in 2021 there were significant numbers of unvaccinated individuals who also had no known exposure to SARS-CoV-2; however as the epidemiology rapidly changed with most people having either been vaccinated, or infected with SARS-CoV-2, or both, the use of SCOV2 only in these populations made rational sense, particularly as it has more mutations in common with the Omicron variant. A protocol amendment submitted in February 2022, permitted the enrolment of participants irrespective of their previous COVID-19 vaccination and/or SARS-CoV-2 infection status, amended the treatment regimen to SCOV2 only, and aligned the administered dose with the doses employed for other DNA vaccines. Immunogenicity analyses will be performed separately for the vaccine-naïve, previously vaccinated and previously infected immunogenicity analysis populations.
Eligible participants will be randomised 1:1 to be vaccinated by either IM or ID needle-free injection in blocks determined by their previous COVID-19 vaccination and SARS-CoV-2 infection status, as follows:
Participants enrolled under the initial protocol (Amendment 1): Two doses of SCOV1 (administered on Day 1 and Day 29), followed by two doses of 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).
Participants enrolled under protocol Amendment 2: Vaccine Naive and Previously Vaccinated participants: Two doses of SCOV2 (administered on Day 1 and Day 29) with a final end of study assessment performed 6 weeks after last dose of study vaccine (Day 71); Previously Infected participants: A single dose of SCOV2 (administered on Day 1) with a final end of study assessment performed 6 weeks after last dose of study vaccine (Day 43)
Each dose of SCOV1 and/or SCOV2 will be administered via needle-free injection, either intradermally (study Arm 1; PharmaJet Tropis® device) or intramuscularly (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).
This study is expected to enrol up to 80 participants at a single centre in South Africa. Enrolment will attempt to continue until at least 10 evaluable participants receive all protocol-required SCOV2 vaccinations for each immunogenicity analysis population. However, should the epidemiology be such that certain populations cannot be enrolled, the Safety Review Committee may determine that enrolment for that population be considered complete.
- Conditions
- COVID-19
- Being tested
- COVIDITY (SCOV1 and SCOV2) administered via needle-free intradermal injection, COVIDITY (SCOV1 and SCOV2) administered via needle-free intramuscular injection, COVIDITY (SCOV2 only) administered via needle-free intradermal injection to vaccine naive and/or previously vaccinated participants, COVIDITY (SCOV2 only) administered via needle-free intramuscular injection to vaccine naive and/or previously vaccinated participants, COVIDITY (SCOV2 only) administered via needle-free intradermal injection to previously infected participants
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVIDITY (SCOV1 and SCOV2) administered via needle-free intradermal injectionBiological
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 (SCOV1 and SCOV2) administered via needle-free intramuscular injectionBiological
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 (SCOV2 only) administered via needle-free intradermal injection to vaccine naive and/or previously vaccinated participantsBiological
Two 0.8 mg doses of the plasmid DNA vaccine SCOV2 administered on Day 1 and Day 29
COVIDITY (SCOV2 only) administered via needle-free intramuscular injection to vaccine naive and/or previously vaccinated participantsBiological
Two 4.0 mg doses of the plasmid DNA vaccine SCOV2 administered on Day 1 and Day 29
COVIDITY (SCOV2 only) administered via needle-free intradermal injection to previously infected participantsBiological
A single 0.8 mg dose of the plasmid DNA vaccine SCOV2 administered on Day 1
COVIDITY (SCOV2 only) administered via needle-free intramuscular injection to previously infected participantsBiological
A single 4.0 mg dose of the plasmid DNA vaccine SCOV2 administered on Day 1
| Study group | Role | What they receive |
|---|---|---|
| COVIDITY administered via needle-free intradermal injection (PharmaJet Tropis) | Experimental | Not described Receives: 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 | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by serum chemistry
Albumin (g/L)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by serum chemistry
Bicarbonate (mmol/L)
Measured: 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).
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by serum chemistry
Chloride (mmol/L)
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by serum chemistry
Creatinine (μmol/L)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by serum chemistry
Potassium (mmol/L)
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by serum chemistry
Sodium (mmol/L)
Measured: 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)
Measured: 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)
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by haematology
Haemoglobin (g/dL)
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by haematology
Haematocrit (L/L)
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by haematology
Mean corpuscular volume (fL)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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/+/++/+++)
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by urinalysis
Leucocytes (negative, trace/+/++/+++)
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by urinalysis
Bilirubin (negative, +/++/+++)
Measured: 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)
Measured: 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])
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by urinalysis
Protein (negative, trace/+/++/+++/++++)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Secondary outcomes (3)
The immunogenicity of COVIDITY as assessed by antibody response
Quantitative COVIDITY-specific antibody responses measured by enzyme-linked immunosorbent assay (ELISA) or using the Meso Scale Discovery (MSD) platform
Measured: 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
The proportion of participants who seroconvert and/or have a 4-fold increase in N ± S protein antibody titre from baseline
Measured: From enrolment through end of study; approximately 6 to 26 weeks
The immunogenicity of COVIDITY as assessed by T cell response
Quantitative COVIDITY-specific T cell responses measured by ELISpot assay
Measured: From enrolment through end of study; approximately 6 to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Oct 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Parallel groups
- Model description
- Open label, uncontrolled study.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scancell Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodney Dawson, MD, Principal investigator, University of Cape Town Lung Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047445
- Sponsor's protocol ID
- COVIDITY-001
- Status last verified
- Nov 2022
- First submitted
- 27 Aug 2021
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual patient data available.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05047445
- Acronym / sponsor ID
- COVIDITY-001
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Scancell LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Sep 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.
