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Phase I Clinical Trial of a Candidate PCV13 in Healthy People

Primary Purpose

Pneumococcal Infections

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
Sponsored by
Wuhan BravoVax Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections focused on measuring Pneumonia, Pneumococcal

Eligibility Criteria

6 Weeks - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Xiangtan Maternal and Child Health HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

1A

2A

3A

4A

5A

6A

6B

6C

7A

7B

Arm Description

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Safety in terms of adverse reactions
Occurrence of AEs on vaccination site (local) and non-vaccination site (systemic) of each subject
Safety in terms of adverse events
Occurrence of solicited AEs of each subject
Safety in terms of adverse events
Occurrence of non-solicited AEs of each subject
Safety in terms of SAEs
Occurrence of SAEs of each subject
Safety in terms of laboratory-based AEs
Occurrence of laboratory-based AEs in subjects of 2 years old and above(Arm 1A-3A)

Secondary Outcome Measures

Immunogencity in terms of seropositivity rates by ELISA
Seropositivity rates of serotype-specific pneumococcal IgG antibody in subjects of each age group
Immunogencity in terms of GMC by ELISA
GMC of serotype-specific pneumococcal IgG antibody in subjects of each age group
Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL
Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL
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

Full Information

First Posted
October 24, 2022
Last Updated
November 11, 2022
Sponsor
Wuhan BravoVax Co., Ltd.
Collaborators
Hunan Provincial Center for Disease Control and Prevention, Liaoning Chengda Biotechnology CO., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT05602480
Brief Title
Phase I Clinical Trial of a Candidate PCV13 in Healthy People
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan BravoVax Co., Ltd.
Collaborators
Hunan Provincial Center for Disease Control and Prevention, Liaoning Chengda Biotechnology CO., LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
Keywords
Pneumonia, Pneumococcal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
One arm, open label in subjects aged 3 months and above; Randomized, blinded and active comparator in subjects aged 2 months.
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1A
Arm Type
Experimental
Arm Description
Subjects received one dose of PCV13 at 18 years of age and above.
Arm Title
2A
Arm Type
Experimental
Arm Description
Subjects received one dose of PCV13 at 6~17 years of age.
Arm Title
3A
Arm Type
Experimental
Arm Description
Subjects received one dose of PCV13 at 2~5 years of age.
Arm Title
4A
Arm Type
Experimental
Arm Description
Subjects received two doses of PCV13 at 12~23 months of age.
Arm Title
5A
Arm Type
Experimental
Arm Description
Subjects received three doses of PCV13 at 7~11 months of age.
Arm Title
6A
Arm Type
Experimental
Arm Description
Subjects received four doses of PCV13 at 3 months of age.
Arm Title
6B
Arm Type
Experimental
Arm Description
Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).
Arm Title
6C
Arm Type
Active Comparator
Arm Description
Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).
Arm Title
7A
Arm Type
Experimental
Arm Description
Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).
Arm Title
7B
Arm Type
Active Comparator
Arm Description
Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).
Intervention Type
Biological
Intervention Name(s)
13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
Other Intervention Name(s)
PCV13
Intervention Description
0.5mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
Other Intervention Name(s)
Prevnar 13
Intervention Description
0.5mL, Intramuscular
Primary Outcome Measure Information:
Title
Safety in terms of adverse reactions
Description
Occurrence of AEs on vaccination site (local) and non-vaccination site (systemic) of each subject
Time Frame
within 30 minutes post each vaccination
Title
Safety in terms of adverse events
Description
Occurrence of solicited AEs of each subject
Time Frame
within 7 days post each vaccination
Title
Safety in terms of adverse events
Description
Occurrence of non-solicited AEs of each subject
Time Frame
within 30 days post each vaccination
Title
Safety in terms of SAEs
Description
Occurrence of SAEs of each subject
Time Frame
within 6 months post last vaccination
Title
Safety in terms of laboratory-based AEs
Description
Occurrence of laboratory-based AEs in subjects of 2 years old and above(Arm 1A-3A)
Time Frame
within 4 days post each vaccination
Secondary Outcome Measure Information:
Title
Immunogencity in terms of seropositivity rates by ELISA
Description
Seropositivity rates of serotype-specific pneumococcal IgG antibody in subjects of each age group
Time Frame
30 days post basic vaccination
Title
Immunogencity in terms of GMC by ELISA
Description
GMC of serotype-specific pneumococcal IgG antibody in subjects of each age group
Time Frame
30 days post basic vaccination
Title
Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL
Description
Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL
Time Frame
30 days post basic vaccination
Title
Immunogencity Comparison with control vaccine group
Description
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
Time Frame
30 days post basic vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Long Xu, Ph.D.
Phone
+86 27 8798 8585 ext. 8251
Email
ct@bravovax.com
Facility Information:
Facility Name
Xiangtan Maternal and Child Health Hospital
City
Xiangtan
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Huang

12. IPD Sharing Statement

Learn more about this trial

Phase I Clinical Trial of a Candidate PCV13 in Healthy People

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