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A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
Sponsor: Minervax ApS
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
338
Start Date
2025-03-07
Completion Date
2029-06-30
Last Updated
2026-01-30
Healthy Volunteers
Yes
Conditions
Interventions
GBS-NN/NN2 vaccine
0.5 mL (50 μg GBS-NN +50 μg GBS-NN2 adsorbed to 0.5 mg aluminium as Alhydrogel®)
Locations (6)
Hvidovre Hospital - Department Of Obstetrics And Gynaecology
Copenhagen, Capital Region, Denmark
Aarhus Universitetshospital
Aarhus N, Central Jutland, Denmark
Sygehus Lillebælt - Kolding Sygehus
Kolding, Region Syddanmark, Denmark
Sefako Makgatho Health Sciences University, Medunsa Clinical Research Unit (MeCRU)
Ga-Rankuwa, Gauteng, South Africa
Wits Reproductive Health and HIV Institute (Wits RHI)
Johannesburg, Guateng Province, South Africa
Setshaba Research Centre
Pretoria, Guateng Province, South Africa