Status:
COMPLETED
Prevention of GBS Colonization Via Immunity
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Beta Haemolytic Streptococcal Infection
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
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 60...
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 and/or meningitis. The long-term go...
Eligibility Criteria
Inclusion
- Participated in and completed the group B Streptococcus (GBS) Screening Protocol
- Non-pregnant women
- Aged 18-40 years at time of the screening protocol
- Currently sexually active at time of enrollment (sex with a male at least once in the last 4 months)
- Current use of effective birth control methods and stated intention to use the method for at least the next 30 days
- Provision of written informed consent
- Intention to stay in the geographical area for the next 18 months
- Access to telephone
Exclusion
- Group B Streptococcus (GBS) positive by culture (vaginal and/or rectal), or culture positive for streptococcal strains that cross-react with GBS typing sera (vaginal and/or rectal).
- Pregnancy (all women will receive a urine pregnancy prior to vaccination).
- Any condition which in the opinion of the investigator would pose a health risk to the subject or interfere with the evaluation of the vaccine.
- Serious underlying disease, which is known at the time of vaccination (including: immunodeficiency, active or chronic hepatitis, immunosuppressive conditions which require systemic steroid therapy, or treatment for a malignancy during the past year).
- Receipt of any vaccine, blood product, or experimental medicine within the past 30 days with the exception of a licensed inactivated influenza vaccine.
- Plans to receive any vaccine, blood product, or experimental medicine in the next 30 days with the exception of a licensed inactivated influenza vaccine.
- Use of any antimicrobial agent(s) (vaginal or systemic) for treatment of any condition within 7 days prior to study enrollment (including: Monistat, Gyne-Lotrimin, et cetera )
- History of hypersensitivity to tetanus toxoid vaccine.
- Tetanus toxoid immunization within the previous 12 months.
- Previous participation in a study in which participants received tetanus toxoid vaccine or vaccine against Group B Streptococcus.
- Spontaneous or surgical menopause.
- Nursing mother.
- Hypersensitivity to thimerosal.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
667 Patients enrolled
Trial Details
Trial ID
NCT00128219
Start Date
July 1 2003
End Date
December 1 2008
Last Update
January 27 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical College of Georgia
Augusta, Georgia, United States, 30912
2
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
3
Planned Parenthood of Houston and Southeast Texas, Inc.
Houston, Texas, United States, 77004