Phase I Clinical Trial of a Candidate PCV13 in Healthy People

Wuhan BravoVax

Status and phase: Enrolling; Phase 1

Conditions: Pneumococcal Infections

Treatments: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05602480

CLI-09-I-2020001

Details and patient eligibility

About

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.

Enrollment: 264 estimated patients

Sex: All

Ages: 6+ weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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264 participants in 10 patient groups

1A

Experimental group

Description:

Subjects received one dose of PCV13 at 18 years of age and above.

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

2A

Experimental group

Description:

Subjects received one dose of PCV13 at 6\~17 years of age.

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

3A

Experimental group

Description:

Subjects received one dose of PCV13 at 2\~5 years of age.

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

4A

Experimental group

Description:

Subjects received two doses of PCV13 at 12\~23 months of age.

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

5A

Experimental group

Description:

Subjects received three doses of PCV13 at 7\~11 months of age.

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

6A

Experimental group

Description:

Subjects received four doses of PCV13 at 3 months of age.

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

6B

Experimental group

Description:

Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

6C

Active Comparator group

Description:

Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

7A

Experimental group

Description:

Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

7B

Active Comparator group

Description:

Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine