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CIRN Pnuemococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study

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ClinicalTrials.gov Identifier: NCT03384589
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Canadian Immunization Research Network
Alberta Children's Hospital
Université de Montréal
IWK Health Centre
University of Calgary
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Manish Sadarangani, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Invasive Pneumococcal Disease, Protection Against Streptococcus Pneumoniae Infection Biological: PCV13 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
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
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1: 3 doses of PCV13
PCV13, 0.5ml intramuscular at 2, 4 and 12 months of age
Biological: PCV13
Vaccine against pneumococcal disease
Other Name: Prevnar 13

Experimental: Group 2: 2 doses of PCV13
PCV13, 0.5ml intramuscular at 2 and 12 months of age
Biological: PCV13
Vaccine against pneumococcal disease
Other Name: Prevnar 13




Primary Outcome Measures :
  1. Immunogenicity of PCV13 post-booster [ Time Frame: 13 months of age ]
    Serotype-specific pneumococcal IgG concentration at 1 month post-booster dose


Secondary Outcome Measures :
  1. Immunogenicity of PCV13 post-priming [ Time Frame: 5 months of age ]
    Serotype-specific pneumococcal IgG concentration post-priming dose(s)

  2. Proportion of protected infants post-booster [ Time Frame: 13 months of age ]
    Proportion of infants achieving serotype-specific pneumococcal IgG concentration ≥0.35 µg/ml post-booster dose

  3. Proportion of protected infants post-priming [ Time Frame: 5 months of age ]
    Proportion of infants achieving serotype-specific pneumococcal IgG concentration ≥0.35 µg/ml post-priming dose(s)

  4. Incidence of adverse events following PCV13 [ Time Frame: 2, 4 and 12 months of age ]
    Adverse events following immunization after doses of PCV13


Other Outcome Measures:
  1. Storage of fecal samples for analysis of the influence of the infant microbiome on vaccine responses [ Time Frame: 2, 4, 6 and 12 months of age ]
    Collection of fecal samples at time of vaccination

  2. Immunogenicity of PCV13 after maternal pertussis immunization [ Time Frame: 5 and 13 months ]
    Comparison of primary and secondary endpoints in infants born to mothers who received pertussis immunization in pregnancy vs. those that did not

  3. Rate of nasopharyngeal colonization after vaccination with S. pneumoniae [ Time Frame: 13 months ]
    Comparison of nasopharyngeal colonization rate with S. pneumoniae in Group 1 vs. Group 2



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Ages Eligible for Study:   2 Months to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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 hemoglobinoptahy
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384589


Contacts
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Contact: Manish Sadarangani, MD 604-875-2422 msadarangani@bcchr.ubc.ca
Contact: Cecilia Jankowski 604-875-2422 cjankowski@bcchr.ubc.ca

Locations
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Canada, British Columbia
Vaccine Evaluation Center (University of BC at Children's Hospital) Recruiting
Vancouver, British Columbia, Canada, V5Z 4H4
Contact: Ivor Chee, BScN - CRC    604 875-2187    vecstudies@bcchr.ubc.ca   
Contact: Sarah McCann, BScN - CRC    604 875-2422    vecstudies@bcchr.ubc.ca   
Principal Investigator: Manish Sadarangani, MD         
Sponsors and Collaborators
University of British Columbia
Canadian Immunization Research Network
Alberta Children's Hospital
Université de Montréal
IWK Health Centre
University of Calgary
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Manish Sadarangani, MD UBC

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Responsible Party: Manish Sadarangani, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03384589     History of Changes
Other Study ID Numbers: H17-02645
CIRN23/CT16 ( Other Identifier: UBC )
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Streptococcal Infections
Pneumonia
Pneumococcal Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs