GBS-NN, GBS-NN2 for Group B streptococcus infection

Inclusion criteria

• {"criterion_text":"- Women ≥18 to ≤49 years of age with a body mass index of >17.5 to <40 kg/m2.\n- Able to read, understand and capable of giving personal signed informed consent.\n- Participants who are willing and able to comply with all trial procedures including completion of the electronic diary (eDiary) using their own personal mobile phone for 28 days after each dose.\n- Healthy females at enrolment, as determined by medical history, physical examination, and clinical judgement of the investigator or participants with well controlled, well treated underlying conditions which will not impact the trial assessments.\n- Women of childbearing potential must be: a. Documented to be surgically sterile or post-menopausal, or b. Willing to practice true abstinence throughout the trial and have a negative pregnancy test on Day 1, or c. Having same sex partners only, or d. Using at least one highly effective contraceptive measure, such as adequate hormonal method (eg, contraceptive implants, injectables, oral contraceptives) or non-hormonal methods (eg, intrauterine device, intrauterine hormone-releasing system) throughout the trial and have a negative pregnancy test on Day 1.\n- Expected to be available for the duration of the trial and who can be contacted by telephone during trial participation"}

Exclusion criteria

• {"criterion_text":"- Pregnant women (positive urine pregnancy test on Day 1), women planning to become pregnant during the trial, and breastfeeding women.\n- Previous vaccination with any licensed or investigational GBS vaccine, or planned receipt during participation in the trial (from the first to the last visit).\n- Vaccination within the previous 5 years with the Tdap vaccine or a vaccine containing any individual component thereof.\n- Participants who have received any vaccine within 30 days of the first dose, or who are planning to receive any vaccine (eg, travel vaccines) up to 30 days after each dose and/or 7 days prior to the third dose.\n- Participants who have received antipyretics/analgesics treatment within 72 hours prior to administration.\n- Participants receiving immunosuppressive or immunomodulatory therapy, including steroids at immunosuppressive doses (10 mg or more prednisolone equivalent daily for at least 2 weeks) or immunoglobulins in the 6 months prior to screening. (Topical/inhaled corticosteroids are allowed.)\n- Receipt or planned receipt of blood/plasma products from 60 days before the first dose until the end of the trial.\n- Participation in other trials involving investigational drug/vaccine(s) within 28 days prior to trial entry and/or planned during the trial.\n- Participants with a deltoid muscle not being sufficiently large to permit the administration of 2 separate vaccinations at the same time visit, as determined by the investigator.\n- Any personnel involved in the conduct of the trial (and their family members), including but not limited to, site staff members, MinervaX employees, and any vendor or contract research organisation (CRO) employees.\n- Women of childbearing potential not planning or willing to take adequate contraception (defined in inclusion criteria) from enrolment until 28 days after the last vaccination.\n- Current or history of drug or alcohol abuse, as judged by the investigator.\n- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) and/or allergic reaction or hypersensitivity to any component of GBS-NN/NN2 or any diphtheria toxoid-containing or CRM197-containing vaccine.\n- History of microbiologically proven invasive disease caused by GBS, such as primary or secondary bacteriaemia, septic arthritis, endocarditis, prosthetic joint infection, necrotising myositis and fasciitis or pyelonephritis.\n- Acute febrile illness, fever (temperature ≥38⁰C) before randomisation or an acute infection in the 7 days before screening and before the first dose.\n- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.\n- Any acute or chronic medical condition that, in the investigator’s judgement, would make the participant unsuitable for participation in the trial.\n- Any psychiatric condition, including recent (within the past year) active suicidal ideation/behaviour that may increase the risk of trial participation or, in the investigator’s judgement, make the participant unsuitable for participation in the trial."}

Primary endpoints

• {"endpoint_text":"- At 28 days after the third vaccination: o Anti-tetanus toxoid antibody concentration ≥0.1 IU/mL o Anti-diphtheria toxoid antibody concentrations ≥0.1 IU/mL","definition_or_measurement_approach":"Antibody concentrations measured 28 days after the third vaccination; thresholds specified: anti-tetanus ≥0.1 IU/mL and anti-diphtheria ≥0.1 IU/mL."}
• {"endpoint_text":"- At 28 days after the third vaccination: o Anti-pertussis toxin antibodies o Anti-FHA antibodies o Anti-PRN antibodies","definition_or_measurement_approach":"Measurement of anti-pertussis toxin, anti-FHA and anti-PRN antibody levels 28 days after the third vaccination."}
• {"endpoint_text":"- At 28 days after the third vaccination for Groups 1 and 2; and 28 days after the second vaccination for Groups 3 and 4: o Antibody concentrations for RibN, Alp1N, Alp2N, and AlpCN","definition_or_measurement_approach":"Measurement of antibody concentrations to RibN, Alp1N, Alp2N and AlpCN at 28 days post-specified vaccination (post-third for Groups1/2; post-second for Groups3/4)."}
• {"endpoint_text":"- Solicited local AEs within 7 days after each dose (ie, the day of dosing + 6 days post-dose)","definition_or_measurement_approach":"Recording of solicited local adverse events during the 7-day window after each dose (day of dosing plus 6 days)."}
• {"endpoint_text":"- Solicited systemic AEs within 7 days after each dose (ie, the day of dosing + 6 days post-dose)","definition_or_measurement_approach":"Recording of solicited systemic adverse events during the 7-day window after each dose (day of dosing plus 6 days)."}
• {"endpoint_text":"- Unsolicited AEs within 28 days after each dose (ie, the day of dosing + 27 days post-dose)","definition_or_measurement_approach":"Collection of unsolicited adverse events during the 28-day window after each dose (day of dosing plus 27 days)."}
• {"endpoint_text":"- SAEs from the first dose to the end of the trial","definition_or_measurement_approach":"Serious adverse events collected from the time of first dose through to trial end (ongoing SAE surveillance)."}

Secondary endpoints

• {"endpoint_text":"- MAAEs from the first dose to the end of the trial","definition_or_measurement_approach":"Medically attended adverse events (MAAEs) collected from first dose until the end of the trial."}

Methods

• Website messages (country-specific recruitment material files for BE and PL titled 'Website-Mail' and 'Website message').
• Social media advertising (files labelled SocialMedia for BE, in Dutch and English versions).
• Email campaigns / short emails to potential participants (files labelled 'Short email' and 'Email').
• Posters and flyers at sites (country-specific posters and flyers for BE and PL).
• Registration and pre-screening forms (registration form and pre-screening form documents provided for BE; registration and pre-screening procedures provided for PL).
• Target audience explicitly healthy non-pregnant women aged 18–49 (materials and trial population specified).

Belgium

Earliest CTIS Part Ii Submission Date

04-10-2024

Latest Decision Or Authorization Date

30-10-2024

Processing Time Days

26

Number Of Sites

2

Number Of Participants

224

Poland

Earliest CTIS Part Ii Submission Date

24-10-2024

Latest Decision Or Authorization Date

31-10-2024

Processing Time Days

7

Number Of Sites

2

Number Of Participants

340

Primary sponsor

Full Name

MinervaX ApS

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties codes: 1,10,11,12,13,2,3,5,6,8

Name

Signant Health Global Solutions Limited

Responsibilities

electronic diary

Name

Almac Clinical Services Limited

Responsibilities

Labelling, packaging of IP

Third parties

• {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"electronic diary","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Labelling, packaging of IP","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Meso Scale Diagnostics LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}