GAS Epi Study to Measure Age-Related Antibody Titers to J8 Vaccine

Streptococcus Group A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264784
• Other study ID #: 05-0081
• Status: Completed
• Phase: N/A
• First received: December 9, 2005
• Last updated: December 19, 2007
• Start date: December 2005
• Est. completion date: May 2006

Study information

• Verified date: October 2007
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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, 7.5 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Individuals of any age who are inpatients or outpatients at Colonial War Memorial Hospital and provide informed consent.

Exclusion Criteria:

Patients will be excluded from participating in the study if they have a history of acute rheumatic fever, acute post streptococcal glomerulonephritis, rheumatic heart disease, or invasive Group A Streptococcus disease or have had a sore throat or skin sores within the past 14 days as determined by self report, or if they have a current febrile illness (>38.0 degrees Celsius).

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Streptococcus Group A

Locations

Country	Name	City	State
Fiji	Colonial War Memorial Hospital	Suva

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Fiji,