Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) An Observational Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Proportion of participants with detectable anti-orthopox antibodies
研究概览
简要总结
This observational study has been designed to characterize humoral and cellular immune responses after vaccination against monkeypox (MKP) in HIV positive and negative individuals at high risk of MKP infection during the vaccination campaign in the current monkeypox outbreak.
详细描述
Of the 23,837 cases of monkeypox reported in the European Region of the WHO, 7.037 have been identified in Spain, according to the National Epidemiological Surveillance Network (RENAVE). Most of diagnosed individuals are men born in Spain, being nearly 40% HIV positive. The clinical evolution was satisfactory, although 3-7% of cases required hospitalization.
Given the limited number of available doses of the MVA-BN vaccine, it has been recently approved its use as a single intradermal dose. However, this posology can be more reactogenic than subcutaneous injection and there is limited data on its immunogenicity and effectiveness in people living with HIV (PLWH), which account for about half of the monkeypox cases in the current outbreak.
The present observational study has been designed to investigate the humoral and cellular immune responses following monkeypox vaccination in PLWH.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult individuals of ≥18 years old.
- •Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the trial.
- •Has understood the information provided and capable of giving informed consent.
排除标准
- •1. Participant has any medical condition and/or finding that in the investigator opinion might increase participant risks, interfere with the study or impair interpretation of study data.
研究组 & 干预措施
MKP vaccination for pre-exposure prophylaxis (HIV positive)
HIV positive individuals who receive MKP vaccination for pre-exposure prophylaxis
MKP vaccination for pre-exposure prophylaxis (seronegative individuals)
HIV seronegative individuals who receive MKP vaccination for pre-exposure prophylaxis
结局指标
主要结局
Proportion of participants with detectable anti-orthopox antibodies
时间窗: Between day 29 - 90
Proportion of participants with detectable anti-orthopox antibodies at 29 - 90 days following first MVA-BN vaccination
Quantification of anti-orthopox antibodies
时间窗: Between day 29 - 90
Quantification of anti-orthopox antibodies at 29 - 90 days following first MVA-BN vaccination
次要结局
- To compare neutralization capacity between HIV negative and HIV positive individuals(Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable))
- Changes of the immunogenicity after the first vaccine dose(Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable))
- Neutralization capacity of anti-orthopox antibodies(Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable))
- To compare immunogenicity between HIV negative and HIV positive individuals(Between day 29 - 90 and between 150-180 (after the first dose) and between 29 - 90 and between 150-180 (after the second dose if applicable))