Phase I Clinical Trial of a Candidate PCV13 in Healthy People

Phase 1

Recruiting

• Conditions: Pneumococcal Infections
• Interventions: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

• Registration Number: NCT05602480
• Lead Sponsor: Wuhan BravoVax Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-27
• Status Verified: 2022-11
• Study Start: 2022-11-01
• Study First Posted: 2022-11-02
• Last Update Submitted: 2022-11-11
• Last Update Posted: 2022-11-17
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2A	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	Subjects received one dose of PCV13 at 6\~17 years of age.
6A	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	Subjects received four doses of PCV13 at 3 months of age.
7B	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).
4A	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	Subjects received two doses of PCV13 at 12\~23 months of age.
5A	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	Subjects received three doses of PCV13 at 7\~11 months of age.
7A	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).
1A	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	Subjects received one dose of PCV13 at 18 years of age and above.
3A	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	Subjects received one dose of PCV13 at 2\~5 years of age.
6B	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).
6C	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).

Primary Outcome Measures

Name	Time	Method
Safety in terms of adverse events	within 30 days post each vaccination	Occurrence of non-solicited AEs of each subject
Safety in terms of SAEs	within 6 months post last vaccination	Occurrence of SAEs of each subject
Safety in terms of laboratory-based AEs	within 4 days post each vaccination	Occurrence of laboratory-based AEs in subjects of 2 years old and above(Arm 1A-3A)
Safety in terms of adverse reactions	within 30 minutes post each vaccination	Occurrence of AEs on vaccination site (local) and non-vaccination site (systemic) of each subject

Secondary Outcome Measures

Name	Time	Method
Immunogencity Comparison with control vaccine group	30 days post basic vaccination	Comparison of the seropositivity rates, GMC of serotype-specific pneumococcal IgG antibody and the Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL in subjects aged 2 months of Experimental group and Control group
Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL	30 days post basic vaccination	Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL
Immunogencity in terms of seropositivity rates by ELISA	30 days post basic vaccination	Seropositivity rates of serotype-specific pneumococcal IgG antibody in subjects of each age group
Immunogencity in terms of GMC by ELISA	30 days post basic vaccination	GMC of serotype-specific pneumococcal IgG antibody in subjects of each age group

Trial Locations

Locations (1)

Xiangtan Maternal and Child Health Hospital; 🇨🇳 Xiangtan, Hunan, China