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.
100 women who are pregnant and living with HIV will randomly receive two 0.5 mL (millilitre) intramuscular injections of GBS-NN/NN2 vaccine (60 women) or placebo (15 women). 100 women who are pregnant and do not have HIV will randomly receive two 0.5 mL intramuscular injections of GBS-NN/NN2 vaccine (60 women) or placebo (15 women). Participants will be screened at 24 to 28 weeks gestation (Days -14 to Day -1) and the groups will be dosed in parallel. The first dose of vaccine or placebo will be administered at Day 0 and the second dose will be administered 28±2 days later. Delivery is anticipated to be approximately 10 to 14 weeks after the first dose of vaccine. For the analysis of the immune response, the placebo groups will be combined. For safety, the placebo groups will be analysed separately and will be combined for comparison with the potential vaccine groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
205
GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
Normal Saline 0.9%
Empilweni Services and Research Unit (ESRU), Rahima Moosa Mother and Child Hospital
Johannesburg, South Africa
University of the Witwatersrand, Johannesburg (Respiratory and Meningeal Pathogens Research unit)
Johannesburg, South Africa
MUJHU Research Collaboration/MUJHU Care Ltd, Kawempe National Referral Hospital
Kawempe, Uganda
Incidence of treatment emergent adverse events
Adverse events
Time frame: From vaccination up to delivery/birth
Gestational age of newborn baby
Gestational age of newborn baby
Time frame: At birth
Weight of newborn baby
Weight of newborn baby
Time frame: At birth
Length of newborn baby
Length of newborn baby
Time frame: At birth
Head circumference of newborn baby
Head circumference of newborn baby
Time frame: At birth
Apgar score for newborn baby
Apgar score for newborn baby
Time frame: At birth
IgG (Immunoglobulin G) antibody concentration
IgG antibody concentration specific to the GBS-NN/NN2 vaccine measured in maternal blood and cord blood
Time frame: At birth
Incidence of significant adverse reactions in mothers
Significant adverse reactions
Time frame: From delivery to 6 months post-delivery
Developmental milestones of babies
Milestones assessed using ages and stages questionnaires
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Time frame: At 6 months
Geometric mean antibody concentration
Geometric mean antibody concentration
Time frame: At 4 weeks post first injection and at 4 weeks post second injection
Geometric mean antibody concentration of cord and maternal blood
Geometric mean antibody concentration of cord (or newborn blood within 48 hours of birth) and maternal blood
Time frame: At delivery
Geometric mean fold increase in antibody concentration in maternal blood
Geometric mean fold increase in antibody concentration in maternal blood
Time frame: At 4 weeks post first injection and at 4 weeks post second injection
Geometric mean fold increase in antibody concentration in maternal blood
Geometric mean fold increase in antibody concentration in maternal blood
Time frame: From baseline to delivery
Proportion of mothers and newborn babies achieving vaccine specific IgG antibody concentrations
Proportion of mothers and newborn babies achieving vaccine specific IgG antibody concentrations in maternal and cord blood samples respectively, above pre-defined arbitrary thresholds.
Time frame: At delivery