InfluenzaPhase 1NCT04439695
Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
A Phase 1 study testing Low dose, Intermediate dose and High dose in people with Influenza, run by KBio Inc at 1 site in United States.
Trial summary
This is an observer-blinded, randomized, placebo-controlled, parallel group study to evaluate safety and immunogenicity of TAP-V001 quadrivalent influenza vaccine in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Low dose, Intermediate dose and High dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to 28 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have read, understood, and signed the informed consent form (ICF)
- Healthy adult males and females ages 18 to 49 years, inclusive at screening
- Body mass index (BMI) of ≥18 and ≤34 kg/m2 at screening
- 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 during the study and for 3 months after the study completion. 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 (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
- Female subjects of childbearing potential must have a negative urine pregnancy test before vaccination
- Must be able to attend all visits for the duration of the study and comply with all study procedures, including completion of Diary Card according to the study schedule.
Who cannot join
- History of an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
- History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
- Individuals with any elevated (Grade 2 or higher) laboratory test assessed as clinically significant by investigator at screening
- Individuals with any elevated (Grade 2 or higher) liver function enzyme at screening, regardless of the appraisal of clinical significance (cannot be retested to qualify for study). See below the criteria for excluding subjects with elevated liver enzymes:
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST): >3 × upper limit of normal (ULN)
- Total bilirubin: >2 × ULN
Show all 22Show fewer
- Alkaline phosphatase (ALP)/gamma-glutamyl transferase (GGT): >2.5 × ULN
- Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
- 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)
- History of autoimmune or inflammatory disease
- Women currently pregnant, nursing, or planning a pregnancy between enrollment and 181 days after randomization
- History of a previous serious adverse reaction to any influenza vaccine
- 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 TAP-V001
- History of illicit drug use or alcohol abuse in the year before screening
- Receipt of any influenza vaccine within 6 months before screening
- Receipt of any vaccine within 1 month before 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 before enrollment in this study; or who expect to receive another experimental agent during participation in this study; or who intend to donate blood during the study period.
- 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 plan to receive another vaccine, including seasonal influenza vaccine, during the entire 6-month study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
This is an observer-blinded, randomized, placebo-controlled, parallel group study to evaluate safety and immunogenicity of TAP-V001 quadrivalent influenza vaccine in healthy adult subjects.
Read the detailed description
Subjects will be screened up to 14 days (Day -14 to Day 0) before randomization.
On the planned day of vaccination (Day 1), subjects will be randomized in a 1:1:1:1 ratio (N = 30 subjects/group) to receive study vaccine or placebo by intramuscular (IM) injection.
Approximately 5 subjects per group (N = 20) will be enrolled in parallel initially, and safety data through Day 8 will be collected. An Independent Data Monitoring Committee (IDMC) will convene to review Day 8 safety data before any additional subjects will be enrolled. If there are no safety concerns in the IDMC meeting, study enrollment will continue.
Blood and serum samples for safety laboratory tests and HAI titers will be obtained at baseline on Day 1 before administration of vaccine dose and after vaccination.
