Immunogenicity and Efficacy of SARS-CoV-2 stabilized prefusion Spike protein vaccines in infant rhesus macaques

SARS-CoV-2 稳定预灌注 Spike 蛋白疫苗在幼年恒河猴中的免疫原性和功效

基本信息

  • 批准号:
    10223633
  • 负责人:
  • 金额:
    $ 13.75万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2020
  • 资助国家:
    美国
  • 起止时间:
    2020-08-10 至 2020-11-30
  • 项目状态:
    已结题

项目摘要

ABSTRACT The emergence of the highly-transmissible novel coronavirus SARS-CoV-2 has led to a global pandemic of severe respiratory disease. While elderly individuals and adults with co-morbidities are high risk populations, coronavirus disease (COVID-19) can occur in individuals across all age groups, including infants. Therefore, it will be important to develop a vaccine that can be administered in early life and generate long term immunity to end the COVID19 pandemic. While initial safety testing of vaccine candidates will occur in adult populations, there are many potential advantages of targeting the vaccine to the pediatric vaccine schedule including high rates of pediatric vaccine coverage and potential for lifelong immunity. In fact, infants can respond remarkably well to protein antigens, including the hepatitis B and candidate HIV envelope vaccines, and there is evidence that HIV-infected infants are better equipped to generate HIV-neutralizing antibodies. Moreover, our previous work in human and rhesus monkeys has established that infants are able to generate HIV Env vaccine responses of comparable or higher magnitude to that of adults that persist for months and are able to be boosted. The parent grant P01 AI117915-06 “Early Life Vaccination to Prevent HIV Acquisition in Adolescence” aims to assess candidate HIV envelope mRNA and SOSIP trimer vaccines in infant rhesus monkey nonhuman primate model and determine their efficacy against HIV acquisition in adolescence. As related complementary studies, we propose to assess the immunogenicity and efficacy of candidate SARS-CoV-2 spike (S) protein and mRNA vaccine candidates in infant rhesus monkeys. We hypothesize that infants can mount effective and persistent systemic and mucosal antibody responses to SARS-CoV-2 vaccination that will protect against virus challenge. This work will provide preclinical safety, immunogenicity, and efficacy data on leading SARS-CoV-2 vaccine platforms that can de-risk human trials in pediatric populations and justify bypassing time consuming and expensive age de-escalation studies. The end of the SARS-CoV-2 pandemic will require high global coverage with a vaccine that prevents viral spread and generates long lasting immunity, which may best be achieved with a pediatric targeted vaccine.
摘要 高度传播的新型冠状病毒SARS-CoV-2的出现导致了全球大流行, 严重的呼吸道疾病。虽然老年人和患有合并症的成年人是高危人群, 冠状病毒病(COVID-19)可发生在所有年龄组的个体中,包括婴儿。因此 开发一种可以在生命早期接种并产生长期免疫力的疫苗将是重要的。 结束COVID 19大流行。虽然候选疫苗的初步安全性测试将在成年人群中进行, 将疫苗靶向于儿科疫苗时间表有许多潜在的优点, 儿童疫苗覆盖率和终身免疫潜力。事实上,婴儿对 以及蛋白抗原,包括乙肝B和候选HIV包膜疫苗,有证据表明, 感染艾滋病毒的婴儿能够更好地产生艾滋病毒中和抗体。此外,我们以前的 在人类和恒河猴身上的研究已经证实,婴儿能够产生HIV Env疫苗 与成年人相当或更高幅度的反应,持续数月,并能够 提振。父母补助金P01 AI 117915 -06“预防青少年感染艾滋病毒的早期接种” 目的是评估候选HIV包膜mRNA和SOSIP三聚体疫苗在婴儿恒河猴非人中的应用 灵长类动物模型,并确定其对青春期艾滋病毒感染的有效性。作为相关补充 研究,我们建议评估候选SARS-CoV-2刺突蛋白的免疫原性和有效性, 在恒河猴幼猴中的mRNA疫苗候选物。我们假设婴儿可以有效地 对SARS-CoV-2疫苗接种的持续全身和粘膜抗体应答, 对抗病毒的挑战。这项工作将提供临床前安全性、免疫原性和有效性数据, 领先的SARS-CoV-2疫苗平台,可以降低儿童人群的人体试验风险, 绕过了耗时且昂贵的年龄递减研究。SARS-CoV-2大流行的结束 将需要全球高覆盖率的疫苗,以防止病毒传播,并产生持久的免疫力, 这可能最好通过儿科靶向疫苗来实现。

