A Phase I/II, Observer-Blind, Randomized, Placebo-Controlled, Dose-Selection Study to Assess the Safety, Tolerability, and Immunogenicity of Hexavalent Group B Streptococcus Conjugate Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age (WOCBA) in the US and South Africa.
To assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen, at three dosage levels in healthy, non-pregnant, adult women of childbearing age (WOCBA).
• Healthy women aged 18-49 years (inclusive) at enrollment.
• Healthy, as defined by the absence of any clinically significant medical conditions, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. Participants with stable chronic conditions may be enrolled in the study at the discretion of the investigator. Stable conditions are conditions that do not require changes to medication or other interventions in the past 6 weeks.
• Willing and able to provide written informed consent prior to performance of any study specific procedure.
• If of childbearing potential\*, not be breastfeeding and not be pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to study vaccination) and having practiced adequate contraception\*\* for at least 30 days prior to study vaccination and willing to continue using adequate contraception consistently throughout the study.
⁃ Participants can be considered not of childbearing potential if they meet at least 1 of the following criteria:
∙ Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state.
‣ Have undergone a documented hysterectomy and/or bilateral oophorectomy.
‣ Have medically confirmed ovarian failure.
‣ They identify as transgender women and do not have ovaries or a uterus. All other participants (including participants with tubal ligations) are considered to be of childbearing potential.
∙ \*\* Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example:
‣ Abstinence from penile-vaginal intercourse
‣ Combined estrogen and progesterone oral contraceptives
‣ Hormonal (e.g., progestogen) injections
‣ Hormonal (e.g., etonogestrel or levonorgestrel) implants
‣ Contraceptive vaginal ring
‣ Percutaneous contraceptive patches
‣ Intrauterine device
‣ Intrauterine hormonal system
• Resides in the study area and is able and willing to adhere to all study restrictions and to all study visits and procedures including completion of seven day post-injection memory aid (as evidenced by a signed informed consent form and assessment by the investigator).