Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
Condition: GBS Disease; Streptococcus Agalactiae
Intervention: GBS trivalent vaccine; Placebo
Intervention description: Intramuscular injection - Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus and conjugated to the Corynebacterium diphtheriae CRM197 carrier protein; Intramuscular injection - Normal saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Maternal vaccine; IgG; IgA; GBS; pregnant women

Summary:

      Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in
      healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific
      antibodies in infants, placental transfer from the pregnant women to the infant and levels of
      antibodies in the breast milk.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy pregnant women 18-40 years of age, inclusive and at 24 0/7 through 34 6/7
             weeks gestation.

          2. Individuals who intend to breastfeed for at least 90 days postpartum.

          3. Individuals who have given written consent after the nature of the study has been
             explained according to local regulatory requirements.

          4. Individuals in good health as determined by the outcome of medical history, physical
             examination and clinical judgment of the investigator.

          5. Individuals who can comprehend and comply with all study procedures and are available
             for follow-up.

        Exclusion Criteria:

          1. Individuals with history of illness or an ongoing illness that, in the opinion of the
             investigator, may pose additional risk to the subject if she participates in the
             study.

          2. Individuals with known hypersensitivity to any component of the vaccine.

          3. Individuals who received or plan to receive any licensed vaccine within 14 days before
             or after the study vaccine with the exception of inactivated influenza vaccine which
             may be administered up to 7 days before or after study vaccine.

          4. Individuals with an infection requiring systemic antibiotic or antiviral treatment
             within 7 days prior to Study Day 1.

          5. Individuals determined as high risk for serious obstetrical complication, including:

               -  Gestational hypertension, as defined by American College of Obstetricians and
                  Gynecologists guidelines (ACOG Practice Bulletin 2012)

               -  Gestational diabetes which is not controlled by diet and exercise as per American
                  College of Obstetricians and Gynecologists guidelines (ACOG Practice Bulletin
                  2013)

               -  Pre-eclampsia or eclampsia as defined by American College of Obstetricians and
                  Gynecologists guidelines (ACOG practice bulletin, 2002)

               -  HIV infection

               -  Obesity class II or greater (pre-pregnancy BMI≥35.0)

               -  multiple pregnancy

          6. Individuals with behavioral or cognitive impairment or psychiatric disease that, in
             the opinion of the investigator, may interfere with the subject's ability to
             participate in the study.

          7. Individuals who are not able to comprehend and to follow all required study procedures
             for the whole period of the study.

          8. Individuals with known or suspected impairment of the immune system including known or
             suspected HIV infection or HIV-related disease, a history of or an active autoimmune
             disorder and receipt of immunosuppressive therapy.

          9. Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day
             or equivalent for more than 2 consecutive weeks (or 2 weeks total) within 30 days
             prior to enrollment. Use of inhaled, intranasal, or topical corticosteroids is
             allowed.

         10. Individuals participating in any clinical trial with another investigational product
             during the pregnancy or intent to participate in another clinical study at any time
             during the conduct of this study.

         11. Pregnant with a fetus with a known or suspected congenital anomaly

         12. Individuals who are acting as study personnel or immediate family members (brother,
             sister, child, parent) or the spouse of study personnel.

         13. Individuals with a fever (oral temperature ≥ 38°C/100.4 °F) within 3 days prior to
             intended study vaccination.

         14. Individuals with a history of culture confirmed GBS case in the infant(s) previously
             born to her.