A Phase I Trial to Evaluate the Safety and Immunogenicity of Influenza Virus Split Vaccine (Adjuvant)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Influenza
• Intervention / Treatment: Biological: influenza vaccine（BK01 adjuvnat）; Biological: approved influenza vaccine; Biological: adjuvant placebo; Biological: placebo

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chen Xin; Phone Number: 0431-87078295; Email: chenxin@bchtpharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Biological: placebo; Each human dose is 0.5 mL. The main ingredient is sodium chloride.
Experimental: influenza vaccine（BK01 adjuvant）	Biological: influenza vaccine（BK01 adjuvnat）; Each human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain.
Active Comparator: approved influenza vaccine	Biological: approved influenza vaccine; Each human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain.
Placebo Comparator: adjuvant placebo	Biological: adjuvant placebo; Each human dose is 0.5 mL, containing no influenza virus strain hemagglutinin. The main ingredient is BK-01 adjuvant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome	Incidence rate of adverse reactions/events	upto 30 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity outcome	seroconversion rate of HI antibody	upto 30 days after vaccination
Immunogenicity outcome	HI antibody titers	upto 30 days after vaccination

Collaborators and Investigators

• Sponsor: Changchun BCHT Biotechnology Co.

Study record dates

Study Major Dates

• Study Start (Estimated): February 7, 2026
• Primary Completion (Estimated): April 25, 2026
• Study Completion (Estimated): March 7, 2027

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: B1701-F20240612-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No