Protocol Number: 01-I-0226

Title:

Evaluation of Immune Response to Vaccines in Primary Immune Disorders

Number:

01-I-0226

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

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Individuals being evaluated by NIH investigators for known or suspected primary immune disorders or undergoing immune reconstitution in separate NIH protocols for the treatment of their primary immune disorder (including bone marrow transplantation or gene therapy).

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/micro L 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.

Special Instructions:

Currently Not Provided

Keywords:

Immunization

Antibody

Immunodeficiency

Pneumococcal Vaccines

Immune Disorder

Immune Reconstitution

Rabies Vaccine

Diphtheria and Tetanus Vaccines

Pneumococcal Vaccine

Recruitment Keyword(s):

Primary Immune Disorders

Immunodeficiency

Condition(s):

Immunologic Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Human rabies prevention--United States, 1999. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 1999 Jan 8;48(RR-1):1-21. Erratum in: MMWR Morb Mortal Wkly Rep 1999 Jan 15;48(1):16. MMWR Morb Mortal Wkly Rep 2000 Aug 18;49(32):737.

Slatter MA, Bhattacharya A, Flood TJ, Spickett GP, Cant AJ, Abinun M, Gennery AR. Polysaccharide antibody responses are impaired post bone marrow transplantation for severe combined immunodeficiency, but not other primary immunodeficiencies. Bone Marrow Transplant. 2003 Jul;32(2):225-9.

Brinkman DM, Jol-van der Zijde CM, ten Dam MM, Vossen JM, Osterhaus AD, Kroon FP, van Tol MJ. Abstract Vaccination with rabies to study the humoral and cellular immune response to a T-cell dependent neoantigen in man. J Clin Immunol. 2003 Nov;23(6):528-38.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/20/2008