Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00264784
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2005-12-09
Brief Title:
GAS Epi Study to Measure Age-Related Antibody Titers to J8 Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Epidemiology of Group A Streptococcal Infections in Fiji Fiji GrASP - Part 5 Establishing Natural Age-Related Titers of Antibodies to the J8 Group A Streptococcal Epitope in Fiji
Status:
COMPLETED
Status Verified Date:
2007-10
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:
The purpose of this ongoing study Part V is to evaluate the cause distribution control and results of group A streptococcus infections GAS in Fiji Patients of all ages presenting to the Colonial War Memorial Hospital Suva Fiji and patients donating blood to the Colonial War Memorial Hospital Suva Fiji may participate Subject duration is less than one day This study may help to develop a vaccine that will prevent group A streptococcal infections
Detailed Description:
Most group A streptococcus GAS disease occurs in childhood and the premise of this study is that with increasing age there is apparent clinical protection from GAS disease which is due to the acquisition of protective antibodies The study therefore seeks to test the hypothesis that titers of anti-J8 antibodies will increase with increasing age This study is part 5 of a series including Division of Microbiology and Infectious Diseases DMID protocols 05-0082 05-0117 05-0118 and 06-0081 Three hundred patients will be selected in 6 age groups with 50 patients in each group 0-4 years of age 5-14 years of age 15-24 years of age 25-34 years of age 35-49 years of age over 50 years of age Participants will be recruited through the Colonial War Memorial CWM Hospital in Suva Patients in the hospital who are having blood taken for reasons other than GAS disease will be approached and asked to participate in the study These patients will include people who are donating blood to the blood collection service for CWM Hospital In addition it will include patients going to the operating room or patients having blood taken as an outpatient by the pathology blood collection service Once informed consent is obtained blood will be collected in a serum separator blood tube The volume of blood required for age groups will vary 3ml whole blood for those aged 5 years 5 mls for those aged 5-14 years 75 mls for those aged greater than 14 years Participants will be excluded if they have a history of serious GAS disease including acute rheumatic fever acute post streptococcal glomerulonephritis invasive disease or rheumatic heart disease or if they have had a sore throat or skin sores within the past 14 days These participants will be excluded because it is not known if J8 titres may correlate with prior serious GAS diseases or if there is an acute J8 antibody response to recent GAS infection and we are aiming to understand background titres of J8 antibodies in this population In addition these illnesses will affect the value of antistreptolysin O titre ASOT and anti-DNase-B to establish the upper limits of normal values After blood is centrifuged it will be divided Aliquots will be prepared for measurement of ASOT and anti-DNase B titers Further aliquots will be stored in the laboratory and sent to Queensland Institute of Medical Research in batch for measurement of J8 antibodies
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