Follow-up on GBS-NN/NN2 Vaccine for Pregnant Women
A Follow-up Trial to Assess the Persistence of the Immune Response to the Group B Streptococcus Vaccine (GBS-NN/NN2) After a Primary Vaccination of Healthy Pregnant Women, and to Assess Safety, Reactogenicity, and Immunogenicity of the GBS-NN/NN2 Vaccine When Administered During Follow-Up as a 1 Booster Dose During a New Pregnancy
This study is testing how long the immunity from the GBS-NN/NN2 vaccine lasts in pregnant women who received it before.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 338 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Minervax ApS Academic / other |
| Drugs / interventions | prednisone |
| Locations | 3 sites (Aarhus N, Midtjylland and 2 other locations) |
| Trial ID | NCT06592586 on ClinicalTrials.gov |
What this trial studies
This study evaluates the persistence of immunoglobulin G (IgG) antibody responses in healthy pregnant women who have previously received the GBS-NN/NN2 vaccine. Participants must have been part of earlier trials and will be monitored for their immune response to specific proteins related to Streptococcus agalactiae. The study aims to gather data on the vaccine's effectiveness in maintaining immunity over time.
Who should consider this trial
Good fit: Ideal candidates are healthy pregnant women living in Denmark or South Africa who have previously participated in related trials and received the GBS-NN/NN2 vaccine.
Not a fit: Patients who have not participated in the earlier trials or those who are not pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the prevention of serious infections in newborns by ensuring effective maternal vaccination.
How similar studies have performed: Other studies on maternal vaccination against Streptococcus agalactiae have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant living in Denmark or South Africa who has participated either in Trial MVX0004 (NCT05154578) or MVX0005 (NCT04596878) and has received at least 1 dose of the GBS-NN/NN2 vaccine. * Participant who is able to read and understand and capable of giving personal signed informed consent. * Participant who is willing and able to comply with scheduled visits, the investigational plan, and other trial procedures. * Participant who is granting access to their trial-related medical records and to their trial materials from Trials MVX0004 or MVX0005, whatever is applicable. * 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: * 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. * Participant with confirmed Group B Streptococcus (GBS) infection since participation in Trial MVX0004 or MVX0005. * 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. * 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. * Participant with known or suspected immunodeficiency or cancer or a family history of congenital or hereditary immunodeficiency. * 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. * 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. * Participant with current or history of drug or alcohol abuse, as judged by the investigator. * 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.
Where this trial is running
Aarhus N, Midtjylland and 2 other locations
- Aarhus Universitetshospital — Aarhus N, Midtjylland, Denmark (Recruiting)
- Sygehus Lillebælt - Kolding Sygehus — Kolding, Syddanmark, Denmark (Recruiting)
- Sefako Makgatho Health Sciences University, Medunsa Clinical Research Unit (MeCRU) — Ga-Rankuwa, Gauteng, South Africa (Active_not_recruiting)
Study contacts
- Study coordinator: Lidia Oostvogels
- Email: lio@minervax.com
- Phone: +45 39178282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.