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CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study

Primary Purpose

Invasive Pneumococcal Disease, Protection Against, Streptococcus Pneumoniae Infection

Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
PCV13
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Invasive Pneumococcal Disease, Protection Against

Eligibility Criteria

2 Months - 2 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy infant born at ≥37 weeks' gestation
  • Age 2 months (+ up to 14 days) at time of first study visit
  • Parent/guardian or legally authorized representative has given informed consent for their child's participation.

Exclusion Criteria:

  • Already received any routine 2-month immunizations
  • Previous laboratory confirmed pneumococcal disease
  • Previous receipt of any pneumococcal vaccine
  • Confirmed or suspected immunodeficiency, including but not limited to:

    • Congenital or acquired asplenia, or splenic dysfunction
    • B-cell (humoral), T-cell mediated, complement, or phagocytic function deficiency
    • HIV infection
    • Hematopoietic stem cell transplant (recipient)
    • Malignant neoplasms, including leukemia and lymphoma
    • Nephrotic syndrome
    • Solid organ or islet transplant (candidate or recipient)
  • A family history of congenital or hereditary immunodeficiency
  • Use of systemic immunosuppressive medication, including long-term corticosteroids, chemotherapy, radiation therapy, post-organ transplant therapy, intravenous immunoglobulin and/or specific monoclonal antibody therapy
  • Bleeding disorder or thrombocytopenia, that contraindicates intramuscular (IM) injection and/or blood collection or taking any anti-platelet or anti-coagulant medications
  • Any contraindication to vaccination as per the NACI Canadian Immunization Guide (https://www.canada.ca/en/public-health/services/canadian-immunization-guide.html, accessed 16 September 2017). Note these factors will be considered an exclusion if known at the time of trial enrollment, but specific screening and/or testing for these conditions will not be part of the trial):

    • Anaphylaxis to any vaccine or vaccine component being given during the trial, including PCV13 and other routine vaccines
    • Any other previous adverse event which in the opinion of the Investigator is a contraindication to any vaccine being given during the trial
    • Congenital malformation of the gastrointestinal tract or previous intussusception (rotavirus vaccine contraindicated)
    • Active, untreated tuberculosis (MMR, varicella, MMRV contraindicated)
  • Additional factors resulting in increased risk of pneumococcal disease as per the National Advisory Committee on Immunization (NACI) Canadian Immunization Guide (16 September 2017)

    • Chronic cerebrospinal fluid (CSF) leak
    • Chronic neurologic condition that may impair clearance of oral secretions
    • Cochlear implants, including children who are due to receive implants
    • Chronic heart disease
    • Diabetes mellitus
    • Chronic kidney disease
    • Chronic liver disease, including hepatic cirrhosis due to any cause
    • Chronic lung disease
    • Sickle cell disease or other hemoglobinopathy
  • Mother received pneumococcal vaccine during pregnancy
  • Mother using systemic immunosuppressive medication during pregnancy, including intravenous immunoglobulin and/or specific monoclonal antibody therapy
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Temporary exclusion criteria:

- If an infant has a temperature ≥ 38°C, then vaccination (and blood and fecal sampling if due to occur at the same visit) will be postponed until resolution of fever.

Sites / Locations

  • Vaccine Evaluation Center (University of BC at Children's Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1: 3 doses of PCV13

Group 2: 2 doses of PCV13

Arm Description

PCV13, 0.5ml intramuscular at 2, 4 and 12 months of age

PCV13, 0.5ml intramuscular at 2 and 12 months of age

Outcomes

Primary Outcome Measures

Immunogenicity of PCV13 post-booster
Serotype-specific pneumococcal IgG concentration at 1 month post-booster dose

Secondary Outcome Measures

Immunogenicity of PCV13 post-priming
Serotype-specific pneumococcal IgG concentration post-priming dose(s)
Proportion of protected infants post-booster
Proportion of infants achieving serotype-specific pneumococcal IgG concentration ≥0.35 µg/ml post-booster dose
Proportion of protected infants post-priming
Proportion of infants achieving serotype-specific pneumococcal IgG concentration ≥0.35 µg/ml post-priming dose(s)
Incidence of adverse events following PCV13
Adverse events following immunization after doses of PCV13

