This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women. There will be 5 treatment groups; three groups of 60 participants will receive will receive two doses of GBS-NN/NN2 vaccine and one dose of placebo (saline); one group of 60 participants will receive one dose of GBS-NN/NN2 vaccine and two doses of placebo (saline), and one group of 30 participants will receive three doses of placebo (saline).
This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women. There will be 5 treatment groups; Group 1 will receive one injection of placebo at 22 (±1) weeks gestational age (GA), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA. Group 2 will receive one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA.Group 3 will receive one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA. Group 4 will receive one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA. Group 5 will receive an injection of placebo at 22, 26 and 30 weeks (±1) GA. Participants will attend the clinic for assessment visits up to delivery and for a further 3 visits at 28 (±4) days, 90 (±6) days and 180 (±14) days post delivery. Babies will be also be assessed at delivery, and 28 (±4) days, 90 (±6) days and 180 (±14) days post delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
269
0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection.
0.5 mL normal saline given by intramuscular injection
Aarhus University Hospital; Skejby
Aarhus, Denmark
Hvidovre University Hospital
Hvidovre, Denmark
Institut for Regional Sundhedsforskning
Kolding, Denmark
ESRU Rahima Moosa Mother and Child Hospital
Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby
Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby at birth.
Time frame: Delivery
Injection Site Reactions in the Mother
Number of participants with solicited injection site reactions following vaccination
Time frame: 7 days following each injection
Adverse Events Following the Vaccinations in the Mother
Number of participants with solicited and other adverse events following the vaccinations
Time frame: To Day 84
Clinically Significant Abnormal Laboratory Tests in the Mother
Number of participants with clinically significant abnormal laboratory tests in the mother
Time frame: To Day 84
Clinically Significant Changes in Vital Signs in the Mother
Number of participants with clinically significant changes in vital signs (heart rate, blood pressure, oral temperature) in the mother
Time frame: To Day 84
Clinically Significant Changes in Physical Examination in the Mother
Number of participants with clinically significant changes in physical examination in the mother
Time frame: To Day 84
Gestational Age
Gestational age at birth
Time frame: Delivery
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Johannesburg, South Africa
Shandukani Research Clinic
Johannesburg, South Africa
Wits Vaccines & Infectious Diseases Analytics
Johannesburg, South Africa
Mecru Clinical Research Unit (MeCRU)
Pretoria, South Africa
Setshaba Research Centre
Pretoria, South Africa
St George's University Hospital
London, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Weight of the Baby
Weight of the baby
Time frame: Delivery
Length of the Baby
Length of the baby
Time frame: Delivery
Head Circumference of the Baby
Head circumference of the baby
Time frame: Delivery
Apgar Score in the Baby
Apgar score in the baby (Appearance; Pulse; Grimace response; Activity; Respiration). Range 0 to 10 where high scores are good and low scores are bad.
Time frame: 1, 5 and 10 minutes
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood
Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in maternal blood
Time frame: Delivery
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby
Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in blood from each baby
Time frame: 1 month, 3 months