Antibody-based Contraceptive MPTs: Advancing the Human Contraceptive Antibody (HCA) through Clinical Trials
基于抗体的避孕 MPT:通过临床试验推进人类避孕抗体 (HCA)
基本信息
- 批准号:10532090
- 负责人:
- 金额:$ 171.54万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-09-14 至 2026-08-31
- 项目状态:未结题
- 来源:
- 关键词:AddressAffectAntibodiesAntigensAtopobium vaginaeBiological AssayBostonCDW52 geneCellsCellular ImmunityCervix MucusChild MortalityClinicalClinical ResearchClinical TrialsContraceptive AgentsContraceptive methodsCouplesDataDatabase Management SystemsDatabasesDeveloped CountriesDeveloping CountriesDevelopmentDoseDouble-Blind MethodEndocervixEngineeringEnrollmentEnzyme-Linked Immunosorbent AssayEpidemicFilmFormulationFundingGene ExpressionGoalsGood Clinical PracticeGrantHIV-1HealthHumanHuman Herpesvirus 2ImmobilizationIndustrializationInfectionInfertilityLeadershipManualsMaternal MortalityMeasuresMethodsMonitoring Clinical TrialsMonoclonal AntibodiesNational Institute of Allergy and Infectious DiseaseNational Institute of Child Health and Human DevelopmentNicotianaOryctolagus cuniculusPharmaceutical PreparationsPhasePhase I Clinical TrialsPlacebo ControlPositioning AttributePovertyPreventionProductionProtocols documentationRandomizedRattusRegimenReproductive HealthResearchResearch InstituteResearch Project GrantsSafetySeminal fluidSexual TransmissionSingle-Blind StudySiteSpecificitySperm AgglutinationSperm MotilityTechnologyTestingTexasTissuesToxicologyTrainingUnited States National Institutes of HealthUniversitiesVaginaVaginal Route of Drug AdministrationVirginiaWomanbasecervicovaginalclinical lotcontraceptive efficacycost effectivecytokinedesigndrug testingefficacy testingefficacy trialhuman malehuman monoclonal antibodieshuman subjectimprovedinnovationintergenerationalirritationmalemanufacturing processmedical schoolsmicrobicideminimal riskoperationpathogenpharmacokinetics and pharmacodynamicspre-clinicalpreclinical studypreventprogramsreproductivereproductive tractresearch and developmentsafety studyscale upsperm cellstability testingstatisticsunintended pregnancyvaginal microbiomeyoung womanzygote
项目摘要
CRC OVERALL – ABSTRACT
The overarching goal of our Contraception Research Center (CRC) is to develop
innovative monoclonal antibody (mAb)-based contraceptive and multipurpose prevention
technology (MPT) products with the potential to improve the lives of millions of women globally
by addressing two concurrent reproductive health crises: an unacceptably high rate of unintended
pregnancies in both developing and developed countries, and an epidemic of sexually
transmissible infections (STIs). With funding from NIAID we developed a vaginal film, MB-66,
containing mAbs against HIV-1 and HSV-2 [the first components of our MPT product]. MB-66
was safe and showed good ex vivo efficacy in a Phase 1 Clinical Trial. Under our current NICHD-
funded CRC program we engineered, produced and characterized a GMP-grade human
antisperm mAb “Human Contraception Antibody (HCA)”, and ZB-06, a vaginal film containing
HCA for topical vaginal application. We obtained an exploratory IND, and are currently testing ZB-
06 in a Phase 1 Clinical Trial in women with safety and exploratory efficacy (postcoital test)
endpoints. Preliminary data from the first six women enrolled in the clinical trial indicate that ZB-
06 is safe and highly effective at preventing motile sperm from entering the endocervix, a key
correlate of contraceptive efficacy.
We are seeking to renew our CRC program to advance ZB-06 through further clinical trials.
In Project 1, ZabBio will improve upon and scale up the production of ZB-06 for use in IND-
enabling studies, and in the proposed Phase 1 and Phase 2a clinical trials. ZabBio will file all
paperwork required by the FDA to obtain an IND for the clinical trials, maintain the IND and
monitor the clinical trials. Project 2, to be conducted at Eastern Virginia Medical School and the
University of Texas San Antonio, will be responsible for the conduct of the two clinical trials: 1) a
Phase 1 safety and PK study of single dose vs. multiple dose application of ZB-06, and 2) a Phase
2a dose-finding study of ZB-06 film with safety and postcoital test efficacy endpoints. Project 3,
based at Boston University School of Medicine and Magee-Women’s Research Institute, will
improve upon the vaginal film design, and conduct essential safety studies to support the clinical
trials. An Administrative Core will provide leadership and fiscal management for all projects, and
database and statistical support for the clinical trials. By the end of the project we expect that ZB-
06 will be positioned for Phase 2b contraceptive efficacy testing by the NIH Contraceptive Trials
Network.
