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临床试验/NCT05863585
NCT05863585尚未招募1 期

An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, Given to a Population of Adults in Good General Health Who Have Received 3 Doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted

International AIDS Vaccine Initiative0 个研究点目标入组 14 人开始时间: 2023年6月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
14
主要终点
To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

研究概览

简要总结

An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to a Population of Adults in Good General Health Who have Received 3 doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted

详细描述

This is an open-label study to evaluate the safety and immunogenicity of 2 doses of 100µg of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to HIV-1 uninfected adults in good general health who have received 3 doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted, as part of Protocol IAVI C101 (NCT04224701).

Up to 14 participants, who had enrolled in and completed the phase 1 Protocol IAVI C101 "A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults (NCT04224701) and who received 3 doses of 300µg of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted, will be recruited into the study. Protocol IAVI C101 evaluated the capacity of GT1.1 to prime desirable on-target responses against the CD4 binding site (CD4bs) of the HIV virion, including but not limited to VRC01 class responses, as well as against V2-apex.

This study, Protocol IAVI C107, will examine if maturation of anti-HIV antibody response occurs following boost immunizations with BG505 SOSIP.664 gp140 Vaccine, Adjuvanted. It is expected that this study will provide insight into if and how BG505 SOSIP.664 immunization can expand and mature desirable on-target CD4bs and V1V2-apex responses.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 51 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

Experimental

BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) Dosage

干预措施: BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) (Drug)

结局指标

主要结局

To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

时间窗: 1 year

Proportion of participants in each group with potential immune-mediated diseases (pIMDs) from the day of first vaccine administration throughout the study period

次要结局

  • To determine the immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)(1 year)

研究者

申办方类型
Network
责任方
Sponsor

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