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.
Detailed description
This is a first time in human (FTiH) study designed to explore the safety, tolerability, and immunogenicity of COVIDITY in healthy adults when administered by needle-free injection.
COVIDITY consists of two DNA plasmid vaccines (SCOV1 and SCOV2). 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. Antibodies induced by SCOV1 and SCOV2 also show strong binding to the B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants in nonclinical models.
When the study commenced in 2021 there were significant numbers of unvaccinated individuals who also had no known exposure to SARS-CoV-2; however as the epidemiology rapidly changed with most people having either been vaccinated, or infected with SARS-CoV-2, or both, the use of SCOV2 only in these populations made rational sense, particularly as it has more mutations in common with the Omicron variant. A protocol amendment submitted in February 2022, permitted the enrolment of participants irrespective of their previous COVID-19 vaccination and/or SARS-CoV-2 infection status, amended the treatment regimen to SCOV2 only, and aligned the administered dose with the doses employed for other DNA vaccines. Immunogenicity analyses will be performed separately for the vaccine-naïve, previously vaccinated and previously infected immunogenicity analysis populations.
Eligible participants will be randomised 1:1 to be vaccinated by either IM or ID needle-free injection in blocks determined by their previous COVID-19 vaccination and SARS-CoV-2 infection status, as follows:
Participants enrolled under the initial protocol (Amendment 1): Two doses of SCOV1 (administered on Day 1 and Day 29), followed by two doses of 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).
Participants enrolled under protocol Amendment 2: Vaccine Naive and Previously Vaccinated participants: Two doses of SCOV2 (administered on Day 1 and Day 29) with a final end of study assessment performed 6 weeks after last dose of study vaccine (Day 71); Previously Infected participants: A single dose of SCOV2 (administered on Day 1) with a final end of study assessment performed 6 weeks after last dose of study vaccine (Day 43)
Each dose of SCOV1 and/or SCOV2 will be administered via needle-free injection, either intradermally (study Arm 1; PharmaJet Tropis® device) or intramuscularly (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).
This study is expected to enrol up to 80 participants at a single centre in South Africa. Enrolment will attempt to continue until at least 10 evaluable participants receive all protocol-required SCOV2 vaccinations for each immunogenicity analysis population. However, should the epidemiology be such that certain populations cannot be enrolled, the Safety Review Committee may determine that enrolment for that population be considered complete.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, uncontrolled study.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| COVIDITY (SCOV1 and SCOV2) administered via needle-free intradermal injectionTwo 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]). | Biological | COVIDITY administered via needle-free intradermal injection (PharmaJet Tropis) |
| COVIDITY (SCOV1 and SCOV2) administered via needle-free intramuscular injectionTwo 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]). | Biological | 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 participantsTwo 0.8 mg doses of the plasmid DNA vaccine SCOV2 administered on Day 1 and Day 29 | Biological | 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 participantsTwo 4.0 mg doses of the plasmid DNA vaccine SCOV2 administered on Day 1 and Day 29 | Biological | COVIDITY administered via needle-free intramuscular injection (PharmaJet Stratis) |
| COVIDITY (SCOV2 only) administered via needle-free intradermal injection to previously infected participantsA single 0.8 mg dose of the plasmid DNA vaccine SCOV2 administered on Day 1 | Biological | COVIDITY administered via needle-free intradermal injection (PharmaJet Tropis) |
| COVIDITY (SCOV2 only) administered via needle-free intramuscular injection to previously infected participantsA single 4.0 mg dose of the plasmid DNA vaccine SCOV2 administered on Day 1 | Biological | COVIDITY administered via needle-free intramuscular injection (PharmaJet Stratis) |
Primary outcome
Safety and tolerability of COVIDITY as assessed by the recording of adverse events (AEs)
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events; CTCAE v5.0.
