drugset / Trial / NCT00023504

Antibody Production in Immune Disorders

NCT00023504

Non-randomizedSequentialOpen-labelTreatment

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

Timeline

Start
2002-06-13
Primary completion
2017-05-22
Completion
2021-10-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pneumovax 23 Vaccine
Comparator Prevnar 13 Vaccine
Comparator Rabies vaccine Vaccine
Comparator Tetanus diphtheria toxoid Vaccine