A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women

Phase 2

Not yet recruiting

• Conditions: Streptococcus Agalactiae Infection; Neonatal Sepsis; Pneumonia; Meningitis; Neonatal Infection; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

• Registration Number: NCT06592586
• Lead Sponsor: Minervax ApS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-9-9
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Female
• Target Recruitment: 338

Inclusion Criteria

Inclusion Criteria:<br><br> - Participant living in Denmark or South Africa who has participated either in Trial<br> MVX0004 (NCT05154578) or MVX0005 (NCT04596878) and has received at least 1 dose of<br> the GBS-NN/NN2 vaccine.<br><br> - Participant who is able to read and understand and capable of giving personal signed<br> informed consent.<br><br> - Participant who is willing and able to comply with scheduled visits, the<br> investigational plan, and other trial procedures.<br><br> - Participant who is granting access to their trial-related medical records and to<br> their trial materials from Trials MVX0004 or MVX0005, whatever is applicable.<br><br> - Participant who are expected to be available for the duration of the trial and who<br> can be contacted by telephone during trial participation.<br><br>Exclusion Criteria:<br><br> - Any personnel involved in the conduct of the trial (and their family members),<br> including, but not limited to, site staff members, MinervaX employees, and any<br> vendor or contract research organisation (CRO) employees.<br><br> - Participant with confirmed Group B Streptococcus (GBS) infection since participation<br> in Trial MVX0004 or MVX0005.<br><br> - Participant with any psychiatric condition, including recent (within the past year)<br> active suicidal ideation/behaviour that may increase the risk of trial participation<br> or, in the investigator's judgement, make the participant unsuitable for<br> participation in the trial.<br><br> - Participant who participated in other trials involving investigational drug(s) or<br> devices within 28 days prior to trial entry, and/or are participating in other<br> trials involving investigational drug(s) or devices at trial entry, or plan to<br> (continue to) participate in other trials involving investigational drug(s) or<br> devices during this trial.<br><br> - Participant with known or suspected immunodeficiency or cancer or a family history<br> of congenital or hereditary immunodeficiency.<br><br> - Participant receiving chronic administration (defined as more than 14 continuous<br> days) of immunosuppressants or other immune-modifying drugs within 6 months prior to<br> trial entry. An immunosuppressive dose of glucocorticoid will be defined as a<br> systemic dose =10 mg of prednisone per day or equivalent. The use of topical,<br> inhaled, and nasal glucocorticoids will be permitted.<br><br> - Participant who received blood, blood products, plasma derivatives, or any<br> immunoglobulin preparations in the 12 weeks prior to trial entry or is planning to<br> receive such products during this trial.<br><br> - Participant with current or history of drug or alcohol abuse, as judged by the<br> investigator.<br><br> - Participant who received any marketed or investigational (other than GBS-NN/NN2 in<br> the MVX0004 or MVX0005 Trial) GBS vaccines or who is planning to receive any<br> marketed or investigational (other than GBS NN/NN2) GBS vaccines during this trial.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum