InfluenzaPhase 1NCT07349017
A Phase I Trial to Evaluate the Safety and Immunogenicity of Influenza Virus Split Vaccine (Adjuvant)
A Phase 1 study testing influenza vaccine（BK01 adjuvnat） and approved influenza vaccine in people with Influenza, run by Changchun BCHT Biotechnology Co..
Trial summary
The goal of this clinical trial is to evaluate the safety and immunogenicity of the influenza virus vaccine (BK-01 adjuvant) in people aged 18 years and older. The main questions it aims to answer is: Incidence rate of adverse reactions/events after administration Participants will be randomly vaccinated with a single… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- influenza vaccine（BK01 adjuvnat） and approved influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 7 Feb 2026to 7 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged 18 years and above;
- Have not received any influenza vaccine in the past six months and have no plan to receive other influenza vaccines during the trial period;
- Have not had influenza in the past 6 months (confirmed by any clinical, serological, or microbiological method);
- Able to obtain the participant's own informed consent;
- The participant themselves can comply with the requirements of the clinical trial protocol.
Who cannot join
- Axillary temperature > 37.0℃ on the day of enrollment;
- Female participants of childbearing age with a positive urine pregnancy test result, or who are breastfeeding, or have a plan to have children within 12 months;
- Those with a history of severe allergic diseases (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction), or who are allergic to any component of the test vaccine, such as eggs, gentamicin sulfate, formaldehyde, TritonX-100, etc.;
- Those with clinically significant abnormal laboratory test results, which are determined by the researcher as unsuitable for vaccine vaccination；
- Those who have had an acute illness, acute exacerbation of a chronic disease, or used antipyretic, analgesic, or anti-allergic drugs within the past 3 days;
- Autoimmune diseases or immune deficiency, asplenia, functional asplenia, and asplenia or splenectomy caused by any condition; those who have received long-term systemic drugs within the past 3 months or plan to receive long-term systemic drugs during the trial, including immunosuppressive and/or immunomodulatory drugs, leukotoxic therapy, etc. (for more than 14 consecutive days);
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- Those with congenital malformations affecting organ function, Down's syndrome, major diseases or major potential diseases that may interfere with or hinder the completion of the trial (such as: severe cardiovascular or chronic diseases in the decompensated stage, cor pulmonale, pulmonary edema, severe liver and kidney diseases, severe or symptomatic diabetes, current malignant tumors, etc.);
- Those with uncontrolled hypertension with drugs (18-59 years old: systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg; ≥ 60 years old: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
- Those with a history or family history of mental and neurological diseases such as convulsions, epilepsy, encephalopathy, and psychosis; Those with contraindications to intramuscular injection and blood collection, such as: diagnosed with sickle cell anemia, thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy, etc.;
- Those who have received blood products or immunoglobulin products within 3 months before receiving the test vaccine or plan to use them during the trial;
- Those who have received other clinical trial drugs within 1 month before receiving the test vaccine or are participating in other clinical trials, received live attenuated vaccines, viral vector vaccines, or nucleic acid vaccines within 14 days, or received subunit, recombinant, or inactivated vaccines within 7 days;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center, Randomized, Blinded Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Influenza Virus Vaccine (BK-01 Adjuvant) in Populations Aged 18 Years and Older
The goal of this clinical trial is to evaluate the safety and immunogenicity of the influenza virus vaccine (BK-01 adjuvant) in people aged 18 years and older.
The main questions it aims to answer is:
- Incidence rate of adverse reactions/events after administration Participants will be randomly vaccinated with a single dose of the trial vaccine, control vaccine, adjuvant placebo, or placebo in a 1:1:1:1 ratio. After vaccination, all participants will undergo up to 30-day observation and blood collection.
