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RECRUITING
NCT06592586
PHASE2/PHASE3

A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women

Sponsor: Minervax ApS

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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