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mRNA Vaccine

PTX-COVID19-B for Coronavirus Vaccines

Phase 2
Waitlist Available
Research Sponsored by Providence Therapeutics Holdings Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 42
Awards & highlights

Study Summary

This trial is testing a new vaccine for COVID-19 to see if it is safe and effective.

Eligible Conditions
  • Coronavirus Vaccines

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 42 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of AEs
Assessment of Safety
Incidence of Solicited Adverse Events (AEs)
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 40µg PTX-COVID19-B Open-labelExperimental Treatment1 Intervention
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.
Group II: 40µg PTX-COVID19-BExperimental Treatment2 Interventions
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.
Group III: Pfizer-BioNTech COVID-19 vaccineActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
PTX-COVID19-B
2021
Completed Phase 2
~630

Find a Location

Who is running the clinical trial?

Providence Therapeutics Holdings Inc.Lead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have joined this experiment?

"At this time, no patients are being recruited for the clinical trial in question. This study was initially released on August 17th 2021 and last edited April 22nd 2022. Currently, there are 1030 vaccine studies actively recruiting participants as well as 27 trials specifically enrolling volunteers for PTX-COVID19-B."

Answered by AI

What has been observed regarding the security of PTX-COVID19-B among patients?

"PTX-COVID19-B was rated a 2 on our team's safety scale, as there is existing evidence that suggests the drug is secure yet no efficacy data."

Answered by AI

Is enrollment for this study still available?

"According to the information on clinicaltrials.gov, recruiting for this particular trial has ended; it was initially posted on August 17th 2021 and last edited April 22nd 2022. Nonetheless, there are an abundance of other studies that require participants at present."

Answered by AI

Is this research the inaugural effort of its kind?

"Since 2020, the development of PTX-COVID19-B has been underway with BioNTech SE sponsoring its initial clinical trial in that same year. This investigation included 512 participants and upon successful completion it was granted Phase 1 & 2 drug approval. At present, 27 active trials are occurring across 220 cities and spanning a total of 27 countries."

Answered by AI

Has PTX-COVID19-B been subject to any other testing in the past?

"PTX-COVID19-B was first trialled in 2020 by a Contract Research Organization. 18338 studies have since been concluded, and currently 27 experiments are ongoing with an abundance of these occurring within Ottawa, Ontario."

Answered by AI

Is eligibility for this study limited to individuals under 35 years of age?

"This clinical study allows for patients aged 18 to 64 to enrol. For minors, there are 146 trials and elderly individuals have access to 922 different medical studies."

Answered by AI

Who is eligible to participate in this trial?

"This medical trial is accepting 890 participants, aged 18 to 64 and already vaccinated. Additionally, female subjects of childbearing potential must agree to use highly effective contraception methods while involved in the study; postmenopausal women will be required to take a pregnancy test before each vaccination if their status is unclear. Male patients whose sexual partners are WOCBP (Women of Childbearing Potential) should also comply with these contraceptive measures. Lastly, all entrants must have no notable health issues that could interfere with assessments and attend all appointments throughout the duration of this research project."

Answered by AI

How many sites have been selected to conduct this experiment?

"At present, there are 6 medical centres that have been approved to run this clinical trial. These include Red Maple in Ottawa, Malton Medical in Mississauga and Manna Toronto in Toronto."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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.
2021. "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.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05175742.
~154 spots leftby Apr 2025
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