Monoclonal Antibody Therapy against Chronic Herpes Simplex Virus 2 infectio
- Conditions
- Chronic recurrent anogenital HSV-2 infectionMedDRA version: 20.0Level: LLTClassification code 10019938Term: Herpes genitalisSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2019-000880-26-DE
- Lead Sponsor
- Heidelberg ImmunoTherapeutics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 125
1. Age = 18 years at the time of signing informed consent.
2. Signed informed consent for participation in the study.
3. Understanding, ability, and willingness to fully comply with study interventions and restrictions.
4. Seropositive for HSV-2. Previous serology laboratory reports (no PCR) provided by the patient are acceptable.
5. History of chronic recurrent anogenital HSV-2 infection with = 4 outbreaks (= 2 under standard suppressive antiviral therapy) in the last year with no active lesion at time of enrolment. Patients with acute lesion(s) can be enrolled when the previous lesion is healed off.
6. No use of any HSV-suppressant therapy (both approved drugs and non-approved drugs including OTC drugs) including topical applications during trial participation and at least 7 days prior to start of first 28 days swabbing period and/or treatment.
7. Willingness to not use any topical or systemic anti-HSV therapy (both approved drugs and non-approved drugs including OTC) during the study apart from the study medication. Topical anti-HSV therapy of orolabial lesions is allowed.
8. Willingness to not use any topical HSV treatment upon lesion development as well as avoid any manipulation or physical impact, e.g., cooling of the lesion particularly in the prodromal stage.
9. Medical assessment with no clinically significant morbidities or abnormalities as per judgement of the investigator.
10. Women of child-bearing potential (WCBP) must have a negative beta-human chorionic gonadotropin (ß-HCG) urine and/or blood test at screening and within 72 hours before receiving study treatment.
11. Willingness to use two independent effective contraceptive methods for 3 months after Visit 1. Male participants and partners of female participants have to use a condom during sexual intercourse or intimacy to reduce the probability of sexually transmitted infection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Patients who do not develop a lesion during the 28-day swabbing period and 3 months (90 days) afterwards (i.e., within 4 months after screening) except patients who have reported lesions to the investigator within this screening period but were not able to be randomized due to timely restrictions (e.g. COVID-19 travel restrictions, holidays, vacation etc.). Those patients can still be randomized after additional 30 days (150 days in total).
2. Medical history or current physical illnesses/medical conditions that constitute an unacceptable risk for study participation in the judgment of the investigator (e.g., clinically significant autoimmune disorder, active infection, uncontrolled medical conditions or organ system dysfunction that, in the investigator’s opinion, could compromise the patient’s safety or put the study outcomes at risk, such as uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled coronary heart disease, uncontrolled psychiatric condition).
3. Patients with herpes keratitis.
4. Immunomodulatory therapy including topical (e.g., rectal, vaginal, cutaneous, etc.) and/or oral and/or parenteral and/or inhaling steroids within 28 days before start of study treatment.
5. Any condition that precludes the sampling of up to 200 mL (additional 150 mL in case of optional participation for exploratory objective (T-cell response) blood over the duration of the study.
6. Known resistance to or intolerance of valaciclovir or active substance or excipients of the study medication.
7. Positive HIV antibody screen, hepatitis B virus (HBV) infection screen, or hepatitis C virus (HCV) infection screen.
8. Any known history of severe allergic or anaphylactic reactions.
9. Participation in any clinical study within the last 30 days prior to enrolment.
10. Prior treatment with HDIT101 in this or other clinical study .
11. Pregnant or breast-feeding women.
12. Prior malignant disease (except basal cell carcinoma or carcinoma in situ) which has not been successfully cured more than 5 years before enrolment.
13. Hemoglobin (Hb) < 10 g/dL.
14. Creatinine (Crea) clearance (Cl) < 40 mL/min (Cockroft-Gault equation will be used)
15. Bilirubin > upper limit of normal (ULN) x 2, except patients with known Morbus Meulengracht.
16. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > ULN x 3.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method