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临床试验/NCT06592586
NCT06592586进行中（未招募）2 期

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

Minervax ApS6 个研究点 分布在 2 个国家目标入组 137 人开始时间: 2025年3月7日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中（未招募）
发起方
Minervax ApS
入组人数
137
试验地点
6
主要终点
All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum
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 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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
Female
接受健康志愿者
是

入选标准

  • •Participant living in Denmark or South Africa who has participated in Trial MVX0004 (NCT05154578) and has received at least 1 dose of the GBS-NN/NN2 vaccine.
  • •Participant who is able to read and understand and capable of giving personal signed informed consent.
  • •Participant who is willing and able to comply with scheduled visits, the investigational plan, and other trial procedures.
  • •Participant who is granting access to their trial-related medical records and to their trial materials from Trials MVX
  • •Participant who is expected to be available for the duration of the trial and who can be contacted by telephone during trial participation.

排除标准

  • •Any personnel involved in the conduct of the trial (and their family members), including, but not limited to, site staff members, MinervaX employees, and any vendor or contract research organisation (CRO) employees.
  • •Participant with confirmed Group B Streptococcus (GBS) infection since participation in Trial MVX
  • •Participant with any psychiatric condition, including recent (within the past year) active suicidal ideation/behaviour that may increase the risk of trial participation or, in the investigator's judgement, make the participant unsuitable for participation in the trial.
  • •Participant who participated in other trials involving investigational drug(s) or devices within 28 days prior to trial entry, and/or are participating in other trials involving investigational drug(s) or devices at trial entry, or plan to (continue to) participate in other trials involving investigational drug(s) or devices during this trial.
  • •Participant with known or suspected immunodeficiency or cancer or a family history of congenital or hereditary immunodeficiency. Note: Human immunodeficiency virus (HIV) infection is not an exclusion criterion if HIV viral load is ≤1000 copies/mL and the participant has been on antiretroviral therapy for at least 3 months prior to screening and is clinically stable.
  • •Participant receiving chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to trial entry. An immunosuppressive dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
  • •Participant who received blood, blood products, plasma derivatives, or any immunoglobulin preparations in the 12 weeks prior to trial entry or is planning to receive such products during this trial.
  • •Participant with current or history of drug or alcohol abuse, as judged by the investigator.
  • •Participant who received any marketed or investigational GBS vaccines (other than GBS-NN/NN2 in the MVX0004 Trial) or who is planning to receive any marketed or investigational (other than GBS NN/NN2) GBS vaccines during this trial.

研究组 & 干预措施

Pregnant Participants: GBS-NN/NN2 Booster Dose

Experimental

Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) and, become pregnant during this trial, and qualify, will receive a GBS-NN/NN2 booster dose.

干预措施: GBS-NN/NN2 vaccine (Biological)

Non-Pregnant Participants: No GBS-NN/NN2 Booster Dose

No Intervention

Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) who do not become pregnant during this trial will not receive a GBS-NN/NN2 booster dose.

Pregnant Participants: No GBS-NN/NN2 Booster Dose

No Intervention

Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) and, become pregnant during this trial but do not qualify for receiving a GBS-NN/NN2 booster dose.

