CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study

Streptococcus Pneumoniae Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384589
• Other study ID #: H17-02645
• Secondary ID: CIRN23/CT16
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 23, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 2 Months

Eligibility

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.

Related Conditions & MeSH terms

• Invasive Pneumococcal Disease, Protection Against
• Pneumococcal Infections
• Pneumonia, Pneumococcal
• Streptococcus Pneumoniae Infection

Intervention

Biological:
• PCV13
Vaccine against pneumococcal disease

Locations

Country	Name	City	State
Canada	Vaccine Evaluation Center (University of BC at Children's Hospital)	Vancouver	British Columbia

Sponsors (7)

Lead Sponsor	Collaborator
University of British Columbia	Alberta Children's Hospital, Canadian Immunization Research Network, Canadian Institutes of Health Research (CIHR), IWK Health Centre, Université de Montréal, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Storage of fecal samples for analysis of the influence of the infant microbiome on vaccine responses	Collection of fecal samples at time of vaccination	2, 4, 6 and 12 months of age
Other	Immunogenicity of PCV13 after maternal pertussis immunization	Comparison of primary and secondary endpoints in infants born to mothers who received pertussis immunization in pregnancy vs. those that did not	5 and 13 months
Other	Rate of nasopharyngeal colonization after vaccination with S. pneumoniae	Comparison of nasopharyngeal colonization rate with S. pneumoniae in Group 1 vs. Group 2	13 months
Primary	Immunogenicity of PCV13 post-booster	Serotype-specific pneumococcal IgG concentration at 1 month post-booster dose	13 months of age
Secondary	Immunogenicity of PCV13 post-priming	Serotype-specific pneumococcal IgG concentration post-priming dose(s)	5 months of age
Secondary	Proportion of protected infants post-booster	Proportion of infants achieving serotype-specific pneumococcal IgG concentration =0.35 µg/ml post-booster dose	13 months of age
Secondary	Proportion of protected infants post-priming	Proportion of infants achieving serotype-specific pneumococcal IgG concentration =0.35 µg/ml post-priming dose(s)	5 months of age
Secondary	Incidence of adverse events following PCV13	Adverse events following immunization after doses of PCV13	2, 4 and 12 months of age