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MM 008首选设计特征识别
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的妇女身上。
避孕药不使用避孕药具的原因多种多样;一个常见的原因是,许多人
由于真实的和感觉到的副作用,妇女对使用外源激素有强烈的反感。很可能
如果有一个非激素的使用者,
控制避孕方法,不需要在性交前立即使用,也不需要每天给药。我们
我相信我们可以创造出一种基于阴道输送抗精子的非激素避孕药
一种单克隆抗体(mAb),它能凝集精子并将其捕获在粘液中,从而阻止精子从粘液中排出。
到达鸡蛋。我们已经开发了一种非常有效的mAb,MM 008,它靶向一种已经充分表征的
并验证了普遍存在于所有人类精子上的抗原靶标。MM 008具有高度均匀性,
稳定,并且可以使用常规的生物制造方法以非常高的产率生产。更
重要的是,MM 008比文献中已知的最好的抗精子IgG--aggulutinate--的效力高>16倍
在绵羊阴道中,精子的运动性可降低99.9%
每只羊仅需33微克的剂量即可在2分钟内完成。我们已经证明,我们可以稳定地释放MM 008
从一个专有的胶囊阴道环(IVR)系统,维持高效浓度的
MM 008在绵羊阴道中持续20天以上(在大多数情况下,
妇女)。这些极具前景的结果促使我们积极将MM 008-IVR推向临床。我们的目标
是推进一种产品,适合许多妇女的避孕需求,既有高效率,
用户采用。因此,对我们来说,严格调查用户的偏好和偏好是很重要的,
可能会影响他们尝试或使用该产品的意愿。在本提案中,我们寻求回应RFA HD-22-
019确定首选使用特征(PUC)并调查用户感官知觉,
MM 008-IVR的经验。在具体目标1中,我们将进行混合方法综合设计研究,
检查非激素避孕的可感知性和PUCs,包括一项手内比较
评估我们的MM 008-IVR的变体。这些用户洞察力将通过定量分析进行初步调查。
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
用户体验研究,以评价阴道插入和使用后的感知性和相关PUC
外观和物理性质与目标1中的优选MM 008-IVR相同的非药物IVR。
成功完成拟议的工作将有助于确保我们正在推进一个产品,可以满足
避孕需求和偏好的数百万妇女在美国和世界各地。
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)
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Keiichiro Kushiro其他文献
Keiichiro Kushiro的其他文献
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{{ truncateString('Keiichiro Kushiro', 18)}}的其他基金
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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:
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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
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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
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$ 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
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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:
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