结局指标

主要结局

All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum

时间窗: Up to approximately 5 years

All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum

时间窗: Up to approximately 4 years

次要结局

  • Concentration of IgG Antibodies to AlpN Proteins in Blood Serum Following GBS-NN/NN2 Booster Dose(Pre-dose, 1 month pots-dose, at delivery, and 6 months post-delivery)
  • Difference in Concentration of IgG Antibodies Between Maternal and Cord Blood at Delivery Following GBS-NN/NN2 Booster Dose(Up until delivery, approximately 5 years)
  • Concentration of IgG Antibodies to AlpN Proteins in Blood Serum at Delivery in the Absence of GBS-NN/NN2 Booster Dose(Up until delivery, approximately 5 years)
  • Number of Offspring Experiencing AESIs from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to 6 months post-birth, approximately 5 years)
  • Difference in Concentration of IgG Antibodies Between Maternal and Cord Blood at Delivery in the Absence of GBS-NN/NN2 Booster Dose(Up until delivery, approximately 5 years)
  • Concentration of IgG Antibody to AlpN Proteins in Blood Serum of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(At delivery and at 1 and 3 months post-birth)
  • Concentration of IgG Antibody to AlpN Proteins in Cord Blood of Offspring from Pregnant Participants who did not Received the GBS-NN/NN2 Booster Dose(Up until birth, approximately 5 years)
  • All Participants: Number of Participants Experiencing Procedure-related Serious Adverse Events (SAEs)(Up to approximately 5 years)
  • Number of Participants Experiencing Solicited Local and Systemic Adverse Events (AEs) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to approximately Day 7)
  • Number of Participants Experiencing Unsolicited AEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to approximately Day 28)
  • Number of Participants Experiencing SAEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to approximately 6 months post-delivery)
  • Number of Participants Experiencing AE of Special Interest (AESI) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up until delivery, approximately 5 years)
  • Gestational Age (GA) of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up until birth, approximately 5 years)
  • Weight of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up until birth, approximately 5 years)
  • Length of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up until birth, approximately 5 years)
  • Head Circumference of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up until birth, approximately 5 years)
  • Apgar Score of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up until birth, approximately 5 years)
  • Number of Offspring Experiencing Unsolicited AEs from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to 1 month post-birth, approximately 5 years)
  • Developmental Milestones of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose as Assessed by the Ages & Stages Questionnaire, 3rd Edition (ASQ-3)(At 6 months post-birth, approximately 5 years)
  • Number of Offspring Experiencing Medically-attended AEs (MAAEs) from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to 6 months post-birth, approximately 5 years)
  • Number of Offspring Experiencing SAEs from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to 6 months post-birth, approximately 5 years)
  • Concentration of IgG Antibodies to AlpN Proteins in Blood Serum in Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Pre-dose, 1 month post-dose, at delivery, and 6 months post-delivery)
  • Concentration Ratio of IgG Antibodies Between Maternal and Cord Blood at Delivery in Pregnant Participants who Received the GBS-NN/NN2 Booster Dose and their Infant(At Delivery, at any time during the trial (Up to approximately 4 years))
  • Concentration of IgG Antibodies to AlpN Proteins in Blood Serum at Delivery in Pregnant Participants who did not Receive the GBS-NN/NN2 Booster Dose(At Delivery, at any time during the trial (Up to approximately 4 years))
  • Concentration Ratio of IgG Antibodies Between Maternal and Cord Blood at Delivery in Participants who did not Receive the of GBS-NN/NN2 Booster Dose(At Delivery, at any time during the trial (Up to approximately 4 years))
  • Concentration of IgG Antibody to AlpN Proteins in Blood Serum in Infants Born to Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(At birth and at 1 and 3 months post-birth)
  • Concentration of IgG Antibody to AlpN Proteins in Cord Blood in Infants Born to Pregnant Participants who did not Receive the GBS-NN/NN2 Booster Dose(At Delivery, at any time during the trial (Up to approximately 4 years))
  • All Participants: Number of Participants Experiencing Procedure-related Serious Adverse Events (SAEs)(Up to approximately 4 years)
  • Number of Participants Experiencing Solicited Local and Systemic Adverse Events (AEs) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to approximately Day 7 post-dose)
  • Number of Participants Experiencing Unsolicited AEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to approximately Day 28 post-dose)
  • Number of Participants Experiencing AEs of Special Interest (AESI) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up until delivery, at any time during the trial (Up to approximately 4 years))
  • Gestational Age (GA) of Infants Born to Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(At Delivery, at any time during the trial (Up to approximately 4 years))
  • Weight of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(At Delivery, at any time during the trial (Up to approximately 4 years))
  • Length of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(At Delivery, at any time during the trial (Up to approximately 4 years))
  • Head Circumference of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(At Delivery, at any time during the trial (Up to approximately 4 years))
  • Apgar Score of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(At Delivery, at any time during the trial (Up to approximately 4 years))
  • Number of Infants Experiencing Unsolicited AEs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to 1 month post-birth)
  • Number of Infants Experiencing Medically-attended AEs (MAAEs) Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to 6 months post-birth)
  • Number of Infants Experiencing SAEs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to 6 months post-birth)
  • Number of Infants Experiencing AESIs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose(Up to 6 months post-birth)

研究者

发起方
Minervax ApS
申办方类型
Other
责任方
Sponsor

研究点 (6)

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