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Herpes simplex candidate vaccine GSK208141

Phase 1

Herpes Simplex | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 2, 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Herpes simplex candidate vaccine GSK208141 · 1 trial · 1 indication

Phase 1 1
NCT00698893Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive AdultsHerpes Simplex
COMPLETED16 Analytics
PHASE1COMPLETED
Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults
Herpes Simplex
NCT0069889316
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Study Endpoints

Primary Endpoints

To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms
Throughout the study
Measurement of haematology/biochemical parameters on blood samples
Throughout the study
Vaccine reactogenicity by soliciting of local and general signs/symptoms
On the day of vaccination and the subsequent 7 days
Vaccine immunogenicity by 6 measurements of anti-HSV antibodies
From day 0 to day 45 following vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -

Interventions

NameTypeDescription
Herpes simplex candidate (gD) vaccine GSK208141BIOLOGICALIntramuscular injection, 2 doses, 2 different formulations (with and without MPL)
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Between 18 and 40 years of age * Seropositive for antibodies against HSV * Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study. * Good physical condition as established b...

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Frequently asked questions about Herpes simplex candidate vaccine GSK208141

What is GSK208141 used for?

GSK208141 is an investigational vaccine candidate being developed for herpes simplex. It is currently in Phase 1 clinical development and is not yet approved. The vaccine is designed for use in healthy adults who are herpes simplex virus-positive, as evaluated in a completed Phase 1 trial.

Who makes GSK208141?

GSK208141 is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this herpes simplex vaccine candidate, which is currently in Phase 1 development.

What phase is GSK208141 in?

GSK208141 is in Phase 1 clinical development. It is an investigational vaccine candidate for herpes simplex and has not been approved by regulatory authorities. A Phase 1 trial evaluating its safety has been completed, but the vaccine remains in early-stage clinical development.

What clinical trials is GSK208141 in?

GSK208141 has one completed Phase 1 clinical trial, identified as NCT00698893. This trial evaluated the safety of a candidate gD vaccine, with or without MPL, in healthy herpes simplex virus-positive adults. The trial enrolled 16 participants and was controlled but not randomized or double-blinded.

Is GSK208141 the same as a gD vaccine?

GSK208141 is associated with a candidate gD vaccine evaluated in clinical trial NCT00698893. The trial title refers to a 'candidate gD vaccine,' indicating that GSK208141 is a herpes simplex vaccine candidate based on the gD antigen. This is the vaccine's investigational identity in the completed Phase 1 study.