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Group B Streptococcal InfectionsPhase 1/2NCT06611371

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

A Phase 1/2 study testing IVT GBS-06 in people with Group B Streptococcal Infections, run by Inventprise Inc. at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Group B Streptococcal Infections
What is being tested?
IVT GBS-06
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
2 sitesin 2 countries
Study dates
12 Nov 2024to Feb 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • Participants meeting any of the following criteria will be excluded from participation:
  • Presence of an acute disease within 72 hours prior to enrollment - temporary exclusion*.
  • 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 *.
  • Presence of an abnormal (> Grade 2) vital sign measurement (heart rate, blood pressure[systolic or diastolic], respiratory rate) - temporary exclusion*
  • 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
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  • 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.
  • Participant is an employee of, or close personal relation of any person employed by the Sponsor, PATH, the CRO, the PI, or key study site personnel.
  • History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ.
  • Any other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for enrollment into this study.
  • Any screening laboratory value that meets the criteria specified below will be excluded from study participation:
  • Hemoglobin < 10.0 g/dL.
  • White blood cells (WBC) increased > 15,000 cells/mm3
  • WBC decreased < 2,600 cells/L
  • Platelet count < 125,000 cells/mm3
  • Creatinine >1.8 mg/dL or 159.1 µmol/L
  • Alanine aminotransaminase (ALT) > 2.5 × the upper limit of normal (ULN)
  • Total bilirubin > 1.5 × ULN

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • NYU Grossman School of Medicine

    New York, New York, 10016

Other trials in United States

South Africa1 site

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

    Johannesburg, Gauteng

Other trials in South Africa

About this study

Official title: 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).

Read the detailed description

This is a phase I/II, randomized, placebo-controlled, observer-blinded trial to evaluate the safety, tolerability, and immunogenicity of a multivalent GBS vaccine candidate in healthy, non-pregnant, adult WOCBA, 18-49 years of age, at two sites, one each in the US and South Africa. Approximately 600 participants will be randomized to receive a single dose of low, mid, or high concentration of IVT GBS-06, or a placebo (saline control) at Day (D)1, administered IM by injecting 0.5 mL into the deltoid muscle. The three dose levels denote the amount of capsular polysaccharide (CPS) for each of the six serotypes per 0.5 mL. These four study groups will be enrolled simultaneously to allow for parallel assessments of overall IVT GBS-06 safety and tolerability. Participants will be randomized in a 1:1:1:1 ratio to one of the dose levels or placebo. This study will utilize a sentinel-cohort design in which 20 participants overall (i.e., N=5 per treatment arm) at the US site will be randomized, vaccinated, and evaluated for safety prior to opening enrolment of additional participants in USA and in South Africa. This study targets representation from both study populations and therefore at least 220 participants will be recruited from each of the two sites and will allow competitive enrollment across the two study sites for the remaining 160 participants to reach 600 within target enrollment period.

Being tested
IVT GBS-06, Placebo
Keywords
Group B streptococcus (GBS), Vaccine, Healthy Volunteer
Medical subject headings
Streptococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVT GBS-06Biological

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

  • PlaceboBiological

    0.9% sodium chloride

Study groups in NCT06611371
Study groupRoleWhat they receive
Group 1; GBS-06 (Low)ExperimentalParticipants 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.
Receives: Biological: IVT GBS-06
Group 2; GBS-06 (Mid)ExperimentalParticipants 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.
Receives: Biological: IVT GBS-06
Group 3; GBS-06 (High)ExperimentalParticipants 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.
Receives: Biological: IVT GBS-06
Group 4; PlaceboPlacebo comparatorParticipants 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.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 30 minutes after vaccination

  2. 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).

    Measured: Day 1 - Day 7 after vaccination

  3. 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)

    Measured: Day 1 - Day 7 after vaccination

  4. 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

    Measured: Day 1 - Day 28 after vaccination

  5. 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

    Measured: Day 1 - Day 7 after vaccination

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

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

    Measured: From Day 1 vaccination through the end of study

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

    The percentage of participants reporting serious adverse events (SAEs)

    Measured: From Day 1 vaccination through the end of study

Secondary outcomes (12)

  1. Immunogenicity - IgG

    Percentage of participants that seroconvert per serotype. Seroconversion is defined as induction of a serotype-specific anti- capsular polysaccharide (anti-CPS) IgG concentration that is at least 4-fold greater than the Multiplex immunoassay (MIA) lower limit of quantitation (LLOQ) or the baseline level, whichever is higher.

    Measured: Day 1 baseline collection through 4-weeks post dose collection

  2. Immunogenicity - IgG

    Percentage of participants attaining or exceeding a concentration of 0.2, 0.5, 1 and 2 µg/mL of serotype-specific IgG. The rate will be assessed overall and stratified by baseline seropositivity.

    Measured: Day 1 baseline collection and 4-weeks post dose collection

  3. Immunogenicity - IgG

    Geometric mean concentration (GMC) of GBS-06 serotype specific IgG

    Measured: Day 1 baseline collection and 4-weeks post dose collection

  4. Immunogenicity - IgG

    Geometric mean fold-rise (GMFR) of GBS-06 serotype specific IgG

    Measured: Day 1 baseline collection and 4-weeks post dose collection

  5. Immunogenicity - IgG

    Rank of IVT GBS-06 dosage levels according to the serotype-specific seroconversion percentages and GMFR

    Measured: Day 1 baseline collection and 4-weeks post dose collection

  6. Immunogenicity - IgG

    Difference in serotype-specific seroconversion percentage for each IVT GBS-06 dosage level and placebo.

    Measured: Day 1 baseline collection and 4-weeks post dose collection

  7. Immunogenicity - IgG

    Difference in percentage of participants attaining or exceeding a concentration of 0.2, 0.5, 1, and 2 µg/mL of serotype specific IgG for each IVT GBS-06 dosage level and placebo.

    Measured: Day 1 baseline collection and 4-weeks post dose collection

  8. Immunogenicity

    GMC serotype-specific ratio between each IVT GBS-06 dosage level and placebo.

    Measured: Day 1 baseline collection and 4-weeks post dose collection

  9. Immunogenicity

    GMFR serotype-specific ratio between each IVT GBS-06 dosage level and placebo.

    Measured: Day 1 baseline collection and 4-weeks post dose collection

  10. Immunogenicity - OPA

    Post vaccination IVT GBS-06 serotype specific OPA geometric mean titer (GMT) assessed overall and stratified by baseline seropositivity. OPA seropositivity cut off will be based on LLOQ for each serotype calculated in µg/ml.

    Measured: Day 1 baseline collection and 4-weeks post dose collection

  11. Immunogenicity - OPA

    IVT GBS-06 serotype-specific OPA GMFR from baseline

    Measured: Day 1 baseline collection and 4-weeks post dose collection

  12. Immunogenicity - OPA

    IVT GBS-06 serotype-specific OPA GMT ratio between each IVT GBS-06 level and placebo.

    Measured: Day 1 baseline collection and 4-weeks post dose collection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2024
  2. Study start12 Nov 2024
  3. Primary completion26 Aug 2025
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06611371
Sponsor's protocol ID
CVIA 103
Status last verified
Nov 2025
First submitted
23 Sep 2024
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IVT GBS-06 in people with Group B Streptococcal Infections, run by Inventprise Inc. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety -percentage of participants reporting immediate AE within 30 minutes of vaccination (time frame: 30 minutes after vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06611371.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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