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Covid19 VaccinePhase 2NCT05175742

PTX-COVID19-B, an mRNA Humoral Vaccine, Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Demonstrate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B in Comparison to the Pfizer-BioNTech COVID-19 Vaccine.

A Phase 2 study testing PTX-COVID19-B and Pfizer-BioNTech COVID-19 vaccine in people with Covid19 Vaccine, run by Providence Therapeutics Holdings Inc. at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 compared to Pfizer-BioNTech COVID-19 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 and Pfizer-BioNTech COVID-19 vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
565 participants
Where
11 sitesin 2 countries
Study dates
17 Aug 2021to 29 Mar 2023
Phase
Phase 2
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

  • Each subject must meet the following criteria to be enrolled and randomized into the study:
  • Willing and able to provide written informed consent to participate prior to commencing any study-related activities.
  • Must be able to attend all visits (scheduled and unscheduled, as applicable) for the duration of the study and comply with all study procedures.
  • Healthy adult males and females 18 to 64 years of age, inclusive, at Screening Visit (Visit 1).
  • Negative to SARS-CoV-2 (COVID-19 disease) at screening and at each dosing, without evidence of recent of exposure or viral respiratory disease not identified as influenza or respiratory syncytial virus (RSV) (febrile or lower respiratory tract infection).
  • Must be in general good health before study participation with no clinically relevant abnormalities that could interfere with study assessments at investigator's discretion. Subjects may have stable comorbidities (no change in medications, exacerbations, or hospitalizations in past three (3) months).
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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 one (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 [six 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, 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.
  • WOCBP must have a negative pregnancy test before each vaccination. If menopausal status is unclear, a pregnancy test is required.
  • Receipt of at least one (1) vaccination prior to Day 42.

Who cannot join

  • Subjects will not be eligible for study participation if they meet any of the exclusion criteria:
  • History of an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
  • History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
  • Subjects with pulse oximetry <90% at screening and prior to each vaccination.
  • Individuals who are antigen positive, seropositive or reverse transcriptase polymerase chain reaction (RT-PCR) positive for SARS-CoV-2, including prior to a second dose of PTX-COVID19-B.
  • Individuals who are at increased risk of exposure to SARS-CoV-2 (e.g., healthcare workers, emergency responders).
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  • Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
  • Individuals with any elevated (Grade 1 or higher) laboratory test assessed as clinically significant for age/sex by the investigator at screening.
  • Individuals known to have anti-platelet antibodies.
  • Individuals with myocarditis and/or arrythmias.
  • Active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) or a history of any hematological malignancy. ("Active" is defined as having received treatment within the past five years).
  • Long-term (> two (2) weeks) use of oral or parenteral steroids or high-dose inhaled steroids (> 800 μg/day of beclomethasone dipropionate or equivalent) within six months before screening (nasal and topical steroids are allowed).
  • History of autoimmune, inflammatory disease, or potential immune-mediated medical conditions (PIMMCs).
  • Women currently pregnant, lactating, or planning a pregnancy between enrollment and Day 42.
  • History of immune thrombocytopenic purpura (ITP).
  • History of Guillain-Barré Syndrome or any degenerative neurology disorder.
  • History of anaphylactic-type reaction to any injected vaccines.
  • Known or suspected hypersensitivity to one or more of the components of the vaccine.
  • Known 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 three (3) days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator and within Protocol-defined windows).
  • 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 one (1) month (three (3) months for immunoglobulins) before enrollment in this study; or who expect to receive another experimental agent up to Day 90 in this study.
  • Receipt of immunoglobulin or another blood product within the three (3) months before enrollment in this study or those who expect to receive immunoglobulin or another blood product during this study.
  • Individuals using prescription medications for prophylaxis of SARS-CoV-2.
  • Individuals who plan to receive another vaccine within the first three (3) months of the study (except influenza vaccine which should not be given within two (2) weeks of vaccine).
  • Receipt of any other SARS-CoV-2 or other experimental coronavirus (MERS, SARS etc.) vaccine at any time prior to or during the study.
  • Receipt of any investigational vaccine or investigational drug within one (1) month of enrollment and through the end of the study (one (1) year after the last vaccination).
  • Planning international travel from enrollment through Day 43.
  • 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 one or more units of blood (within 56 days for males and 84 days for females) or plasma (within two (2) weeks) prior to study participation.
  • Positive urine drugs of abuse screen test result.
  • Positive screen for HIV-1 and HIV-2 antibodies, HBsAg, or HCV antibody.
  • Involved in the planning or conduct of this study.
  • Unwilling or unlikely to comply with the requirements of the study.
  • Participation in a study that would affect potential immunogenicity evaluation during ongoing participation in this study. Participation in any other study is allowed after Day 90.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Canada6 sites

  • LMC Clinical Research Inc. (Calgary)

    Calgary, Alberta, T2H 2G4

  • Malton Medical

    Mississauga, Ontario, L4V1P1

  • Red Maple

    Ottawa, Ontario, K1H 1E4

  • Pharma Medica Research Inc.

    Toronto, Ontario, M1S3V6

  • Manna Bayview

    Toronto, Ontario, M4G3E8

  • Manna Toronto

    Toronto, Ontario, M9W4L6

Other trials in Canada

South Africa5 sites

  • TREAD Research

    Cape Town, Western Cape, 7500

  • UCT Lung Institute

    Cape Town, Western Cape, 7700

  • Wits Vaccines & Infections Diseases Analytics (VIDA) Research Unit

    Johannesburg, Gauten, 1864

  • MERC Middleburg

    Middleburg, Mpumalanga, 1055

  • Be Part Research

    Paarl, Western Cape, 7626

Other trials in South Africa

About this study

Official title: A Phase 2, Randomized, Double-dummy, Observer-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Compared to Pfizer-BioNTech COVID-19 Vaccine in Healthy Seronegative Adults Aged 18 to 64 Years

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 compared to Pfizer-BioNTech COVID-19 vaccine in healthy seronegative adults aged 18 to 64.

Conditions
Covid19 Vaccine
Being tested
PTX-COVID19-B, Pfizer-BioNTech COVID-19 vaccine, 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

  • Pfizer-BioNTech COVID-19 vaccineBiological

    Sterile solution for injection

  • PlaceboBiological

    0.9% sodium chloride (normal saline) injection

Study groups in NCT05175742
Study groupRoleWhat they receive
40µg PTX-COVID19-B Open-labelExperimentalParticipants, 15 healthy adults 18 to 64 years of age will receive 1 intramuscular (IM) injection of 40µg PTX-COVID19-B vaccine on Day 1, followed by a second dose on Day 28.
Receives: Biological: PTX-COVID19-B
40µg PTX-COVID19-BExperimentalParticipants, 360 healthy adults 18 to 64 years of age, will receive 1 intramuscular (IM) injection of 40µg PTX-COVID19-B vaccine on Day 1, followed by a second dose on Day 28. Participants will receive a placebo dose on Day 21.
Receives: Biological: PTX-COVID19-B; Biological: Placebo
Pfizer-BioNTech COVID-19 vaccineActive comparatorParticipants, 190 healthy adults 18 to 64 years of age, will receive 1 intramuscular (IM) injection of Pfizer-BioNTech COVID-19 vaccine on Day 1, followed by a placebo dose on Days 21. Participants will receive a placebo dose on Day 28.
Receives: Biological: Pfizer-BioNTech COVID-19 vaccine; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Injection Site Reactions

    Injection site reactions (e.g., arm check evaluations including pain, tenderness, erythema/redness, induration/swelling) through the seventh day post each vaccination

    Measured: Day 1 through Day 42

  2. Incidence of Solicited Adverse Events (AEs)

    Incidence of solicited adverse events (AEs) (e.g., fever, chills, nausea/vomiting, diarrhea, headache, fatigue, myalgia) through the seventh day post each vaccination and Serious Adverse Events (SAEs)

    Measured: Day 1 through Day 7 for each dose administration

  3. Assessment of AEs

    Incidence of unsolicited AEs and SAEs

    Measured: Day 1 through Day 42

  4. Assessment of Safety

    Medically attended AEs

    New onset chronic disease

    SAEs, AEs of special interest

    Potential immune-mediated medical conditions

    Measured: Day 1 through Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2022
  2. Study start17 Aug 2021
  3. Primary completion29 Mar 2023
  4. Study completion29 Mar 2023

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05175742
Sponsor's protocol ID
PRO-CL-002
Status last verified
Apr 2023
First submitted
30 Dec 2021
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PTX-COVID19-B and Pfizer-BioNTech COVID-19 vaccine in people with Covid19 Vaccine, run by Providence Therapeutics Holdings Inc. at 11 sites in 2 countries.

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 34 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 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Injection Site Reactions (time frame: Day 1 through Day 42). 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 NCT05175742.

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 7 Apr 2023.

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