Covid19 VaccinePhase 1NCT04765436
PTX-COVID19-B, an mRNA Humoral Vaccine, is Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Evaluate Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64
A Phase 1 study testing PTX-COVID19-B in people with Covid19 Vaccine, run by Providence Therapeutics Holdings Inc. at 1 site in Canada.
Trial summary
The Vaccine Product, PTX-COVID19-B mRNA Humoral Vaccine, is intended for prevention of COVID-19 in a general population. This study is designed to evaluate the safety, tolerability, and immunogenicity of PTX-COVID19-B vaccine in healthy seronegative adults aged 18 to 64. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19 Vaccine
- What is being tested?
- PTX-COVID19-B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2021to 30 Mar 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all inclusion criteria to be eligible for study participation. In addition, racial and ethnic minorities will be sought to obtain a diverse study population.
- Subject has read, understood, and signed the informed consent form.
- Healthy adult males and females 18 to 64 years of age, inclusive, at screening
- Seronegative to SARS-CoV-2 and reverse transcription-polymerase chain reaction (RT-PCR)-negative at screening, without evidence of recent of exposure or viral respiratory disease not identified as influenza or RSV (febrile or lower respiratory tract infection)
- Body mass index of ≥ 18 and ≤ 30 kg/m2 at screening
- Must be in general good health before study participation with no clinically relevant abnormalities that could interfere with study assessments.
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- Women of childbearing potential (WOCBP) and men whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception (i.e., including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, hormonal oral [in combination with male condoms with spermicide], transdermal, implant, or injection, barrier [i.e., condom, diaphragm with spermicide]; intrauterine device; vasectomized partner [6 months minimum], clinically sterile partner; or abstinence) during the study.
- A female subject is considered a WOCBP after menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile.
- Subjects not of childbearing potential are not required to use any other forms of contraception during the study. Non-childbearing potential is defined as subject confirmed:
- Surgical sterilization (e.g., bilateral oophorectomy, bilateral salpingectomy, bilateral occlusion by cautery [Essure System® is not acceptable], hysterectomy, or tubal ligation)
- Postmenopausal (defined as permanent cessation of menstruation for at least 12 consecutive months prior to screening); if postmenopausal status is unclear, pregnancy tests will be performed prior to vaccinations.
- Women of childbearing potential must have a negative pregnancy test before each vaccination. If menopausal status is unclear, a pregnancy test is required.
- Must be able to attend all visits (scheduled and unscheduled, as applicable) for the duration of the study and comply with all study procedures, including daily completion of the Diary Card after each injection.
Who cannot join
- Subjects will not be eligible for study participation if they meet any of the exclusion criteria, or will be discontinued at the discretion of the investigator if they develop any of the exclusion criteria during the study.
- History of an acute or chronic medical condition including dementia that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
- History of any medical conditions that place subjects at higher risk for severe illness due to SARS-CoV-2 will be excluded including:
- Chronic kidney disease
- COPD (chronic obstructive pulmonary disease)
- Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
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- Any Immunocompromised state including from transplantation, history immunodeficiency, HIV, immunosuppressive drug intake.
- Sickle cell disease
- Current smoker or history of >5 pack/years of smoking.
- Type 2 diabetes mellitus
- Subjects with history of any of the following conditions might be at an increased risk of complications from Covid 19 and will be excluded:
- Asthma (moderate-to-severe)
- Cerebrovascular disease (affects blood vessels and blood supply to the brain)
- Cystic fibrosis
- Hypertension or high blood pressure
- Neurologic conditions, such as dementia
- Liver disease
- Pulmonary fibrosis (having damaged or scarred lung tissues)
- Thalassemia (a type of blood disorder)
- Type 1 diabetes mellitus
- History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
- Individuals who are seropositive or RT-PCR positive for SARS-CoV-2, including prior to a second dose of PTX-COVID19-B vaccine.
- Individuals who are at increased risk of exposure to SARS-CoV-2 (e.g., healthcare workers, emergency responders).
- Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
- Living in a group setting or group care facility (e.g., dormitory, assisted living or nursing home).
- Individuals with any elevated (Grade 1 or higher) laboratory test assessed as clinically significant for age/sex by the investigator at screening.
- Individuals with any elevated for age/sex (Grade 1 or higher) liver function enzyme at screening, regardless of the appraisal of clinical significance (one retest permitted). The criteria for excluding subjects with elevated liver enzymes are as follows:
- Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase > 1.5 × upper limit of normal (ULN)
- Total bilirubin > 1.5 × ULN
- Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) or a history of any hematological malignancy. "Active" is defined as having received treatment within the past 5 years.
