The purpose of this study is to evaluate whether a GBS III-TT vaccine can prevent vaginal acquisition of GBS III in non-pregnant sexually active women, as defined by the first vaginal swab that is GBS culture positive, with all previous cultures negative for type III GBS.

Condition	Intervention	Phase
Streptococcus group B	Vaccine: GBS Type III Polysaccharide  Vaccine: Tetanus Toxoid Conjugate	Phase II

Further Study Details: 

Expected Total Enrollment:  600

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. It is possible that vaccination against GBS could protect infants by transfer of antibodies to the fetus and inhibition of colonization of the vagina by GBS. Maternal vaginal colonization by GBS is recognized as the single most important risk factor for neonatal infection. The proposed randomized trial shortens the sampling interval and extends the length of follow-up adding 6 additional months during which women could have GBS acquisition. The long-term goal is to determine whether vaccine-induced serum antibody to type III GBS will be sufficient to prevent vaginal acquisition of type III GBS.

Ages Eligible for Study:  18 Years   -   40 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

1. Participated in and completed the GBS Screening Protocol
2. Non-pregnant women
3. Aged 18-40 years at time of the screening protocol
4. Currently sexually active at time of enrollment (sex with a male at least once in the last 4 months)
5. Current use of effective birth control methods and stated intention to use the method for at least the next 30 days
6. Provision of written informed consent
7. Intention to stay in the geographical area for the next 18 months
8. Access to telephone

Exclusion Criteria:

1. 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)
2. Pregnancy (all women will receive a urine pregnancy prior to vaccination)
3. 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.
4. 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).
5. Receipt of any vaccine, blood product, or experimental medicine within the past 30 days.
6. Plans to receive any vaccine, blood product, or experimental medicine in the next 30 days.
7. Use of any antimicrobial agent (s) (vaginal or systemic) for treatment of any condition within 7 days prior to study screening.
8. History of hypersensitivity to tetanus toxoid vaccine.
9. Tetanus toxoid immunization within the previous 5 years.
10. Previous participation in a study in which in which participants received tetanus toxoid vaccine or vaccine against Group B Streptococcus.
11. Spontaneous or surgical menopause.
12. Nursing mother.
13. Hypersensitivity to thimerosal.

Please refer to this study by ClinicalTrials.gov identifier  NCT00128219

Sharon Hillier      (412) 641-6416    slh6+@pitt.edu

Georgia
      Medical College Of Georgia, Augusta,  Georgia,  30912,  United States; Not yet recruiting
Pennsylvania
      Magee Womens Hospital, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Texas
      Planned Parenthood of Houston and Southeast Texas, Inc., Houston,  Texas,  77004,  United States; Not yet recruiting

Study ID Numbers:  02-015
Last Updated:  August 22, 2005
Record first received:  August 5, 2005
ClinicalTrials.gov Identifier:  NCT00128219
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23