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Virus Vaccine

Low Dose of KBP-COVID-19 for Coronavirus

Phase 1 & 2
Waitlist Available
Research Sponsored by Kentucky BioProcessing, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Surgical sterilization (eg, bilateral oophorectomy, bilateral salpingectomy, bilateral occlusion by cautery [Essure System is not acceptable], hysterectomy, or tubal ligation).
Subject read, understood, and signed the informed consent form (ICF).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 8, 15, 22, 29, 43, 90, 181, 273, 365
Awards & highlights

Study Summary

This trial is testing a new vaccine for safety and effectiveness in people of two age groups.

Eligible Conditions
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 8, 15, 22, 29, 43, 90, 181, 273, 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 8, 15, 22, 29, 43, 90, 181, 273, 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Solicited Administration site reactions
Solicited systemic events
Secondary outcome measures
Serious Adverse Events, Medically Attended Adverse Events and New Onset Chronic Diseae
Seroconversion rates
Unsolicited Adverse Events and medically attended adverse events
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose KBP-COVID-19 and adjuvantExperimental Treatment1 Intervention
Two age groups. Part A (18-49 years). Part B (50-85 years). All subjects in these groups will receive the low dose of KBP-COVID-19
Group II: High Dose KBP-COVID-19 and adjuvantExperimental Treatment1 Intervention
Two age groups. Part A (18-49 years). Part B (50-85 years). All subjects in these groups will receive the high dose of KBP-COVID-19
Group III: PlaceboPlacebo Group1 Intervention
Two age groups. Part A (18-49 years). Part B (50-85 years). All subjects in these groups will receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KBP-COVID-19
Not yet FDA approved
KBP-COVID-19
Not yet FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Kentucky BioProcessing, Inc.Lead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
KBio IncLead Sponsor
3 Previous Clinical Trials
178 Total Patients Enrolled
Hugh HaydonStudy DirectorKentucky BioProcessing
1 Previous Clinical Trials
120 Total Patients Enrolled

Frequently Asked Questions

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

Is this the first time KBP-COVID-19 has been trialed as a medication?

"The first low-dose study of KBP-COVID-19 was completed in 2020 at LMC Manna Research. A total of 18,244 studies have been completed thus far. There is currently one live study, with several trials taking place in Burlington, Burlington/Ontario."

Answered by AI

Is this research project novel in comparison to others in its field?

"As of right now, there is a single study concerning Low Dose of KBP-COVID-19 that is still active. It began in 2020 and is being conducted across 8 cities in 2 different countries. The study is sponsored by Kentucky BioProcessing, Inc. and thus far 101 people have participated. It completed its Phase 1 & 2 approvals in 2020, and since then 18244 other trials have been completed."

Answered by AI

What are the guidelines for participants in this trial?

"This clinical trial is recruiting 101 patients that have covid-19 and are between 18 and 85 years old. Candidates are required to meet the following criteria: Must be able to attend all visits, including unscheduled visits if respiratory symptoms develop during the study, for the duration of the study and comply with all study procedures, including daily completion of the Diary Card for 7 days after each injection., Subject read, understood, and signed the informed consent form (ICF)., Healthy adult males and females 18-49 years of age (Part A) or 50-85 years of age (Part B), inclusive, at"

Answered by AI

Is the age limit for this experiment 60 years or older?

"The age bracket for individuals that this study is looking to recruit are those that are over 18 and under 85."

Answered by AI

What are the researchers' aims with this clinical trial?

"The primary outcome of this trial is solicited systemic events, which will be measured over the course of 7 days after vaccination. Secondary objectives include serious adverse events, medically attended adverse events, and new onset chronic disease (defined as safety endpoints), vaccine ELISA and neutralizing antibody titers for each treatment group (defined as immunogenicity), and unsolicited adverse events and medically attended adverse events (defined as safety endpoints)."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
~24 spots leftby Apr 2025