- Conditions
- Influenza
- Being tested
- Low dose, Intermediate dose, High dose, Placebo
- Keywords
- Influenza, Vaccine, Influenza Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low doseBiological
Low dose of KBP-V001
Intermediate doseBiological
Intermediate dose of KBP-V001
High doseBiological
High dose of KBP-V001
PlaceboBiological
Buffered Saline Solution
| Study group | Role | What they receive |
|---|---|---|
| Low Dose KBP-V001 | Experimental | Subjects in this group will receive the low dose of KBP-V001. Receives: Biological: Low dose |
| Intermediate KBP-V001 | Experimental | Subjects in this group will receive the intermediate dose of KBP-V001. Receives: Biological: Intermediate dose |
| High Dose KBP-V001 | Experimental | Subjects in this group will receive the high dose of KBP-V001. Receives: Biological: High dose |
| Placebo | Placebo comparator | Subjects in this group 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
Occurrences of Adverse Events
Measured: 7 days after vaccination
Solicited systemic events
Occurrences of Adverse Events
Measured: 7 days after vaccination
Secondary outcomes (3)
Number of Unsolicited Adverse Events
Safety Endpoint
Measured: 43 days after vaccination
Number of Serious Adverse Events and Medically Attended Events
Safety Endpoint
Measured: 181 days after vaccination
Vaccine HAI antibody Titers
Vaccine HAI antibody Titers for each treatment group
Measured: Day 1, 29, 43, 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start25 Jun 2020
- Primary completion25 Feb 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- KBio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugh Haydon, Study director, Kentucky BioProcessingBrandon Essink, MD, Principal investigator, Meridian Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439695
- Sponsor's protocol ID
- KBP-101
- Status last verified
- Sep 2021
- First submitted
- 17 Jun 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT04439695
- Acronym / sponsor ID
- KBP-101
- Conditions
- Influenza
- Keywords
- Influenza, Vaccine, Influenza Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- KBio IncIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
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 observer-blinded, randomized, placebo-controlled, parallel group study to evaluate safety and immunogenicity of TAP-V001 quadrivalent influenza vaccine in healthy adult subjects.
Detailed description
Subjects will be screened up to 14 days (Day -14 to Day 0) before randomization.
On the planned day of vaccination (Day 1), subjects will be randomized in a 1:1:1:1 ratio (N = 30 subjects/group) to receive study vaccine or placebo by intramuscular (IM) injection.
Approximately 5 subjects per group (N = 20) will be enrolled in parallel initially, and safety data through Day 8 will be collected. An Independent Data Monitoring Committee (IDMC) will convene to review Day 8 safety data before any additional subjects will be enrolled. If there are no safety concerns in the IDMC meeting, study enrollment will continue.
Blood and serum samples for safety laboratory tests and HAI titers will be obtained at baseline on Day 1 before administration of vaccine dose and after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose KBP-V001 | Experimental | Biological: Low doseSubjects in this group will receive the low dose of KBP-V001. |
| Intermediate KBP-V001 | Experimental | Biological: Intermediate doseSubjects in this group will receive the intermediate dose of KBP-V001. |
| High Dose KBP-V001 | Experimental | Biological: High doseSubjects in this group will receive the high dose of KBP-V001. |
| Placebo | Placebo comparator | Biological: PlaceboSubjects in this group will receive placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Have read, understood, and signed the informed consent form (ICF)
- Healthy adult males and females ages 18 to 49 years, inclusive at screening
- Body mass index (BMI) of ≥18 and ≤34 kg/m2 at screening
- 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 during the study and for 3 months after the study completion. 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 (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
Key exclusion criteria (22 listed)
- History of an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
- History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
- Individuals with any elevated (Grade 2 or higher) laboratory test assessed as clinically significant by investigator at screening
- Individuals with any elevated (Grade 2 or higher) liver function enzyme at screening, regardless of the appraisal of clinical significance (cannot be retested to qualify for study). See below the criteria for excluding subjects with elevated liver enzymes:
- Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
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 doseLow dose of KBP-V001 | Biological | Low Dose KBP-V001 |
| Intermediate doseIntermediate dose of KBP-V001 | Biological | Intermediate KBP-V001 |
| High doseHigh dose of KBP-V001 | Biological | High Dose KBP-V001 |
| PlaceboBuffered Saline Solution | Biological | Placebo |
Primary outcome
Solicited administration site reactions
Time frame: 7 days after vaccination
Occurrences of Adverse Events
Solicited systemic events
Time frame: 7 days after vaccination
Occurrences of Adverse Events
3 secondary outcomes
Number of Unsolicited Adverse Events
Time frame: 43 days after vaccination
Number of Serious Adverse Events and Medically Attended Events
Time frame: 181 days after vaccination
Vaccine HAI antibody Titers
Time frame: Day 1, 29, 43, 181
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- 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.
Hugh Haydon study director
Kentucky BioProcessing
Brandon Essink, MD principal investigator
Meridian Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose, Intermediate dose and High dose in people with Influenza, run by KBio Inc at 1 site in United States.
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 7 inclusion and 22 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 after vaccination). 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 16 Sep 2021.