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Adjuvanted herpes simplex candidate vaccine GSK 208141

Phase 1

Prophylaxis Herpes Simplex | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 17, 2008

Target and mechanism

ModalityMonoclonal antibody

Also known as Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment130

FDA Designations

No designations recorded

Clinical trial landscape

Adjuvanted herpes simplex candidate vaccine GSK 208141 · 1 trial · 1 indication

Phase 1 1
NCT00698490Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell LinesProphylaxis Herpes Simplex
COMPLETED130 Analytics
PHASE1COMPLETED
Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines
Prophylaxis Herpes Simplex
NCT00698490130
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Study Endpoints

Primary Endpoints

To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA)
After the second and third doses of each vaccine
To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon)
After the second and third dose of each vaccine formulation
To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms
During 3 days after each dose of each vaccine
To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies
After 2 and 3 doses of vaccines
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALHSV-seronegative subjects
Group BEXPERIMENTALHSV-seropositive subjects
Group CEXPERIMENTALHSV-seronegative subjects
Group DEXPERIMENTALHSV-seronegative subjects
Group EEXPERIMENTALHSV-seronegative subjects

Interventions

NameTypeDescription
Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141BIOLOGICALIntramuscular injection, 3 doses, 2 different formulations
Herpes simplex virus containing gD-AlumBIOLOGICALIntramuscular injection, 3 doses
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Between 18 and 45 years of age * Written informed consent * Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course * Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV s...

Countries:Belgium
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