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
Verified date | June 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
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
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 |
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