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

Herpes Simplex Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698893
• Other study ID #: 208141/001
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2008
• Last updated: June 1, 2017
• Start date: May 1, 1992
• Est. completion date: July 1, 1992

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 1, 1992
• Est. primary completion date: July 1, 1992
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Herpes Simplex

Intervention

Biological:
• Herpes simplex candidate (gD) vaccine GSK208141
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms		Throughout the study
Primary	Measurement of haematology/biochemical parameters on blood samples		Throughout the study
Primary	Vaccine reactogenicity by soliciting of local and general signs/symptoms		On the day of vaccination and the subsequent 7 days
Primary	Vaccine immunogenicity by 6 measurements of anti-HSV antibodies		From day 0 to day 45 following vaccination

External Links

•   Results for study 208141/001 can be found on the GSK Clinical Study Register