Phase 2 N=269 Randomized Triple-blind Prevention

Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women

Group B Streptococcal Infection

Bottom Line

View on ClinicalTrials.gov: NCT05154578 ↗

Enrolled (actual)

269

Serious AEs

30.5%

Results posted

Jan 2025

Primary outcome: Primary: Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby — 11.12; 5.52; 7.95; 3.51 μg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: GBS-NN/NN2 Vaccine (Biological); Placebo (Biological)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: Minervax ApS
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby	11.12; 5.52; 7.95; 3.51; 0.07; 7.93	—
SECONDARY Injection Site Reactions in the Mother	7; 5; 9; 5; 5; 2	—
SECONDARY Adverse Events Following the Vaccinations in the Mother	56; 54; 57; 56; 26	—
SECONDARY Clinically Significant Abnormal Laboratory Tests in the Mother	0; 0; 0; 0; 0	—
SECONDARY Clinically Significant Changes in Vital Signs in the Mother	0; 0; 0; 0; 0	—
SECONDARY Clinically Significant Changes in Physical Examination in the Mother	0; 0; 0; 0; 0	—
SECONDARY Gestational Age	38.7; 38.9; 38.9; 38.8; 39.4	—
SECONDARY Weight of the Baby	3165.4; 3086.5; 3230.1; 2955.3; 3272.4	—
SECONDARY Length of the Baby	50.3; 49.9; 49.3; 48.9; 49.7	—
SECONDARY Head Circumference of the Baby	34.4; 34.3; 33.8; 34.0; 34.8	—
SECONDARY Apgar Score in the Baby	8.8; 9.0; 8.8; 8.9; 8.8; 9.7	—
SECONDARY Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood	40.57; 15.81; 32.91; 12.38; 1.03; 61.69	—
SECONDARY Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby	4.81; 2.92; 7.02; 1.72; 0.05; 1.91	—

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).

Eligibility Criteria

Inclusion Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05154578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.