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Antibody Production in Immune Disorders

NCT00023504 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-10-15

No results posted yet for this study

Summary

This study will evaluate immune function in people with a known or suspected immune disorder. It will determine participants immune response to vaccines by measuring blood antibody levels after vaccination.

Patients enrolled in a NIH protocol involving immune reconstitution (bone marrow transplantation or gene therapy) for a known or suspected primary immune disorder may be eligible for this study.

Participants may be asked to have more than one vaccine, based on their age, use of IVIG, past immunization history and underlying immune problem. The possible vaccinations include:

Rabies vaccine

Diphtheria and tetanus booster

23 valent pneumococcal polysaccharide vaccine

Pneumococcal 7-valent conjugate vaccine

The diphtheria, tetanus, pneumococcus and rabies vaccines are approved by the Food and Drug Administration (FDA) and used routinely to protect against disease.

Study participants will have a blood sample drawn before vaccination. The number of additional samples collected will vary according to the vaccines administered; 1 for rabies; 1 for tetanus; and 1 to 2 for the pneumococcal vaccines. Each sample will be up to 5 teaspoonfuls. Participation in the study may last up to a year, depending on the blood sampling scheduling

Conditions

  • Primary Immune Deficiency

Interventions

BIOLOGICAL

Pneumovax

To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.

BIOLOGICAL

Rabavert

To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.

BIOLOGICAL

Prevnar

To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.

BIOLOGICAL

Tetanus diphtheria toxoid

To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Gulbu Uzel, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-13
Primary Completion
2017-05-22
Completion
2021-10-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00023504 on ClinicalTrials.gov