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: Active_not_recruiting
Location: See all (6) 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
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• 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
Aarhus N
Hvidovre Hospital - Department Of Obstetrics And Gynaecology
Copenhagen
Sygehus Lillebælt - Kolding Sygehus
Kolding
South Africa
Sefako Makgatho Health Sciences University, Medunsa Clinical Research Unit (MeCRU)
Ga-rankuwa
Wits Reproductive Health and HIV Institute (Wits RHI)
Johannesburg
Setshaba Research Centre
Pretoria
Time Frame
Start Date:2025-03-07
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.