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 vaccine in healthy seronegative adults aged 18 to 64.
Interventions
BIOLOGICALPTX-COVID19-B
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
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. 1. Subject has read, understood, and signed the informed consent form. 2. Healthy adult males and females 18 to 64 years of age, inclusive, at screening 3. 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) 4. Body mass index of ≥ 18 and ≤ 30 kg/m2 at screening 5. Must be in general good health before study participation with no clinically relevant abnormalities that could interfere with study assessments. 6. 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. 7. Women of childbearing potential must have a negative pregnancy test before each vaccination. If menopausal status is unclear, a pregnancy test is required. 8. 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.
Exclusion criteria
Subjects will not be eligible for study participation if they meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events (AEs) during the follow-up after each vaccination | Day 1 through Day 3 | Daily solicited adverse events will be analyzed using both the Per Protocol (PP) and Safety Populations. |
| Assessments of AEs | Day 1 through Day 42 | Reports of unsolicited AEs |
| Assessment of Safety | 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 | 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) |
Countries
Canada
Outcome results
None listed