Prevention of Group B Streptococcus infection in neonates. MedDRA version: 20.0 Level: PT Classification code 10053588 Term: Group B streptococcus neonatal sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: GBS NN/NN2 vaccine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: GBS-NN
Current Sponsor code: GBS-NN
Other descriptive name: GBS-NN
Concentration unit: mg/ml milligr
Sponsors
MinervaX Aps
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy pregnant woman above the legally defined age of consent at the time of screening 2. Carrying a normal singleton pregnancy and is at 21+0 to 23+6 weeks GA at the planned time of the 1st vaccination, as established by first/second trimester ultrasound examination 3. Properly informed about the study and has given written informed consent and parental consent (for her baby) in accordance with ICH GCP and local legislation prior to the first study intervention 4. Grants access to her own and her baby’s study related medical records Are the trial subjects under 18? yes Number of subjects for this age range: 270 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous vaccination with an investigational Group B Streptococcus (GBS) Vaccine 2. BMI of 40 at the time of screening 3. HIV, HBV and/or HCV positive or positive for syphilis 4. 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) 5. Chronic or pregnancy induced hypertension at screening, >1+ protein in urine regardless of blood pressure or 1+ protein in urine and hypertension 6. Experienced a previous stillbirth prior to going into labour 7. Gestational, type 1 or type 2 diabetes 8. Potential placenta previa as per malformation ultrasound scan 9. Rhesus negative and has anti-D antibodies or other potential harmful antibodies 10. 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 11. 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) 12. Received systemic steroids in the 6 weeks before the first dose (inhaled and topical steroids are acceptable) 13. Any lesion (including tattoos) at the planned injection site that will impair the assessment of the injection site. 14. Received immunosuppressive medication, chemotherapy or radiotherapy in the 24 weeks before the first dose 15. Received blood, blood products, plasma derivatives or any immunoglobulin preparations in the 12 weeks before the first dose 16. Anaemia, haemoglobin (<10 g/dL, 100 g/L, 6.2 mmol/L) 17. Currently breast feeding 18. Received any investigational medicinal product or vaccine in the 12 weeks or 5 half-lives before the first dose 19. 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.) 20. Known or suspected immunodeficiency or cancer (leukaemia, lymphoma), or a family history of congenital or hereditary immunodeficiency 21. 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 22. History of, or current drug or alcohol abuse 23. In the opinion of the investigator not suitable for inclusion in the study 24. The pregnancy is considered high risk by treating physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the concentrations of IgG specific to the AlpN proteins (RibN, Alp1N, Alp2N and AlpCN) in cord blood from babies, born to women who received the GBS-NN/NN2 vaccine or placebo, according to four vaccination regimens during pregnancy, between the GBS-NN/NN2 and placebo groups: • Group 1: 2 doses GBS-NN/NN2 at 26 & 30 weeks GA • Group 2: 2 doses GBS-NN/NN2 at 22 & 26 weeks GA • Group 3: 2 doses GBS-NN/NN2 at 22 & 30 weeks GA • Group 4: 1 dose GBS-NN/NN2 at 26 weeks GA • Group 5: Placebo at 22, 26, and 30 weeks GA ;Secondary Objective: To evaluate the safety and tolerability of the GBS-NN/NN2 vaccine in pregnant women from 22 (±1) weeks GA and to evaluate developmental milestones in the baby up to 6 months post-delivery. To compare the concentrations of IgG, specific to the AlpN proteins (RibN, Alp1N, Alp2N and AlpCN) in maternal blood at delivery, from women who received the GBS-NN/NN2 vaccine or placebo, according to four vaccination regimens during pregnancy, between the GBS-NN/NN2 and placebo groups . Secondary immunogenicity objectives: • To compare the concentrations of IgG specific to the AlpN proteins, in maternal blood at 4 weeks after each dose of vaccine/placebo for the different vaccination regimens • To evaluate the ratios of antibody concentrations between maternal and cord blood at delivery • To evaluate the concentrations of IgG specific to the AlpN proteins, up to 3 months post-delivery, in infant blood ;Primary end point(s): The following primary endpoints will be evaluated, by group:, to support the primary objectives: • Concentrations of IgG antibodies specific to the AlpN proteins in µg/mL in cord blood from each baby: o The geometric mean antibody concentrations at birth will be calculated o The proportions of babies who achieve a concentration of IgG specific to the AlpN proteins above 0.1, 0.2, 0.5, 1, 2, 4 and 8 µg/mL at birth will be calculated ;Timepoint(s) of evaluation of this end point: The t | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following key safety secondary endpoint(s) will be evaluated in the mother: Local and systemic reactogenicity and adverse events: • Solicited injection site reactions following the vaccinations • Solicited systemic adverse events following the vaccinations • All other adverse events following the vaccinations • Laboratory tests; urinalysis; vital signs (heart rate, blood pressure, oral body temperature); physical examinations The following key safety secondary endpoints will be evaluated in the baby: • Gestational age; weight; length; head circumference; Apgar score at 1, 5 and 10 minutes • Developmental milestones at 6 months of age The following secondary immunogenicity endpoints will be evaluated, by group and time-point: • Concentrations of IgG antibodies specific to the AlpN proteins in µg/mL in maternal blood: o The geometric mean antibody concentrations at delivery, and geometric mean concentration ratios relative to baseline will be calculated o The proportions of mothers who achieve a concentration of IgG specific to the AlpN proteins above 0.1, 0.2, 0.5, 1, 2, 4 and 8 µg/mL at delivery will be calculated o The geometric mean antibody concentrations at 4 weeks after each dose of vaccine/placebo and geometric mean concentration ratios relative to baseline will be calculated • The ratios of antibody concentrations between maternal and cord blood at delivery will be calculated The following immunogenicity endpoints will be evaluated in the baby: • Concentrations of IgG antibodies specific to the AlpN proteins in µg/mL in blood from each baby at 1 month and 3 months of age: o The geometric mean antibody concentrations at 1 month and 3 months after birth will be calculated o The proportions of babies who achieve a concentration of IgG specific to the AlpN proteins above 0.1, 0.2, 0.5, 1, 2, 4 and 8 µg/mL at 1 month and 3 months after birth will be calculated. ;Timepoint(s) of evaluation | — |
Countries
Denmark, South Africa, United Kingdom
Contacts
Public ContactClinical Trials Information
MinervaX Aps
Outcome results
None listed