Testing a new vaccine for Haemophilus Influenzae Type b infection

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

This study is testing a new vaccine to see if it can safely protect people of all ages from infections caused by Haemophilus Influenzae Type b.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 2 Months to 59 Years
• Sex: All
• Sponsor: CanSino Biologics Inc. (industry)
• Locations: 1 site (Chongqing)
• Trial ID: NCT06621654 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, partially blinded, positively controlled phase I study aimed at evaluating the safety and immunogenicity of a lyophilized Haemophilus Influenzae Type b conjugate vaccine. A total of 160 participants, ranging from 2 months to 59 years of age, will be enrolled in age groups starting from the oldest to the youngest. Safety assessments will be conducted on the 8th day after the first dose for each age group, and subsequent groups will only be enrolled after confirming safety. The study aims to gather important data on the vaccine's effectiveness in preventing infections caused by Haemophilus Influenzae Type b.

Who should consider this trial

Good fit: Ideal candidates for this study include individuals aged 2 months to 59 years who have not previously received Hib-containing vaccines.

Not a fit: Patients with a history of Haemophilus influenzae type b infection or those who have been vaccinated with Hib-containing vaccines will not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the incidence of Haemophilus Influenzae Type b infections in vaccinated populations.

How similar studies have performed: Other studies have shown success with similar vaccine approaches, indicating a promising potential for this vaccine.

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

Where this trial is running

Chongqing

• Jiulongpo District Center for Disease Control and Prevention — Chongqing, China (RECRUITING)

Study contacts

• Principal investigator: Hongying Li — Chongqing Center for Disease Control and Prevention (Chongqing Academy of Preventive Medicine)
• Study coordinator: Haojie Liu

Conditions: Haemophilus Influenzae Type B Infection, Vaccine, Safety, Immunogenicity, 2 months of age and older