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.

NCT05175742 | Completed Phase 2 DMC

• 1 other identifier: PRO-CL-002
• Study Type: interventional
• Target: 565
• Locations: 2 countries
• Sites: 11

Brief 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.

Conditions

Covid19 Vaccine

Outcome Measures

Primary Outcomes (4)

• 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

  Day 1 through Day 42

• 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)

  Day 1 through Day 7 for each dose administration

• Assessment of AEs

  Incidence of unsolicited AEs and SAEs

  Day 1 through Day 42

• Assessment of Safety

  Medically attended AEs New onset chronic disease SAEs, AEs of special interest Potential immune-mediated medical conditions

  Day 1 through Day 42

Study Arms (3)

40µg PTX-COVID19-B Open-label

EXPERIMENTAL

Participants, 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.

Biological: PTX-COVID19-B

40µg PTX-COVID19-B

EXPERIMENTAL

Participants, 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.

Biological: PTX-COVID19-B; Biological: Placebo

Pfizer-BioNTech COVID-19 vaccine

ACTIVE COMPARATOR

Participants, 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.

Biological: Pfizer-BioNTech COVID-19 vaccine; Biological: Placebo

Interventions

PTX-COVID19-B BIOLOGICAL

Sterile solution for injection

40µg PTX-COVID19-B; 40µg PTX-COVID19-B Open-label

Pfizer-BioNTech COVID-19 vaccine BIOLOGICAL

Sterile solution for injection

Pfizer-BioNTech COVID-19 vaccine

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

40µg PTX-COVID19-B; Pfizer-BioNTech COVID-19 vaccine

Eligibility Criteria

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

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Providence Therapeutics Holdings Inc.: lead

Study Sites (11)

LMC Clinical Research Inc. (Calgary)

Calgary, Alberta, T2H 2G4, Canada

Location

Malton Medical

Mississauga, Ontario, L4V1P1, Canada

Location

Red Maple

Ottawa, Ontario, K1H 1E4, Canada

Location

Pharma Medica Research Inc.

Toronto, Ontario, M1S3V6, Canada

Location

Manna Bayview

Toronto, Ontario, M4G3E8, Canada

Location

Manna Toronto

Toronto, Ontario, M9W4L6, Canada

Location

Wits Vaccines & Infections Diseases Analytics (VIDA) Research Unit

Johannesburg, Gauten, 1864, South Africa

Location

MERC Middleburg

Middleburg, Mpumalanga, 1055, South Africa

Location

TREAD Research

Cape Town, Western Cape, 7500, South Africa

Location

UCT Lung Institute

Cape Town, Western Cape, 7700, South Africa

Location

Be Part Research

Paarl, Western Cape, 7626, South Africa

Location

MeSH Terms

Interventions

PTX-COVID19-B COVID-19 vaccine; BNT162 Vaccine

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: observer-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 4, 2022
• Study Start: August 17, 2021
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

CA (6); ZA (5)