CoVPN 3008, Multi-Center, Randomized, Efficay Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern

CoVPN 3008，在 SARS-CoV-2 变异关注地区进行 COVID-19 mRNA 疫苗的多中心、随机、功效研究

• 批准号: 10425151
• 负责人: MYRON Scott COHEN
• 金额: $ 2107.49万
• 依托单位: FAMILY HEALTH INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10425151
• 关键词: AIDS prevention; Address; Adverse effects; Affect; Africa South of the Sahara; Anti-Retroviral Agents; Behavioral; COVID-19; COVID-19 Prevention Network; Characteristics; Clinical Trials; Collaborations; Communities; Complement; Discrimination; Drug Interactions; Epidemic; Evaluation; Face; Goals; HIV; HIV Infections; HIV Vaccine Trials Network; HIV prevention trials network; Individual; Injecting drug user; Intervention; Leadership; New Agents; Opiate Addiction; Participant; Pharmacologic Substance; Phase; Play; Population; Populations at Risk; Poverty; Pregnancy; Prevention; Process; Public Health; RNA vaccine; Randomized; Research; Research Design; Research Personnel; Risk; SARS-CoV-2 variant; Safety; Sexually Transmitted Diseases; Site; Social Behavior; Structure; System; Technology; Woman; appropriate dose; design; drug development; female sex worker; member; men who have sex with men; neutralizing antibody; phase 1 designs; pre-exposure prophylaxis; preference; prevent; preventive intervention; product development; social stigma; success; tool; transgender women who have sex with men; variants of concern; viral resistance; young man; young woman

PROJECT SUMMARY The overarching goal of the HIV Prevention Trials Network (HPTN) is to identify acceptable, feasible, safe, effective and scalable interventions for HIV prevention that address the needs of populations at risk in the U.S. and around the world. The HPTN will address this goal by identifying: 1) new biomedical products and tools for HIV prevention that have unique characteristics, such as longer duration of action, new targets for inhibition of HIV replication, or as multipurpose prevention technologies (MPTs); and (2) integrated strategies that optimize use of proven efficacious prevention interventions and new tools tailored to specific populations at risk to achieve maximal public health impact. These interventions will be evaluated in priority populations for HIV prevention including women in sub-Saharan Africa, young men and women at risk, men who have sex with men (MSM), transgender women (TGW) who have sex with men, female sex workers (FSW) and persons who inject drugs (PWID). The specific aims of this research will be 1) To design and conduct studies of long-acting antiretroviral (ARV) agents and delivery systems for pre-exposure prophylaxis (PrEP); 2) To design and conduct studies to evaluate MPTs that concurrently prevent HIV and pregnancy, sexually transmitted infections (STIs) or opioid dependence; 3) To design and conduct studies in collaboration with the HIV Vaccine Trials Network to evaluate broadly neutralizing antibodies (bnAbs), alone and in combination, for PrEP; 4) To design and conduct integrated strategies for HIV prevention. For the first three aims, the HPTN will use a sequential multi-phase drug development strategy for the evaluation of new candidates for prevention. Phase 1 and 2 studies will be conducted for the evaluation of appropriate dose, safety and tolerability of the agent(s). The most promising systemic agents will be advanced using the criteria for a favorable target product profile for new agents including highly effective and durable protection against HIV, minimal adverse effects and drug interactions, high levels of user acceptability, and a high barrier to viral resistance. Efficacious biomedical prevention interventions will be incorporated into integrated strategy study designs that also include socio- behavioral interventions tailored to the HIV prevention imperatives and contextual needs of the specific populations at risk for HIV infection. Socio-Behavioral research (SBR) will be integral to the success of all aspects of the proposed HPTN HIV prevention agenda. Supportive SBR will be used to strengthen biomedical HIV product development (i.e. to inform user preference and ultimately product design for Phase 1-3 clinical trials), while integrative SBR will play a key role in the process of designing and adapting behavioral and structural interventions to complement biomedical interventions in integrated strategy studies. The HPTN will design and conduct the research through collaboration with its scientific leadership, its research teams, community partners, research participants, pharmaceutical companies and funders.

项目摘要 HIV预防试验网络（HPTN）的总体目标是确定可接受，可行，安全， 有效且可扩展的艾滋病毒预防干预措施，以满足美国有风险的人口需求 和世界各地。 HPTN将通过识别：1）新的生物医学产品和工具来解决此目标 具有独特特征的艾滋病毒预防，例如较长的作用持续时间，抑制的新目标 艾滋病毒复制或作为多用途预防技术（MPT）； （2）优化的集成策略 使用经过验证的有效的预防干预措施和针对有风险的特定人群量身定制的新工具 实现最大的公共卫生影响。这些干预措施将在HIV的优先人群中评估 预防措施，包括撒哈拉以南非洲的妇女，年轻男子和有风险的妇女，与男性发生性关系的男性 男性（MSM），跨性别女性（TGW）与男性发生性关系，女性性工作者（FSW）和 注入药物（PWID）。这项研究的具体目的是1）设计和进行长效研究 抗逆转录病毒（ARV）药物和递送系统，用于预防前预防（PREP）； 2）设计和 进行研究以评估同时预防艾滋病毒和怀孕，性传播感染的MPT （STI）或阿片类药物依赖性； 3）与HIV疫苗试验一起设计和进行研究 网络评估广泛中和抗体（bnabs），单独和组合，以进行准备； 4）设计 并制定预防艾滋病毒的综合策略。对于前三个目标，HPTN将使用顺序 评估新候选者的多相药物开发策略。第1阶段和2 将进行研究以评估适当的剂量，安全性和耐受性。这 最有前途的系统代理将使用有利目标产品配置文件的标准来提高 新药物包括对艾滋病毒的高效和耐用保护，最小的不良反应和药物 相互作用，高水平的用户可接受性以及病毒抗性的高障碍。有效的生物医学 预防干预措施将纳入综合战略研究设计中，其中还包括社会 针对预防HIV预防的命令和特定的上下文需求量身定制的行为干预措施 艾滋病毒感染风险的人群。社会行为研究（SBR）将是所有人的成功不可或缺的一部分 拟议的HPTN HIV预防议程的各个方面。支持SBR将用于增强生物医学 HIV产品开发（即，为用户偏好和最终的产品设计提供了1-3阶段的临床设计 试验），而综合SBR将在设计和适应行为的过程中起关键作用 在综合策略研究中补充生物医学干预措施的结构干预措施。 hptn会 通过与科学领导力，研究团队合作设计和进行研究， 社区合作伙伴，研究参与者，制药公司和资助者。