NCT05005247

Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine

A follow-on Study to Assess the Safety and Immunogenicity of a Booster Dose of GBS-NN/NN2 Vaccine 1 to 5 Years After GBS-NN/NN2 Recipients in Study MVX0002 Have Completed the Primary Vaccination Course, in Comparison With a Single Dose of GBS-NN/NN2 Administered in Placebo Participants From Study MVX0002 or Vaccine naïve Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Minervax ApS · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is an open label booster vaccine follow-up study. Participants who had received a primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive a booster dose (or first dose in the case of placebo or vaccine naïve participants) 1 to 5 years after the completion of the primary course of vaccination. All participants will receive a single dose of GBS-NN/NN2 containing 50μg of each fusion protein.

Detailed description

This is an open label vaccine booster follow-up study. Participants who had received a primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive a booster dose (or first dose in the case of placebo or vaccine naïve participants) 1 to 5 years after the completion of the primary course of vaccination. All participants will receive a single dose of GBS-NN/NN2 containing 50μg of each fusion protein. A minimum of 30 and a maximum of 40 female participants will be recruited, comprised of between 20 and 30 participants who had received previous vaccination with GBS-NN/NN2 in the MVX0002 study and up to 10 participants who had received placebo in the MVX0002 study. If an insufficient number of participants (less than 5) who previously received placebo return to this study, vaccine naïve participants will be recruited. The study will include 7 visits: Visit 1 (Screening), Visit 2 (Day 1 dosing), Visit 3 (Day 8), Visit 4 (Day 29), Visit 5 (Day 57), Visit 6 (Day 85) and Visit 7 (Day 183 Follow-up).

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: 2021-08-17
• Primary completion: 2022-08-05
• Completion: 2022-08-05
• First posted: 2021-08-13
• Last updated: 2024-10-10
• Results posted: 2024-10-10

Locations

1 site across 1 country: United Kingdom