Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age.
Condition: Infection by Streptococcus Group B
Intervention: GBS-NN vaccine
Intervention description: Three dose levels will be administered, with and without Alhydrogel®
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 240.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Part A: The primary objective is to evaluate the safety and tolerability of a potential
      vaccine against Group B streptococcus.

      Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year
      following the first dose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult female volunteers (as determined by medical history, physical
             examination, laboratory test values, vital signs and electrocardiograms [ECGs] at
             screening) aged 18 - 40 years.

          2. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.

          3. Volunteers weight ≥ 50kg and ≤100kg at screening.

          4. Able to voluntarily provide written informed consent to participate in the study.

          5. Must understand the purposes and risks of the study and agree to follow the
             restrictions and schedule of procedures as defined in the protocol.

          6. Volunteers must be pre-menopausal. Volunteers who have had a hysterectomy will have
             pre-menopausal status confirmed by a FSH and oestradiol test.

          7. Females of childbearing potential must have a negative pregnancy test at screening (β
             HCG) and prior to each dose and must be willing to use an adequate and highly
             effective method of contraception until at least Day 85 of the study. A highly
             effective method of birth control is defined as one which results in a low failure
             rate (i.e. less than 1% per year) when used consistently and correctly such as
             sterilisation, implants, injectables, combined oral contraceptives, IUDs (Intrauterine
             Device), condoms, occlusive caps (cervical/vault caps) with spermicidal foam/gel/
             film/cream/suppository. True sexual abstinence is acceptable when this is in line with
             the preferred and usual lifestyle of the volunteer (periodic abstinence e.g. calendar,
             ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the
             duration of the trial, and withdrawal are not acceptable methods of contraception)

          8. In Part A: Volunteers must be non-smokers for at least 3 months prior to first
             studyvaccine administration. In Part B: Volunteers may be light smokers i.e. up to a
             maximum of 5 cigarettes per day or nicotine equivalent.

          9. Must be willing to consent to have data entered into The Over Volunteering Prevention
             System (TOPS).

         10. The volunteer's primary care physician has confirmed within the last 12 months that
             there is nothing in their medical history that would preclude their enrolment into a
             clinical trial.

        Exclusion Criteria:

          1. Volunteers with history or presence of significant cardiovascular disease, pulmonary,
             hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal,
             endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease
             or current infection.

          2. Pregnant or lactating females.

          3. Laboratory values at screening which are deemed to be clinically significant, unless
             agreed in advance by the Sponsor's Responsible Medic and Principal Investigator.

          4. Current or history of drug or alcohol abuse, or a positive alcohol breath test prior
             to first dosing.

          5. Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.

          6. Participation in a clinical drug study during the 90 days preceding the initial dose
             in this study.

          7. Any significant illness during the 4 weeks preceding check-in for this study (Day 1).

          8. Volunteers with a history of severe allergic reactions after previous vaccination.

          9. Volunteers who have received any vaccine within 30 days of screening, or who are
             planning to receive a vaccine up to Day 85 of the study.

         10. Volunteers receiving immunosuppressive therapy (e.g. systemic steroids, cancer
             therapies, methotrexate, azathioprine) in the 6 months prior to screening, antibiotics
             within 10 days of receiving the first dose or taking any short-term medications
             including over-the-counter preparations, vitamins, herbal and/or mineral supplements
             within 7 days of the first dose. Chronic medications such as antihypertensives,
             bronchodilators, oral contraceptives or statins that do not affect the immune system,
             will be permitted and allowed to continue during the study at the discretion of the
             Investigator. Paracetamol will be permitted for the treatment of headache or other
             symptoms.

         11. Volunteers with tattoos at the proposed site of vaccine administration.

         12. Donation of blood or blood products within 90 days prior to vaccine administration.

         13. Volunteers who, in the opinion of the Investigator, are unsuitable for participation
             in the study.