Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in immunogenic response from baseline, Prevenar13/Pneumovax23
研究概览
简要总结
MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment.
Participants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®/Pneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration.
Immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Seropositive for HIV-1
- •Recipient of ART
- •Plasma HIV-RNA < 500 copies/ml
- •Patients written consent obtained
排除标准
- •Pregnancy or breastfeeding
- •History of meningococcal or pneumococcal vaccination
- •Allergies towards any of the vaccine components
- •Temperature > 38 ᵒC
- •Sign of bacterial infection
- •Previous known or suspected disease caused by N. meningitidis
- •Active AIDS associated illness
- •Active malignancy
- •End-stage renal or liver disease
- •Bleeding disorder
- •Recipient of any blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within the last month
- •Use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.)
研究组 & 干预措施
Menveo + Bexsero
干预措施: Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine (Drug)
Prevenar13 + Pneumovax23
干预措施: 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine (Drug)
结局指标
主要结局
Change in immunogenic response from baseline, Prevenar13/Pneumovax23
时间窗: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
A ≥2-fold rise in serum anti-capsular IgG GMC for 12 shared pneumococcal polysaccharides (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F)
Change in immunogenic response from baseline, Menveo
时间窗: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
A ≥4-fold rise in rabbit complement source (rSBA) for the four serogroups A, C, Y, and W-135. Seroprotection is defined as an rSBA titre ≥1:8 and patients will be classified as previously immune if baseline rSBA is ≥1:8.
Change in immunogenic response from baseline, Bexsero
时间窗: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
A ≥4-fold rise in antibody titers against a panel of four meningococcal serogroup B reference strains between pre-vaccination and post-vaccination timepoints, or a post-vaccination antibody titre ratio of ≥1:4 for individuals who were seronegative before vaccination.
次要结局
- Streptococcus pneumoniae carriage rates(Baseline and day 30 post-vaccination)
- Number of participants with short term adverse events(Day 5 post vaccination)
- Number of participants with long term adverse events(Day 90 post-vaccination)
- Number of participants with immediate adverse events(30 minutes post-vaccination)
- Neisseria meningitidis carriage rates(Baseline and day 30 post-vaccination)
研究者
Thomas Benfield
Clinical professor
Hvidovre University Hospital