Covid19 Vaccine
Conditions
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.
Interventions
BIOLOGICALPTX-COVID19-B
Sterile solution for injection
BIOLOGICALPfizer-BioNTech COVID-19 vaccine
Sterile solution for injection
BIOLOGICALPlacebo
0.9% sodium chloride (normal saline) injection
Sponsors
Providence Therapeutics Holdings Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
observer-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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). * 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. 7. WOCBP must have a negative pregnancy test before each vaccination. If menopausal status is unclear, a pregnancy test is required. Inclusion into the open label safety extension 8. Receipt of at least one (1) vaccination prior to Day 42.
Exclusion criteria
Subjects will not be eligible for study participation if they meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Injection Site Reactions | Day 1 through Day 42 | Injection site reactions (e.g., arm check evaluations including pain, tenderness, erythema/redness, induration/swelling) through the seventh day post each vaccination |
| Incidence of Solicited Adverse Events (AEs) | Day 1 through Day 7 for each dose administration | 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) |
| Assessment of AEs | Day 1 through Day 42 | Incidence of unsolicited AEs and SAEs |
| Assessment of Safety | Day 1 through Day 42 | Medically attended AEs New onset chronic disease SAEs, AEs of special interest Potential immune-mediated medical conditions |
Countries
Canada, South Africa
Outcome results
None listed