A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy Volunteers (NCT06280157) | Clinical Trial Compass
TerminatedNot Applicable
A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy Volunteers
Stopped: Based on data collected in the trial, the primary endpoint could be concluded.
United Kingdom29 participantsStarted 2024-01-18
Plain-language summary
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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. Able to voluntarily provide written informed consent to participate in the study.
✓. Participant must be fit to participate in the study, as assessed by the investigator.
✓. Participant must be able to comply with study procedures and provide at least 2 blood samples.
Exclusion criteria
✕. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or MinervaX employees, including their family members.
✕. Any known or suspected immunocompromising or immune suppressive condition (including conditions caused by certain immunocompromising/immunosuppressive medication), unless the condition is expected to normalise within 12 weeks after enrolment. If this is the case, then the subject can be enrolled but the blood sampling will be postponed until the condition has normalised.
✕. Received systemic steroids in the 6 weeks before any blood sampling (inhaled and topical steroids are acceptable).
What they're measuring
1
Antibody Concentration Specific for GBS-NN and GBS-NN2
Timeframe: Baseline (Year 0), Years 1, 2, 3, 4
2
Ig G Antibody Responses Specific to Alpha like proteins (Alp): AlpCN
✕. Received blood, blood products, plasma derivatives or any immunoglobulin preparations in the 12 weeks before any blood sampling.
✕. While participants who are enrolled on this study will also be eligible for participation in other clinical trials which may be ongoing during the overall period of participation in this study, they are not allowed to participate in another vaccine study nor in a study involving a licensed or investigational drug which is known or suspected to have an impact on the immune response (immune compromising/suppressing/stimulating).