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KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04473690
Recruitment Status : Not yet recruiting
First Posted : July 16, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Kentucky BioProcessing, Inc.

Brief Summary:
This is an First In Human (FIH), observer-blinded, randomized, placebo-controlled, parallel group study to evaluate the safety and immunogenicity of KBP-COVID-19 vaccine in healthy CoV-2seronegative adult subjects in 2 age groups, Part A (18-49 years) and Part B (50-70 years).

Condition or disease Intervention/treatment Phase
Covid19 Biological: Low Dose of KBP-COVID-19 Biological: High Dose of KBP-COVID-19 Biological: Placebo Phase 1 Phase 2

Detailed Description:

Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization.

Approximately 90 eligible healthy seronegative adults ages 18-49 years (inclusive) will be enrolled for Part A and 90 eligible healthy seronegative adults ages 50-70 years will be enrolled for Part B.

Sentinel dosing (three subjects in each group) will be utilized in this FIH study. Sentinel cohorts will be used for the following groups:

Part A (18-49 years) low dose Part B (50-70 years) low dose Part A (18-49 years) high dose Part B (50-70 years) high dose

The iSRC will review the safety data for the sentinel subjects through Day 8 prior to enrollment of the remaining cohort subjects.

When all subjects in Part A (18-49 years) low dose have received the first vaccination and have all safety data through Day 8, the iSRC will convene and review the safety data to ensure that there are no safety concerns and that none of the Study Halting Rules have been met before recommending that the study enroll Part A high dose. The same strategy will be used for Part B (50-70 years) when going from low to high dose.

When 50 percent of the subjects for Part A in each dose cohort have been enrolled and have data available through Day 29, the iSRC will convene and review all the data through Day 29 and any available data through Day 43 to ensure that there are no safety concerns and that none of the Study Halting Rules have been met before recommending that the study enroll the Part B (50-70 years) corresponding dose in parallel.

Overall, subjects will be randomized in a 1:1:1 ratio to receive study vaccine or placebo by IM injection on Days 1 and 22.

All study visits will be conducted at the clinical sites on an outpatient basis. Subjects will participate in the study for approximately 1 year from the first dose.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I/II, First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of KBP-COVID-19 Vaccine in Healthy Seronegative Adults Aged 18-49 and 50-70
Estimated Study Start Date : November 14, 2020
Estimated Primary Completion Date : March 25, 2021
Estimated Study Completion Date : February 23, 2022

Arm Intervention/treatment
Experimental: Low Dose KBP-COVID-19

Two age groups.

Part A (18-49 years).

Part B (50-70 years).

All subjects in these groups will receive the low dose of KBP-COVID-19

Biological: Low Dose of KBP-COVID-19
Low Dose of KBP-COVID-19

Experimental: High Dose KBP-COVID-19

Two age groups.

Part A (18-49 years).

Part B (50-70 years).

All subjects in these groups will receive the high dose of KBP-COVID-19

Biological: High Dose of KBP-COVID-19
High Dose of KBP-COVID-19

Placebo Comparator: Placebo

Two age groups.

Part A (18-49 years).

Part B (50-70 years).

All subjects in these groups will receive placebo

Biological: Placebo
Buffered saline solution




Primary Outcome Measures :
  1. Solicited Administration site reactions [ Time Frame: 7 days after vaccination ]
    Occurrence of Adverse Events

  2. Solicited systemic events [ Time Frame: 7 days after vaccination ]
    Occurrence of Adverse Events


Secondary Outcome Measures :
  1. Unsolicited Adverse Events and medically attended adverse events [ Time Frame: 43 days after vaccination ]
    Safety Endpoints

  2. Serious Adverse Events, Medically Attended Adverse Events and New Onset Chronic Diseae [ Time Frame: 365 days after vaccination ]
    Safety Endpoints

  3. Vaccine ELISA and neutralizing antibody titers for each treatment group [ Time Frame: Baseline, Day 8, 15, 22, 29, 43, 90, 181, 273, 365 ]
    Immunogenicity

  4. Seroconversion rates [ Time Frame: Days 8, 15, 22, 29, 43, 90, 181, 273, 365 ]
    Immunogenicity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject read, understood, and signed the informed consent form (ICF).
  2. Healthy adult males and females 18-49 years of age (Part A) or 50-70 years of age (Part B), inclusive, at screening.
  3. Seronegative to SARS-CoV-2 and reverse transcription polymerase chain reaction (RT-PCR) negative at time of screening.
  4. Body mass index (BMI) of ≥ 18 and ≤ 34 kg/m2 at screening. BMI = weight (kg)/(height [m])2.
  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 (ie, include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, hormonal oral [in combination with male condoms with spermicide], transdermal, implant, or injection, barrier [ie, condom, diaphragm with spermicide]; intrauterine device; vasectomized partner [6 months minimum], clinically sterile partner; or abstinence) during the study. A female subject is considered to be 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. Note: 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 (eg, 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) with FSH ≥ 30 mIU/mL at screening.
  7. WOCBP must have a negative urine pregnancy test before each vaccination.
  8. 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.