- Conditions
- Influenza
- Being tested
- influenza vaccine（BK01 adjuvnat）, approved influenza vaccine, adjuvant placebo, placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza vaccine（BK01 adjuvnat）Biological
Each human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain.
approved influenza vaccineBiological
Each human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain.
adjuvant placeboBiological
Each human dose is 0.5 mL, containing no influenza virus strain hemagglutinin. The main ingredient is BK-01 adjuvant.
placeboBiological
Each human dose is 0.5 mL. The main ingredient is sodium chloride.
| Study group | Role | What they receive |
|---|---|---|
| influenza vaccine（BK01 adjuvant） | Experimental | Not described Receives: Biological: influenza vaccine（BK01 adjuvnat） |
| approved influenza vaccine | Active comparator | Not described Receives: Biological: approved influenza vaccine |
| adjuvant placebo | Placebo comparator | Not described Receives: Biological: adjuvant placebo |
| placebo | Placebo comparator | Not described Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome
Incidence rate of adverse reactions/events
Measured: upto 30 days after vaccination
Secondary outcomes (2)
Immunogenicity outcome
seroconversion rate of HI antibody
Measured: upto 30 days after vaccination
Immunogenicity outcome
HI antibody titers
Measured: upto 30 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start7 Feb 2026 (estimated)
- Primary completion25 Apr 2026 (estimated)
- Study completion7 Mar 2027 (estimated)
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.
- More trials run by Changchun BCHT Biotechnology Co.The sponsor's other registered studies.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349017
- Sponsor's protocol ID
- B1701-F20240612-1
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Blinded Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Influenza Virus Vaccine (BK-01 Adjuvant) in Populations Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT07349017
- Acronym / sponsor ID
- B1701-F20240612-1
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2026 (estimated)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 7 Mar 2027 (estimated)
- First posted
- 16 Jan 2026 (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.
The goal of this clinical trial is to evaluate the safety and immunogenicity of the influenza virus vaccine (BK-01 adjuvant) in people aged 18 years and older.
The main questions it aims to answer is:
- Incidence rate of adverse reactions/events after administration Participants will be randomly vaccinated with a single dose of the trial vaccine, control vaccine, adjuvant placebo, or placebo in a 1:1:1:1 ratio. After vaccination, all participants will undergo up to 30-day observation and blood collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| influenza vaccine（BK01 adjuvant） | Experimental | Biological: influenza vaccine（BK01 adjuvnat） |
| approved influenza vaccine | Active comparator | Biological: approved influenza vaccine |
| adjuvant placebo | Placebo comparator | Biological: adjuvant placebo |
| placebo | Placebo comparator | Biological: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants aged 18 years and above;
- Have not received any influenza vaccine in the past six months and have no plan to receive other influenza vaccines during the trial period;
- Have not had influenza in the past 6 months (confirmed by any clinical, serological, or microbiological method);
- Able to obtain the participant's own informed consent;
- The participant themselves can comply with the requirements of the clinical trial protocol.
Key exclusion criteria (11 listed)
- Axillary temperature > 37.0℃ on the day of enrollment;
- Female participants of childbearing age with a positive urine pregnancy test result, or who are breastfeeding, or have a plan to have children within 12 months;
- Those with a history of severe allergic diseases (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction), or who are allergic to any component of the test vaccine, such as eggs, gentamicin sulfate, formaldehyde, TritonX-100, etc.;
- Those with clinically significant abnormal laboratory test results, which are determined by the researcher as unsuitable for vaccine vaccination；
- Those who have had an acute illness, acute exacerbation of a chronic disease, or used antipyretic, analgesic, or anti-allergic drugs within the past 3 days;
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 |
|---|---|---|
| influenza vaccine（BK01 adjuvnat）Each human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain. | Biological | influenza vaccine（BK01 adjuvant） |
| approved influenza vaccineEach human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain. | Biological | approved influenza vaccine |
| adjuvant placeboEach human dose is 0.5 mL, containing no influenza virus strain hemagglutinin. The main ingredient is BK-01 adjuvant. | Biological | adjuvant placebo |
| placeboEach human dose is 0.5 mL. The main ingredient is sodium chloride. | Biological | placebo |
Primary outcome
Safety outcome
Time frame: upto 30 days after vaccination
Incidence rate of adverse reactions/events
2 secondary outcomes
Immunogenicity outcome
Time frame: upto 30 days after vaccination
Immunogenicity outcome
Time frame: upto 30 days after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing influenza vaccine（BK01 adjuvnat） and approved influenza vaccine in people with Influenza, run by Changchun BCHT Biotechnology Co..
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Xin (0431-87078295, chenxin@bchtpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcome (time frame: upto 30 days after vaccination). 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 Jan 2026.