A Long-term Follow-up Study to Assess the Persistence of Immunoglobin G (IgG) Antibodies to the GBS-NN/NN2 Vaccine After Vaccination With the GBS-NN/NN2 Vaccine in MVX0002 and/or in MVX0003

Minervax ApS1 个研究点分布在 1 个国家目标入组 29 人开始时间: 2024年1月18日最近更新: 2026年2月25日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方: Minervax ApS
入组人数: 29
试验地点: 1
主要终点: Antibody Concentration Specific for GBS-NN and GBS-NN2

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•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/NN
•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.

排除标准

•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).
•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).

研究组 & 干预措施

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.

干预措施: GBS-NN/NN2 (Biological)

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.

干预措施: GBS-NN/NN2 (Biological)

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.

干预措施: GBS-NN/NN2 (Biological)