Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.

Inclusion Criteria:

1. Healthy women aged 18-49 years (inclusive) at enrollment.

2. 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 thediscretion of the investigator. Stable conditions are conditions that do not requirechanges to medication or other interventions in the past 6 weeks.

3. Willing and able to provide written informed consent prior to performance of anystudy specific procedure.

4. If of childbearing potential*, not be breastfeeding and not be pregnant (based on anegative serum pregnancy test at screening and a negative urine pregnancy testduring the 24 hours prior to study vaccination) and having practiced adequatecontraception** for at least 30 days prior to study vaccination and willing tocontinue using adequate contraception consistently throughout the study.

• Participants can be considered not of childbearing potential if they meet atleast 1 of the following criteria:
• Achieved postmenopausal status, defined as follows: cessation of regularmenses for at least 12 consecutive months with no alternative pathologicalor physiological cause; status may be confirmed with a serumfollicle-stimulating hormone (FSH) level confirming the postmenopausalstate.
• 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) areconsidered to be of childbearing potential. ** Adequate contraception is defined as a contraceptive method with afailure rate of less than 1% per year when used consistently and correctlyand 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

5. Resides in the study area and is able and willing to adhere to all studyrestrictions and to all study visits and procedures including completion of sevenday post-injection memory aid (as evidenced by a signed informed consent form andassessment by the investigator).

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from participation:

1. Presence of an acute disease within 72 hours prior to enrollment - temporaryexclusion*.

2. Presence of recorded fever (axillary temperature ≥ 37.5°C or oral temperature of ≥ 37.5°C) or use of an antipyretic medication within 72 hours prior to enrollment-temporary exclusion *.

3. Presence of an abnormal (> Grade 2) vital sign measurement (heart rate, bloodpressure[systolic or diastolic], respiratory rate) - temporary exclusion*

4. Laboratory confirmed active infection with human immunodeficiency virus, chronichepatitis B virus infection (hepatitis B virus surface antigen positive), orhepatitis C virus infection. HCV RNA negative (if tested) may be allowed.

5. BMI <17 or ≥ 40 kg/m2

6. Presence of any chronic or degenerative neurological disease or history ofsignificant neurological disorder (e.g., dementia, meningitis, seizures, multiplesclerosis, vasculitis, or Guillain-Barré syndrome), genetic/congenital or acquired.

7. Evidence of a major depression disorder not well controlled in the past 2 yearsprior to screening (by history and medication review, at discretion of theinvestigator) or history of suicidal ideation or attempt in the past 2 years priorto screening.

8. History of severe adverse reaction and/or severe allergic reaction (e.g.,anaphylaxis) to polyethylene glycol (PEG) or any vaccine.

9. History of microbiologically proven invasive disease caused by GBS (S. agalactiae)or receipt of any investigational GBS vaccine.

10. Participation in another investigational product (drug or vaccine) clinical trialwithin 30 days prior to enrollment in this study or receipt of any suchinvestigational product other than the study vaccine within 30 days prior toadministration of study vaccine or planned use during the study period.

11. Immunocompromising condition with known or suspected immunodeficiency.

12. Prior use of or anticipated need of any long-acting immunomodulating drug (e.g.,infliximab or rituximab cytotoxic agents), or chronic administration (defined asmore than 14 days) of high dose (≥ 20 mg of prednisolone or equivalent/day) systemiccorticosteroids during the study period. If systemic corticosteroids have beenadministered short term (<14 days) for treatment of an acute illness, participantsshould not be enrolled into the study until corticosteroid therapy has beendiscontinued for at least 30 days before investigational product administration.Inhaled/nebulized, intra-articular, intra-bursal, or topical (skin or eyes)corticosteroids are permitted.

13. Indications of drug abuse or excessive use of alcohol as deemed by the investigatorto confound safety assessments or render the participant unable or unlikely toadhere to protocol requirements or provide accurate safety reports.

14. Administration of any vaccine other than the study vaccine within 28 days prior toor after study vaccination. Exceptions of seasonal inactivated influenza andCOVID-19 vaccines which are prohibited for only 14 days prior to or following studyvaccination is applicable.

15. Receipt of transfusion of any blood product or application of immunoglobulins withinthe 12 weeks prior to the administration of study vaccine or planned use during thestudy period.

16. Any planned surgery during the study period that would require hospitalization, useof prohibited medication, or will interfere with follow-up visits.

17. History of known disturbance of coagulation or blood disorder that could causeanemia or excess bleeding.

18. Participant is an employee of, or close personal relation of any person employed bythe Sponsor, PATH, the CRO, the PI, or key study site personnel.

19. History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ.

20. Any other acute or chronic medical or psychiatric condition or laboratoryabnormality that may increase the risk associated with study participation orinvestigational product administration or may interfere with the interpretation ofstudy results and, in the judgment of the investigator, would make the participantinappropriate for enrollment into this study.

21. Any screening laboratory value that meets the criteria specified below will beexcluded from study participation:

22. Hemoglobin < 10.0 g/dL.

23. White blood cells (WBC) increased > 15,000 cells/mm3

24. WBC decreased < 2,600 cells/L

25. Platelet count < 125,000 cells/mm3

26. Creatinine >1.8 mg/dL or 159.1 µmol/L

27. Alanine aminotransaminase (ALT) > 2.5 × the upper limit of normal (ULN)

28. Total bilirubin > 1.5 × ULN