Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women
- Conditions
- Group B Streptococcal Infection
- Interventions
- Biological: GBS-NN/NN2 VaccineBiological: Placebo
- Registration Number
- NCT05154578
- Lead Sponsor
- Minervax ApS
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 269
- Healthy pregnant woman above the legally defined age of consent at the time of screening
- Carrying a normal singleton pregnancy, and is at 21+0 to 23+6 weeks GA at the planned tme of the 1st vaccination, as established by first/second trimester ultrasound examination
- Properly informed about the study and has given written informed consent and parental consent (for her baby) in accordance with the International Conference on Harmonization Good Clinical Practice (ICH GCP) and local legislation prior to the first study intervention
- Grants access to her own and her baby's study related medical records
Exclusion Criteria
- Previous vaccination with an investigational Group B Streptococcus (GBS) Vaccine
- BMI of <17 or >40 at the time of screening
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) positive or positive for syphilis
- Knowingly carrying, at screening, a malformed or genetically abnormal foetus, incl. renal pelvis dilation, single umbilical artery (screening will be undertaken after the ultrasound conducted for the detection of anomalies)
- Chronic or pregnancy induced hypertension at screening, >1+ protein in urine regardless of blood pressure or 1+ protein in urine and hypertension
- Experienced a previous stillbirth prior to going into labour
- Gestational, type 1 or type 2 diabetes
- Potential placenta previa as per malformation ultrasound scan
- Rhesus negative and has anti-D antibodies or other potential harmful antibodies
- Known or suspected allergies to any components of the vaccine including to aluminium or aminoglycoside antibiotics, or an allergic reaction related to a previous vaccination
- Fever (temperature >37.9°C) on the day of receiving the first dose or an acute infection in the 7 days before the first dose (the first dose can be delayed if gestational age permits)
- Received systemic steroids in the 6 weeks before the first dose (inhaled and topical steroids are acceptable)
- Any lesion (including tattoos) at the planned injection site that will impair the assessment of the injection site
- Received immunosuppressive medication, chemotherapy or radiotherapy in the 24 weeks before the first dose
- Received blood, blood products, plasma derivatives or any immunoglobulin preparations in the 12 weeks before the first dose
- Anaemia, haemoglobin (<10 g/dL, 100 g/L, 6.2 mmol/L)
- Currently breast feeding
- Received any investigational medicinal product or vaccine in the 12 weeks or 5 half-lives before the first dose
- Received an approved vaccine within the 4 weeks before the first dose or expects to receive an approved vaccine during the study. Routine vaccinations recommended during pregnancy (e.g., pertussis and influenza) are permitted but every effort should be made to separate routine vaccinations from the trial vaccinations by at least 7 days.
- Known or suspected immunodeficiency or cancer (leukaemia, lymphoma), or a family history of congenital or hereditary immunodeficiency
- History or presence of uncontrolled cardiovascular disease, pulmonary, hepatic, gall bladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, or autoimmune disease
- History of, or current drug or alcohol abuse
- In the opinion of the investigator not suitable for inclusion in the study
- The pregnancy is considered high risk by treating physicians
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2: early intervention; 4 week dose interval; 2 doses GBS-NN/NN2 Vaccine Participants 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 2: early intervention; 4 week dose interval; 2 doses Placebo Participants 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: early intervention; 8 week dose interval; 2 doses GBS-NN/NN2 Vaccine Participants 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 3: early intervention; 8 week dose interval; 2 doses Placebo Participants 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: single dose GBS-NN/NN2 Vaccine Participants 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 4: single dose Placebo Participants 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: placebo Placebo Participants will receive one injection of placebo at 22, 26 and 30 weeks (±1) GA Group 1: 4 week dose interval; 2 doses GBS-NN/NN2 Vaccine Participants 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 GBS- NN/NN2 at 30 (±1) weeks GA Group 1: 4 week dose interval; 2 doses Placebo Participants 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 GBS- NN/NN2 at 30 (±1) weeks GA
- Primary Outcome Measures
Name Time Method Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby Delivery Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby at birth.
- Secondary Outcome Measures
Name Time Method Injection Site Reactions in the Mother 7 days following each injection Number of participants with solicited injection site reactions following vaccination
Adverse Events Following the Vaccinations in the Mother To Day 84 Number of participants with solicited and other adverse events following the vaccinations
Clinically Significant Abnormal Laboratory Tests in the Mother To Day 84 Number of participants with clinically significant abnormal laboratory tests in the mother
Clinically Significant Changes in Vital Signs in the Mother To Day 84 Number of participants with clinically significant changes in vital signs (heart rate, blood pressure, oral temperature) in the mother
Clinically Significant Changes in Physical Examination in the Mother To Day 84 Number of participants with clinically significant changes in physical examination in the mother
Gestational Age Delivery Gestational age at birth
Weight of the Baby Delivery Weight of the baby
Length of the Baby Delivery Length of the baby
Head Circumference of the Baby Delivery Head circumference of the baby
Apgar Score in the Baby 1, 5 and 10 minutes 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.Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby 1 month, 3 months 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 Maternal Blood Delivery Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in maternal blood
Trial Locations
- Locations (10)
St George's University Hospital
🇬🇧London, United Kingdom
Institut for Regional Sundhedsforskning
🇩🇰Kolding, Denmark
Mecru Clinical Research Unit (MeCRU)
🇿🇦Pretoria, South Africa
ESRU Rahima Moosa Mother and Child Hospital
🇿🇦Johannesburg, South Africa
Setshaba Research Centre
🇿🇦Pretoria, South Africa
University Hospital Southampton
🇬🇧Southampton, United Kingdom
Shandukani Research Clinic
🇿🇦Johannesburg, South Africa
Aarhus University Hospital; Skejby
🇩🇰Aarhus, Denmark
Hvidovre University Hospital
🇩🇰Hvidovre, Denmark
Wits Vaccines & Infectious Diseases Analytics
🇿🇦Johannesburg, South Africa