Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population (ProPositive Study)
试验速览
- 阶段
- 4 期
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in hSBA geometric mean titres to relevant strains of meningococcal B following two doses of the 4CmenB vaccine (Bexsero®) in people living with HIV
研究概览
简要总结
This study aims to evaluate the immunogenicity, safety and tolerability of co-administration of vaccinations for meningitis B (Bexsero®) and meningitis ACWY (Menveo®) in adults and children aged 10-45 years living with HIV. All participants will be vaccinated with both Menveo® and Bexsero® on days 0 and 30. Immunogenicity will be determined on venous blood sampled at days 0 and 60. Adverse effects will be recorded to evaluate safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any 10-45-year old male or female patients with confirmed HIV infection where they (or someone with parental responsibility) can sign fully informed consent and are able to comply with study requirements.
排除标准
- •Pregnancy or breast feeding,
- •History of MenACWY (Menveo® or Nimenrix®) and 4CMenB (Bexsero®) vaccination in the previous 2 years,
- •Receipt of other non-live vaccines within 2 weeks and live vaccines within 4 weeks of first dose, planned receipt of vaccine within 2 weeks of study visits,
- •Current active malignancy,
- •Known latex allergy
- •Known or suspected hypersensitivity to any components of the vaccines or history of severe allergic reaction after previous vaccination
- •Bleeding disorder preventing IM vaccination,
- •Any acute or chronic illness which according to the investigators judgement would prevent patients to receive the vaccines or participate in the study
- •Participation in clinical trials concerning investigational medical product within 0 days or before completion of the study
- •Children in care
研究组 & 干预措施
Single arm
Single arm, open-label, all participants will receive both Bexsero® (meningitis B vaccine) and Menveo® (meningitis ACWY vaccine) vaccines.
干预措施: Bexsero® (meningitis B vaccine) (Biological)
Single arm
Single arm, open-label, all participants will receive both Bexsero® (meningitis B vaccine) and Menveo® (meningitis ACWY vaccine) vaccines.
干预措施: Menveo® (meningitis ACWY vaccine) (Biological)
结局指标
主要结局
Change in hSBA geometric mean titres to relevant strains of meningococcal B following two doses of the 4CmenB vaccine (Bexsero®) in people living with HIV
时间窗: Day 0 (baseline) and Day 60
The human complement serum bactericidal assay (hSBA) mean titres against relevant strains of meningococcal B at baseline and one month after completion of vaccination.
The proportion of participants who achieve at least a four fold increase in hSBA titres.
时间窗: Day 60
Blood will be taken one month after the second vaccine and serum tested for hSBA titres. The proportion of participants who achieve at least a four fold increase in hSBA titres will be calculated.
The proportion of participants who achieve a 'protective' hSBA titre of >1:4 after two doses of Bexsero
时间窗: Day 60
Blood will be taken one month after the second vaccine and serum tested for hSBA titres. The proportion of participants who are deemed to have protective titres \>1:4 will be calculated.
次要结局
- The incidence of solicited and unsolicited adverse and serious adverse events after two doses of MenACWY (Menveo®) and 4CMenB (Bexsero®) vaccines when co-administered in people living with HIV(Day 7 after vaccines 1 and 2)
- The geometric mean titres to Meningococcal ACWY antigens after two doses of the MenACWY (Menveo®) vaccine in people with HIV at one month after the second vaccination(Day 60)
- The proportion of subjects with at least a four fold change in rSBA from baseline to 30 days after the second vaccine(Day 0 and Day 60)
- The proportion of subjects with "protective" rSBA titres >1:8 against relevant MenACWY serogroups after two doses of Menveo(Day 60)