Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128219
Status:
COMPLETED
Last Update Posted:
2015-01-27
First Post:
2005-08-05
Brief Title:
Prevention of GBS Colonization Via Immunity
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Double-Blinded Comparative Clinical Trial for a Group B Streptococcus Serotype III-Tetanus Toxoid GBS III-TT Vaccine to Prevent Vaginal Acquisition of GBS Type III
Status:
COMPLETED
Status Verified Date:
2009-08
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 group B streptococcus GBS vaccine study is being done to see if a single vaccination with a GBS type III vaccine can stop women from getting GBS type III bacteria in the vagina Approximately 600 women ages 18-40 will be enrolled from the clinical sites participating in this study Participants will be non-pregnant sexually active sex with a male at least once in the last 4 months and GBS negative in the vagina or rectum at the screening visit Participants will be randomly assigned to receive the experimental GBS type III vaccine or a licensed vaccine containing Tetanus and Diphtheria Toxoids Td Participants will be followed at one month 2 months and every other month thereafter following vaccination for vaginal and rectal swab collection and a blood draw for 1½ years or a total of 10 post vaccination visits
Detailed Description:
Vaginal colonization is the single most important risk factor for transmission of group B Streptococcus GBS from mothers to neonates resulting in neonatal sepsis andor meningitis The long-term goal of this study is to determine whether vaccine-induced serum antibody to type III GBS will be sufficient to prevent vaginal acquisition of type III GBS This study is linked to Division of Microbiology and Infectious Diseases protocol 04-018 It is a randomized double-blinded comparative clinical trial among young 18-40 years old non-pregnant sexually active women who are not currently colonized vaginally or rectally with type III GBS it will be conducted to evaluate the efficacy of a GBS type III-TT vaccine for prevention of type III GBS vaginal acquisition The observation period for each patient will be 18 months following vaccination The specific objectives are enroll 600 women previously screened within last 14 days in a GBS Screening Protocol identified as GBS type III negative vaginally and rectally vaccinate 600 women randomized to a 11 ratio with 50 micrograms of type III GBS polysaccharide conjugated to tetanus toxoid GBS III-TT or licensed vaccine containing Tetanus and Diphtheria Toxoids adsorbed for adult use Td measure reactogenicity by subject report in a 7-day symptom diary and by 1-2 day follow-up telephone call evaluate women at 1 2 4 6 8 10 12 14 16 and 18 months for serum antibody response Blood will be obtained at each of these clinic follow-up visits and serum will be used to compare type III GBS specific antibody levels at baseline and follow-up assess vaginal and rectal acquisition by GBS at months 1 2 4 6 8 10 12 14 16 and 18 months using specimens obtained at the clinic visits compare women receiving GBS III-TT vaccine to women receiving Td vaccine with respect to the time to first vaginal culture positive for type III GBS assess the relationship between person-level covariates including features of the decrease of type III GBS antibody levels over time and the time to first vaginal culture positive for type III GBS and assess the effect of vaginal colonization by hydrogen peroxide H2O2-producing Lactobacillus sexual activity antibiotic usage rectal colonization with GBS and demographic features as risk factors for acquisition of type III GBS independent of serum antibody levels The primary study endpoint will be the time to the first vaginal swab that is type III GBS culture positive with all previous cultures negative for type III GBS not just the immediately preceding culture The secondary endpoints include the proportion of vaginal swabs that are type III GBS culture positive the proportion of subjects whose vaginal cultures are type III GBS culture negative throughout the study the frequency of vaginal colonization with GBS serotypes Ia Ib II and V the measurement of serum immunoglobulin IgG antibody levels to type III GBS at 1 2 4 6 8 10 12 14 16 and 18 months following vaccination the measurement of post-vaccination antibody levels to type III GBS stratified by pre-vaccination levels of native antibody the frequency of local and systemic symptoms attributable to vaccination and the density of type III GBS cultured from vaginal swabs at culture positive visits
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