Clinical trial NCT06621654: Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
Official title: A Randomized, Partially Blinded, Positively Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine in a Population Aged 2 Months and Older
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Haemophilus Influenzae Type B Infection
Keywords: Vaccine
Safety
Immunogenicity
2 months of age and older
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is a randomized, partially blinded, positively controlled phase I clinical study. A total of 160 persons aged 18-59 years, 1-5 years, 6-11 months and 2 months (60-89 days) will be recruited into the trial, and the enrollment will be done according to the progression of age groups, from the oldest to the youngest, and the initial safety assessment will be conducted on the 8th day after the first dose of vaccination for each age group, and the next group will be enrolled only after the safety is confirmed.


Eligibility criteria: Inclusion Criteria:

* Subjects aged 2 months, 6-11 months, 1-5 years, and 18-59 years at the time of screening
* Informed consent is obtained from the subject and the subject and/or guardian (attorney-in-fact) is able to sign the informed consent form
* Subjects are able and willing to comply with the requirements of the clinical trial protocol and are able to complete the full study follow up

Exclusion criteria for first dose:

* 2 months old, 6 months old \~ 5 years old people have been vaccinated with Hib-containing vaccines
* 2-month-old, 6\~11-month-old infants who were born prematurely (delivered before the 37th week of gestation), low birth weight (birth weight \<2500g)
* 2-month-old, 6\~11-month-old infants with abnormal labor and delivery, history of asphyxia rescue, history of neurological damage
* Those with history of Haemophilus influenzae type b infection
* Those with history of epilepsy, convulsions, convulsions, cerebral palsy, or history of psychiatric illness or family history or other progressive neurological diseases
* Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases
* History of allergy to vaccines or vaccine components, severe side effects to vaccines such as urticaria, dyspnea, angioneurotic edema
* Female with positive urine pregnancy test or breastfeeding subjects, subjects or their partners with pregnancy plan within 6 months (only for 18\~59 years old)
* Fever with axillary temperature \> 37.0°C
* Known or suspected to be suffering from acute diseases or serious chronic diseases (including: serious respiratory diseases, serious cardiovascular diseases, liver and kidney diseases, serious skin diseases, malignant tumors, tuberculosis, etc.); or in the acute exacerbation of chronic diseases
* Those who have hypertension that cannot be controlled by medication (at the time of on-site measurement: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg) (only applicable to 18\~59 years old)
* Any of the routine blood biochemistry indexes during the screening period judged to be clinically significant by the investigator (only applicable to 2\~5, 18\~59 years old)
* Have no spleen or functional absence of spleen
* Suffering from thrombocytopenia, bleeding disorders, or other coagulation disorders (which may cause contraindication to intramuscular injection)
* Immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroids for acute uncomplicated dermatitis) within the past 6 months
* Received blood products within 3 months prior to receiving the experimental drug
* Participation in other studies involving interventional studies within 1 month prior to receiving the investigational drug and/or during the study participation period
* Having received an injectable live attenuated vaccine within 14 days or another vaccine within 7 days prior to vaccination
* In the judgment of the investigator, due to a variety of medical, psychological, social or other conditions that are contrary to the trial protocol or that affect the subject's ability to sign informed consent

Exclusion criteria for subsequent doses

* A vaccine-related serious adverse event occurred after the previous dose of vaccination
* Who has experienced a Grade 3 or higher allergic reaction related to the vaccine after the previous dose of vaccination
* Any other factors that, in the judgment of the investigator, make the subject unsuitable for continued participation in the clinical trial

Primary outcomes:
measure: Adverse reactions in all subjects
timeFrame: Within 30 days of each dose of vaccine
Secondary outcomes:
measure: Adverse reactions in all subjects
timeFrame: Within 30 minutes of each dose of vaccine
measure: Adverse events in all subjects
timeFrame: Within 30 days of each dose of vaccine
measure: Incidence of SAEs in all subjects
timeFrame: From the first dose to 6 months after full vaccination
measure: Incidence of abnormal and clinically significant (CS) white blood cell counts, hemoglobin, platelet counts, Alanine aminoTransferase (ALT), Aspartate Transaminase (AST), and TBIL assays in subjects 18-59, 2-5 years of age
timeFrame: Day 8 post-immunization
measure: Proportion of 2-month-old subjects with anti-Hib-PRP antibody concentrations ≥1.0 μg/ml
timeFrame: 30 days after basic immunization, before booster immunization, 30 days after booster immunization
measure: Positive transfer rate of anti-Hib-PRP antibodies in 2-month-old subjects
timeFrame: 30 days after basic immunization, before booster immunization, 30 days after booster immunization
measure: Positivity of anti-Hib-PRP antibodies in 2-month-old subjects
timeFrame: 30 days after basic immunization, before booster immunization, 30 days after booster immunization
measure: Geometric Mean Concentration (GMC) of anti-Hib-PRP antibodies in 2-month-old subjects
timeFrame: 30 days after basic immunization, before booster immunization, 30 days after booster immunization
measure: Geometric Mean Increase (GMI) of anti-Hib-PRP antibodies in 2-month-old subjects
timeFrame: 30 days after basic immunization, before booster immunization, 30 days after booster immunization
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Jiulongpo District Center for Disease Control and Prevention
Study officials:
affiliation: Chongqing Center for Disease Control and Prevention (Chongqing Academy of Preventive Medicine)
name: Hongying Li
role: PRINCIPAL_INVESTIGATOR
References: