Antibody Production in Immune Disorders

Phase 4

Terminated

• Conditions: Primary Immune Deficiency
• Interventions: Biological: Pneumovax; Biological: Rabavert; Biological: Prevnar; Biological: Tetanus diphtheria toxoid

• Registration Number: NCT00023504
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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

Detailed Description

The purpose of this study is to evaluate immune responses to vaccines in subjects (both children and adults) with known or suspected primary immune disorders. We intend to characterize immune responsiveness to standard, well characterized antigens (vaccines) in subjects with primary immune disorders, and/or in subjects who have received treatments to correct their primary immune disorders. This will be an open label, prospective study investigating the functional status of the adaptive immune system. Up to 50 subjects may be enrolled. It is anticipated that subjects will be referred by any investigators at NIH studying inherited disorders of the immune system under their own protocols.

After giving standard vaccines, we will test specific antibody. The vaccines include licensed and universally mandated diphtheria and tetanus toxoid, two licensed pneumococcal vaccine formulations recommended for protection of children from pneumonia, and rabies vaccine licensed in 1997 (not the formerly available reaction-prone formulation). We will obtain peripheral blood samples from subjects before vaccination and at a specific time intervals after vaccination. Measurement of specific antibody titers will be conducted by the immunology laboratory at the Department of Laboratory Medicin at the NIH. Subjects may be offered one or more of the vaccines based on available information about their exposure history and their immune status, and the vaccines may be offered sequentially or in combination to shorten study time.

While the vaccines used here are often medically indicated and given outside of research protocols both to provide protection and to assess immune responses, the investigators have elected to use a protocol for the following reasons:

* Enhancement of subject understanding of the use of vaccines for in vivo assessment of immune responses.

* Emphasis on the importance of obtaining pre- and post-immunization blood samples to monitor how well the body's immune system is working.

* Administration of rabies vaccine to subjects who would not ordinarily need it.

* Recognition that vaccine side effects have been widely publicized and may be of concern to potential enrollees.

Study Timeline

• Study First Submitted: 2001-09-07
• Study First Submitted QC: 2001-09-07
• Study First Posted: 2001-09-10
• Study Start: 2002-06-13
• Primary Completion: 2017-05-22
• Status Verified: 2021-10
• Study Completion: 2021-10-14
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Pneumococcal Vaccine	Pneumovax	To determine the function of T and B cells in vivo using Pneumococcal vaccine immunization in patients with known or suspected immune disorders.
Pneumococcal Vaccine	Prevnar	To determine the function of T and B cells in vivo using Pneumococcal vaccine immunization in patients with known or suspected immune disorders.
Pneumococcal Vaccine	Tetanus diphtheria toxoid	To determine the function of T and B cells in vivo using Pneumococcal vaccine immunization in patients with known or suspected immune disorders.
Rabies Vaccine	Rabavert	To determine the function of T and B cells in vivo using Rabies vaccine immunization in patients with known or suspected immune disorders.

Primary Outcome Measures

Name	Time	Method
Post vaccine antibody level	28 days	To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States