A Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts.
NCT04543357
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1. Males or females who weigh at least 9 kg
2. Anticipated to be living or working in the same household (> or = 10 hours per week and expected to have direct contact with the participant) as a participant in the Phase 3 interventional study, C3391003, for at least 4 months from the time of the screening visit. The participant in C3391003 must have completed their Baseline Visit, but not yet have received IP as part of C3391003
3. The C3391003 participant is subsequently dosed with study intervention after the Baseline Visit
1. Prior treatment with gene therapy utilizing AAV vectors of any serotype.
2. Living or working in a household where 5 other participants are already participating
in this study (C3391007).
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Descriptive Information | |||||
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Brief Title | A Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts. | ||||
Official Title | A Low-Interventional Study Of AAV9 Neutralizing Antibody Seroconversion in Household Contacts of Participants Within the C3391003 Clinical Trial | ||||
Brief Summary | This study will include male and female participants who live or work in the same household as a participant in the Phase 3 interventional study, C3391003. Up to 5 participants from the same household may be enrolled. The objective is to estimate the likelihood of NAb seroconversion to AAV9 in household contacts of a participant in study C3391003 who is treated with PF-06939926 gene therapy. | ||||
Detailed Description | This single center study to include approximately 50 to 250 participants is designed to estimate the likelihood of NAb seroconversion to AAV9 because of exposure to shed viral vector material released by a DMD participant treated with PF-06939926 in study C3391003. Eligible participants will undergo a blood draw provided by a Home Health Care Vendor at three home visits. To maintain the blinded nature of study C3391003, all C3391007 study participants and investigators as well as the sponsor will remain blinded to the Cohort assignment of the C3391003 study participant in the same household until C3391003 becomes unblinded. Additionally, the detailed individual results will be considered sensitive clinical data and will not be shared with the participants, investigators, or the Sponsor until study C3391003 becomes unblinded. The total duration of participation in the study is up to 4 months, including up to 48 days for the screening/baseline period and up to 66 days after dosing of investigational product in the C3391003 participant of the same household. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Other | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description: Blood | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | This single center study will include approximately 50 to 250 participants who live or work in the same household as a participant in the Phase 3 interventional study, C3391003. Up to 5 participants from the same household may be enrolled. | ||||
Condition | Household Contacts | ||||
Intervention | Other: Blood Draw
Blood Samples for NAb and ADA to AAV9 | ||||
Study Groups/Cohorts | All participants
Household contacts of a participant in study C3391003 Intervention: Other: Blood Draw | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Not yet recruiting | ||||
Estimated Enrollment | 250 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | January 29, 2022 | ||||
Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04543357 | ||||
Other Study ID Numbers | C3391007 ARISEN ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | December 2020 |