A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes

Phase 4

Completed

• Conditions: Type 1 Diabetes
• Interventions: Biological: Pneumovax 23- pneumococcal polysaccharide; Procedure: Blood draw

• Registration Number: NCT04481243
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to determine if children with type 1 diabetes have adequate immune response to PPSV23 vaccination and to assess factors affecting immune response.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-22
• Study Start: 2021-04-30
• Primary Completion: 2023-01-20
• Study Completion: 2023-01-20
• Status Verified: 2023-10
• Results First Submitted: 2023-10-18
• Results First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Results First Posted: 2023-11-08
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Children ages 3-18 years old.
• Clinical diagnosis of Type 1 diabetes.

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Exclusion Criteria

• Newly diagnosed with Type 1 diabetes with in the past month of study date.
• Contraindications to receiving 23 valent pneumococcal vaccines.
• Other conditions associated with compromised immunity and vaccine response.
• Primary or Secondary Immune deficiency.
• Previous receipt of PPSV-23 vaccination.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pneumovax 23	Blood draw	Type 1 Diabetes subjects will receive Pneumovax 23-pneumococcal polysaccharide (PPSV23)
Pneumovax 23	Pneumovax 23- pneumococcal polysaccharide	Type 1 Diabetes subjects will receive Pneumovax 23-pneumococcal polysaccharide (PPSV23)

Primary Outcome Measures

Name	Time	Method
Immunoglobulin G (IgG) Antibodies	6 months post vaccination	Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States