Clinical trial NCT05602480: Phase I Clinical Trial of a Candidate PCV13 in Healthy People
Official title: Phase I Clinical Trial to Evaluate the Safety and Explore the Immunogenicity of a Candidate PCV13 in Healthy People Aged 2 Months (Minimum 6 Weeks) and Above
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pneumococcal Infections
Keywords: Pneumonia, Pneumococcal
Lead sponsor: Wuhan BravoVax Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Hunan Provincial Center for Disease Control and Prevention
name: Liaoning Chengda Biotechnology CO., LTD
First posted: 2022-11-02
Enrollment: 264
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world.

This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.


Eligibility criteria: Inclusion Criteria:

* Satisfy the age requirements of the clinical trial; willing to provide proof of identity;
* Subjects or guardians must provide informed consent forms with personal signature and date;
* Male and female of childbearing age should agree to take effective contraception measures;
* Subjects or guardians can obey the requirements of the clinical study;
* Axillary temperature below 37.3 °C.

Exclusion Criteria:

* Laboratory indicators (expect those have no clinical significance) out of normal ranges required;
* Received any pneumococcal vaccine;
* Allergic history to any drugs, vaccine or vaccine-related component;
* Infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
* Infants diagnosed with pathological jaundice that lasts for 2\~4 weeks and occurs repeatedly;
* Breast-feeding or pregnant women, or positive U-HCG;
* High blood pressure uncontrolled by medication;
* Known or suspected immune deficiency or immune suppression;
* Serious congenital malformation, history of organ resection or serious chronic illness;
* Received blood products or intravenous immunoglobulin (except Hepatitis B immunoglobulin);
* History of clinic-proven or serology-proven infectious disease especially caused by streptococcus pneumoniae;
* History of convulsions, epilepsy or encephalopathy or a family history of mental illness;
* A vaccination-related contraindications that other investigator believes;
* Plans to participate in or is participating in any other clinical study;
* Any other factors judged by investigator that may interfere subject's compliance with the protocol.

Primary outcomes:
measure: Safety in terms of adverse reactions
timeFrame: within 30 minutes post each vaccination
measure: Safety in terms of adverse events
timeFrame: within 7 days post each vaccination
measure: Safety in terms of adverse events
timeFrame: within 30 days post each vaccination
measure: Safety in terms of SAEs
timeFrame: within 6 months post last vaccination
measure: Safety in terms of laboratory-based AEs
timeFrame: within 4 days post each vaccination
Secondary outcomes:
measure: Immunogencity in terms of seropositivity rates by ELISA
timeFrame: 30 days post basic vaccination
measure: Immunogencity in terms of GMC by ELISA
timeFrame: 30 days post basic vaccination
measure: Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL
timeFrame: 30 days post basic vaccination
measure: Immunogencity Comparison with control vaccine group
timeFrame: 30 days post basic vaccination
Other outcomes:
Locations:
city: Xiangtan
country: China
facility: Xiangtan Maternal and Child Health Hospital
state: Hunan
Study officials:
References: