Clinical trial • Phase I/II • Infectious Disease
ChAdOx1.tHIVconsvX for HIV infection
Phase I/II trial of ChAdOx1.tHIVconsvX for HIV infection. Randomised, placebo (blinded comparator); no dose or schedule specified-controlled.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- HIV infection
- Trial Stage
- Phase I/II
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 12-07-2024
- First CTIS Authorization Date
- 05-08-2024
Trial design
Randomised, placebo (blinded comparator); no dose or schedule specified-controlled Phase I/II trial across 1 site in Italy.
- Randomised
- Yes
- Comparator
- Placebo (blinded comparator); no dose or schedule specified
- Target Sample Size
- 33
Eligibility
Recruits 33 Vulnerable population selected (isVulnerablePopulationSelected: true). No information on consent or assent handling available in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). No information on consent or assent handling available in the record.
Recruitment
- Planned Sample Size
- 33
- Recruitment Window Months
- 19
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 33
Italy
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 05-08-2024
- Processing Time Days
- 67
- Number Of Sites
- 1
- Number Of Participants
- 33
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Ematologia e TMO
- Principal Investigator Name
- Raffaele Dell'Acqua
- Principal Investigator Email
- dellacqua.raffaele@hsr.it
- Contact Person Name
- Raffaele Dell'Acqua
- Contact Person Email
- dellacqua.raffaele@hsr.it
- Number Of Participants
- 33
Sponsor
Primary sponsor
- Full Name
- Ospedale San Raffaele S.r.l.
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- ChAdOx1.tHIVconsvX
- Modality
- Vaccine
- Investigational Product Name
- MVA.tHIVconsvX
- Modality
- Vaccine
- Combination Treatment
- Yes
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