KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers

NCT04473690 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: KBP-201
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 8

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 plus CPG adjuvant vaccine in healthy adult subjects in 2 age groups, Part A (18-49 years) and Part B (50-85 years).

Conditions

Covid19

Keywords

Vaccine; Covid19 Vaccine

Outcome Measures

Primary Outcomes (2)

• Solicited Administration Site Reactions

  Occurrence of Adverse Events

  7 days following the first vaccination on day 1 and 7 days following the second vaccination on day 22, up to 29 days

• Solicited Systemic Events

  Occurrence of Adverse Events

  7 days following the first vaccination on day 1 and 7 days following the second vaccination on day 22, up to 29 days

Study Arms (3)

Low Dose KBP-COVID-19 and adjuvant

EXPERIMENTAL

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

Biological: Low Dose of KBP-COVID-19

High Dose KBP-COVID-19 and adjuvant

EXPERIMENTAL

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

Biological: High Dose of KBP-COVID-19

Placebo

PLACEBO COMPARATOR

Two age groups. Part A (18-49 years). Part B (50-85 years). All subjects in these groups will receive placebo

Biological: Placebo

Interventions

Low Dose of KBP-COVID-19 BIOLOGICAL

Low Dose of KBP-COVID-19 and adjuvant

Low Dose KBP-COVID-19 and adjuvant

High Dose of KBP-COVID-19 BIOLOGICAL

High Dose of KBP-COVID-19 and adjuvant

High Dose KBP-COVID-19 and adjuvant

Placebo BIOLOGICAL

Buffered saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 screening.
• RT-PCR negative at time of screening.
• Body mass index (BMI) of ≥ 18 and ≤ 30 kg/m2 at screening. BMI = weight (kg)/(height \[m\])2.
• 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 (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.
• WOCBP must have a negative urine pregnancy test before each vaccination.
• 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.

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. Chronic conditions that are NOT included on the Center for Disease Control'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.
• History of any medical conditions that place subjects at higher risk for severe illness due to SARS-CoV-2 including but not limited to cancer, chronic kidney disease at any stage, chronic lung disease, dementia or other neurological conditions, diabetes (Type 1 or Type 2), Down syndrome, heart conditions, human immunodeficiency virus (HIV) infection, immunocompromised state (weakened immune system), liver disease, overweight/obesity, pregnancy, sickle cell disease or thalassemia, smoker (current or former), transplants (solid organ or blood stem cell), stroke or cerebrovascular disease, and substance use disorders.
• History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
• Individuals who are PCR positive for SARS-CoV-2 at screening or prior to second dose of TAP-COVID-19 vaccine.
• Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare workers, emergency responders).
• Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
• Living in a group care facility (eg, assisted living or nursing home).
• Individuals with any elevated (Grade 1 or higher) laboratory test assessed as clinically significant for age by the Investigator at screening.
• Individuals with any elevated (Grade 1 or higher) liver function enzyme at screening,
• 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.
• Long-term (greater than 2 weeks) use of oral or parenteral steroids, high-dose inhaled steroids (\>800 μg/day of beclomethasone dipropionate or equivalent), or immunomodulatory drugs within 6 months before screening (nasal and topical steroids are allowed).
• History of autoimmune, inflammatory disease, or potential immune-mediated medical conditions (Appendix B).
• Women currently pregnant, lactating, or planning a pregnancy between enrollment and 181 days after randomization.
• History of Guillain-Barré Syndrome.
• History of anaphylactic-type reaction to injected vaccines.

Sponsors & Collaborators

• KBio Inc: lead

Study Sites (8)

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Velocity Clinical Research

Meridian, Idaho, 83642, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

PanAmerican Clinical Research

Brownsville, Texas, 78520, United States

Location

ICON

San Antonio, Texas, 78209, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

LMC Manna Research

Burlington, Burlington/Ontario, L7M 441, Canada

Location

LMC Manna Research

Montreal, Point Claire, Quebec, H9R 45B, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Katrina Whelan
• Organization: KBio Inc

katrinaw@KBio.com

2706893345

Study Officials

• Barry Bratcher

  KBio Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 16, 2020
• Study Start: December 30, 2020
• Primary Completion: May 31, 2022
• Study Completion: October 14, 2022
• Last Updated: May 18, 2025
• Results First Posted: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (6)