Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Dynamics of the Immune Response in Children to the 23-valent Pneumococcal Capsular Polysaccharide Vaccine (Pneumovax)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03460730
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Anthony Scott, KEMRI-Wellcome Trust Collaborative Research Program

Brief Summary:
To explore a further dimension of susceptibility to disease, the investigators tested the hypothesis that natural variation exists in the rapidity of IgG responses following exposure to pneumococcal polysaccharides, and that these differences are sufficiently great to affect susceptibility to and outcome of IPD. The study recruited children aged 24-36 months, who had recovered from IPD, and age-matched healthy controls and vaccinated them with 1 dose of the 23-valent PPV to mimic natural exposure. The investigators collected serum samples after vaccination and analysed the dynamics of anti-polysaccharide antibody responses to several capsular antigens.

Condition or disease Intervention/treatment Phase
Pneumonia, Pneumococcal Biological: Pneumovax Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Dynamics of the Immune Response in Children to the 23-valent Pneumococcal Capsular Polysaccharide Vaccine (Pneumovax)
Actual Study Start Date : November 4, 2004
Actual Primary Completion Date : July 3, 2006
Actual Study Completion Date : July 3, 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immunised children
Single 0.5 ml sub-cutaneous dose of 23-valent pneumococcal polysaccharide vaccine (Pneumovax)
Biological: Pneumovax
23-valent pneumococcal polysaccharide vaccine




Primary Outcome Measures :
  1. Study 1 - Pilot study: Time to reach the "response threshold" in IgG concentration to serotypes 1, 6B, 14, 19F and 23F [ Time Frame: day 0, 5, 7, 9, 11, 14 and 28 days after vaccination ]
    Individual response curves for each subject and each antigen will be drawn and the pre-vaccination and the maximum concentrations will be defined. The outcome variable "response threshold" is defined as the time in days to make at least one half of the total IgG response. (The total IgG response is the difference between the maximum observed antibody concentration and the starting concentration). This is a single outcome measure derived as a composite from the different antibody concentrations across the span of the study.

  2. Study 2 Proportional IgG Response to serotypes 1, 6B, 14, 19F and 23F within 7 days [ Time Frame: day 0, day 7, day 11 after vaccination ]
    The proportion of the maximal antibody response (on day 11) that has taken place by day 7 will be estimated as follows: proportional rise = C7-C0/C11-C0, where C0, C7 and C11 represent concentrations on day 0, 7 and 11 respectively.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   24 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Pilot study (study 1)

Inclusion Criteria:

A convenience sample of 40 children aged 24-36 248 months was selected from among healthy siblings of patients admitted to the 249 paediatric ward in Kilifi District Hospital and who lived within 30km of the hospital.

Exclusion Criteria:

Subjects were excluded if they had any of the following:

  1. a history of invasive pneumococcal infection including pneumonia, bacteremia, or meningitis documented at the hospital;
  2. a history of previous vaccination with any pneumococcal vaccine;
  3. receipt of any other vaccine in the last 2 months;
  4. admission to hospital in the last 3months;
  5. malnutrition, as defined by a weight-for-age z-score of <-3.0; or
  6. HIV infection.

Study 2

Inclusion Criteria:

Thirty children who had recovered from an episode of invasive pneumococcal disease (the Prior IPD group) were compared with 30 healthy age-matched children who had not had IPD (the Healthy Control group). Controls were selected at random from a cohort study investigating environmental and genetic susceptibility to invasive pneumococcal disease in Kilifi District Hospital. An episode of IPD was defined as admission to hospital with cultures of blood, cerebrospinal fluid (CSF) or pleural aspirate that grew S. pneumoniae.

Exclusion Criteria:

Same as for Study 1 (pilot) except that for the Prior IPD group, history of invasive pneumococcal disease was an inclusion criterion.


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): NCT03460730


Locations
Layout table for location information
Kenya
Kilifi District Hospital
Kilifi, Coast, Kenya
Sponsors and Collaborators
KEMRI-Wellcome Trust Collaborative Research Program
Investigators
Layout table for investigator information
Principal Investigator: Anthony Scott, MD, PhD KEMRI-Wellcome Trust Collaborative Research Program

Layout table for additonal information
Responsible Party: Anthony Scott, Prof Anthony Scott, KEMRI-Wellcome Trust Collaborative Research Program
ClinicalTrials.gov Identifier: NCT03460730    
Other Study ID Numbers: KEMRI_CT_2018\0022
SSC 613 ( Other Identifier: KEMRI )
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthony Scott, KEMRI-Wellcome Trust Collaborative Research Program:
Invasive Pneumococcal Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia, Pneumococcal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs