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 range18 Years – 49 Years
SexFEMALE
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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 \*.
✕
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.
✕. 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.
Timeframe: From Day 1 vaccination through the end of study