Study of 4 regimens of Group B Streptococcus vaccine (GBS-NN/NN2) in pregnant women.

Phase 1

Active, not recruiting

• Conditions: Prevention of Group B Streptococcus infection in neonates.; MedDRA version: 20.0Level: PTClassification code 10053588Term: Group B streptococcus neonatal sepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-003214-40-DK
• Lead Sponsor: MinervaX Aps

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-16
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 270

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

1. Previous vaccination with an investigational Group B Streptococcus (GBS) Vaccine
2. BMI of <17 or >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified