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 艾滋病毒预防试验网络（HPTN）的总体目标是确定可接受的，可行的，安全的， 有效和可扩展的艾滋病毒预防干预措施，以满足美国高危人群的需求。 和在世界各地. HPTN将通过以下方式实现这一目标：1）新的生物医学产品和工具， 艾滋病毒预防具有独特的特点，如作用持续时间更长，新的抑制目标， 艾滋病毒复制，或作为多用途预防技术（MPT）;（2）优化 使用经证明有效的预防干预措施和针对特定高危人群的新工具， 实现最大的公共卫生影响。这些干预措施将在艾滋病毒优先人群中进行评价 包括撒哈拉以南非洲的妇女、处于危险中的青年男女、与同性恋发生性关系的男子 男男性行为者（MSM）、男男性行为者（TGW）、女性性工作者（FSW）和 注射毒品（PWID）。本研究的具体目的是：1）设计和进行长效 抗逆转录病毒（ARV）药物和暴露前预防（PrEP）输送系统; 2）设计和 开展研究，评估同时预防艾滋病毒和怀孕、性传播感染的MPT （3）与艾滋病毒疫苗试验合作设计和开展研究 网络，以评估广泛中和抗体（bnAb），单独和组合，为PrEP; 4）设计 并实施艾滋病毒预防综合战略。对于前三个目标，HPTN将使用顺序 多阶段药物开发战略，用于评价新的预防候选药物。1期和2期 将进行研究以评估药物的适当剂量、安全性和耐受性。的 大多数有前途的全身性药物将使用有利的目标产品特征的标准来推进， 新的药物，包括对艾滋病毒的高度有效和持久的保护，最小的副作用和药物 交互性、高水平的用户可接受性以及对病毒抗性的高屏障。高效生物医学 预防干预措施将被纳入综合战略研究设计，其中还包括社会、 针对艾滋病毒预防的必要性和特定人群的背景需要的行为干预措施 有感染艾滋病毒风险的人群。社会行为研究（SBR）将是所有成功的组成部分 HPTN艾滋病毒预防议程的各个方面。支持SBR将用于加强生物医学 HIV产品开发（即告知用户偏好并最终用于1-3期临床的产品设计） 试验），而综合SBR将在设计和适应行为和 在综合战略研究中采取结构性干预措施，以补充生物医学干预措施。HPTN将 通过与其科学领导层、研究团队 社区合作伙伴、研究参与者、制药公司和资助者。