| Eligibility |
Inclusion Criteria:
1. Healthy female subjects aged 18 - 40 years.
2. Body mass index (BMI) =18 and =30 kg/m2.
3. Subjects weight =50kg and =100kg at screening.
4. Able to voluntarily provide written informed consent to participate in the study.
5. Subjects are pre-menopausal.
6. Females of childbearing potential must have a negative pregnancy test at screening (ß
HCG) and prior to each dose. To prevent pregnancy female subjects of childbearing
potential must take adequate contraceptive precautions for the entire duration of
study participation (up to Day 85). Adequate and highly effective contraceptive
precautions include:
- Established use of oral, injected or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Condom or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Male sterilisation (with the appropriate post-vasectomy documentation of the
absence of sperm in the ejaculate). [For female subjects, the vasectomised male
partner should be the sole partner for that subject].
- True abstinence, when this is in line with the preferred and usual lifestyle of
the subject.
[Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of contraception].
• The chosen contraception method(s) must be followed from the first dose until at
least Day 85 of the study.
7. Non-smokers for at least 3 months prior to first study vaccine administration.
Exclusion Criteria:
1. Subjects who have received GBS-NN vaccine previously.
2. Subjects 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.
3. Pregnant or lactating females.
4. Laboratory values at screening which are deemed by the investigator to be clinically
significantly abnormal.
5. Positive drug screen for drugs of abuse or a positive alcohol urine test prior to
first dosing unless there is a documented medical explanation for the positive result
other than drugs of abuse (e.g., the subject has been prescribed opioids for pain).
6. Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
7. Participation in a clinical drug study during the 90 days preceding the initial dose
in this study.
8. Any significant illness during the 4 weeks preceding check-in for this study (Day 1).
9. Subjects with a history of allergic reactions after previous vaccination.
10. Subjects 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.
11. Subjects receiving immunosuppressive therapy in the 6 months prior to screening,
taking any short-term medications including over-the-counter (OTC) preparations,
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. Use of OTC vitamins and dietary supplements is allowed
12. Subjects with tattoos at the proposed site of vaccine administration.
13. Donation of blood or blood products within 90 days prior to vaccine administration or
intending to donate blood or blood products within 90 days of the last visit.
14. Subjects who, in the opinion of the Investigator, are unsuitable for participation in
the study.
|
