New York City Observational Study of Mpox Immunity: NYC OSMI
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination
研究概览
简要总结
The goal of this study is to assess the immune response, tolerance, and safety of the low-dose intradermal (forearm) mpox vaccine in people who are HIV+ compared to people who are HIV-, and compared to the standard-dose subcutaneous (upper arm) vaccine. The resulting data will fill knowledge gaps, inform public health practices, and address community concerns about the absence of data for low-dose intradermal mpox vaccinations in people living with HIV.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to understand and sign the Informed Consent Form (ICF)
- •≥18 years of age
- •a. Including breastfeeding and pregnant people
- •Must have one or the other of criteria a and b, or can have both:
- •Planning receipt of (in the next 30 days) or have received the mpox vaccine, and/or
- •people with recent mpox infection who are out of isolation (≥30 days after symptom onset)
- •Willingness and ability to participate in all study procedures
排除标准
- •Known clinically significant anemia (i.e., Hb < 10 g/dL)
- •Contraindication to phlebotomy based on investigator judgement; e.g., anti-coagulation therapy with history of phlebotomy complications, or clinically significant thrombocytopenia
- •Any condition that, in the opinion of the Investigator, would make study participation unsafe for the individual or would interfere with the objectives of the study
结局指标
主要结局
Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination
时间窗: Day 14 Post-Second Vaccination
Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
Number of Solicited Adverse Events through Day 14 Post-Vaccinations
时间窗: Day 14 Post-Vaccination
Participants will complete a 14-day diary recording solicited adverse events following each vaccination.
Number of Adverse Events that Occur within 28 Days After Final Vaccination
时间窗: Day 28 Post-Final Vaccination
次要结局
- GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination(Day 28 Post-First Vaccination)
- GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 56 Days After First Vaccination(Day 56 Post-First Vaccination)
- GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 14 Days After Second Vaccination(Day 56 Post-Second Vaccination)
- GMT of Serum Neutralization of Mpox Virus approximately 56 Days After First Vaccination(Day 56 Post-First Vaccination)
- GMT of Serum Neutralization of Mpox Virus approximately 28 Days After First Vaccination(Day 28 Post-First Vaccination)