Antibody Production in Immune Disorders

October 14, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Evaluation of Immune Response to Vaccines in Primary Immune Disorders

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Individuals being evaluated by NIH investigators for known or suspected primary immune disorders.

Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for at least 21 days prior to receipt of each vaccine and for the duration of study participation.

EXCLUSION CRITERIA:

Documented HIV infection.

Active malignancy.

Immunosuppressive therapy, other than steroids.

Symptomatic cardiac disease or ongoing treatment for it.

Pregnant or lactating women (due to restrictions on use of vaccines).

Surgery during the two weeks prior to entry.

Serious, ongoing, or uncontrolled infections.

Platelet count less than 40,000/microL or other coagulation disorder.

Any other major illness that, in the investigator's judgment, may substantially increase the risk associated with the patient's participation in this study.

History of previous systemic reaction to the particular vaccine product being considered for administration.

For RabAvert, persons known to be sensitive to:

  • Processed bovine gelatin
  • Chicken protein
  • Neomycin
  • Chlortetrycyline
  • Amphotericin B

For Prevnar, persons with know or possible latex sensitivity.

The effects of the vaccines on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for at least 21 days prior to each vaccine and for the duration of study participation. Females of child bearing age will have a pregnancy test prior to each vaccination. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform study staff and her primary care physician immediately.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pneumococcal Vaccine
To determine the function of T and B cells in vivo using Pneumococcal vaccine immunization in patients with known or suspected immune disorders.
Biological: Pneumovax
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.
Active Comparator: Rabies Vaccine
To determine the function of T and B cells in vivo using Rabies vaccine immunization 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2002

Primary Completion (Actual)

May 22, 2017

Study Completion (Actual)

October 14, 2021

Study Registration Dates

First Submitted

September 7, 2001

First Submitted That Met QC Criteria

September 7, 2001

First Posted (Estimate)

September 10, 2001

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010226
  • 01-I-0226

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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