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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like protein 2 and 3 (Alp2-3N), after a primary vaccination with GBS-NN/NN2 in all participants.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus N
Sygehus Lillebælt - Kolding Sygehus
RECRUITING
Kolding
South Africa
Sefako Makgatho Health Sciences University, Medunsa Clinical Research Unit (MeCRU)
RECRUITING
Ga-rankuwa
Wits Reproductive Health and HIV Institute (Wits RHI)
RECRUITING
Johannesburg
Setshaba Research Centre
RECRUITING
Pretoria
Contact Information
Primary
Lidia Oostvogels
lio@minervax.com
+45 39178282
Time Frame
Start Date:2025-03-07
Estimated Completion Date:2029-06-30
Participants
Target number of participants:338
Treatments
No_intervention: Non-Pregnant Participants: No GBS-NN/NN2 Booster Dose
Participants who received at least one dose of GBS-NN/NN2 during the parent studies but do not become pregnant during this study will not receive the GBS-NN/NN2 booster dose.
Participants who received at least one dose of GBS-NN/NN2 during the parent studies and, become pregnant during this study, and qualify, will receive become pregnant during this study will receive the GBS-NN/NN2 booster dose.
No_intervention: Pregnant Participants: No GBS-NN/NN2 Booster Dose
Participants who received at least one dose of GBS-NN/NN2 during the parent studies and, become pregnant during this study but do not qualify for receiving the GBS-NN/NN2 booster dose.