NCT06280157

A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy Volunteers

A Long-term Follow-up Study to Assess the Persistence of Immunoglobin G (IgG) Antibodies to the GBS-NN/NN2 Vaccine After Vaccination With the GBS-NN/NN2 Vaccine in MVX0002 and/or in MVX0003

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Minervax ApS · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2. The main question it aims to answer is to determine the persistence of the immune response induced by the GBS-NN/NN2 vaccine by measuring antibody concentrations. Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination.

Detailed description

This is a follow-up study to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine. No vaccine or placebo will be administered. A single 10 mL blood sample will be collected from participants, every year, for a maximum of 4 years. Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination. Only participants that received two doses GBS-NN/NN2 in MVX0002 and all participants that received a single dose in MVX0003 will be eligible. Hence, participants will have received: One dose of GBS-NN/NN2 prior to this study, i.e., participants from MVX0003 who had not received GBS-NN/NN2 in MVX0002 and received a single dose in MVX0003. Or two doses of GBS-NN/NN2 prior to this study, i.e., participants from MVX0002 who had received two doses of GBS-NN/NN2 in MVX0002 and did not take part in MVX0003. Or three doses of GBS-NN/NN2 prior to this study, i.e., participants from MVX0003 who had received two doses of GBS-NN/NN2 in MVX0002 and received a single dose in MVX0003.

Conditions

• Group B Streptococcus Infection

Interventions

Type	Name	Description
BIOLOGICAL	GBS-NN/NN2	GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2

Timeline

• Start date: 2024-01-18
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-02-28
• Last updated: 2026-02-25

Locations

1 site across 1 country: United Kingdom