Antibody Production in Immune Disorders

NCT00023504 | Terminated Phase 4 FDA Drug

• 2 other identifiers: 01022601-I-0226
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Immune Deficiency

Keywords

Antibody; Vaccination

Outcome Measures

Primary Outcomes (1)

• Post vaccine antibody level

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

  28 days

Study Arms (2)

Pneumococcal Vaccine

ACTIVE COMPARATOR

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; Biological: Prevnar; Biological: Tetanus diphtheria toxoid

Rabies Vaccine

ACTIVE COMPARATOR

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

Interventions

Pneumovax BIOLOGICAL

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

Pneumococcal Vaccine

Rabavert BIOLOGICAL

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

Rabies Vaccine

Prevnar BIOLOGICAL

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

Pneumococcal Vaccine

Tetanus diphtheria toxoid BIOLOGICAL

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

Pneumococcal Vaccine

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

Pneumococcal Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Gulbu Uzel, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2001
• First Posted: September 10, 2001
• Study Start: June 13, 2002
• Primary Completion: May 22, 2017
• Study Completion: October 14, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

US (1)