Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1)

This is an interventional screening trial for HSV focused on measuring Squaric Acid, Squaric acid dibutyl ester, cold sores Read More

Inclusion Criteria:

1. Age ≥18 and <65
2. Positive test for IgG against herpes simplex virus type 1 (HSV-1).
3. Groups A and B only: Clinical diagnosis of herpes labialis, which may be made at the screening visit based on the patient's self-reported history of symptoms. An active herpes labialis outbreak at the time of entry into the clinical trial will neither be required nor will be an exclusion criteria.
4. Group A only: Self report having six or more episodes of herpes labialis in the past 12 months. Subjects will NOT be told that six-or-more episodes in the previous 12 months is the entry criterion. Subjects will be asked "How many separate episodes of cold sores have you had in the previous 12 months?" They will be included if they give an answer of six or more and excluded from Group A if they give an answer of five or fewer.
5. Group A only: At least half of the subject's episodes of the previous 12 months should be vesicular in nature and at least half preceded by prodromal symptoms.
6. Group B only: Self report having exactly 1 or 2 episodes of herpes labialis in the past 12 months. Subjects will NOT be told that one or two episodes in the previous 12 months is the entry criterion. Subjects will be asked "How many separate episodes of cold sores have you had in the previous 12 months?" They will be included if they give an answer of one or two and excluded from Group B if they give a different answer.
7. Group C only: Self report having zero episodes of herpes labialis in the past 12 months. Subjects will NOT be told that zero episodes in the previous 12 months is the entry criterion. Subjects will be asked "How many separate episodes of cold sores have you had in the previous 12 months?" They will be included if they give an answer of zero and excluded from Group C if they give an answer of one or more.

Exclusion Criteria:

1. Pregnant or lactating females.
2. Current or recurrent non-herpetic infection or any underlying condition that may predispose to infection or anyone who has been admitted to the hospital due to bacteremia, pneumonia or any other serious infection in the last 12 months.
3. Therapy with glucocorticoid or immunosuppressants at time of recruitment or within past 4 weeks prior to the screening visit (including inhaled corticosteroids for asthma), except for topical steroids in sites other than face.
4. History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers).
5. History of organ transplantation.
6. HIV-positive status determined by history at screening or known history of any other immunosuppressive disease.
7. Severe co-morbidities (diabetes mellitus requiring insulin, CHF (NYHA class II or worse) MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease
8. Known hypersensitivity to Dimethyl sulfoxide (DMSO).
9. Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
10. Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
11. Previous exposure to SADBE (squaric acid or squaric acid dibutyl ester).
12. Subject has an abnormal skin condition (e.g., acne, eczema, rosacea, psoriasis, albinism, or chronic vesiculo-bullous disorder) that occurs in the area ordinarily affected by herpes labialis.
13. Subject has had a vaccine for either HSV-1 or HSV-2.
14. Group A only: People that have had treatment with anti viral therapy within 2 weeks before sensitization dose of SADBE.
15. Groups B and C only: People that have had treatment with anti-viral therapy any time in the past 12 months.