{"id":420092,"date":"2024-04-05T19:00:00","date_gmt":"2024-04-06T00:00:00","guid":{"rendered":"https:\/\/platohealth.ai\/?post_type=platowire&p=420092"},"modified":"2024-04-05T19:00:00","modified_gmt":"2024-04-06T00:00:00","slug":"connors-protocol-for-the-management-and-use-of-stored-human-specimens-stored-human-specimens","status":"publish","type":"platowire","link":"https:\/\/platohealth.ai\/platowire\/connors-protocol-for-the-management-and-use-of-stored-human-specimens-stored-human-specimens\/","title":{"rendered":"Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)"},"content":{"rendered":"
\n

Studies<\/h3>\n\n\n\n\n\n\n\n\n\n\n<\/tr>\n<\/table>\n<\/div>\n
\n

Detailed Descriptions<\/h3>\n

Study First Submitted Date<\/td>\n2019-03-27<\/td>\n<\/tr>\n
Study First Posted Date <\/td>\n2019-03-29<\/td>\n<\/tr>\n
Last Update Posted Date<\/td>\n2023-04-19<\/td>\n<\/tr>\n
Start Month Year<\/td>\nApril 6, 2024<\/td>\n<\/tr>\n
Primary Completion Month Year<\/td>\nDecember 31, 2029<\/td>\n<\/tr>\n
Verification Month Year<\/td>\nMarch 29, 2023<\/td>\n<\/tr>\n
Verification Date<\/td>\n2023-03-29<\/td>\n<\/tr>\n
Last Update Posted Date<\/td>\n2023-04-19<\/td>\n<\/tr>\n
\n\n\n
Sequence:<\/td>\n20824434<\/td>\n<\/tr>\n
Description<\/td>\nThe HIV intramural research program of NIAID conducts clinical investigations to increase our<\/p>\n

knowledge of the biology, pathogenesis and immunology of HIV infection and vaccine<\/p>\n

development. After all study-related interventions, follow-up, and primary specimen and data<\/p>\n

analyses are complete for an IRB-approved protocol, some human specimens may remain in<\/p>\n

storage, and data may continue to be analyzed to meet secondary and exploratory objectives. This protocol will allow for additional laboratory and data analyses to be continued to complete the analyses described under closed NIAID protocol #14-I-0011, Phase 1 Study of Safety and Immunogenicity of Ad4-HIV Vaccine Vectors in Healthy Volunteers.<\/td>\n<\/tr>\n<\/table>\n<\/div>\n

\n

Facilities<\/h3>\n\n\n\n<\/tr>\n\n\n\n\n\n
Sequence:<\/td>\n201052748<\/td>\n<\/tr>\n
Name<\/td>\nNational Institute of Allergy and Infectious Diseases (NIAID)<\/td>\n<\/tr>\n
City<\/td>\nBethesda<\/td>\n<\/tr>\n
State<\/td>\nMaryland<\/td>\n<\/tr>\n
Zip<\/td>\n20892<\/td>\n<\/tr>\n
Country<\/td>\nUnited States<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Conditions<\/h3>\n\n\n\n\n
Sequence:<\/td>\n52435529<\/td>\n<\/tr>\n
Name<\/td>\nHealthy Volunteer Samples<\/td>\n<\/tr>\n
Downcase Name<\/td>\nhealthy volunteer samples<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Id Information<\/h3>\n\n\n\n\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n<\/table>\n<\/div>\n
\n

Countries<\/h3>\n

Sequence:<\/td>\n40346715<\/td>\nSequence:<\/td>\n40346716<\/td>\n<\/tr>\n
Id Source<\/td>\norg_study_id<\/td>\nId Source<\/td>\nsecondary_id<\/td>\n<\/tr>\n
Id Value<\/td>\n999919074<\/td>\nId Value<\/td>\n19-I-N074<\/td>\n<\/tr>\n
\n\n\n\n
Sequence:<\/td>\n42779426<\/td>\n<\/tr>\n
Name<\/td>\nUnited States<\/td>\n<\/tr>\n
Removed<\/td>\nFalse<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Design Groups<\/h3>\n\n\n\n<\/tr>\n\n\n
Sequence:<\/td>\n55886251<\/td>\n<\/tr>\n
Title<\/td>\nStudy Participants<\/td>\n<\/tr>\n
Description<\/td>\nParticipants on the studies' samples that are transferred to this protocol<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Keywords<\/h3>\n\n\n\n\n
Sequence:<\/td>\n80225755<\/td>\nSequence:<\/td>\n80225756<\/td>\n<\/tr>\n
Name<\/td>\nStored Samples<\/td>\nName<\/td>\nNatural History<\/td>\n<\/tr>\n
Downcase Name<\/td>\nstored samples<\/td>\nDowncase Name<\/td>\nnatural history<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Design Outcomes<\/h3>\n\n\n\n\n\n\n<\/tr>\n\n
Sequence:<\/td>\n178373069<\/td>\n<\/tr>\n
Outcome Type<\/td>\nprimary<\/td>\n<\/tr>\n
Measure<\/td>\nContinued analysis<\/td>\n<\/tr>\n
Time Frame<\/td>\nOngoing<\/td>\n<\/tr>\n
Description<\/td>\nThe objective of this protocol is to continue to have human subjects' protection oversight by the NIH IRB while making stored specimens and\/or data available to approved research laboratories and investigators after the study of specimen origin has been terminated. Continued analyses will be for the purpose of research, exploratory immunology, and infectious disease research within the original study objectives and consents under which the specimens and data were collected. Manuscript completion for the primary study objectives will also be covered under this or the original study protocol.<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Sponsors<\/h3>\n\n\n\n\n\n
Sequence:<\/td>\n48563867<\/td>\n<\/tr>\n
Agency Class<\/td>\nNIH<\/td>\n<\/tr>\n
Lead Or Collaborator<\/td>\nlead<\/td>\n<\/tr>\n
Name<\/td>\nNational Institute of Allergy and Infectious Diseases (NIAID)<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Overall Officials<\/h3>\n\n\n\n\n\n
Sequence:<\/td>\n29422614<\/td>\n<\/tr>\n
Role<\/td>\nPrincipal Investigator<\/td>\n<\/tr>\n
Name<\/td>\nMark Connors, M.D.<\/td>\n<\/tr>\n
Affiliation<\/td>\nNational Institute of Allergy and Infectious Diseases (NIAID)<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Eligibilities<\/h3>\n\n\n\n\n\n\n\n\n\n\n<\/tr>\n\n<\/tr>\n\n\n\n
Sequence:<\/td>\n30916715<\/td>\n<\/tr>\n
Sampling Method<\/td>\nNon-Probability Sample<\/td>\n<\/tr>\n
Gender<\/td>\nAll<\/td>\n<\/tr>\n
Minimum Age<\/td>\n18 Years<\/td>\n<\/tr>\n
Maximum Age<\/td>\n116 Years<\/td>\n<\/tr>\n
Healthy Volunteers<\/td>\nNo<\/td>\n<\/tr>\n
Population<\/td>\nHealthy volunteers<\/td>\n<\/tr>\n
Criteria<\/td>\nThe study populations were defined by the original protocols under which the stored specimens and\/or data were collected. The total population included on this omnibus protocol comprises the<\/p>\n

