Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Prophylaxis Herpes Simplex

Treatments: Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant; Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697567

208141/002

Details and patient eligibility

About

The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.

Full description

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Enrollment: 80 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

• History of persistent hepatic, renal, cardiac or respiratory diseases.
• Clinical signs of acute illness at the time of entry into the study.
• Seropositive for antibodies against the human immunodeficiency virus (HIV).
• Pregnancy, lactation.
• Treatment with corticosteroids or immunomodulating drugs.
• Simultaneous participation in another clinical trial.
• Any previous history of allergy.
• Any concomitant vaccination or administration of immunoglobulin during the study period.
• Any abnormal laboratory value among the tests performed at screening

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Group A

Experimental group

Description:

HSV seropositive subjects

Treatment:

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

Group B

Experimental group

Description:

HSV seronegative subjects

Treatment:

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

Group C

Experimental group

Description:

HSV seropositive subjects

Treatment:

Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant

Group D

Experimental group

Description:

HSV seronegative subjects

Treatment:

Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant