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

NCT ID: NCT05154578

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2023-10-18

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.

Conditions

Group B Streptococcal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group 1: 4 week dose interval; 2 doses

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 Type: EXPERIMENTAL

GBS-NN/NN2 Vaccine

Intervention Type: BIOLOGICAL

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.

Placebo

Intervention Type: BIOLOGICAL

0.5 mL normal saline given by intramuscular injection

Group 2: early intervention; 4 week dose interval; 2 doses

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 Type: EXPERIMENTAL

GBS-NN/NN2 Vaccine

Intervention Type: BIOLOGICAL

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.

Placebo

Intervention Type: BIOLOGICAL

0.5 mL normal saline given by intramuscular injection

Group 3: early intervention; 8 week dose interval; 2 doses

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 Type: EXPERIMENTAL

GBS-NN/NN2 Vaccine

Intervention Type: BIOLOGICAL

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.

Placebo

Intervention Type: BIOLOGICAL

0.5 mL normal saline given by intramuscular injection

Group 4: single dose

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 Type: EXPERIMENTAL

GBS-NN/NN2 Vaccine

Intervention Type: BIOLOGICAL

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.

Placebo

Intervention Type: BIOLOGICAL

0.5 mL normal saline given by intramuscular injection

Group 5: placebo

Participants will receive one injection of placebo at 22, 26 and 30 weeks (±1) GA

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

0.5 mL normal saline given by intramuscular injection

Interventions

GBS-NN/NN2 Vaccine

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.

Intervention Type: BIOLOGICAL

Placebo

0.5 mL normal saline given by intramuscular injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Normal saline

Eligibility 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 tme 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 the International Conference on Harmonization Good Clinical Practice (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

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. Human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Larix A/S

INDUSTRY

Sponsor Role: collaborator

Minervax ApS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeannett Dimsits

Role: STUDY_DIRECTOR

jdi@minervax.com

Locations

Aarhus University Hospital; Skejby

Aarhus, , Denmark

Hvidovre University Hospital

Hvidovre, , Denmark

Institut for Regional Sundhedsforskning

Kolding, , Denmark

ESRU Rahima Moosa Mother and Child Hospital

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

Countries

Denmark; South Africa; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MVX0004

Identifier Type: -

Identifier Source: org_study_id