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

NCT03460730 | Completed Phase 1 DMC

• 2 other identifiers: KEMRI_CT_2018\0022SSC 613
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Pneumococcal

Keywords

Invasive Pneumococcal Disease

Outcome Measures

Primary Outcomes (2)

• Study 1 - Pilot study: Time to reach the "response threshold" in IgG concentration to serotypes 1, 6B, 14, 19F and 23F

  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.

  day 0, 5, 7, 9, 11, 14 and 28 days after vaccination

• Study 2 Proportional IgG Response to serotypes 1, 6B, 14, 19F and 23F within 7 days

  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.

  day 0, day 7, day 11 after vaccination

Study Arms (1)

Immunised children

EXPERIMENTAL

Single 0.5 ml sub-cutaneous dose of 23-valent pneumococcal polysaccharide vaccine (Pneumovax)

Biological: Pneumovax

Interventions

Pneumovax BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Immunised children

Eligibility Criteria

• Age: 24 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Subjects were excluded if they had any of the following:
• a history of invasive pneumococcal infection including pneumonia, bacteremia, or meningitis documented at the hospital;
• a history of previous vaccination with any pneumococcal vaccine;
• receipt of any other vaccine in the last 2 months;
• admission to hospital in the last 3months;
• malnutrition, as defined by a weight-for-age z-score of \<-3.0; or
• HIV infection.
• Study 2
• 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.

Sponsors & Collaborators

• KEMRI-Wellcome Trust Collaborative Research Program: lead

Study Sites (1)

Kilifi District Hospital

Kilifi, Coast, Kenya

Location

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Anthony Scott, MD, PhD

  KEMRI-Wellcome Trust Collaborative Research Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Anthony Scott

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 9, 2018
• Study Start: November 4, 2004
• Primary Completion: July 3, 2006
• Study Completion: July 3, 2006
• Last Updated: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)