GBS-NN, GBS-NN2 for Group B streptococcus infection | Group B streptococcus neonatal sepsis

Inclusion criteria

• {"criterion_text":"- 1. Participant living in Denmark or South Africa who has participated either in Trial MVX0004 or MVX0005 and has received at least 1 dose of the GBS-NN/NN2 vaccine\n- 2. Participant who is able to read and understand and capable of giving personal signed informed consent\n- 3. Participant who is willing and able to comply with scheduled visits, the investigational plan, and other trial procedures\n- 4. Participant who is granting access to their trial-related medical records and to their trial materials from Trials MVX0004 or MVX0005, whatever is applicable\n- 5. Participant who are expected to be available for the duration of the trial and who can be contacted by telephone during trial participation."}

Exclusion criteria

• {"criterion_text":"- 1. 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 employees\n- 2. Participant with confirmed Group B Streptococcus (GBS) infection since participation in Trial MVX0004 or MVX0005\n- 3. Participant with 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\n- 4. Participant who participated in other trials involving investigational drug(s) or devices within 28 days prior to trial entry, and/or are participating in other trials involving investigational drug(s) or devices at trial entry, or plan to (continue to) participate in other trials involving investigational drug(s) or devices during this trial;\n- 5. Participant with known or suspected immunodeficiency or cancer or a family history of congenital or hereditary immunodeficiency\n- 6. Participant receiving chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to trial entry. An immunosuppressive dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted\n- 7. Participant who received blood, blood products, plasma derivatives, or any immunoglobulin preparations in the 12 weeks prior to trial entry or is planning to receive such products during this trial\n- 8. Participant with current or history of drug or alcohol abuse, as judged by the investigator\n- 9. Participant who received any marketed or investigational (other than GBS-NN/NN2 in the MVX0004 or MVX0005 Trial) GBS vaccines or who is planning to receive any marketed or investigational (other than GBS-NN/NN2) GBS vaccines during this trial."}

Primary endpoints

• {"endpoint_text":"- Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL, measured once a year in all participants","definition_or_measurement_approach":"Concentration of IgG antibodies specific to AlpN proteins measured in μg/mL, measured once a year in all participants."}

Secondary endpoints

• {"endpoint_text":"- 1. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL pre-dose, at 1 month post-dose, at delivery, and 6 months after delivery\n- 2. In pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine and their infant: The ratios of antibody concentrations (IgG) between maternal and cord blood at delivery/birth\n- 3. In the pregnant participants who did not receive a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL at delivery\n- 4. In pregnant participants who did not receive a booster dose of the GBS-NN/NN2 vaccine and their infant: The ratios of antibody concentrations (IgG) between maternal and cord blood at delivery/birth\n- 5. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood and at 1 month and 3 months of age\n- 6. In the infants born to participants who did not receive a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood\n- 7. In all participants: Any trial procedure-related SAEs (ie, SAEs related to blood sampling) during the entire trial period\n- 8. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with solicited local and systemic AEs within 7 days after dosing (ie, day of dosing +6 days post-dose)\n- 9. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with unsolicited AEs within 28 days after dosing (ie, the day of dosing +27 days post-dose)\n- 10. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with SAEs up to 6 months after delivery\n- 11. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with AESIs up to delivery\n- 12. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: GA, weight, length, head circumference, and Apgar score\n- 13. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of infant participants with unsolicited AEs up to 1 month of age\n- 14. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: Developmental milestones at 6 months of age\n- 15. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of infant participants with MAAEs, SAEs, and AESIs up to 6 months of age\n- 16. In pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine and their infant: OPkA titres in maternal blood at 1 month post-dose and at delivery\n- 17. In pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine and their infant: PkA titres in infant participants cord blood and at 1 month and 3 months of age","definition_or_measurement_approach":"Endpoints specify concentration measurements of IgG in μg/mL at listed timepoints (pre-dose, 1 month post-dose, delivery, 6 months after delivery, cord blood, infant 1 and 3 months). Other endpoints are proportions of participants experiencing solicited/unlisted AEs within specified windows, SAEs/AESIs up to defined timepoints, transfer ratios between maternal and cord blood, OPkA/PKA titres, and infant birth and developmental measures as described."}

Methods

• Re-contact of participants who previously participated in Trial MVX0004 or MVX0005 and who received at least one dose of GBS-NN/NN2 (eligible population) — countries indicated: Denmark and South Africa (inclusion criterion 1).
• Documented recruitment materials for Denmark: K1_DK_Recruitment Procedure (Recruitment arrangements) and K2_DK_Recruitment Material_Physician to Participant Letter (Danish) — titles available in submission; content not extracted.

Denmark

Earliest CTIS Part Ii Submission Date

02-12-2024

Latest Decision Or Authorization Date

06-12-2024

Processing Time Days

4

Number Of Sites

3

Number Of Participants

52

Primary sponsor

Full Name

MinervaX ApS

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

Almac Clinical Services Limited

Responsibilities

sponsorDuties codes: 14; 15 (15: Labelling, packaging of IP)

Name

Drug Development Solutions Limited

Responsibilities

sponsorDuties codes: 4

Name

Icon Clinical Research Limited

Responsibilities

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

Third parties

• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: 14; 15 (value for code 15: 'Labelling, packaging of IP')","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1, 10, 11, 12, 13, 2, 3, 5, 6, 8","organisation_type":"Pharmaceutical company"}