Phase I Clinical Trial of a Candidate PCV13 in Healthy People

NCT05602480 | Unknown Phase 1

• 1 other identifier: CLI-09-I-2020001
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Infections

Keywords

Pneumonia, Pneumococcal

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Immunogencity in terms of seropositivity rates by ELISA

  30 days post basic vaccination

• Immunogencity in terms of GMC by ELISA

  30 days post basic vaccination

• Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL

  30 days post basic vaccination

• Immunogencity Comparison with control vaccine group

  30 days post basic vaccination

Study Arms (10)

1A

EXPERIMENTAL

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

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

2A

EXPERIMENTAL

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

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

3A

EXPERIMENTAL

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

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

4A

EXPERIMENTAL

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

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

5A

EXPERIMENTAL

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

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

6A

EXPERIMENTAL

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

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

6B

EXPERIMENTAL

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

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

6C

ACTIVE COMPARATOR

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

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

7A

EXPERIMENTAL

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

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

7B

ACTIVE COMPARATOR

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

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Interventions

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine BIOLOGICAL

0.5mL, Intramuscular

Also known as: PCV13

1A; 2A; 3A; 4A; 5A; 6A; 6B; 7A

Eligibility Criteria

• Age: 6 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Xiangtan Maternal and Child Health Hospital

Xiangtan, Hunan, China

RECRUITING

MeSH Terms

Conditions

Pneumococcal Infections; Pneumonia, Pneumococcal

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Long Xu, Ph.D.

CONTACT

+86 27 8798 8585 ext. 8251; ct@bravovax.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One arm, open label in subjects aged 3 months and above; Randomized, blinded and active comparator in subjects aged 2 months.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 2, 2022
• Study Start: November 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

CN (1)