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

ConditionInfluenza
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChangchun BCHT Biotechnology Co.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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；

Trial design

Design model

Single group

Treatments tested in this trial

  • influenza vaccine（BK01 adjuvnat）

    Biological/Vaccine

    Each human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain.

  • approved influenza vaccine

    Biological/Vaccine

    Each human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain.

  • adjuvant placebo

    Biological/Vaccine

    Each human dose is 0.5 mL, containing no influenza virus strain hemagglutinin. The main ingredient is BK-01 adjuvant.

  • placebo

    Biological/Vaccine

    Each human dose is 0.5 mL. The main ingredient is sodium chloride.

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: influenza vaccine（BK01 adjuvant）Experimental treatment 1 intervention
Group B: approved influenza vaccineActive comparator 1 intervention
Group C: adjuvant placeboPlacebo comparator 1 intervention
Group D: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety outcome

Incidence rate of adverse reactions/events

Time frame
upto 30 days after vaccination

Secondary outcomes

1

Immunogenicity outcome

seroconversion rate of HI antibody

Time frame
upto 30 days after vaccination
2

Immunogenicity outcome

HI antibody titers

Time frame
upto 30 days after vaccination

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changchun BCHT Biotechnology Co.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: