Recent Updates
Recently added Catalysts

Herpes simplex candidate vaccine- adjuvanted GSK 208141

Phase 3

Herpes Simplex | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 7, 2016

Target and mechanism

ModalityMonoclonal antibody

Also known as Herpes simplex candidate vaccine- adjuvanted GSK208141

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment2,491

FDA Designations

No designations recorded

Clinical trial landscape

Herpes simplex candidate vaccine- adjuvanted GSK 208141 · 2 trials · 2 indications

Phase 3 2
NCT00698568Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative SubjectsProphylaxis for Herpes Simplex
COMPLETED7,460 Analytics
NCT00699764Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes DiseaseHerpes Simplex
COMPLETED2,491 Analytics
PHASE3COMPLETED
Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects
Prophylaxis for Herpes Simplex
NCT006985687,460
Unlock trial analytics
PHASE3COMPLETED
Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease
Herpes Simplex
NCT006997642,491
Unlock trial analytics

Study Endpoints

Primary Endpoints

To compare between herpes simplex vaccine and placebo recipients the general safety of the vaccine by recording all the unsolicited adverse experiences and all serious adverse experiences
During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs)
To compare between herpes simplex vaccine (gD2t with adjuvant) and placebo the general safety of the vaccine by recording all the unsolicited adverse experiences
During the 7 month vaccination period
To evaluate the protective efficacy of gD2t with adjuvant to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative or HSV seropositive at baseline
Survival analysis beginning at Month 0

Secondary Endpoints

To compare between vaccine and placebo recipients the incidence and severity of the reactogenicity as measured by recording the local reactions and the general symptoms
On the day of each vaccination and on the following 3 days
To compare between vaccine and placebo recipients the effect on the haematological and biochemical parameters in subjects from 20% of the centers in each country
At day -90 to day -7, and at month 7 and month 13
To compare between vaccine and placebo recipients the effect on pre-existing herpes simplex virus infection by recording the frequency and severity of all herpes simplex clinical episodes
Day 0 through month 19
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Herpes simplex candidate vaccine- adjuvanted GSK 208141BIOLOGICALIntramuscular injection, 3 doses
PlaceboBIOLOGICALIntramuscular injection, 3 doses
Herpes simplex candidate vaccine- adjuvanted GSK208141BIOLOGICALIntramuscular injection, 3 doses
Placebo injectionBIOLOGICALIntramuscular injection, 3 doses
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites47

Inclusion Criteria: * 18 years of age and over at the time of first vaccination * Written informed consent * Females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control Exclusion Criteria: * Any...

Countries:United StatesAustraliaAustriaBelgiumCanadaDenmarkFranceGermanyPuerto RicoSouth AfricaSpainSwitzerland
Unlock Eligibility Criteria