Prevention of GBS Colonization Via Immunity
Condition: Beta Haemolytic Streptococcal Infection
MeSH terms: Streptococcal Infections
Intervention: GBS III-TT; Tetanus and diptheria toxoids vaccine
Intervention description: 50 mcg GBS Type III capsular polysaccharide conjugated to 32 mcg of tetanus toxoid. A single dose of vaccine administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml.; Td vaccine is a sterile solution of alum-precipitated toxoids in isotonic sodium chloride solution. A single dose of vaccine will be administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml. Each 0.5 ml dose is formulated to contain 5 Lf (flocculation units) of tetanus toxoid and 2 Lf of diphtheria toxoid.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 667.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Group B Streptococcus, women, vaccine

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.