Genital HerpesPhase 1NCT00231049
Trial Evaluating Safety, Tolerability and Immune Response of AG-707
A Phase 1 study testing AG-707 in people with Genital Herpes, run by Agenus Inc. at 3 sites in United States.
Trial summary
This is a randomized, multi-center, sequential, dose-escalating study of three dose cohorts of AG-707. Individuals who meet all of the inclusion and exclusion criteria for eligibility will be randomized to receive either AG-707 (at the 80 µg dose), AG-707 with QS-21 (at the 80 µg dose), placebo, or QS-21. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Genital Herpes
- What is being tested?
- AG-707
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2006to not given
- Phase
- Phase 1
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must be seropositive for HSV-2 (+/- HSV-1) and have a documented history of clinically active genital herpes (at least one prior outbreak).
- Patients must be seronegative for HIV.
- Patients must be seronegative for hepatitis B and C
- Have baseline chemistry and hematology (hemoglobin, white blood cell (WBC), absolute neutrophil count (ANC), eosinophils) within normal limits; prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal (ULN), and platelets above the lower limit of normal (LLN). Basophils, lymphocytes and monocytes must be within 1.2 x ULN or 0.8 x LLN and considered not clinically significant by the investigator. Total creatine phosphokinase (CPK) laboratory values < 1.25X the upper limit of normal (according to the normal reference ranges of the Central Laboratory) at baseline (Screening and Pre-Study Visit) and considered not clinically significant by the Investigator.
- Patients must not be taking antiviral therapy.
- Must be between the ages of 18 and 50 years of age and willing to either use an effective method of contraception or abstain from sexual activity for the 28-week duration of the trial.
Who cannot join
- Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the Principal Investigator, would prevent study completion.
- History of HSV infection of the eye (herpes simplex interstitial keratitis or uveitis), or herpes-associated erythema multiforme.
- History of immune suppression or autoimmune disorder.
- Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable.
- Patients with known hypersensitivity or allergies to acyclovir or valacyclovir.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Indianapolis, Indiana
Study site
Portland, Oregon
Study site
Seattle, Washington
About this study
Official title: A Phase 1 Trial Evaluating Safety, Tolerability and Immune Response of AG-707 Compared to Placebo in HSV-2 Seropositive Patients
This is a randomized, multi-center, sequential, dose-escalating study of three dose cohorts of AG-707. Individuals who meet all of the inclusion and exclusion criteria for eligibility will be randomized to receive either AG-707 (at the 80 µg dose), AG-707 with QS-21 (at the 80 µg dose), placebo, or QS-21. Each patient will be monitored for safety as specified in the protocol.
Read the detailed description
Primary Objective:
Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 80, 240 and 400 µg compared to placebo and QS-21 alone in HSV-2 seropositive adults.
Secondary Objective:
Determine immune response to AG-707 vaccination (with and without QS-21) at dose cohorts of 80, 240, and 400 µg as compared to placebo and QS-21 alone.
- Conditions
- Genital Herpes
- Being tested
- AG-707
- Keywords
- Genital Herpes, HSV-2 Seropositive, Vaccine
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-707Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 80, 240 and 400 µg compared to placebo and QS-21 alone in herpes simplex virus-2 (HSV-2) seropositive adults
Secondary outcomes (1)
Determine immune response to AG-707 vaccination (with and without QS-21) at dose cohorts of 80, 240, and 400 µg as compared to placebo and QS-21 alone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital HerpesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agenus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231049
- Sponsor's protocol ID
- C-400-01
- Status last verified
- Oct 2008
- First submitted
- 30 Sep 2005
- Last updated
- 27 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial Evaluating Safety, Tolerability and Immune Response of AG-707 Compared to Placebo in HSV-2 Seropositive Patients
- ClinicalTrials.gov ID
- NCT00231049
- Acronym / sponsor ID
- C-400-01
- Conditions
- Genital Herpes
- Keywords
- Genital Herpes, HSV-2 Seropositive, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Agenus Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- First posted
- 4 Oct 2005 (estimated)
- 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, multi-center, sequential, dose-escalating study of three dose cohorts of AG-707. Individuals who meet all of the inclusion and exclusion criteria for eligibility will be randomized to receive either AG-707 (at the 80 µg dose), AG-707 with QS-21 (at the 80 µg dose), placebo, or QS-21. Each patient will be monitored for safety as specified in the protocol.
Detailed description
Primary Objective:
Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 80, 240 and 400 µg compared to placebo and QS-21 alone in HSV-2 seropositive adults.
Secondary Objective:
Determine immune response to AG-707 vaccination (with and without QS-21) at dose cohorts of 80, 240, and 400 µg as compared to placebo and QS-21 alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients must be seropositive for HSV-2 (+/- HSV-1) and have a documented history of clinically active genital herpes (at least one prior outbreak).
- Patients must be seronegative for HIV.
- Patients must be seronegative for hepatitis B and C
- Have baseline chemistry and hematology (hemoglobin, white blood cell (WBC), absolute neutrophil count (ANC), eosinophils) within normal limits; prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal (ULN), and platelets above the lower limit of normal (LLN). Basophils, lymphocytes and monocytes must be within 1.2 x ULN or 0.8 x LLN and considered not clinically significant by the investigator. Total creatine phosphokinase (CPK) laboratory values < 1.25X the upper limit of normal (according to the normal reference ranges of the Central Laboratory) at baseline (Screening and Pre-Study Visit) and considered not clinically significant by the Investigator.
- Patients must not be taking antiviral therapy.
Key exclusion criteria (5 listed)
- Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the Principal Investigator, would prevent study completion.
- History of HSV infection of the eye (herpes simplex interstitial keratitis or uveitis), or herpes-associated erythema multiforme.
- History of immune suppression or autoimmune disorder.
- Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable.
- Patients with known hypersensitivity or allergies to acyclovir or valacyclovir.
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 |
|---|---|---|
| AG-707 | Drug | – |
Primary outcome
Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 80, 240 and 400 µg compared to placebo and QS-21 alone in herpes simplex virus-2 (HSV-2) seropositive adults
1 secondary outcome
Determine immune response to AG-707 vaccination (with and without QS-21) at dose cohorts of 80, 240, and 400 µg as compared to placebo and QS-21 alone
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 27 Oct 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AG-707 in people with Genital Herpes, run by Agenus Inc. at 3 sites in United States.
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 6 inclusion and 5 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 27 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 80, 240 and 400 µg compared to placebo and QS-21 alone in herpes simplex virus-2 (HSV-2) seropositive adults. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2008.