Herpes GenitalisPhase 2MATCH-2NCT04165122
Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection
A Phase 2 study testing HDIT101 and Valaciclovir in people with Herpes Genitalis, run by Heidelberg ImmunoTherapeutics GmbH at 8 sites in Germany.
Trial summary
This is a randomized, double-blind, double-dummy study of single dose HDIT101 versus Standard of Care Valaciclovir. HSV-2-positive patients with at least 4 anogenital herpes lesions in the last 12 months (or at least 2 herpes lesions with previous valaciclovir long-term therapy) can be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Genitalis
- What is being tested?
- HDIT101 and Valaciclovir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 8 sitesGermany
- Study dates
- 15 Nov 2019to 1 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of signing informed consent.
- Signed informed consent for participation in the study.
- Understanding, ability, and willingness to fully comply with study interventions and restrictions.
- Seropositive for HSV-2.
- 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.
- No use of any HSV-suppressant therapy (both approved drugs and non-approved drugs including OTC drugs) including topical applications at least 7 days prior to enrolment.
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- 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.
- 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.
- Medical assessment with no clinically significant morbidities or abnormalities as per judgement of the investigator.
- Women of child-bearing potential (WCBP) must have a negative beta-human chorionic gonadotropin (β-HCG) urine and/or blood test at screening and within 72 hours before receiving study treatment.
- 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.
Who cannot join
- 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).
- 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).
- Patients with herpes keratitis.
- 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.
- 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.
- Known resistance to or intolerance of valaciclovir or active substance or excipients of the study medication.
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- Positive HIV antibody screen, hepatitis B virus (HBV) infection screen, or hepatitis C virus (HCV) antibody screen.
- Any known history of severe allergic or anaphylactic reactions.
- Participation in any clinical study within the last 30 days prior to enrolment.
- Prior participation in this or other clinical study with HDIT101.
- Pregnant or breast-feeding women.
- Prior malignant disease except basal cell carcinoma or carcinoma in situ which has been successfully cured more than 5 years before enrolment.
- Hemoglobin (Hb) < 10 g/dL.
- Creatinine (Crea) clearance (Cl) < 40 mL/min (Cockcroft-Gault equation will be used)
- Bilirubin > upper limit of normal (ULN) x 2, except patients with known Morbus Meulengracht.
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > ULN x 3.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
emovis GmbH
Berlin, 10629
Praxis Jessen2+Kollegen
Berlin, 10777
WIR "Walk In Ruhr" im St. Elisabeth Hospital
Bochum, 44787
Dr. Scholten und Schneeweiß GbR
Cologne, 50674
Infektio Research GmbH & Co. KG
Frankfurt, 60596
Universitätsklinikum Freiburg, Medizin II, Infektiologie
Freiburg im Breisgau, 79106
ICH Grindel
Hamburg, 20146
Prinzmed
München, 80336
About this study
Official title: A Randomized, Double-Blind, Double-Dummy Phase II Study of Single Dose HDIT101 Versus Standard of Care Valaciclovir in Patients With Chronic Recurrent Anogenital HSV-2 Infection
This is a randomized, double-blind, double-dummy study of single dose HDIT101 versus Standard of Care Valaciclovir.
HSV-2-positive patients with at least 4 anogenital herpes lesions in the last 12 months (or at least 2 herpes lesions with previous valaciclovir long-term therapy) can be included.
Read more
If a patients develops a anogenital Herpes lesion within 4 months after the screening visit, the patients will be randomized in a 2:1 ratio to HDIT i.v. infusion + episodic treatment with 500 mg Valaciclovir-placebo OR to a single HDIT placebo infusion + episodic treatment with 500 mg Valaciclovir orally bid for 3 days.
Study duration per patient will be 180 days starting with the randomization visit. In addition to the randomization visit, 4 visits at the site and 2 phone calls are scheduled.
At every occurence of a herpetic lesion during the study, patients are treated with Valaciclovir/ Valaciclovir-placebo and need to present at the site twice to document start and end date of the lesion (unscheduled visits).
Read the detailed description
In this trial, patients with chronic recurrent herpes simplex virus (HSV-2) infections (with at least 4 herpes lesions in the last 12 months or at least 2 herpes lesions with previous valaciclovir long-term therapy) can be included.
After signature of ICF and during the screening period, the patients take daily swabs of the anogenital area for 28 days to determine HSV shedding.
Patients not developing a lesion within 4 months after screening are not randomised. Patients developing a lesion within 4 months can be randomised and the treatment must be initiated within 72 Hours upon lesion occurence.
Approximately 125 patients will be randomized in a 2:1 ratio to one of the following treatment groups:
- Arm A: single HDIT i.v. infusion applied over 1 hour at the randomization visit + episodic treatment with 500 mg Valaciclovir-placebo orally bid for 3 days.
- Arm B: single HDIT placebo i.v. infusion applied over 1 hour at the randomization visit + episodic treatment with 500 mg Valaciclovir orally bid for 3 days.
The HDIT101/HDIT101-placebo infusion is only applied once during the trial, Valaciclovir (or corresponding placebo) has to be taken upon every occurence of another Herpes lesion.
