Experimental flu vaccine with booster enters first human tests
NCT ID NCT07349017
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-stage trial tests a new influenza vaccine that includes a special booster called BK-01 adjuvant. The goal is to see if it is safe and triggers a strong immune response in adults 18 and older. 160 volunteers will receive either the new vaccine, a standard flu vaccine, or a placebo, and be monitored for 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- influenza vaccine with BK-01 adjuvant
- What this could lead to
- If successful, this could lead to a more effective seasonal flu vaccine that provides better protection against influenza.
- What could go wrong
- This is a very early Phase 1 trial with only 160 people, so safety and immune response are still unknown. The vaccine may not work as hoped or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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); * 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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- When the immune system Can't fight back: tracking three respiratory viruses
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- Can a stronger flu shot boost immunity in older adults?
- A nudge in the mailbox: could a letter boost flu shots for millions at risk?
- Can a new pill shorten the flu?