Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479323
Status:
COMPLETED
Last Update Posted:
2016-12-26
First Post:
2007-05-24
Brief Title:
Pneumococcal Reference Standard
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Stimulation of Donors for Pneumococcal Reference Serum
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None