- Long-term (> 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (> 800 μg/day of beclomethasone dipropionate or equivalent) within 6 months before screening (nasal and topical steroids are allowed).
- History of autoimmune, inflammatory disease, or PIMMCs.
- Women currently pregnant, lactating, or planning a pregnancy between enrollment and 181 days after randomization.
- History of Guillain-Barré Syndrome or any degenerative neurology disorder.
- History of anaphylactic-type reaction to any injected vaccines.
- Known or suspected hypersensitivity to 1 or more of the components of the vaccine.
- History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of screening.
- Acute illness or fever (temperature >37.5C) within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator).
- Individuals currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication); or who have received an experimental agent within 1 month (3 months for immunoglobulins) before enrollment in this study; or who expect to receive another experimental agent during participation in this study.
- Receipt of immunoglobulin or another blood product within the 3 months before enrollment in this study or those who expect to receive immunoglobulin or another blood product during this study.
- Individuals who intend to donate blood within 6 months after the first vaccination and within 30 days post the last donation from Visit 1.
- Individuals using prescription medications for prophylaxis of SARS-CoV-2.
- Individuals who plan to receive another vaccine within the first 3 months of the study except influenza vaccine which should not be given within 2 weeks of vaccine.
- Receipt of any other SARS-CoV-2 or other experimental coronavirus (Middle East Respiratory Syndrome, SARS etc.) vaccine at any time prior to or during the study.
- Receipt of any investigational vaccine or investigational drug within 1 month of enrollment and through the end of the study (1 year after the last vaccination).
- Plan to travel outside Canada from enrollment through Day 42.
- History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
- Significant blood loss (> 400 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation.
- Strenuous activity or significant alcohol intake (as assessed by the investigator) within 72 hours prior to safety laboratory sample collection.
- Positive urine drugs of abuse screen.
- Positive screen for human immunodeficiency virus-1 and -2 antibodies, hepatitis B surface antigen, or hepatitis C virus antibody.
- Involved in the planning or conduct of this study.
- Unwilling or unlikely to comply with the requirements of the study.
- Subjects is an employee, contractor, or friend or relative of any employee of sponsor, CRO, study site, or site affiliate.
- Subjects oximetry is <90%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, First-in-Human, Observer-Blinded, Randomized, Placebo Controlled, Ascending Dose Study to Evaluate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64
The Vaccine Product, PTX-COVID19-B mRNA Humoral Vaccine, is intended for prevention of COVID-19 in a general population. This study is designed to evaluate the safety, tolerability, and immunogenicity of PTX-COVID19-B vaccine in healthy seronegative adults aged 18 to 64.
- Conditions
- Covid19 Vaccine
- Being tested
- PTX-COVID19-B, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTX-COVID19-BBiological
Sterile solution for injection
PlaceboBiological
0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| PTX-COVID19-B | Experimental | Participants, 45 healthy adults 18 to 64 years of age, will receive 1 intramuscular (IM) injection of PTX-COVID19-B vaccine in doses of 16 μg, 40 μg and 100 μg on Day 1, followed by a second dose on Day 28, respectively. Receives: Biological: PTX-COVID19-B |
| Placebo | Placebo comparator | Participants, 15 healthy adults 18 to 64 years of age, will receive 1 IM injection of matching placebo on Day 1, followed by a second dose on Day 28. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AEs) during the follow-up after each vaccination
Daily solicited adverse events will be analyzed using both the Per Protocol (PP) and Safety Populations.
Measured: Day 1 through Day 3
Assessments of AEs
Reports of unsolicited AEs
Measured: Day 1 through Day 42
Assessment of Safety
Reports of Medically attended AEs
Reports of serious adverse events (SAEs)
Reports of adverse events of special interest
Reports of potential immunemediated medical conditions
Measured: Day 1 through Day 395
Immunogenicity analysis
Cell-mediated immunity using blood/peripheral blood mononuclear cells (PBMCs [Flow Cytometry Assay])
Antibodies (anti-COVID-19 immunoglobulin (Ig), IgG, IgA [enzyme-linked immunosorbent assay]; and anti-COVID-19 neutralization titer assays)
Measured: Day 1 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start14 Jan 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19 VaccineStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Therapeutics Holdings Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765436
- Sponsor's protocol ID
- PRO-CL-001
- Status last verified
- Apr 2022
- First submitted
- 16 Feb 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin-Orozco N, Vale N, Mihic A, Amor T, Reiter L, Arita Y, Samson R, Hu Q, Gingras AC, Sorenson BT, Marcusson EG, Patel P. Phase I randomized, observer-blinded, placebo-controlled study of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B. Sci Rep. 2023 May 26;13(1):8557. doi: 10.1038/s41598-023-35662-y.