Study duration per Patient will be 180 days starting with the randomization visit. In addition to the randomization visit, 4 visits at the site and 2 phone calls are scheduled.
In case of developing another lesion after the randomization visit, patients take a single swab of the lesion and episodic SoC treatment with Valaciclovir/ Valaciclovir-placebo is started and documented in an electronic diary by the patient within 24 hours after development of first symptoms. Quality of life is also recorded.
In addition to this, the patients need to present at the site within 72 hours after occurence of a the new herpes outbreak for medical examination and to confirm the HSV-2 lesion. At this unscheduled visit at the site, the PI will take a second swab and assess the lesion (including start date). Another unscheduled visit will take place upon healing of lesion.
This procedure will be repeated for every outbreak during the trial.
- Conditions
- Herpes Genitalis
- Being tested
- HDIT101, Valaciclovir, HDIT101 placebo, Valaciclovir placebo
- Keywords
- Herpes Genitalis
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDIT101Biological
i.v. Infusion
ValaciclovirDrug
Also called Valtrex
oral application of encapsulated Valaciclovir tablets
HDIT101 placeboBiological
i.v. Infusion
Valaciclovir placeboDrug
oral application of encapsulated Valaciclovir placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| HDIT101 + Valaciclovir placebo | Experimental | Group A:
Patients treated with a single i.v. infusion of 2 g HDIT101 for 60 min at the randomization visit and with an episodic Valaciclovir placebo bid for 3 days. Receives: Biological: HDIT101; Drug: Valaciclovir placebo |
| HDIT101 placebo + Valaciclovir | Active comparator | Group B:
Patients treated with a single i.v. infusion of HDIT101 placebo for 60 min at the randomization visit and with episodic Valaciclovir 500 mg twice daily for 3 days. Receives: Drug: Valaciclovir; Biological: HDIT101 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of days with lesion(s) per treatment group
Primary objective is calculated as the number of days with lesion (except the lesion episode at randomization) divided by the number of study days after IMP infusion.
Measured: 180 days
Secondary outcomes (6)
Time to first recurrence of lesion
Time to first recurrence of lesion as reported by patient and verified by investigator
Measured: 180 days
Recurrence rate of lesions
Recurrence rate is defined as number of recurrences divided by the total number of study days after IMP infusion
Measured: 180 days
Duration of recurrent lesions
Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7
Measured: 180 days
Disease-specific symptoms
Disease-specific symptoms assessed by Herpes Symptoms Checklist
Measured: 180 days
Herpes outbreak impact
Herpes outbreak impact assessed by Herpes Outbreak Impact Questionnaire
Measured: 180 days
QoL
Change in QoL between baseline and EoS assessed by the Recurrent Genital Herpes
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start15 Nov 2019
- Primary completion25 Aug 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes GenitalisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Double-Dummy
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg ImmunoTherapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Schoeffel, Study director, Heidelberg ImmunoTherapeutics GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165122
- Sponsor's protocol ID
- HTX101-02G
- Acronym
- MATCH-2
- Status last verified
- Jan 2022
- First submitted
- 11 Nov 2019
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stellbrink HJ, Schaller T, Sturm K, Brockmeyer NH, Potthoff A, Bickel M, Scholten S, Postel N, Jessen A, Muller M, Jager D, Muller C, Seyfizadeh N, Schoffel S, Ullrich B, Brosi L, Kunz C, Thomas D, Laage R, Hanakam F, Schwab M, Schonborn-Kellenberger O, Mangold M, Och K, Lehr T, Arndt MA, Krauss J. Safety and efficacy of monoclonal antibody therapy in patients with chronic herpes simplex virus-2 genital infections: MATCH-2, a randomized double-blinded, parallel-group phase 2 multi-center trial. Pharmacol Res. 2025 Nov;221:107999. doi: 10.1016/j.phrs.2025.107999. Epub 2025 Oct 16.
PubMed 41109488
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy Phase II Study of Single Dose HDIT101 Versus Standard of Care Valaciclovir in Patients With Chronic Recurrent Anogenital HSV-2 Infection
- ClinicalTrials.gov ID
- NCT04165122
- Acronym / sponsor ID
- MATCH-2 / HTX101-02G
- Conditions
- Herpes Genitalis
- Keywords
- Herpes Genitalis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Heidelberg ImmunoTherapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, double-dummy study of single dose HDIT101 versus Standard of Care Valaciclovir.
HSV-2-positive patients with at least 4 anogenital herpes lesions in the last 12 months (or at least 2 herpes lesions with previous valaciclovir long-term therapy) can be included.
If a patients develops a anogenital Herpes lesion within 4 months after the screening visit, the patients will be randomized in a 2:1 ratio to HDIT i.v. infusion + episodic treatment with 500 mg Valaciclovir-placebo OR to a single HDIT placebo infusion + episodic treatment with 500 mg Valaciclovir orally bid for 3 days.
Study duration per patient will be 180 days starting with the randomization visit. In addition to the randomization visit, 4 visits at the site and 2 phone calls are scheduled.