项目成果

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Sallie R. Permar其他文献

Neonatal Cytomegalovirus Infection: Advocacy, Legislation, and Changing Practice
新生儿巨细胞病毒感染:倡导、立法和实践的改变
  • DOI:
    10.1016/j.clp.2024.10.008
  • 发表时间:
    2025-03-01
  • 期刊:
  • 影响因子:
    2.400
  • 作者:
    Ashley Stark;Chelsea M. Crooks;Sallie R. Permar;Kristin Elizabeth Dew Weimer
  • 通讯作者:
    Kristin Elizabeth Dew Weimer
Maternal immune protection against infectious diseases
针对传染病的母体免疫保护
  • DOI:
    10.1016/j.chom.2022.04.007
  • 发表时间:
    2022-05-11
  • 期刊:
  • 影响因子:
    18.700
  • 作者:
    Stephanie N. Langel;Maria Blasi;Sallie R. Permar
  • 通讯作者:
    Sallie R. Permar
Breast milk delivery of an engineered dimeric IgA protects neonates against rotavirus
工程化二聚体免疫球蛋白 A 的母乳递送可保护新生儿免受轮状病毒感染
  • DOI:
    10.1016/j.mucimm.2025.01.002
  • 发表时间:
    2025-04-01
  • 期刊:
  • 影响因子:
    7.600
  • 作者:
    Stephanie N. Langel;Claire E. Otero;Justin T. Steppe;Caitlin A. Williams;Tatiana Travieso;Jerry Chang;Helen Webster;Lauren E. Williamson;James E. Crowe;Harry B. Greenberg;Huali Wu;Christoph P. Hornik;Katayoun Mansouri;Robert J. Edwards;Victoria Stalls;Priyamvada Acharya;Maria Blasi;Sallie R. Permar
  • 通讯作者:
    Sallie R. Permar
Advances in nanomaterial vaccine strategies to address infectious diseases impacting global health
用于解决影响全球健康的传染病的纳米材料疫苗策略的进展
  • DOI:
    10.1038/s41565-020-0739-9
  • 发表时间:
    2020-08-17
  • 期刊:
  • 影响因子:
    34.900
  • 作者:
    Chelsea N. Fries;Elizabeth J. Curvino;Jui-Lin Chen;Sallie R. Permar;Genevieve G. Fouda;Joel H. Collier
  • 通讯作者:
    Joel H. Collier

Sallie R. Permar的其他文献

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{{ truncateString('Sallie R. Permar', 18)}}的其他基金

Identifying and modeling immune correlates of protection against congenital CMV transmission after primary maternal infection
原发性母体感染后预防先天性巨细胞病毒传播的免疫相关性的识别和建模
  • 批准号:
    10677439
  • 财政年份:
    2023
  • 资助金额:
    $ 13.75万
  • 项目类别:
Pediatric Scientist Development Program
儿科科学家发展计划
  • 批准号:
    10619351
  • 财政年份:
    2022
  • 资助金额:
    $ 13.75万
  • 项目类别:
Escape of maternal plasma broadly neutralizing antibody as a mechanism of mother to child HIV transmission
母体血浆广泛中和抗体的逃逸是艾滋病毒母婴传播的机制
  • 批准号:
    10327003
  • 财政年份:
    2021
  • 资助金额:
    $ 13.75万
  • 项目类别:
Pediatric Scientist Development Program
儿科科学家发展计划
  • 批准号:
    10349771
  • 财政年份:
    2020
  • 资助金额:
    $ 13.75万
  • 项目类别:
Pediatric Scientist Development Program
儿科科学家发展计划
  • 批准号:
    10220089
  • 财政年份:
    2020
  • 资助金额:
    $ 13.75万
  • 项目类别:
Project-003
项目-003
  • 批准号:
    10461206
  • 财政年份:
    2019
  • 资助金额:
    $ 13.75万
  • 项目类别:
Core-001
核心001
  • 批准号:
    10461201
  • 财政年份:
    2019
  • 资助金额:
    $ 13.75万
  • 项目类别:
Project-003
项目-003
  • 批准号:
    10441007
  • 财政年份:
    2019
  • 资助金额:
    $ 13.75万
  • 项目类别:
Core-004
核心004
  • 批准号:
    10441005
  • 财政年份:
    2019
  • 资助金额:
    $ 13.75万
  • 项目类别:
Project 1: Immune correlates of cCMV
项目 1:cCMV 的免疫相关因素
  • 批准号:
    10215784
  • 财政年份:
    2019
  • 资助金额:
    $ 13.75万
  • 项目类别:

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青春期和成人发展期间的认知和非认知能力与职业发展:从遗传和环境结构的角度
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