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Trial record 2 of 5 for:    minervax

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05154578
Recruitment Status : Recruiting
First Posted : December 13, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
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 60 participants will receive three doses of placebo (saline).

Condition or disease Intervention/treatment Phase
Group B Streptococcal Infection Biological: GBS-NN/NN2 Vaccine Biological: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to one of 5 groups
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicentre, Multinational, Parallel Group, Observer-blind, Randomised, Placebo-controlled Study on the Group B Streptococcus Vaccine (GBS-NN/NN2), Investigating the Immunogenicity and Safety of Four Vaccination Regimens in Pregnant Woman, Assessing IgG Specific to AlpN Proteins in Cord Blood and Maternal Blood, and the Safety Profile in Mother and Infant up to 6 Months Post-delivery
Actual Study Start Date : February 17, 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Biological: 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.

Biological: Placebo
0.5 mL normal saline given by intramuscular injection
Other Name: Normal saline

Experimental: 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
Biological: 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.

Biological: Placebo
0.5 mL normal saline given by intramuscular injection
Other Name: Normal saline

Experimental: 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
Biological: 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.

Biological: Placebo
0.5 mL normal saline given by intramuscular injection
Other Name: Normal saline

Experimental: 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.
Biological: 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.

Biological: Placebo
0.5 mL normal saline given by intramuscular injection
Other Name: Normal saline

Placebo Comparator: Group 5: placebo
Participants will receive one injection of placebo at 22, 26 and 30 weeks (±1) GA
Biological: Placebo
0.5 mL normal saline given by intramuscular injection
Other Name: Normal saline




Primary Outcome Measures :
  1. Concentrations of Immunoglobulin (Ig) G antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby [ Time Frame: Delivery ]
    Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby


Secondary Outcome Measures :
  1. Injection site reactions in the mother [ Time Frame: To Day 84 ]
    Number of participants with solicited injection site reactions following vaccination

  2. Adverse events following the vaccinations in the mother [ Time Frame: To Day 84 ]
    Number of participants with solicited and other adverse events following the vaccinations

  3. Clinically significant abnormal laboratory tests in the mother [ Time Frame: To Day 84 ]
    Number of participants with clinically significant abnormal laboratory tests in the mother

  4. Clinically significant changes in vital signs in the mother [ Time Frame: To Day 84 ]
    Number of participants with clinically significant changes in vital signs (heart rate,blood pressure, oral temperature) in the mother

  5. Clinically significant changes in physical examination in the mother [ Time Frame: To Day 84 ]
    Number of participants with clinically significant changes in physical examination in the mother

  6. Gestational weight in the baby [ Time Frame: Delivery, 28 days, 90 days and 180 days post delivery. ]
    Gestational weight in the baby

  7. Weight in the baby [ Time Frame: Delivery, 28 days, 90 days and 180 days post delivery. ]
    Weight in the baby

  8. Length in the baby [ Time Frame: Delivery, 28 days, 90 days and 180 days post delivery. ]
    Length in the baby

  9. Head circumference in the baby [ Time Frame: Delivery, 28 days, 90 days and 180 days post delivery. ]
    Head circumference in the baby

  10. Apgar score in the baby [ Time Frame: 1, 5 and 10 minutes ]
    Apgar score in the baby, range 0 to 10 where high scores are good and low scores are bad

  11. Developmental milestones in the baby using Ages & Stages questionnaire [ Time Frame: 6 months ]
    Developmental milestones in the baby using Ages & Stages questionnaire

  12. Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in maternal blood [ Time Frame: Delivery ]
    Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in maternal blood

  13. Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in blood from each baby [ Time Frame: 1 month, 3 months ]
    Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in blood from each baby


Other Outcome Measures:
  1. Opsonophagocytic killing assay (OPKA) titres [ Time Frame: Delivery ]
    OPKA titres in cord blood and maternal blood

  2. Concentrations of IgG antibodies specific to the NN and NN2 fusion proteins in maternal blood [ Time Frame: 4 weeks after each dose; at delivery ]
    Concentrations of IgG antibodies specific to the NN and NN2 fusion proteins in maternal blood

  3. Concentrations of IgG and IgA antibodies specific to the AlpN proteins in colostrum and in breast milk [ Time Frame: Within 48 hours of delivery; 1 month and 3 months post-delivery ]
    Concentrations of IgG and IgA antibodies specific to the AlpN proteins in colostrum and in breast milk



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy pregnant woman above the legally defined age of consent at the time of screening
  2. Approximately 20(±1) weeks gestation at screening and carrying a normal singleton pregnancy
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05154578


Contacts
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Contact: Per Fisher, PhD +45 2025 2038 pbf@minervax.com
Contact: Birgit Thierry-Carstensen, M.Sc. +45 2683 8437 btc@minervax.com

Locations
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Denmark
Hvidovre University Hospital Recruiting
Copenhagen, Denmark
Principal Investigator: Anette Kjaerbye-Thygesen, MD         
Aarhus University Hospital Recruiting
Skejby, Denmark
Principal Investigator: Rikke Helmig, MD         
United Kingdom
St George's University Hospital Not yet recruiting
London, United Kingdom, SW17 OQT
Principal Investigator: Paul Heath, MD         
University Hospital Southampton Not yet recruiting
Southampton, United Kingdom, SO16 6YD
Principal Investigator: Christine Jones, MD         
Sponsors and Collaborators
Minervax ApS
Investigators
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Study Director: Geoff Kitson, BMBS MFPM ProPharma Partners Limited
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Responsible Party: Minervax ApS
ClinicalTrials.gov Identifier: NCT05154578    
Other Study ID Numbers: MVX0004
First Posted: December 13, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections