Phase I Clinical Trial of a Candidate PCV13 in Healthy People

Pneumococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602480
• Other study ID #: CLI-09-I-2020001
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: Wuhan BravoVax Co., Ltd.
• Contact: Long Xu, Ph.D.
• Phone: +86 27 8798 8585 ext. 8251
• Email: ct[@]bravovax.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL, Intramuscular
• 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL, Intramuscular

Locations

Country	Name	City	State
China	Xiangtan Maternal and Child Health Hospital	Xiangtan	Hunan

Sponsors (3)

Lead Sponsor	Collaborator
Wuhan BravoVax Co., Ltd.	Hunan Provincial Center for Disease Control and Prevention, Liaoning Chengda Biotechnology CO., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety in terms of adverse events	Occurrence of solicited AEs of each subject	within 7 days post each vaccination
Primary	Safety in terms of adverse events	Occurrence of non-solicited AEs of each subject	within 30 days post each vaccination
Primary	Safety in terms of SAEs	Occurrence of SAEs of each subject	within 6 months post last vaccination
Primary	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	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
Secondary	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
Secondary	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
Secondary	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