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

NCT06611371 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CVIA 103
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 2

Brief Summary

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).

Conditions

Group B Streptococcal Infections

Keywords

Group B streptococcus (GBS); Vaccine; Healthy Volunteer

Outcome Measures

Primary Outcomes (7)

• Safety -percentage of participants reporting immediate AE within 30 minutes of vaccination

  The percentage of participants reporting immediate AE within 30 minutes of vaccination.

  30 minutes after vaccination

• Safety - percentage of participants reporting solicited local adverse events (AEs) within 7 days of vaccination

  The percentage of participants reporting solicited local adverse events (AEs) within 7 days following study vaccination (pain, redness and swelling/induration at the injection site).

  Day 1 - Day 7 after vaccination

• Safety- percentage of participants reporting solicited systemic AEs within 7 days following study vaccination (fever, fatigue, headache, chills, myalgia, arthralgia, and nausea/vomiting)

  The percentage of participants reporting solicited systemic AEs within 7 days following study vaccination (fever, fatigue, headache, chills, myalgia, arthralgia, and nausea/vomiting)

  Day 1 - Day 7 after vaccination

• Safety - percentage of participants reporting unsolicited AEs within 28 days following study vaccination

  The percentage of participants reporting unsolicited AEs within 28 days following study vaccination

  Day 1 - Day 28 after vaccination

• Safety - percentage of participants with clinically significant laboratory abnormalities within 7 days following study vaccination

  The percentage of participants with clinically significant laboratory abnormalities within 7 days following study vaccination

  Day 1 - Day 7 after vaccination

• Safety - percentage of participants reporting medically attended adverse events (MAAEs)

  The percentage of participants reporting medically attended adverse events (MAAEs)

  From Day 1 vaccination through the end of study

• Safety - percentage of participants reporting serious adverse events (SAEs)

  The percentage of participants reporting serious adverse events (SAEs)

  From Day 1 vaccination through the end of study

Secondary Outcomes (12)

• Immunogenicity - IgG

  Day 1 baseline collection through 4-weeks post dose collection

• Immunogenicity - IgG

  Day 1 baseline collection and 4-weeks post dose collection

• Immunogenicity - IgG

  Day 1 baseline collection and 4-weeks post dose collection

• Immunogenicity - IgG

  Day 1 baseline collection and 4-weeks post dose collection

• Immunogenicity - IgG

  Day 1 baseline collection and 4-weeks post dose collection

Study Arms (4)

Group 1; GBS-06 (Low)

EXPERIMENTAL

Participants will receive a single 0.5mL dose of IVT GBS-06 Formulation 1 (low dose polysaccharide concentration) administered by intramuscular injection to the non-dominant deltoid muscle on Day 1.

Biological: IVT GBS-06

Group 2; GBS-06 (Mid)

EXPERIMENTAL

Participants will receive a single 0.5mL dose of IVT GBS-06 Formulation 2 (mid-dose polysaccharide concentration) administered by intramuscular injection to the non-dominant deltoid muscle on Day 1.

Biological: IVT GBS-06

Group 3; GBS-06 (High)

EXPERIMENTAL

Participants will receive a single 0.5mL dose of IVT GBS-06 Formulation 3 (high dose polysaccharide concentration) administered by intramuscular injection to the non-dominant deltoid muscle on Day 1.

Biological: IVT GBS-06

Group 4; Placebo

PLACEBO COMPARATOR

Participants will receive a single 0.5mL dose of 0.9% sodium chloride placebo administered by intramuscular injection to the non-dominant deltoid muscle on Day 1.

Biological: Placebo

Interventions

IVT GBS-06 BIOLOGICAL

Hexavalent Group B Streptococcus polysaccharide conjugate vaccine (serotypes Ia, Ib, II, III, V, and VII) administered as a single dose.

Group 1; GBS-06 (Low); Group 2; GBS-06 (Mid); Group 3; GBS-06 (High)

Placebo BIOLOGICAL

0.9% sodium chloride

Group 4; Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Women between the ages of 18 to 49.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from participation:
• Laboratory confirmed active infection with human immunodeficiency virus, chronic hepatitis B virus infection (hepatitis B virus surface antigen positive), or hepatitis C virus infection. HCV RNA negative (if tested) may be allowed.
• BMI \<17 or ≥ 40 kg/m2
• Presence of any chronic or degenerative neurological disease or history of significant neurological disorder (e.g., dementia, meningitis, seizures, multiple sclerosis, vasculitis, or Guillain-Barré syndrome), genetic/congenital or acquired.
• Evidence of a major depression disorder not well controlled in the past 2 years prior to screening (by history and medication review, at discretion of the investigator) or history of suicidal ideation or attempt in the past 2 years prior to screening.
• History of severe adverse reaction and/or severe allergic reaction (e.g., anaphylaxis) to polyethylene glycol (PEG) or any vaccine.
• History of microbiologically proven invasive disease caused by GBS (S. agalactiae) or receipt of any investigational GBS vaccine.
• Participation in another investigational product (drug or vaccine) clinical trial within 30 days prior to enrollment in this study or receipt of any such investigational product other than the study vaccine within 30 days prior to administration of study vaccine or planned use during the study period.
• Immunocompromising condition with known or suspected immunodeficiency.
• Prior use of or anticipated need of any long-acting immunomodulating drug (e.g., infliximab or rituximab cytotoxic agents), or chronic administration (defined as more than 14 days) of high dose (≥ 20 mg of prednisolone or equivalent/day) systemic corticosteroids during the study period. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 30 days before investigational product administration. Inhaled/nebulized, intra-articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted.
• Indications of drug abuse or excessive use of alcohol as deemed by the investigator to confound safety assessments or render the participant unable or unlikely to adhere to protocol requirements or provide accurate safety reports.
• Administration of any vaccine other than the study vaccine within 28 days prior to or after study vaccination. Exceptions of seasonal inactivated influenza and COVID-19 vaccines which are prohibited for only 14 days prior to or following study vaccination is applicable.
• Receipt of transfusion of any blood product or application of immunoglobulins within the 12 weeks prior to the administration of study vaccine or planned use during the study period.
• Any planned surgery during the study period that would require hospitalization, use of prohibited medication, or will interfere with follow-up visits.
• History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding.

Sponsors & Collaborators

• Inventprise Inc.: lead
• PATH: collaborator

Study Sites (2)

NYU Grossman School of Medicine

New York, New York, 10016, United States

Location

Wits Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), University of the Witwatersrand

Johannesburg, Gauteng, South Africa

Location

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Sybil Tasker, MD, MPH, FIDSA

  Inventprise Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects randomized 1:1:1:1, placebo-controlled, observer blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single dose of low, mid or high concentrations of IVT GBS-06, or a placebo (saline control) at Day 1 (Randomized 1:1:1:1). The four study groups will be enrolled simultaneously to allow for parallel assessments of participants.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 24, 2024
• Study Start: November 12, 2024
• Primary Completion: August 26, 2025
• Study Completion: February 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

ZA (1); US (1)