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GSK HIV vaccine 732462

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment190

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

GSK HIV vaccine 732462 is an investigational vaccine being studied for the prevention of AIDS, a condition caused by HIV infection. It is currently in Phase 1 clinical development and is not yet approved for use.

Who makes GSK HIV vaccine 732462?

GSK HIV vaccine 732462 is developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.

What phase is GSK HIV vaccine 732462 in?

GSK HIV vaccine 732462 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the vaccine remains under evaluation.

What clinical trials is GSK HIV vaccine 732462 in?

GSK HIV vaccine 732462 has been studied in one clinical trial, NCT01092611, titled "Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine." This Phase 1 trial, which enrolled 190 participants, has been completed and included sites in the United States, France, Germany, and Spain.

Is GSK HIV vaccine 732462 a monoclonal antibody?

GSK HIV vaccine 732462 is classified as a monoclonal antibody modality, though it is being developed as a vaccine for AIDS. The trial NCT01092611 evaluated long-term follow-up of participants from studies assessing this vaccine candidate.