User-based identification of preferred design features for MM008, a non-hormonal contraceptive vaginal ring
基于用户的非激素避孕阴道环 MM008 的首选设计特征识别
基本信息
- 批准号:10459077
- 负责人:
- 金额:$ 25.95万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-09-01 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAdherenceAdoptionAntibodiesAntigen TargetingAntigensAppearanceBehaviorBehavioralBenefits and RisksBindingBiomanufacturingCharacteristicsClinicClinical TrialsCoitusColorComplexContraceptive AgentsContraceptive UsageContraceptive methodsDevelopmentDevicesDoseEffectivenessEngineeringEnrollmentEnsureEstheticsEvaluation StudiesExcisionExerciseExogenous Hormone TherapyFederal GovernmentFeedbackFemaleFertilityFocus GroupsFormulationGoalsGroup MeetingsHandHormonalHormonesHospitalsHumanImmunoglobulin GInnovation CorpsInstitutional Review BoardsInterviewLeadLiteratureMeasuresMethodsMonoclonal AntibodiesMucous body substanceOutcomeParticipantPatient RecruitmentsPerceptionPersonsPharmacologyPregnancyProcessPropertyProviderReportingResearch DesignResearch PersonnelSafetySensorySheepSiteSperm MotilitySpermatozoa antibodyState GovernmentSurveysSystemTarget PopulationsThinkingUnited States National Institutes of HealthVaginaVaginal RingVaginal delivery procedureVariantWomanWorkbasecapsulecell motilitycomparativecostdemographicsdesigneggexperiencein vivoinsightmalephysical propertypreferencepreventproduct developmentprogramsprototypereproductive tractsatisfactionside effectsperm cellsuccesssynergismunintended pregnancyuptakewillingness
项目摘要
User-based identification of preferred design features for MM008, a non-hormonal contraceptive
vaginal ring
Project Summary
Nearly half of all pregnancies in the U.S. are unintended, and most occur in women who are not using
contraceptives. There are diverse reasons for not using contraceptives; one common reason is that many
women have a strong aversion to using exogenous hormones due to real and perceived side effects. It is likely
that contraceptive use and satisfaction would substantially increase if there was a non-hormonal, user-
controlled contraceptive method that did not require use immediately prior to intercourse, nor daily dosing. We
believe we can create such a non-hormonal contraceptive based on vaginal delivery of an anti-sperm
monoclonal antibody (mAb) that agglutinates and traps sperm in mucus, thereby preventing sperm from
reaching the egg. We have developed an exceptionally potent mAb, MM008, that target a well characterized
and validated antigen target universally present on all human sperm. MM008 is highly homogeneous and
stable, and can be produced at very high yields using conventional biomanufacturing processes. More
importantly, MM008 is >16-fold more potent than the best anti-sperm IgG known in the literature, aggulutinate
sperm even down to <100 ng/mL, and can reduce progressively motile sperm by 99.9% in the sheep vagina
within 2 mins at a dose of just 33 µg per sheep. We have since shown that we can steadily release MM008
from a proprietary capsule-intravaginal ring (IVR) system that sustains highly effective concentrations of
MM008 in the sheep vagina for over 20 days (more than adequate to cover the fertility window in most
women). These highly promising results motivated us to actively advance MM008-IVR into the clinic. Our goal
is to advance a product that suits the contraceptive needs for many women, with both high efficacy and high
user adoption. Thus, it is important for us to rigorously investigate user pereceptions and preferences that
could impact their willingness to try or use the product. In this proposal, we seek to respond to the RFA HD-22-
019 to identify preferred use characteristics (PUC) and investigate the user sensory perceptions and
experiences for MM008-IVR. In Specific Aim 1, we will conduct mixed method integrative design study to
examine the perceptibility and PUCs of non-hormonal contraception, including an in mano comparative
assessment of variants of our MM008-IVR. These user insights will be investigated initially through quantitative
online survey, and then followed by in-person focus groups. In Specific Aim 2, we will conduct a short-term
user experience study to evaluate the perceptibility and related PUC following vaginal insertion and use of a
non-medicated IVR identical in appearance and physical properties to the preferred MM008-IVR from Aim 1.
Successful completion of the proposed work will help ensure we are advancing a product that can meet the
contraceptive needs and preferences of millions of women in the U.S. and worldwide.
基于用户的非激素避孕药MM008首选设计特征的识别
阴道环
项目摘要
在美国,近一半的怀孕是意外的,大多数发生在没有使用
避孕药。不使用避孕药的原因多种多样;一个共同的原因是
由于实际和感知的副作用,女性对使用外源性激素有强烈的反感。很有可能
如果有一个非荷尔蒙的使用者,避孕用法和满意度将大大增加-
受控避孕方法,不需要在性交前立即使用,也不要求每天服用。我们
相信我们可以创造出这样一种非荷尔蒙避孕药,这种避孕药是基于阴道交付的抗精子
一种单抗,能在粘液中凝集和捕获精子,从而防止精子
够到蛋了。我们已经开发出一种非常有效的单抗MM008,它针对的是一种具有良好特性的
所有人类精子上普遍存在的有效抗原靶标。MM008高度同质化,
稳定性好,可以使用传统的生物制造工艺以非常高的产量生产。更多
重要的是,MM008的效力是文献中已知的最好的抗精子抗体Aggulutate的16倍。
精子含量最低可达100毫微克/毫升,可使绵羊阴道内的活动性精子逐渐减少99.9%
在2分钟内,每只羊只需33微克的剂量。自那以后,我们已经证明,我们可以稳步发布MM008
来自一种专有的胶囊-阴道内环(IVR)系统,该系统可维持高效浓度的
MM008在绵羊阴道中超过20天(足以覆盖大多数受精窗口
女性)。这些非常有希望的结果促使我们积极推动MM008-IVR进入临床。我们的目标
就是开发一种既能满足许多女性的避孕需求,又能达到高效、高效的产品。
用户采用率。因此,对我们来说,严格调查用户的看法和偏好是很重要的
可能会影响他们尝试或使用该产品的意愿。在这项提案中,我们寻求回应RFA HD-22-
019以确定首选使用特征(PUC)并调查用户的感官感知和
MM008-IVR的几点体会在具体目标1中,我们将进行混合方法集成设计研究
检查非荷尔蒙避孕的可知性和PUC,包括操作上的比较
我们的MM008-IVR变种的评估。这些用户洞察力将首先通过量化调查进行
在线调查,然后是面对面的焦点小组。在具体目标2中,我们将进行短期
一项用户体验研究,以评估阴道置入和使用一种药物后的知觉和相关的PUC
非药物IVR在外观和物理特性上与AIM 1的首选MM008-IVR相同。
成功完成拟议的工作将有助于确保我们正在推进的产品能够满足
美国和世界各地数百万女性的避孕需求和偏好。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Keiichiro Kushiro其他文献
Keiichiro Kushiro的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Keiichiro Kushiro', 18)}}的其他基金
Highly Acidifying Intravaginal Rings with Lactobacillus Probiotics to Treat Bacterial Vaginosis
含乳酸菌益生菌的高度酸化阴道环可治疗细菌性阴道病
- 批准号:
10699458 - 财政年份:2023
- 资助金额:
$ 25.95万 - 项目类别:
Fast dissolving antibody tablets for preventing vaginal HSV transmission
用于预防 HSV 阴道传播的快速溶解抗体片
- 批准号:
10547476 - 财政年份:2022
- 资助金额:
$ 25.95万 - 项目类别:
Development of a qualified pharmacokinetic bioassay to support preclinical and clinical studies of MM-008, a non-hormonal contraceptive antibody
开发合格的药代动力学生物测定法以支持非激素避孕抗体 MM-008 的临床前和临床研究
- 批准号:
10459074 - 财政年份:2022
- 资助金额:
$ 25.95万 - 项目类别:
Capsule-intravaginal ring for sustained release of antibodies for non-hormonal contraception and vaginal protection against HIV
胶囊阴道环,用于持续释放抗体,用于非激素避孕和阴道艾滋病毒保护
- 批准号:
9799170 - 财政年份:2021
- 资助金额:
$ 25.95万 - 项目类别:
Capsule-intravaginal ring for sustained release of antibodies for non-hormonal contraception and vaginal protection against HIV
胶囊阴道环,用于持续释放抗体,用于非激素避孕和阴道艾滋病毒保护
- 批准号:
10381449 - 财政年份:2021
- 资助金额:
$ 25.95万 - 项目类别:
相似海外基金
I-Corps: Medication Adherence System
I-Corps:药物依从性系统
- 批准号:
2325465 - 财政年份:2023
- 资助金额:
$ 25.95万 - 项目类别:
Standard Grant
Improving Repositioning Adherence in Home Care: Supporting Pressure Injury Care and Prevention
提高家庭护理中的重新定位依从性:支持压力损伤护理和预防
- 批准号:
490105 - 财政年份:2023
- 资助金额:
$ 25.95万 - 项目类别:
Operating Grants
An innovative, AI-driven prehabilitation platform that increases adherence, enhances post-treatment outcomes by at least 50%, and provides cost savings of 95%.