At every occurence of a herpetic lesion during the study, patients are treated with Valaciclovir/ Valaciclovir-placebo and need to present at the site twice to document start and end date of the lesion (unscheduled visits).
Detailed description
In this trial, patients with chronic recurrent herpes simplex virus (HSV-2) infections (with at least 4 herpes lesions in the last 12 months or at least 2 herpes lesions with previous valaciclovir long-term therapy) can be included.
After signature of ICF and during the screening period, the patients take daily swabs of the anogenital area for 28 days to determine HSV shedding.
Patients not developing a lesion within 4 months after screening are not randomised. Patients developing a lesion within 4 months can be randomised and the treatment must be initiated within 72 Hours upon lesion occurence.
Approximately 125 patients will be randomized in a 2:1 ratio to one of the following treatment groups:
- Arm A: single HDIT i.v. infusion applied over 1 hour at the randomization visit + episodic treatment with 500 mg Valaciclovir-placebo orally bid for 3 days.
- Arm B: single HDIT placebo i.v. infusion applied over 1 hour at the randomization visit + episodic treatment with 500 mg Valaciclovir orally bid for 3 days.
The HDIT101/HDIT101-placebo infusion is only applied once during the trial, Valaciclovir (or corresponding placebo) has to be taken upon every occurence of another Herpes lesion.
Study duration per Patient will be 180 days starting with the randomization visit. In addition to the randomization visit, 4 visits at the site and 2 phone calls are scheduled.
In case of developing another lesion after the randomization visit, patients take a single swab of the lesion and episodic SoC treatment with Valaciclovir/ Valaciclovir-placebo is started and documented in an electronic diary by the patient within 24 hours after development of first symptoms. Quality of life is also recorded.
In addition to this, the patients need to present at the site within 72 hours after occurence of a the new herpes outbreak for medical examination and to confirm the HSV-2 lesion. At this unscheduled visit at the site, the PI will take a second swab and assess the lesion (including start date). Another unscheduled visit will take place upon healing of lesion.
This procedure will be repeated for every outbreak during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Double-Dummy
| Arm | Type | Receives |
|---|---|---|
| HDIT101 + Valaciclovir placebo | Experimental | Biological: HDIT101, Drug: Valaciclovir placeboGroup A: Patients treated with a single i.v. infusion of 2 g HDIT101 for 60 min at the randomization visit and with an episodic Valaciclovir placebo bid for 3 days. |
| HDIT101 placebo + Valaciclovir | Active comparator | Drug: Valaciclovir, Biological: HDIT101 placeboGroup B: Patients treated with a single i.v. infusion of HDIT101 placebo for 60 min at the randomization visit and with episodic Valaciclovir 500 mg twice daily for 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years at the time of signing informed consent.
- Signed informed consent for participation in the study.
- Understanding, ability, and willingness to fully comply with study interventions and restrictions.
- Seropositive for HSV-2.
- 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.
Key exclusion criteria (16 listed)
- 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).
- 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).
- Patients with herpes keratitis.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDIT101i.v. Infusion | Biological | HDIT101 + Valaciclovir placebo |
| ValaciclovirAlso: Valtrexoral application of encapsulated Valaciclovir tablets | Drug | HDIT101 placebo + Valaciclovir |
| HDIT101 placeboi.v. Infusion | Biological | HDIT101 placebo + Valaciclovir |
| Valaciclovir placebooral application of encapsulated Valaciclovir placebo tablets | Drug | HDIT101 + Valaciclovir placebo |
Primary outcome
Percentage of days with lesion(s) per treatment group
Time frame: 180 days
Primary objective is calculated as the number of days with lesion (except the lesion episode at randomization) divided by the number of study days after IMP infusion.
6 secondary outcomes
Time to first recurrence of lesion
Time frame: 180 days
Recurrence rate of lesions
Time frame: 180 days
Duration of recurrent lesions
Time frame: 180 days
Disease-specific symptoms
Time frame: 180 days
Herpes outbreak impact
Time frame: 180 days
QoL
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Derived from this study: PubMed 41109488Stellbrink HJ, Schaller T, Sturm K, Brockmeyer NH, Potthoff A, Bickel M, Scholten S, Postel N, Jessen A, Muller M, Jager D, Muller C, Seyfizadeh N, Schoffel S, Ullrich B, Brosi L, Kunz C, Thomas D, Laage R, Hanakam F, Schwab M, Schonborn-Kellenberger O, Mangold M, Och K, Lehr T, Arndt MA, Krauss J. Safety and efficacy of monoclonal antibody therapy in patients with chronic herpes simplex virus-2 genital infections: MATCH-2, a randomized double-blinded, parallel-group phase 2 multi-center trial. Pharmacol Res. 2025 Nov;221:107999. doi: 10.1016/j.phrs.2025.107999. Epub 2025 Oct 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Schoeffel study director
Heidelberg ImmunoTherapeutics GmbH
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDIT101 and Valaciclovir in people with Herpes Genitalis, run by Heidelberg ImmunoTherapeutics GmbH at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of days with lesion(s) per treatment group (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04165122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.