Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women With and Wit… (NCT05832502) | Clinical Trial Compass
UnknownPhase 2
Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women With and Without HIV (PREPARE)
Uganda300 participantsStarted 2022-10-14
Plain-language summary
A placebo controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 to ≤ 40 years of age, inclusive at day of signing the ICF.
✓. Pregnant at ≥ 27 0/7 to ≤35 6/7 gestation on the day of planned vaccination, verified by ultrasound scan (U/S).
✓. Low risk, singleton pregnancy, as assessed by the study physician based on ultra-sound scan and previous obstetric history.
✓. Documented negative HBV surface antigen, HCV antibody, and syphilis tests at screening.
✓. Documented HIV test during pregnancy undertaken as per the national guidelines.
✓. If HIV infected pregnant women, stable on ART for at least 3 months prior to study start
✓. Determined by medical history, physical examination, screening laboratory assessment, and clinical judgment to be appropriate for inclusion in the study.
✓. Receiving prenatal standard of care including HIV care if applicable at the clin-ics/physician offices/hospital network affiliated with the clinical study site.
Exclusion criteria
✕. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
✕. Participants whose unborn baby have been fathered by investigational site staff members directly involved in the conduct of the study or their family members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study.
What they're measuring
1
Primary mother outcome 1
Timeframe: 7 days following administration of IMP
2
Primary mother outcome 2
Timeframe: 7 days following administration of IMP
3
Primary mother outcome 3
Timeframe: Through 1 month following administration of IMP
4
Primary mother outcome 4
Timeframe: Visit 1 through 12 months post-delivery
✕. Participation in other studies involving investigational drug(s), vaccines, or medical devices within 28 days prior to study entry and/or during study participation.
✕. Previous vaccination with any licensed or investigational GBS vaccine.
✕. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the investigational product.
✕. History of microbiologically proven invasive disease caused by GBS, or history of an infant with GBS disease.
✕. Current alcohol abuse or illicit drug use.
✕. Body mass index (BMI) of ≥40 kg/m2 at the time of the screening visit.