Sample collection for an assay development to determine HSV-specific T-cell responses in blood samples from HSV-2 infected individuals and HSV-1 + HSV-2 infected individuals

• Conditions: genital herpesoral herpes; B00; Herpesviral [herpes simplex] infections

• Registration Number: DRKS00031143
• Lead Sponsor: Heidelberg ImmunoTherapeutics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-06-28
• Study Start: 2023-07-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

The subject is at least 18 years old and capable of giving consent.
Present consent to participate in the study.
Proven seropositivity for HSV-2 or HSV-2 and HSV-1 combined.

Exclusion Criteria

Any disease or condition that does not medically permit blood sampling in the opinion of the physician providing information.
Positive serostatus for HIV, hepatitis B or hepatitis C.
Previous treatment with the antibody HDIT 101 (former MATCH-2 study patients who received placebo may be included).
Vaccination with an HSV 1/2 vaccine (e.g. experimental)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in the strength and specificity of T-cell responses against inactivated HSV-2 between the three groups: 1. subjects without HSV infection (PBMC samples already present), 2. HSV-2 infected subjects, and 3. HSV-1 + HSV-2 infected subjects. Evaluation after the single blood draw.<br><br>

Secondary Outcome Measures

Name	Time	Method
HLA-specific differences in the strength and specificity of T-cell responses to inactivated HSV-2 within the groups: 1. subjects without HSV infection (PBMC samples already present), 2. HSV-2 infected subjects, and 3. HSV-1 + HSV-2 infected subjects. Evaluation after the single blood draw.