%20创新、%20AI驱动%20康复%20平台%20%20增加%20依从性、%20增强%20治疗后%20结果%20by%20at%20至少%2050%、%20和%20提供%20成本%20节省%20of%2095%
- 批准号:
10057526 - 财政年份:2023
- 资助金额:
$ 25.95万 - 项目类别:
Grant for R&D
CO-LEADER: Intervention to Improve Patient-Provider Communication and Medication Adherence among Patients with Systemic Lupus Erythematosus
共同领导者:改善系统性红斑狼疮患者的医患沟通和药物依从性的干预措施
- 批准号:
10772887 - 财政年份:2023
- 资助金额:
$ 25.95万 - 项目类别:
Nuestro Sueno: Cultural Adaptation of a Couples Intervention to Improve PAP Adherence and Sleep Health Among Latino Couples with Implications for Alzheimer’s Disease Risk
Nuestro Sueno:夫妻干预措施的文化适应,以改善拉丁裔夫妇的 PAP 依从性和睡眠健康,对阿尔茨海默病风险产生影响
- 批准号:
10766947 - 财政年份:2023
- 资助金额:
$ 25.95万 - 项目类别:
Pharmacy-led Transitions of Care Intervention to Address System-Level Barriers and Improve Medication Adherence in Socioeconomically Disadvantaged Populations
药房主导的护理干预转型,以解决系统层面的障碍并提高社会经济弱势群体的药物依从性
- 批准号:
10594350 - 财政年份:2023
- 资助金额:
$ 25.95万 - 项目类别:
Unintrusive Pediatric Logging Orthotic Adherence Device: UPLOAD
非侵入式儿科记录矫形器粘附装置:上传
- 批准号:
10821172 - 财政年份:2023
- 资助金额:
$ 25.95万 - 项目类别:
Antiretroviral therapy adherence and exploratory proteomics in virally suppressed people with HIV and stroke
病毒抑制的艾滋病毒和中风患者的抗逆转录病毒治疗依从性和探索性蛋白质组学
- 批准号:
10748465 - 财政年份:2023
- 资助金额:
$ 25.95万 - 项目类别:
Improving medication adherence and disease control for patients with multimorbidity: the role of price transparency tools
提高多病患者的药物依从性和疾病控制:价格透明度工具的作用
- 批准号:
10591441 - 财政年份:2023
- 资助金额:
$ 25.95万 - 项目类别:
Development and implementation of peer-facilitated decision-making and referral support to increase uptake and adherence to HIV pre-exposure prophylaxis in African Caribbean and Black communities in Ontario
制定和实施同行协助决策和转介支持,以提高非洲加勒比地区和安大略省黑人社区对艾滋病毒暴露前预防的接受和依从性
- 批准号:
491109 - 财政年份:2023
- 资助金额:
$ 25.95万 - 项目类别:
Fellowship Programs














{{item.name}}会员




