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

NCT04481243 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20-004356
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Immunoglobulin G (IgG) Antibodies

  Serological response. Blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/mL

  6 months post vaccination

Study Arms (1)

Pneumovax 23

EXPERIMENTAL

Type 1 Diabetes subjects will receive Pneumovax 23-pneumococcal polysaccharide (PPSV23)

Biological: Pneumovax 23- pneumococcal polysaccharide; Procedure: Blood draw

Interventions

Pneumovax 23- pneumococcal polysaccharide BIOLOGICAL

PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously.

Also known as: PPSV23

Pneumovax 23

Blood draw PROCEDURE

6 ml blood draw at baseline and 6 months post immunization

Pneumovax 23

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Ender E, Joshi A, Snyder M, Kumar S, Hentz R, Creo A. Seroconversion following PPSV23 vaccination in children with type 1 diabetes mellitus. Vaccine. 2025 Jan 25;45:126592. doi: 10.1016/j.vaccine.2024.126592. Epub 2024 Dec 11.

  PMID: 39667114 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

23-valent pneumococcal capsular polysaccharide vaccine; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Ana L. Creo, M.D.
• Organization: Mayo Clinic

Creo.Ana@mayo.edu

507-284-3300

Study Officials

• Ana Creo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Will study immunological response to vaccination

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 22, 2020
• Study Start: April 30, 2021
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: November 8, 2023
• Results First Posted: November 8, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)