CRC总体-摘要
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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Deborah J Anderson其他文献
Human Male Genital Tract Immunity
人类男性生殖道免疫
- DOI:
10.1016/b978-0-12-415847-4.00109-9 - 发表时间:
2015 - 期刊:
- 影响因子:6
- 作者:
Deborah J Anderson;J. Pudney - 通讯作者:
J. Pudney
The Induction of Mucosal Immunity in the Female Genital Tract Using Gene‐Gun Technology Part 1: Antigen Expression
利用基因枪技术诱导女性生殖道粘膜免疫第1部分:抗原表达
- DOI:
10.1111/j.1749-6632.1995.tb44755.x - 发表时间:
1995 - 期刊:
- 影响因子:5.2
- 作者:
J. Livingston;Shan Lu;H. Robinson;Deborah J Anderson - 通讯作者:
Deborah J Anderson
Detection of human immunodeficiency virus type 1 in semen from seropositive men using culture and polymerase chain reaction deoxyribonucleic acid amplification techniques.
使用培养和聚合酶链反应脱氧核糖核酸扩增技术检测血清阳性男性精液中的 1 型人类免疫缺陷病毒。
- DOI:
- 发表时间:
1991 - 期刊:
- 影响因子:6.7
- 作者:
B. V. Van Voorhis;A. Martínez;K. Mayer;Deborah J Anderson - 通讯作者:
Deborah J Anderson
Understanding the biology of HIV-1 transmission
了解 HIV-1 传播的生物学
- DOI:
10.1016/b978-0-12-374235-3.00002-9 - 发表时间:
2009 - 期刊:
- 影响因子:6
- 作者:
Deborah J Anderson - 通讯作者:
Deborah J Anderson
Evaluation and Treatment of the Infertile Male: White blood cells in semen and their impact on fertility
不育男性的评估和治疗:精液中的白细胞及其对生育力的影响
- DOI:
- 发表时间:
1996 - 期刊:
- 影响因子:0
- 作者:
Deborah J Anderson;Joseph A. Politc - 通讯作者:
Joseph A. Politc
Deborah J Anderson的其他文献
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{{ truncateString('Deborah J Anderson', 18)}}的其他基金
Synthetic mRNA-mediated reversible immunocontraception
合成 mRNA 介导的可逆免疫避孕
- 批准号:
10018523 - 财政年份:2019
- 资助金额:
$ 171.54万 - 项目类别:
Synthetic mRNA-mediated reversible immunocontraception
合成 mRNA 介导的可逆免疫避孕
- 批准号:
10474919 - 财政年份:2019
- 资助金额:
$ 171.54万 - 项目类别:
Preclinical Testing of Human Contraceptive Antibody (HCA) and HCA products
人类避孕抗体(HCA)和HCA产品的临床前测试
- 批准号:
10159120 - 财政年份:2018
- 资助金额:
$ 171.54万 - 项目类别:
Antibody-based Contraceptive MPTs: Preclinical and Clinical Research
基于抗体的避孕 MPT:临床前和临床研究
- 批准号:
10159117 - 财政年份:2018
- 资助金额:
$ 171.54万 - 项目类别:
Project 3: Film Formulation, PK/PD and Safety Studies of ZB-06
项目3:ZB-06的成膜、PK/PD及安全性研究
- 批准号:
10532094 - 财政年份:2018
- 资助金额:
$ 171.54万 - 项目类别:
Project Three: Assessing effects of anti-CD52g Mabs on STD pathogens in semen
项目三:评估抗 CD52g Mab 对精液中 STD 病原体的影响
- 批准号:
9977700 - 财政年份:2017
- 资助金额:
$ 171.54万 - 项目类别:
Project One: Development and Testing of the HCA IVR
项目一:HCA IVR的开发与测试
- 批准号:
9548350 - 财政年份:2017
- 资助金额:
$ 171.54万 - 项目类别:
Seminal Microbiota Associated with Inflammation and HIV Transmission
精液微生物群与炎症和艾滋病毒传播相关
- 批准号:
9221010 - 财政年份:2016
- 资助金额:
$ 171.54万 - 项目类别:
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