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GSK HIV vaccine 732462

Phase 1

AIDS | Monoclonal antibody | Other |GSK plc|Last Updated: Mar 2, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment190
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01092611Long-term Follow-up of Participants From Studies Evaluating GSK HIV VaccinePHASE1 COMPLETED 190Mar 22, 2010May 19, 2014Mar 2, 201841 United States, France +2
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Study Endpoints
Primary Endpoints
Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)
Once a year after Visit 1 (during a maximum of 4 years)
CD4 count
Once a year after Visit 1 (during a maximum of 4 years)
Viral load (VL) and method of measurement
Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of HIV disease progression
Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of each separate defining condition for HIV-disease progression
Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of specific clinical events and death
Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of adverse events (AEs) or serious adverse events (SAEs) considered by the Investigator to be related to vaccination (performed in the preceding vaccination study)
Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of potential immune-mediated diseases (pIMDs)
Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of SAEs related to study participation
Once a year after Visit 1 (during a maximum of 4 years)
Secondary Endpoints
Time between dose 1 and ART (re)-initiation or ART modification
Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and CD4 count measurement
Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and VL measurement
Once a year after Visit 1 (during a maximum of 4 years)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Group AOTHERSubjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study
Group BOTHERSubjects who were administered placebo in primary studies and who accepted to participate in this study
Interventions
NameTypeDescription
Blood collectionPROCEDUREOnce a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.
GSK HIV vaccine 732462BIOLOGICALNo vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: * HIV-infected subject. * Previous participation in a study evaluating GSK HIV vaccine 732462. * Written informed consent obtained from the subject. Exclusion Criteria: The following criteria should be check...

Countries:United StatesFranceGermanySpain
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