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临床试验/NCT03970733
NCT03970733已完成2 期

ALTERNATIVE SCHEDULE STUDY FOR VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS, IN HEALTHY ADULTS AGED 18 TO 65 YEARS - A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY.

Pfizer10 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2019年7月1日最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
发起方
Pfizer
入组人数
246
试验地点
10
主要终点
GMTs for IgG Against Each OspA Serotype
研究概览研究设计入排标准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

In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180.

In the Booster Phase subjects from the higher dose group who completed their primary immunization schedule according to protocol will be randomized 2:1 to receive an additional higher dose VLA15 vaccination or Placebo at Month 18.

Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months.

Study duration per subject in the Booster Phase is a maximum of approximately 13 months.

Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months.

Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.

详细描述

This is a randomized, observer-blind (subject, Sponsor and investigator/site staff involved in Clinical Evaluation of subjects are blinded), Placebo controlled, multicenter Phase 2 study.

In Main Study Phase a total of 246 healthy subjects,aged 18 to 65 years, were randomized 2:2:1 to receive either VLA15 with Alum (lower or higher doser Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1 (Month 0), Day 57 (Month 2) and Day 180 (Month 6).

Subjects from the higher dose group who completed their primary immunization schedule according to protocol, will be randomized 2:1 to receive an additional injection of the higher dose VLA15 with Alum or Placebo in a Booster Phase. The additional vaccination is administered as intramuscular injection approximately 18 months after the first immunization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

GMTs for IgG Against Each OspA Serotype

时间窗: Day 208 (Month 7)

Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer Surface Protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 208 (Month 7)

次要结局

  • GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase(Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18))
  • Percentage of Participants With Related Unsolicited AEs During the Main Study Phase(From Day 1 of vaccination up to Day 545 (Month 18))
  • SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population(Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30)
  • GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population(Month 18 (from where comparison was done), Month 19, Month 24 and Month 30)
  • GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years(Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18))
  • Percentage of Participants With Related AESIs During the Main Study Phase(From Day 1 of vaccination up to Day 545 (Month 18))
  • Percentage of Participants With Unsolicited AEs During the Main Study Phase(From Day 1 of vaccination up to Day 545 (Month 18))
  • GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years(At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18))
  • GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years(Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18))
  • Percentage of Participants With Serious Adverse Events (SAEs) During the Main Study Phase(From Day 1 of vaccination up to Day 545 (Month 18))
  • GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population(Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30)
  • Percentage of Participants With Related SAEs During the Entire Booster Phase(From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months))
  • Percentage of Participants With Related AESIs During the Entire Booster Phase(From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months))
  • Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase(SAEs and AESIs: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months); AEs: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month))
  • GMTs for IgG Against Each OspA Serotype During the Main Study Phase(At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 365 (Month 12) and Day 545 (Month 18))
  • SCRs for Each OspA Serotype Specific IgG During the Main Study Phase(Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18))
  • SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years(Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18))
  • Percentage of Participants Adverse Event of Special Interest (AESIs) During the Main Study Phase(From Day 1 of vaccination up to Day 545 (Month 18))
  • Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase(From Day 1 of vaccination up to Day 545 (Month 18))
  • Percentage of Participants With Related Unsolicited AEs During the Booster Phase up to Month 19(From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month))
  • GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years(At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18))
  • SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years(Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18))
  • Percentage of Participants With Related SAEs During the Main Study Phase(From Day 1 of vaccination up to Day 545 (Month 18))
  • GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years(At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30)
  • SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years(Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30)
  • Percentage of Participants With Unsolicited AEs During the Booster Phase up to Month 19(From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month))
  • Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase(Up to 7 days after Vaccination 1, 2 and 3; Up to 7 days after any vaccination)
  • GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population(At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30)
  • GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population(Day 208 (from where comparison was done), Month 19, Month 24 and Month 30)
  • Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination(Within 7 days after booster vaccination)
  • GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years(At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30)
  • SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years(Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30)
  • Percentage of Participants With SAEs During the Entire Booster Phase(From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months))
  • Percentage of Participants With Adverse Event of Special Interest (AESIs) During the Entire Booster Phase(From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months))

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (10)

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