populations of other protocols.<\/td>\n<\/tr>\n

Adult<\/td>\nTrue<\/td>\n<\/tr>\n
Child<\/td>\nFalse<\/td>\n<\/tr>\n
Older Adult<\/td>\nTrue<\/td>\n<\/tr>\n<\/table>\n<\/div>\n
\n

Calculated Values<\/h3>\n\n\n\n\n<\/tr>\n\n<\/tr>\n\n\n<\/tr>\n\n<\/tr>\n\n\n<\/tr>\n\n\n\n\n\n\n\n\n<\/tr>\n\n<\/tr>\n<\/table>\n<\/div>\n
\n

Designs<\/h3>\n

Sequence:<\/td>\n254183089<\/td>\n<\/tr>\n
Number Of Facilities<\/td>\n1<\/td>\n<\/tr>\n
Registered In Calendar Year<\/td>\n2019<\/td>\n<\/tr>\n
Were Results Reported<\/td>\nFalse<\/td>\n<\/tr>\n
Has Us Facility<\/td>\nTrue<\/td>\n<\/tr>\n
Has Single Facility<\/td>\nTrue<\/td>\n<\/tr>\n
Minimum Age Num<\/td>\n18<\/td>\n<\/tr>\n
Maximum Age Num<\/td>\n116<\/td>\n<\/tr>\n
Minimum Age Unit<\/td>\nYears<\/td>\n<\/tr>\n
Maximum Age Unit<\/td>\nYears<\/td>\n<\/tr>\n
Number Of Primary Outcomes To Measure<\/td>\n1<\/td>\n<\/tr>\n
\n\n\n<\/tr>\n\n<\/tr>\n\n\n<\/tr>\n\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n<\/table>\n<\/div>\n
\n

Responsible Parties<\/h3>\n

Sequence:<\/td>\n30662400<\/td>\n<\/tr>\n
Observational Model<\/td>\nCase-Only<\/td>\n<\/tr>\n
Time Perspective<\/td>\nOther<\/td>\n<\/tr>\n
\n\n\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n\n<\/tr>\n<\/table>\n<\/div>\n
\n

Ipd Information Types<\/h3>\n

Sequence:<\/td>\n29029085<\/td>\n<\/tr>\n
Responsible Party Type<\/td>\nSponsor<\/td>\n<\/tr>\n
\n\n\n
Sequence:<\/td>\n3356489<\/td>\n<\/tr>\n
Name<\/td>\nStatistical Analysis Plan (SAP)<\/td>\n<\/tr>\n<\/table>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Studies Study First Submitted Date 2019-03-27 Study First Posted Date 2019-03-29 Last Update Posted Date 2023-04-19 Start Month Year April 6, 2024 Primary Completion Month Year December 31, 2029 Verification Month Year March 29, 2023 Verification Date 2023-03-29 Last Update Posted Date 2023-04-19 Detailed Descriptions Sequence: 20824434 Description The HIV intramural research program of NIAID […]<\/p>\n","protected":false},"author":2,"featured_media":329,"menu_order":0,"template":"Default","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"aiwire-tag":[64,65,58,63,60,61,62,59],"aiwire":[17],"acf":[],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/platowire\/420092"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/platowire"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/platowire"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/platowire\/420092\/revisions"}],"predecessor-version":[{"id":569609,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/platowire\/420092\/revisions\/569609"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/329"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=420092"}],"wp:term":[{"taxonomy":"aiwire-tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/aiwire-tag?post=420092"},{"taxonomy":"aiwire","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/aiwire?post=420092"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}