Safety and tolerability of COVIDITY as assessed by the recording of vital signs
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Oral temperature (°C)
Safety and tolerability of COVIDITY as assessed by the recording of vital signs
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Pulse (beats per minute)
Safety and tolerability of COVIDITY as assessed by the recording of vital signs
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Respiratory rate (breaths per minute)
Safety and tolerability of COVIDITY as assessed by the recording of vital signs
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Systolic and diastolic blood pressure (mm Hg)
Safety and tolerability of COVIDITY as assessed by a physical examination of the participant
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Physical examination findings (binary classification: normal or abnormal)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Albumin (g/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Alanine aminotransferase (IU/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Alkaline phosphatase (IU/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Aspartate aminotransferase (IU/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Bicarbonate (mmol/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Corrected Calcium (mmol/L).
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Chloride (mmol/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Creatinine (μmol/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Creatine kinase (IU/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Total bilirubin (and direct if clinically indicated; μmol/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Gamma glutamyl transferase (IU/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Lactate dehydrogenase (IU/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Random glucose (mmol/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Phosphorus (measured as phosphate; mmol/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Potassium (mmol/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Sodium (mmol/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Uric acid (urate; mmol/L)
Safety and tolerability of COVIDITY as assessed by serum chemistry
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Total protein (g/L)
Safety and tolerability of COVIDITY as assessed by haematology
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Haemoglobin (g/dL)
Safety and tolerability of COVIDITY as assessed by haematology
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Haematocrit (L/L)
Safety and tolerability of COVIDITY as assessed by haematology
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Mean corpuscular volume (fL)
Safety and tolerability of COVIDITY as assessed by haematology
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Mean corpuscular haemoglobin concentration (g/dL)
Safety and tolerability of COVIDITY as assessed by haematology
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Platelet count (cells x 10^9/L)
Safety and tolerability of COVIDITY as assessed by haematology
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Red blood cell count (cells x 10^12/L)
Safety and tolerability of COVIDITY as assessed by haematology
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
White blood cell count (cells x 10^9/L)
Safety and tolerability of COVIDITY as assessed by haematology
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
White blood cell differential (cells x 10^9/L)
Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
International normalised ratio (no units)
Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Activated partial prothrombin time (sec)
Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Fibrinogen (g/L)
Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
D-dimer (ng/mL)
Safety and tolerability of COVIDITY as assessed by urinalysis
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Glucose (negative, 100/250/500/1000/2000+ mg/dL)
Safety and tolerability of COVIDITY as assessed by urinalysis
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Ketones (negative, trace/small/moderate/large, 5/15/40/80/160 mg/dL)
Safety and tolerability of COVIDITY as assessed by urinalysis
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Blood (negative, trace, non-haemolysed trace/moderate, haemolysed trace/+/++/+++)
Safety and tolerability of COVIDITY as assessed by urinalysis
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Leucocytes (negative, trace/+/++/+++)
Safety and tolerability of COVIDITY as assessed by urinalysis
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Bilirubin (negative, +/++/+++)
Safety and tolerability of COVIDITY as assessed by urinalysis
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
pH (5.0/5.5/6.0/6.5/7.0/7.5/8.0/8.5 pH units)
Safety and tolerability of COVIDITY as assessed by urinalysis
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Specific gravity (1.000/1.004/1.005/1.010/1.015/1.020/1.025/1.030 [no units])
Safety and tolerability of COVIDITY as assessed by urinalysis
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Protein (negative, trace/+/++/+++/++++)
Safety and tolerability of COVIDITY as assessed by urinalysis
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Microscopy (if clinically indicated only) examination for bacteria, red blood cells, white blood cells, casts, and crystals (binary classification: absent or present)
Safety and tolerability of COVIDITY as assessed by 12-lead electrocardiogram (ECG)
Time frame: From enrolment through end of study; approximately 6 to 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
Safety and tolerability of COVIDITY as assessed by local and systemic reactogenicity events
Time frame: From enrolment through end of study; approximately 6 to 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.
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 6 to 26 weeks
3 secondary outcomes
The immunogenicity of COVIDITY as assessed by antibody response
Time frame: 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
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
The immunogenicity of COVIDITY as assessed by T cell response
Time frame: From enrolment through end of study; approximately 6 to 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Individual participant dataSharing planned: No. There is not a plan to make individual patient data available.
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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.
Rodney Dawson, MD principal investigator
University of Cape Town Lung Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVIDITY (SCOV1 and SCOV2) administered via needle-free intradermal injection, COVIDITY (SCOV1 and SCOV2) administered via needle-free intramuscular injection and COVIDITY (SCOV2 only) administered via needle-free intradermal injection to vaccine naive and/or previously vaccinated participants in people with COVID-19, run by Scancell Ltd at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of COVIDITY as assessed by the recording of adverse events (AEs) (time frame: From enrolment through end of study; approximately 6 to 26 weeks). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2022.