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Herpes simplex candidate vaccine GSK208141

Phase 1

Herpes Simplex | Vaccine | Infectious Disease |GSK plc|Trials Updated: Jun 2, 2017

Herpes simplex candidate vaccine GSK208141 target and mechanism

ModalityVaccine

Also known as Herpes simplex candidate (gD) vaccine GSK208141

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Herpes simplex candidate vaccine GSK208141 clinical trials

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 SimplexUnlock trial analytics

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 the herpes simplex candidate vaccine GSK208141?

GSK208141 is an investigational vaccine developed by GSK plc for herpes simplex. It is a Phase 1 candidate studied in healthy adults who were already herpes simplex virus-positive. The program has completed one Phase 1 trial with 16 participants and is not currently listed as having active trials.

What is GSK208141 used for?

GSK208141 is being studied for herpes simplex, the viral infection caused by herpes simplex virus. The completed Phase 1 trial enrolled healthy herpes simplex virus-positive adults, so the candidate was evaluated in people already carrying the virus rather than as a preventive vaccine in uninfected volunteers.

Who makes GSK208141?

GSK208141 is developed by GSK plc, which trades under the ticker GSK. The candidate is part of the company's infectious disease pipeline and is described as a vaccine modality. The single registered trial, NCT00698893, was sponsored and completed under GSK.

What phase is GSK208141 in?

GSK208141 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are listed. The study was a controlled Phase 1 evaluation of the candidate gD vaccine, with or without MPL, in healthy herpes simplex virus-positive adults.

What clinical trials is GSK208141 in?

GSK208141 has been studied in one completed Phase 1 trial, NCT00698893, titled Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults. The trial enrolled 16 participants aged 18 years and older, of all sexes, and was controlled but not randomized or double-blind.

Is GSK208141 the same as the herpes simplex candidate (gD) vaccine GSK208141?

Yes, GSK208141 is also known as the herpes simplex candidate (gD) vaccine GSK208141. The gD designation refers to the glycoprotein D component described in the candidate's name. Both names refer to the same GSK plc Phase 1 vaccine candidate for herpes simplex.