Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women … (NCT04596878) | Clinical Trial Compass
CompletedPhase 2
Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV
South Africa, Uganda205 participantsStarted 2020-11-19
Plain-language summary
A randomised, placebo-controlled, double-blind study to evaluate the safety, tolerability and immunogenicity of the GBS-NN/NN2 (Recombinant protein vaccine against Group B Streptococcus) vaccine in women living with HIV and women without HIV,and their newborn babies from vaccination up to delivery/birth. Mothers and babies will be followed up for 6 months post-delivery.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. Participants at least 18 years old and not older than 40 years of age.
✓. Pregnant women who are between 26 weeks and 30 weeks (inclusive) gestation on the planned day of vaccination with a singleton, uncomplicated pregnancy. Gestational age to be determined on the following hierarchal basis with guidance to the GAIA (Global Alignment of Immunisation Safety Assessment in pregnancy) criteria:
✓. ultrasound estimate of gestational age,
✓. date of last menstrual period
✓. fundal height
✓. HIV status to be based on rapid, confirmatory test, unless a documented test of the participant being sero-positive for HIV and history documented in the notes.
✓. Women living with HIV, HIV viral load \<1000, on antiretroviral therapy for at least 3 months prior to screening and clinically well.
✓. Expected to be available for the scheduled clinic visits for the duration of the study, agree to be contacted by telephone during study participation, and is willing to give parental consent for her infant to participate in the study
Exclusion criteria
✕. Women who are HBSAg and/or HCV (hepatitis C virus) positive
✕. Women who test positive for syphilis as per standard testing
✕. Women knowingly carrying, at screening, a malformed or genetically abnormal foetus based on ultrasound
✕. Women who have experienced a previous stillbirth prior to going into labour
✕. Women with placenta previa
✕. Women with documented chronic or pregnancy induced hypertension at screening
✕. Women with 1+ protein in urine and hypertension defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) at ≥20 weeks of gestation in a woman with a previously normal blood pressure
✕. Women with \>1+ of protein in urine (regardless of blood pressure)