PACTR202210840719552尚未招募2 期
A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of rVSV?G-LASV-GPC Vaccine in Adults and Children Residing in West Africa.
IAVI0 个研究点目标入组 612 人开始时间: 2022年4月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 612
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •Adults, adolescents, and children in good general health as assessed by medical history, physical examination, and laboratory tests who are =18 months and <71 years of age, who (themselves or as parents of minor children) are willing to comply with the requirements of the protocol and understand the information provided and potential impact and/or risks associated with the trial, are eligible to participate. People Living with HIV (PLWH) can also participate if they are on stable Highly Active Antiretroviral Therapy (HAART) therapy and meet specific criteria including viral load <50 copies/ml. Women of childbearing potential (WOCBP) must commit to use an effective method of contraception and all sexually active participants must be willing to use male or female condoms for 4 months after receipt of IP. Potential participants must be willing to forgo donation of blood or any other tissues from screening onward throughout the course of the study.
排除标准
- •1. Potential participants will not be eligible to participate in this study if they have confirmed HIV-1 or HIV-2 infection (except for Group 2).
- •2. They will also be excluded if they have any clinically relevant abnormality on history or examination or have any clinically significant acute or chronic medical condition that is considered progressive (group-specific exceptions apply).
- •3. Participants must not be pregnant or lactating.
- •4. Except as specifically described in the protocol, if participants have a bleeding disorder, any acute or active chronic infectious disease, history of splenectomy or other immunocompromising as well as significantly abnormal laboratory parameters, they are also excluded.
- •5. They are excluded if they have recently received an investigational product (IP) in another clinical trial or have a history of severe local or systemic reactogenicity to vaccines.
- •6. Participants are not eligible if they report a history of symptomatic, diagnosed Lassa fever disease (LF), or Ebola virus disease (EVD), or have received a candidate vaccine against LF.
- •7. Participation will be deferred in case of other recent vaccinations. Body mass index (BMI) must be <35 for adults, and weight for height <2 standard deviation (SD) from median for adolescents. Weight for height/length must be >-2 SD from median for children and adolescents.
- •8. They should have no psychiatric condition or substance abuse in the last 3 years that compromises their safety, nor seizure disorder in the last 3 years.
- •9. Hearing must be normal for all participants or mildly reduced for adult participants aged 18 years and risk factors for hearing loss must be absent.
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