Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, No… (NCT06611371) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
United States, South Africa600 participantsStarted 2024-11-12
Plain-language 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).
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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).
Exclusion criteria
. 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 \*.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety -percentage of participants reporting immediate AE within 30 minutes of vaccination
Timeframe: 30 minutes after vaccination
2
Safety - percentage of participants reporting solicited local adverse events (AEs) within 7 days of vaccination
Timeframe: 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)
Timeframe: Day 1 - Day 7 after vaccination
4
Safety - percentage of participants reporting unsolicited AEs within 28 days following study vaccination
Timeframe: Day 1 - Day 28 after vaccination
5
Safety - percentage of participants with clinically significant laboratory abnormalities within 7 days following study vaccination
. 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
. 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.
7
Safety - percentage of participants reporting serious adverse events (SAEs)
Timeframe: From Day 1 vaccination through the end of study