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COMPLETEDPHASE2

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, 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

NCT05175742•Providence Therapeutics Holdings Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Each subject must meet the following criteria to be enrolled and randomized into the study:
•1. Willing and able to provide written informed consent to participate prior to commencing any study-related activities.
•2. Must be able to attend all visits (scheduled and unscheduled, as applicable) for the duration of the study and comply with all study procedures.
•3. Healthy adult males and females 18 to 64 years of age, inclusive, at Screening Visit (Visit 1).
•4. 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).
•5. 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).
•6. 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).
+4 more criteria

Exclusion Criteria

•1. 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.
•2. History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
•3. Subjects with pulse oximetry \<90% at screening and prior to each vaccination.
•4. 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.
•5. Individuals who are at increased risk of exposure to SARS-CoV-2 (e.g., healthcare workers, emergency responders).
•6. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
•7. Individuals with any elevated (Grade 1 or higher) laboratory test assessed as clinically significant for age/sex by the investigator at screening.
•8. Individuals known to have anti-platelet antibodies.
•9. Individuals with myocarditis and/or arrythmias.
•10. 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).
+24 more criteria

Locations (11)

LMC Clinical Research Inc. (Calgary)

Calgary, Alberta, Canada

Malton Medical

Mississauga, Ontario, Canada

Red Maple

Ottawa, Ontario, Canada

Pharma Medica Research Inc.

Toronto, Ontario, Canada

Manna Bayview

Toronto, Ontario, Canada

Manna Toronto

Toronto, Ontario, Canada

Wits Vaccines & Infections Diseases Analytics (VIDA) Research Unit

Johannesburg, Gauten, South Africa

MERC Middleburg

Middleburg, Mpumalanga, South Africa

TREAD Research

Cape Town, Western Cape, South Africa

UCT Lung Institute

Cape Town, Western Cape, South Africa

Key Dates

Start Date

August 17, 2021

Primary Completion Date

March 29, 2023

Completion Date

March 29, 2023

Last Updated

April 7, 2023

Enrollment

565

ACTUAL participants

Conditions

Covid19 Vaccine

Interventions

PTX-COVID19-B

BIOLOGICAL

Pfizer-BioNTech COVID-19 vaccine

BIOLOGICAL

Placebo

BIOLOGICAL