PTX-COVID19-B, an mRNA Humoral Vaccine, is Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Evaluate Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64

NCT04765436 | Completed Phase 1 DMC

• 1 other identifier: PRO-CL-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19 Vaccine

Outcome Measures

Primary Outcomes (4)

• Occurrence of adverse events (AEs) during the follow-up after each vaccination

  Daily solicited adverse events will be analyzed using both the Per Protocol (PP) and Safety Populations.

  Day 1 through Day 3

• Assessments of AEs

  Reports of unsolicited AEs

  Day 1 through Day 42

• Assessment of Safety

  Reports of Medically attended AEs Reports of serious adverse events (SAEs) Reports of adverse events of special interest Reports of potential immunemediated medical conditions

  Day 1 through Day 395

• Immunogenicity analysis

  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)

  Day 1 and Day 28

Study Arms (2)

PTX-COVID19-B

EXPERIMENTAL

Participants, 45 healthy adults 18 to 64 years of age, will receive 1 intramuscular (IM) injection of PTX-COVID19-B vaccine in doses of 16 μg, 40 μg and 100 μg on Day 1, followed by a second dose on Day 28, respectively.

Biological: PTX-COVID19-B

Placebo

PLACEBO COMPARATOR

Participants, 15 healthy adults 18 to 64 years of age, will receive 1 IM injection of matching placebo on Day 1, followed by a second dose on Day 28.

Biological: Placebo

Interventions

PTX-COVID19-B BIOLOGICAL

Sterile solution for injection

PTX-COVID19-B

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject has read, understood, and signed the informed consent form.
• Healthy adult males and females 18 to 64 years of age, inclusive, at screening
• 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)
• Body mass index of ≥ 18 and ≤ 30 kg/m2 at screening
• Must be in general good health before study participation with no clinically relevant abnormalities that could interfere with study assessments.
• 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.
• Women of childbearing potential must have a negative pregnancy test before each vaccination. If menopausal status is unclear, a pregnancy test is required.
• 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.

You may not qualify if:

• History of an acute or chronic medical condition including dementia that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
• History of any medical conditions that place subjects at higher risk for severe illness due to SARS-CoV-2 will be excluded including:
• Chronic kidney disease
• COPD (chronic obstructive pulmonary disease)
• Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
• Any Immunocompromised state including from transplantation, history immunodeficiency, HIV, immunosuppressive drug intake.
• Sickle cell disease
• Current smoker or history of \>5 pack/years of smoking.
• Type 2 diabetes mellitus
• Subjects with history of any of the following conditions might be at an increased risk of complications from Covid 19 and will be excluded:
• Asthma (moderate-to-severe)
• Cerebrovascular disease (affects blood vessels and blood supply to the brain)
• Cystic fibrosis
• Hypertension or high blood pressure
• Neurologic conditions, such as dementia

Sponsors & Collaborators

• Providence Therapeutics Holdings Inc.: lead

Study Sites (1)

Manna Research

Toronto, Ontario, M9W 4L6, Canada

Location

Related Publications (1)

• Martin-Orozco N, Vale N, Mihic A, Amor T, Reiter L, Arita Y, Samson R, Hu Q, Gingras AC, Sorenson BT, Marcusson EG, Patel P. Phase I randomized, observer-blinded, placebo-controlled study of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B. Sci Rep. 2023 May 26;13(1):8557. doi: 10.1038/s41598-023-35662-y.

  PMID: 37236995 DERIVED

MeSH Terms

Interventions

PTX-COVID19-B COVID-19 vaccine

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: February 16, 2021
• First Posted: February 21, 2021
• Study Start: January 14, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)