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

Primary Purpose

Herpes Simplex

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Herpes simplex candidate (gD) vaccine GSK208141

About this trial

This is an interventional prevention trial for Herpes Simplex focused on measuring Herpes simplex, Herpes simplex candidate (gD) vaccine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms

Measurement of haematology/biochemical parameters on blood samples

Vaccine reactogenicity by soliciting of local and general signs/symptoms

Vaccine immunogenicity by 6 measurements of anti-HSV antibodies

Secondary Outcome Measures

Full Information

NCT ID

NCT00698893

First Posted

June 13, 2008

Last Updated

June 1, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00698893

Brief Title

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

Official Title

An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without 3D MPL

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

May 1, 1992 (Actual)

Primary Completion Date

July 1, 1992 (Actual)

Study Completion Date

July 1, 1992 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Simplex

Keywords

Herpes simplex, Herpes simplex candidate (gD) vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Title

Group B

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Herpes simplex candidate (gD) vaccine GSK208141

Intervention Description

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

Primary Outcome Measure Information:

Title

To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms

Time Frame

Throughout the study

Title

Measurement of haematology/biochemical parameters on blood samples

Time Frame

Throughout the study

Title

Vaccine reactogenicity by soliciting of local and general signs/symptoms

Time Frame

On the day of vaccination and the subsequent 7 days

Title

Vaccine immunogenicity by 6 measurements of anti-HSV antibodies

Time Frame

From day 0 to day 45 following vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

18845199

Citation

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.

Results Reference

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

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