PubMed 37236995
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-in-Human, Observer-Blinded, Randomized, Placebo Controlled, Ascending Dose Study to Evaluate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64
- ClinicalTrials.gov ID
- NCT04765436
- Acronym / sponsor ID
- PRO-CL-001
- Conditions
- Covid19 Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Providence Therapeutics Holdings Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 21 Feb 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 Vaccine Product, PTX-COVID19-B mRNA Humoral Vaccine, is intended for prevention of COVID-19 in a general population. This study is designed to evaluate the safety, tolerability, and immunogenicity of PTX-COVID19-B vaccine in healthy seronegative adults aged 18 to 64.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTX-COVID19-B | Experimental | Biological: PTX-COVID19-BParticipants, 45 healthy adults 18 to 64 years of age, will receive 1 intramuscular (IM) injection of PTX-COVID19-B vaccine in doses of 16 μg, 40 μg and 100 μg on Day 1, followed by a second dose on Day 28, respectively. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants, 15 healthy adults 18 to 64 years of age, will receive 1 IM injection of matching placebo on Day 1, followed by a second dose on Day 28. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects must meet all inclusion criteria to be eligible for study participation. In addition, racial and ethnic minorities will be sought to obtain a diverse study population.
- Subject has read, understood, and signed the informed consent form.
- Healthy adult males and females 18 to 64 years of age, inclusive, at screening
- Seronegative to SARS-CoV-2 and reverse transcription-polymerase chain reaction (RT-PCR)-negative at screening, without evidence of recent of exposure or viral respiratory disease not identified as influenza or RSV (febrile or lower respiratory tract infection)
- Body mass index of ≥ 18 and ≤ 30 kg/m2 at screening
Key exclusion criteria (55 listed)
- Subjects will not be eligible for study participation if they meet any of the exclusion criteria, or will be discontinued at the discretion of the investigator if they develop any of the exclusion criteria during the study.
- History of an acute or chronic medical condition including dementia that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
- History of any medical conditions that place subjects at higher risk for severe illness due to SARS-CoV-2 will be excluded including:
- Subjects with history of any of the following conditions might be at an increased risk of complications from Covid 19 and will be excluded:
- History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
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 |
|---|---|---|
| PTX-COVID19-BSterile solution for injection | Biological | PTX-COVID19-B |
| Placebo0.9% sodium chloride (normal saline) injection | Biological | Placebo |
Primary outcome
Occurrence of adverse events (AEs) during the follow-up after each vaccination
Time frame: Day 1 through Day 3
Daily solicited adverse events will be analyzed using both the Per Protocol (PP) and Safety Populations.
Assessments of AEs
Time frame: Day 1 through Day 42
Reports of unsolicited AEs
Assessment of Safety
Time frame: Day 1 through Day 395
Reports of Medically attended AEs Reports of serious adverse events (SAEs) Reports of adverse events of special interest Reports of potential immunemediated medical conditions
Immunogenicity analysis
Time frame: Day 1 and Day 28
Cell-mediated immunity using blood/peripheral blood mononuclear cells (PBMCs [Flow Cytometry Assay]) Antibodies (anti-COVID-19 immunoglobulin (Ig), IgG, IgA [enzyme-linked immunosorbent assay]; and anti-COVID-19 neutralization titer assays)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 37236995Martin-Orozco N, Vale N, Mihic A, Amor T, Reiter L, Arita Y, Samson R, Hu Q, Gingras AC, Sorenson BT, Marcusson EG, Patel P. Phase I randomized, observer-blinded, placebo-controlled study of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B. Sci Rep. 2023 May 26;13(1):8557. doi: 10.1038/s41598-023-35662-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 PTX-COVID19-B in people with Covid19 Vaccine, run by Providence Therapeutics Holdings Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 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 Canada. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of adverse events (AEs) during the follow-up after each vaccination (time frame: Day 1 through Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04765436, which also lists 1 linked publication.
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 Apr 2022.