Prevention of GBS Colonization Via Immunity
Completed · Phase 2
Conditions studied: Beta Haemolytic Streptococcal Infection
In brief
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.
Key facts
- Study ID
- NCT00128219
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 667
- Starts
- 2003-07-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2015-01-27
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Medical College of Georgia — Augusta, Georgia, United States
- Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States
- Planned Parenthood of Houston and Southeast Texas, Inc. — Houston, Texas, United States
Full record on ClinicalTrials.gov
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