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GSK HIV vaccine 732462

Phase 1

AIDS | Vaccine | Infectious Disease |GSK plc|Trials Updated: Mar 2, 2018

GSK HIV vaccine 732462 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment190

FDA Designations

No designations recorded

GSK HIV vaccine 732462 clinical trials

GSK HIV vaccine 732462 · 1 trial · 1 indication

Phase 1 1
NCT01092611Long-term Follow-up of Participants From Studies Evaluating GSK HIV VaccineAIDS
COMPLETED190 Analytics
PHASE1COMPLETED
Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine
AIDSUnlock trial analytics

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 to 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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Frequently asked questions about GSK HIV vaccine 732462

What is GSK HIV vaccine 732462?

GSK HIV vaccine 732462 is an investigational vaccine candidate developed by GSK plc for AIDS. It is a preventive vaccine modality that has been studied in a Phase 1 clinical trial. The candidate is not approved and remains in clinical development.

What is GSK HIV vaccine 732462 used for?

GSK HIV vaccine 732462 is being studied for AIDS, the disease caused by HIV infection. The clinical program has focused on evaluating the vaccine in participants with HIV, including long-term follow-up of prior study volunteers. It is not approved for any indication.

Who makes GSK HIV vaccine 732462?

GSK HIV vaccine 732462 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this investigational HIV vaccine candidate.

What phase is GSK HIV vaccine 732462 in?

GSK HIV vaccine 732462 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is GSK HIV vaccine 732462 in?

GSK HIV vaccine 732462 has been evaluated in one completed Phase 1 trial, NCT01092611, titled Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine. The trial enrolled 190 participants across the United States, France, Germany, and Spain, and included controlled, randomized design elements.