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| ID | Type | Description | Link |
|---|---|---|---|
| 332126 | Other Identifier | IRAS |
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Based on data collected in the trial, the primary endpoint could be concluded.
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| Name | Class |
|---|---|
| Simbec-Orion Group | INDUSTRY |
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The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2. The main question it aims to answer is to determine the persistence of the immune response induced by the GBS-NN/NN2 vaccine by measuring antibody concentrations.
Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination.
This is a follow-up study to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine. No vaccine or placebo will be administered. A single 10 mL blood sample will be collected from participants, every year, for a maximum of 4 years. Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination.
Only participants that received two doses GBS-NN/NN2 in MVX0002 and all participants that received a single dose in MVX0003 will be eligible.
Hence, participants will have received:
One dose of GBS-NN/NN2 prior to this study, i.e., participants from MVX0003 who had not received GBS-NN/NN2 in MVX0002 and received a single dose in MVX0003.
Or two doses of GBS-NN/NN2 prior to this study, i.e., participants from MVX0002 who had received two doses of GBS-NN/NN2 in MVX0002 and did not take part in MVX0003.
Or three doses of GBS-NN/NN2 prior to this study, i.e., participants from MVX0003 who had received two doses of GBS-NN/NN2 in MVX0002 and received a single dose in MVX0003.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One dose of GBS-NN/NN2 | Participants who participated in study MVX003 and had received one dose of GBS-NN/NN2 prior to this study. |
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| Two doses of GBS-NN/NN2 | Participants who participated in study MVX002 and had received two doses of GBS-NN/NN2 prior to this study. |
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| Three doses of GBS-NN/NN2 | Participants who participated in study MVX002 and MVX003 and had received three doses of GBS-NN/NN2 prior to this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBS-NN/NN2 | Biological | GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2 |
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| Measure | Description | Time Frame |
|---|---|---|
| Antibody Concentration Specific for GBS-NN and GBS-NN2 | Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for GBS-NN and GBS-NN2 will be collected during the study. | Baseline (Year 0), Years 1, 2, 3, 4 |
| Ig G Antibody Responses Specific to Alpha like proteins (Alp): AlpCN | Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study | Baseline (Year 0), Years 1, 2, 3, 4 |
| Ig G Antibody Responses Specific to Alp: RibN | Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study | Baseline (Year 0), Years 1, 2, 3, 4 |
| Ig G Antibody Responses Specific to Alp: Alp1N | Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study | Baseline (Year 0), Years 1, 2, 3, 4 |
| Ig G Antibody Responses Specific to Alp: Alp2-3N | Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study | Baseline (Year 0), Years 1, 2, 3, 4 |
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Inclusion Criteria:
Exclusion Criteria:
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A minimum of 20 and a maximum of 55 female participants, all of whom received previous vaccination with GBS-NN/NN2 in the MVX0002 and MVX0003 studies, will be recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Ebbe Englev | Study Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec-Orion Clinical Pharmacology | Merthyr Tydfil | Pentrebach Merthyr Tydfil CF48 4DR | United Kingdom |
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