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Herpes simplex candidate vaccine GSK208141- non-MPL-containing adjuvant

Phase 2

Prophylaxis Herpes Simplex | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 16, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Herpes simplex candidate vaccine GSK208141- non-MPL-containing adjuvant · 1 trial · 1 indication

Phase 2 1
NCT00697567Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without AdjuvantProphylaxis Herpes Simplex
COMPLETED80 Analytics
PHASE2COMPLETED
Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant
Prophylaxis Herpes Simplex
NCT0069756780
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Study Endpoints

Primary Endpoints

To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers
Days 0, 30, 60, 180 and 365 after vaccination
To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers
Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

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

Interventions

NameTypeDescription
Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvantBIOLOGICALIntramuscular injection, 3 doses
Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvantBIOLOGICALIntramuscular injection, 3 doses
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Between 18 and 40 years of age * Written informed consent * Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study. * Good clinical condition as evidenced by history taking and physical examination Exclusion Criteria: ...

Countries:Belgium
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