Pneumococcal Reference Standard
Serum 89 SF is a supply of serum that was collected from people who were vaccinated with the pneumococcal vaccine in the late 1980s. The supply of this serum is running low. The purpose of this study is to give the pneumococcal vaccine to healthy volunteers and take serum blood samples in order to increase the reference serum supply. Study participants will include 250 healthy men and women, ages 18-45. Study procedures will include a physical exam, interviews, blood samples and blood testing. All volunteers will receive the pneumococcal vaccine in the deltoid muscle of the arm. Participants will be involved in the study for approximately 17 weeks.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Stimulation of Donors for Pneumococcal Reference Serum|
- To immunize healthy volunteers with pneumococcal vaccine (Pneumovax 23) to obtain a pool of hyperimmune sera in a quantity sufficient to generate reference sera. [ Time Frame: Duration of study. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Immunize healthy volunteers with pneumococcal vaccine (Pneumovax 23) to obtain a pool of hyperimmune sera in a quantity sufficient to generate reference sera.
Biological: Pneumovax 23
Licensed pneumococcal vaccine (Pneumovax 23).
Serum 89SF is a pooled sera from individuals vaccinated with a 23 valent pneumococcal polysaccharide vaccine collected in the late 1980s. The 89SF standard for ELISA is running low (2-3 year supply) and is insufficient to serve for opsinophagocytosis assay (OPA), which requires large volumes. The objective of this study is to immunize healthy volunteers with licensed polyvalent pneumococcal polysaccharide vaccine (Pneumovax 23) with subsequent blood donation in a quantity sufficient to make reference sera. Two hundred fifty volunteer subjects will be recruited from a total population of up to 600. Study participants will include healthy men and nonpregnant females, ages 18-45. Subjects will undergo physical examination by a licensed clinician, subject interview, and clinical laboratory and serologic testing. Potential subjects must provide written informed consent and meet all eligibility criteria. On Day 0, subjects will receive 0.5 mL pneumococcal vaccine (Pneumovax 23) in the deltoid muscle. Volunteers will remain in the clinic for 30 minutes following immunization for observation of any adverse reactions. Volunteers will return to clinic in 10-35 days following immunization to donate 1 unit (approximately 500 mL) of blood. Volunteers will return for a second donation of 1 unit of blood not less than 8 weeks and not more than 14 weeks following the first donation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479323
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|