Phase I Clinical Trial of a Candidate PCV13 in Healthy People

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Long Xu, Ph.D.; Phone Number: +86 27 8798 8585 ext. 8251; Email: ct@bravovax.com

Study Locations

• China
  • Hunan
    • Xiangtan, Hunan, China
      • Recruiting
      • Xiangtan Maternal and Child Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1A; Subjects received one dose of PCV13 at 18 years of age and above.	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; 0.5mL, Intramuscular; Other Names: Prevnar 13
Experimental: 2A; Subjects received one dose of PCV13 at 6~17 years of age.	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; 0.5mL, Intramuscular; Other Names: Prevnar 13
Experimental: 3A; Subjects received one dose of PCV13 at 2~5 years of age.	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; 0.5mL, Intramuscular; Other Names: Prevnar 13
Experimental: 4A; Subjects received two doses of PCV13 at 12~23 months of age.	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; 0.5mL, Intramuscular; Other Names: Prevnar 13
Experimental: 5A; Subjects received three doses of PCV13 at 7~11 months of age.	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; 0.5mL, Intramuscular; Other Names: Prevnar 13
Experimental: 6A; Subjects received four doses of PCV13 at 3 months of age.	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; 0.5mL, Intramuscular; Other Names: Prevnar 13
Experimental: 6B; Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; 0.5mL, Intramuscular; Other Names: Prevnar 13
Active Comparator: 6C; Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; 0.5mL, Intramuscular; Other Names: Prevnar 13
Experimental: 7A; Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; 0.5mL, Intramuscular; Other Names: Prevnar 13
Active Comparator: 7B; Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; 0.5mL, Intramuscular; Other Names: Prevnar 13

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety in terms of adverse reactions	Occurrence of AEs on vaccination site (local) and non-vaccination site (systemic) of each subject	within 30 minutes post each vaccination
Safety in terms of adverse events	Occurrence of solicited AEs of each subject	within 7 days post each vaccination
Safety in terms of adverse events	Occurrence of non-solicited AEs of each subject	within 30 days post each vaccination
Safety in terms of SAEs	Occurrence of SAEs of each subject	within 6 months post last vaccination
Safety in terms of laboratory-based AEs	Occurrence of laboratory-based AEs in subjects of 2 years old and above(Arm 1A-3A)	within 4 days post each vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogencity in terms of seropositivity rates by ELISA	Seropositivity rates of serotype-specific pneumococcal IgG antibody in subjects of each age group	30 days post basic vaccination
Immunogencity in terms of GMC by ELISA	GMC of serotype-specific pneumococcal IgG antibody in subjects of each age group	30 days post basic vaccination
Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL	Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL	30 days post basic vaccination
Immunogencity Comparison with control vaccine group	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	30 days post basic vaccination

Collaborators and Investigators

• Sponsor: Wuhan BravoVax Co., Ltd.
• Collaborators: Hunan Provincial Center for Disease Control and Prevention; Liaoning Chengda Biotechnology CO., LTD

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pneumonia, Pneumococcal
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CLI-09-I-2020001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No