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> Record changed: 2026-10-13

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

NCT07349017

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

Recruitment status

Not yet recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

Participants

160

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

Lead sponsor

Changchun BCHT Biotechnology Co.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

Start date

2026-02-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

## Title and summary

**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 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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Recruitment status**

Not yet recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

## Dates

**Completion date**

2027-03-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**First posted**

2026-01-16

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Registry last updated**

2026-01-16

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Primary completion date**

2026-04-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Start date**

2026-02-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

## Size and sites

**Participants**

160

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Planned participants**

160

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Randomisation ratio**

1:1:1:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Lead sponsor**

Changchun BCHT Biotechnology Co.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

## Identifiers

**Registry ID**

NCT07349017

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**ClinicalTrials.gov ID**

NCT07349017

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

## Study design

**Allocation**

Randomised

**Model**

Single group

**Purpose**

Prevention

**Masking**

Double masking

**Masked roles**

Participants, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

## Outcomes

### Primary outcomes

1. Safety outcome  
Timeframe: upto 30 days after vaccination  
Incidence rate of adverse reactions/events

### Secondary outcomes

1. Immunogenicity outcome  
Timeframe: upto 30 days after vaccination  
seroconversion rate of HI antibody
2. Immunogenicity outcome  
Timeframe: upto 30 days after vaccination  
HI antibody titers

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

Yes

### 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;

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349017)

## Related records

### Drugs (1)

- [Sintilimab](https://trialight.com/data/asset/sintilimab-e2618eaf-967e-401c-aed4-7546875a6d3e.md)

### Lead sponsors (1)

- [Changchun BCHT Biotechnology Co.](https://trialight.com/data/company/changchun-bcht-biotechnology-co-2f38a069-5e9a-44f3-93e1-84ac3c4da340.md)

### Conditions (1)

- [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md) Primary condition

### Targets (1)

- [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md)

---

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