Exclusion Criteria:

  1. 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. Chronic condition that are NOT included on the CDC's list of subjects at higher risk for severe illness from SARS-CoV-2 are acceptable if the condition has been stable for the 3 months prior to vaccine administration (Day 1), with no medication changes, and no hospitalization in the past 6 months).
  2. History of any medical conditions that place subjects at higher risk for severe illness due to SARS-CoV-2 including but not limited to asthma, chronic kidney disease being treated with dialysis, chronic lung disease, diabetes, hemoglobin disorders, immunocompromised, liver disease, serious heart conditions, severe obesity.
  3. History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
  4. Individuals who are seropositive or RT-PCR positive for SARS-CoV-2 at screening.
  5. Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare workers, emergency responders).
  6. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
  7. Living in a group care facility (eg, assisted living or nursing home).
  8. Individuals with any elevated (Grade 1 or higher) laboratory test assessed as clinically significant for age by the investigator at screening.
  9. Individuals with any elevated (Grade 1 or higher) liver function enzyme at screening, regardless of the appraisal of clinical significance (cannot be retested to qualify for study).
  10. Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) or a history of any hematological malignancy. "Active" is defined as having received treatment within the past 5 years.
  11. Long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (> 800 μg/day of beclomethasone dipropionate or equivalent) within 6 months before screening (nasal and topical steroids are allowed).
  12. History of autoimmune or inflammatory disease.
  13. Women currently pregnant, lactating, or planning a pregnancy between enrollment and 181 days after randomization.
  14. History of Guillain-Barré Syndrome.
  15. History of anaphylactic-type reaction to injected vaccines.
  16. Known or suspected hypersensitivity to 1 or more of the components of the vaccine, including thimerosal.
  17. History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of screening.
  18. Acute illness or fever within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator).
  19. Individuals currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication); or who have received an experimental agent within 1 month (3 months for immunoglobulins) before enrollment in this study; or who expect to receive another experimental agent during participation in this study.
  20. Receipt of immunoglobulin or another blood product within the 3 months before enrollment in this study or those who expect to receive immunoglobulin or another blood product during this study.
  21. Individuals who intend to donate blood within 6 months after the first vaccination.
  22. Individuals using prescription medications for prophylaxis of SARS-CoV-2.
  23. Individuals who plan to receive another vaccine within the first 3 months of the study except influenza vaccine which should not be given within 2 weeks of study vaccine.
  24. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.
  25. Receipt of any investigational vaccine or drug within 1 month of enrollment and through the end of the study (1 year after first vaccination).
  26. Plan to travel outside the US (continental US, Hawaii, and Alaska) from enrollment through Day 43.
  27. History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
  28. Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation.
  29. Strenuous activity (as assessed by the investigator) within 48 hours prior to dosing (Days 1 and 22).
  30. Positive urine drugs of abuse or alcohol screen.
  31. Positive screen for HIV-1 and HIV-2 antibodies, HBsAg, or HCV antibody.
  32. Involved in the planning or conduct of this study.
  33. Unwilling or unlikely to comply with the requirements of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473690


Contacts
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Contact: Oscar Guzman 336-741-5043 guzmano@rjrt.com

Sponsors and Collaborators
Kentucky BioProcessing, Inc.
Investigators
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Study Director: Hugh Haydon Kentucky BioProcessing
Principal Investigator: Kevin Cannon, MD PMG Research of Wilmington, LLC
Principal Investigator: Dennis Ruff, MD ICON Early Phase Service
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Responsible Party: Kentucky BioProcessing, Inc.
ClinicalTrials.gov Identifier: NCT04473690    
Other Study ID Numbers: KBP-201
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plan is to share study data by dosing group in publications

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kentucky BioProcessing, Inc.:
Vaccine
Covid19 Vaccine