Covid19Phase 1/2NCT04473690
KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers
A Phase 1/2 study testing Low Dose of KBP-COVID-19 and High Dose of KBP-COVID-19 in people with Covid19, run by KBio Inc at 8 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Low Dose of KBP-COVID-19 and High Dose of KBP-COVID-19
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 30 Dec 2020to 14 Oct 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
- Known or suspected hypersensitivity to 1 or more of the components of the vaccine, including thimerosal, tobacco, and CpG adjuvant.
- 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.
- Acute illness or fever within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the Investigator).
- 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.
- 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.
- Individuals who intend to donate blood within 6 months after the first vaccination.
- Individuals using prescription medications for prophylaxis of SARS-CoV-2.
- 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.
- Receipt of any other approved SARS CoV 2 vaccine prior to the first study vaccine or within 90 days after administration of the first study vaccine.
- Receipt of any other experimental coronavirus vaccine at any time prior to or during the study.
- Receipt of any investigational vaccine or drug within 1 month of enrollment and through the end of the study (1 year after first vaccination).
- Plan to travel outside the subjects' country of residence from enrollment through Day 43.
- History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
- Significant blood loss (>450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation.
- Strenuous activity (as assessed by the Investigator) within 48 hours prior to dosing (Days 1 and 22).
- A positive urine drug screen without evidence of corresponding prescribed concomitant medication(s) at Screening.
- Positive alcohol screen.
- Positive screen for HIV-1 and HIV-2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody.
- Involved in the planning or conduct of this study.
- Unwilling or unlikely to comply with the requirements of the study.
- Subject is an employee, contractor, friend of or relative of any employee of Sponsor, contract research organization (CRO), study site or site affiliate.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
PanAmerican Clinical Research
Brownsville, Texas, 78520
Velocity Clinical Research
Meridian, Idaho, 83642
ICON
San Antonio, Texas, 78209
DM Clinical Research
Tomball, Texas, 77375
Palm Beach Research Center
West Palm Beach, Florida, 33409
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
Canada2 sites
LMC Manna Research
Burlington, Burlington/Ontario, L7M 441
LMC Manna Research
Montreal, Point Claire, Quebec, H9R 45B
About this study
Official title: A Phase I/II, First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of TAP-COVID-19 SARS-CoV-2 Vaccine With CpG Adjuvant in Healthy Adults Aged 18-49 and 50-85
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).
Read the detailed description
Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization.
Approximately 90 eligible healthy adults ages 18-49 years (inclusive) will be enrolled for Part A and 90 eligible healthy seronegative adults ages 50-85 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 (50-85 years) low dose Part A (18-49 years) high dose Part B (50-85 years) high dose
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.
- Conditions
- Covid19
- Being tested
- Low Dose of KBP-COVID-19, High Dose of KBP-COVID-19, Placebo
- Keywords
- Vaccine, Covid19 Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose of KBP-COVID-19Biological
Low Dose of KBP-COVID-19 and adjuvant
High Dose of KBP-COVID-19Biological
High Dose of KBP-COVID-19 and adjuvant
PlaceboBiological
Buffered saline solution
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited Administration Site Reactions
Occurrence of Adverse Events
Measured: 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
Measured: 7 days following the first vaccination on day 1 and 7 days following the second vaccination on day 22, up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start30 Dec 2020
- Primary completion31 May 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- KBio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry Bratcher, Study director, KBio Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473690
- Sponsor's protocol ID
- KBP-201
- Status last verified
- May 2025
- First submitted
- 14 Jul 2020
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Plan is to share study data by dosing group in publications
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of TAP-COVID-19 SARS-CoV-2 Vaccine With CpG Adjuvant in Healthy Adults Aged 18-49 and 50-85
- ClinicalTrials.gov ID
- NCT04473690
- Acronym / sponsor ID
- KBP-201
- Conditions
- Covid19
- Keywords
- Vaccine, Covid19 Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- KBio IncIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Posted 18 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization.
Approximately 90 eligible healthy adults ages 18-49 years (inclusive) will be enrolled for Part A and 90 eligible healthy seronegative adults ages 50-85 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 (50-85 years) low dose Part A (18-49 years) high dose Part B (50-85 years) high dose
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose KBP-COVID-19 and adjuvant | Experimental | Biological: Low Dose of KBP-COVID-19Two 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 |
| High Dose KBP-COVID-19 and adjuvant | Experimental | Biological: High Dose of KBP-COVID-19Two 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 |
| Placebo | Placebo comparator | Biological: PlaceboTwo age groups. Part A (18-49 years). Part B (50-85 years). All subjects in these groups will receive placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (36 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose of KBP-COVID-19Low Dose of KBP-COVID-19 and adjuvant | Biological | Low Dose KBP-COVID-19 and adjuvant |
| High Dose of KBP-COVID-19High Dose of KBP-COVID-19 and adjuvant | Biological | High Dose KBP-COVID-19 and adjuvant |
| PlaceboBuffered saline solution | Biological | Placebo |
Primary outcome
Solicited Administration Site Reactions
Time frame: 7 days following the first vaccination on day 1 and 7 days following the second vaccination on day 22, up to 29 days
Occurrence of Adverse Events
Solicited Systemic Events
Time frame: 7 days following the first vaccination on day 1 and 7 days following the second vaccination on day 22, up to 29 days
Occurrence of Adverse Events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Plan is to share study data by dosing group in publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Bratcher study director
KBio Inc
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low Dose of KBP-COVID-19 and High Dose of KBP-COVID-19 in people with Covid19, run by KBio Inc at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited Administration Site Reactions (time frame: 7 days following the first vaccination on day 1 and 7 days following the second vaccination on day 22, up to 29 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.