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Emory Healthcare Clinical Trial
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A double-blind, randomized, controlled Phase II study to assess the prophylactic efficacy and safety of gD-Alum/MPL vaccine in the prevention of genital herpes disease in young women who are HSV-1 and -2 seronegative.
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Summary
This trial is to study the effectiveness of an investigational herpes vaccine in preventing genital herpes in young women who are negative for both herpes simplex viruses (type-1 and -2, oral and genital).
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Study Involves
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Inclusion Criteria
Age: 18-30
Sex: Female
Ethinic Origin: Any
Diagnosis required to participate: Healthy young women ages 18-30 uninfected with type I and II herpes |
Exclusion Criteria
- Pregnant or nursing female
- Cinical signs or symptoms of current oro-labial, genital or non-genital HSV disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, pain, burning, itching, tingling, or dysuria
- History of previous or planned vaccinations against hepatitis A or a history of hepatitis A infection
- Previous vaccinations against herpes
- Previous administration of monophosphoryl lipid A (MPL) adjuvant (no vaccines currently licensed in the USA contains this)
- History of any confirmed oro-labial, genital or non-genital HSV disease or infection
- Planned administration/administration of non-study vaccine within 30 days of the first dose of the study vaccine with the following exceptions: Administration of routine Moninggococcal, Hepatitis B, inactivated Influenza, and Diptheria/Tetanus vaccine up to 8 days before the first dose of study vaccine is allowed.
- History of allergic disease or reactions likely to be exacerbated buy and component of the study vaccines, e.g. aluminum, MPL, alum-MPL, 2-phenoxyethanol or neomycin
- Any confirmed or suspected immunosuppressive or immunodeficiency virus (HIV) infection
- Acute or chronic, clinically significant (unresolved, requiring on-going medical management or medication, etc.) pulmonary, cardiovascular, hepatic or renal function abnormality, as determined by medical history or physical examination.
- Acute disease at the time of enrollment (defer vaccinations until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever. Study vaccine can be administered to persons with minor illness such as diarrhea, mile upper respiratory infections with or without low-grade febrile illness.
- Administration of immunoglobins and/or any blood products within the three months preceeding the first dose of study vaccine or planned administration during the study period.
- Recent history of chronic alcoholism consumption (defined as more than 5 oz. of ethanol [absolute alcohol] per day) and/or drug abuse.
- History of sexually transmitted infection within 30 days preceeding the first dose of study vaccine.
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Patient Involvement
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Contact Information
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| , Study Nurse |
404-727-4044 |
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