Antibody Production in Immune Disorders

  • STATUS
    Recruiting
  • End date
    Sep 19, 2026
  • participants needed
    50
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
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Updated on 9 December 2020
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Investigator
Lisa A Barnhart, R.N.
Primary Contact
National Institutes of Health Clinical Center, 9000 Rockville Pike (9.7 mi away) Contact
vaccination
igiv
prevnar
rabavert
pneumococcal vaccines

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

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.

Details
Treatment Pneumovax, Rabavert, Prevnar, Tetanus diphtheria toxoid
Clinical Study IdentifierNCT00023504
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on9 December 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 2 yrs?
Gender: Male or Female
Do you have any of these conditions: Primary Immune Deficiency or Disorder of immune system?
Do you have any of these conditions: Primary Immune Deficiency or Disorder of immune system or Primary Immunodeficiency or Primary Immune Deficiencies or Primary Immunodeficiency Disorder...?
Do you have any of these conditions: Disorder of immune system or Primary Immune Deficiencies or Primary Immunodeficiency or Primary Immune Deficiency or Primary Immunodeficiency Disorder...?
Do you have any of these conditions: Primary Immunodeficiency Disorders or Disorder of immune system or Primary Immune Deficiencies or Primary Immunodeficiency or Primary Immune Deficienc...?
Do you have any of these conditions: Primary Immunodeficiency or Primary Immune Deficiencies or Disorder of immune system or Primary Immune Deficiency or Primary Immunodeficiency Disorder...?
Do you have any of these conditions: Primary Immunodeficiency or Primary Immunodeficiency Disorders or Primary Immune Deficiency or Primary Immune Deficiencies or Disorder of immune syste...?
Do you have any of these conditions: Primary Immune Deficiencies or Primary Immunodeficiency Disorders or Primary Immunodeficiency or Primary Immune Deficiency or Disorder of immune syste...?
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
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