Full Information

First Posted
December 15, 2017
Last Updated
May 17, 2022
Sponsor
University of British Columbia
Collaborators
Canadian Immunization Research Network, Alberta Children's Hospital, Université de Montréal, IWK Health Centre, University of Calgary, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03384589
Brief Title
CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study
Official Title
A Randomized Controlled Trial to Compare a 1-dose vs. 2-dose Priming Schedule of 13-valent Pneumococcal Conjugate Vaccine in Canadian Infants; a Canadian Immunization Research Network (CIRN) Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Immunization Research Network, Alberta Children's Hospital, Université de Montréal, IWK Health Centre, University of Calgary, Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
This study is assessing if a reduced dosing schedule (1+1) of the 13-valent pneumococcal conjugate vaccine (PCV13) is non-inferior to the currently used schedule used in most of Canada.The vaccine is currently usually given as 3 doses at 2, 4 and 12 months of age. This study aims to find out if it is possible to achieve the same protection using just 2 doses, at 2 and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Pneumococcal Disease, Protection Against, Streptococcus Pneumoniae Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Group 1: 3 doses of PCV13 (2, 4, 12 months), 2+1 Group 2: 2 doses of PCV13 (2, 12 months), 1+1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: 3 doses of PCV13
Arm Type
Active Comparator
Arm Description
PCV13, 0.5ml intramuscular at 2, 4 and 12 months of age
Arm Title
Group 2: 2 doses of PCV13
Arm Type
Experimental
Arm Description
PCV13, 0.5ml intramuscular at 2 and 12 months of age
Intervention Type
Biological
Intervention Name(s)
PCV13
Other Intervention Name(s)
Prevnar 13
Intervention Description
Vaccine against pneumococcal disease
Primary Outcome Measure Information:
Title
Immunogenicity of PCV13 post-booster
Description
Serotype-specific pneumococcal IgG concentration at 1 month post-booster dose
Time Frame
13 months of age
Secondary Outcome Measure Information:
Title
Immunogenicity of PCV13 post-priming
Description
Serotype-specific pneumococcal IgG concentration post-priming dose(s)
Time Frame
5 months of age
Title
Proportion of protected infants post-booster
Description
Proportion of infants achieving serotype-specific pneumococcal IgG concentration ≥0.35 µg/ml post-booster dose
Time Frame
13 months of age
Title
Proportion of protected infants post-priming
Description
Proportion of infants achieving serotype-specific pneumococcal IgG concentration ≥0.35 µg/ml post-priming dose(s)
Time Frame
5 months of age
Title
Incidence of adverse events following PCV13
Description
Adverse events following immunization after doses of PCV13
Time Frame
2, 4 and 12 months of age
Other Pre-specified Outcome Measures:
Title
Storage of fecal samples for analysis of the influence of the infant microbiome on vaccine responses
Description
Collection of fecal samples at time of vaccination
Time Frame
2, 4, 6 and 12 months of age
Title
Immunogenicity of PCV13 after maternal pertussis immunization
Description
Comparison of primary and secondary endpoints in infants born to mothers who received pertussis immunization in pregnancy vs. those that did not
Time Frame
5 and 13 months
Title
Rate of nasopharyngeal colonization after vaccination with S. pneumoniae
Description
Comparison of nasopharyngeal colonization rate with S. pneumoniae in Group 1 vs. Group 2
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy infant born at ≥37 weeks' gestation Age 2 months (+ up to 14 days) at time of first study visit Parent/guardian or legally authorized representative has given informed consent for their child's participation. Exclusion Criteria: Already received any routine 2-month immunizations Previous laboratory confirmed pneumococcal disease Previous receipt of any pneumococcal vaccine Confirmed or suspected immunodeficiency, including but not limited to: Congenital or acquired asplenia, or splenic dysfunction B-cell (humoral), T-cell mediated, complement, or phagocytic function deficiency HIV infection Hematopoietic stem cell transplant (recipient) Malignant neoplasms, including leukemia and lymphoma Nephrotic syndrome Solid organ or islet transplant (candidate or recipient) A family history of congenital or hereditary immunodeficiency Use of systemic immunosuppressive medication, including long-term corticosteroids, chemotherapy, radiation therapy, post-organ transplant therapy, intravenous immunoglobulin and/or specific monoclonal antibody therapy Bleeding disorder or thrombocytopenia, that contraindicates intramuscular (IM) injection and/or blood collection or taking any anti-platelet or anti-coagulant medications Any contraindication to vaccination as per the NACI Canadian Immunization Guide (https://www.canada.ca/en/public-health/services/canadian-immunization-guide.html, accessed 16 September 2017). Note these factors will be considered an exclusion if known at the time of trial enrollment, but specific screening and/or testing for these conditions will not be part of the trial): Anaphylaxis to any vaccine or vaccine component being given during the trial, including PCV13 and other routine vaccines Any other previous adverse event which in the opinion of the Investigator is a contraindication to any vaccine being given during the trial Congenital malformation of the gastrointestinal tract or previous intussusception (rotavirus vaccine contraindicated) Active, untreated tuberculosis (MMR, varicella, MMRV contraindicated) Additional factors resulting in increased risk of pneumococcal disease as per the National Advisory Committee on Immunization (NACI) Canadian Immunization Guide (16 September 2017) Chronic cerebrospinal fluid (CSF) leak Chronic neurologic condition that may impair clearance of oral secretions Cochlear implants, including children who are due to receive implants Chronic heart disease Diabetes mellitus Chronic kidney disease Chronic liver disease, including hepatic cirrhosis due to any cause Chronic lung disease Sickle cell disease or other hemoglobinopathy Mother received pneumococcal vaccine during pregnancy Mother using systemic immunosuppressive medication during pregnancy, including intravenous immunoglobulin and/or specific monoclonal antibody therapy Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. Temporary exclusion criteria: - If an infant has a temperature ≥ 38°C, then vaccination (and blood and fecal sampling if due to occur at the same visit) will be postponed until resolution of fever.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish Sadarangani, MD
Organizational Affiliation
UBC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vaccine Evaluation Center (University of BC at Children's Hospital)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study

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