Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults

NCT ID: NCT00698893

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1992-05-01
• Study Completion Date: 1992-07-01

Brief Summary

The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.

Detailed Description

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

Conditions

Herpes Simplex

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Group Type: EXPERIMENTAL

Herpes simplex candidate (gD) vaccine GSK208141

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)

Group B

Group Type: EXPERIMENTAL

Herpes simplex candidate (gD) vaccine GSK208141

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)

Interventions

Herpes simplex candidate (gD) vaccine GSK208141

Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 by physical examination and history taking at the time of entry

Exclusion Criteria

• Any abnormal laboratory value among the tests performed at screening.
• History of persistent hepatic, renal, cardiac or respiratory diseases
• Clinical signs of acute illness at the time of entry into the study.
• Previous history of asthma or hypersensitivity to drugs.
• Seropositive for antibodies against the human immunodeficiency virus
• Pregnancy and lactation.
• Treatment with corticosteroids or immunomodulating drugs.
• Simultaneous participation in another clinical trial.
• Administration of any other vaccine or immunoglobulins during the study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

Reference Type: BACKGROUND

PMID: 18845199 (View on PubMed)

Other Identifiers

208141/001

Identifier Type: -

Identifier Source: org_study_id