Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the effect of recombinant human heat shock protein 70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital herpes by evaluating viral shedding before and after treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This study will evaluate the biological effectiveness and safety of the HerpV vaccine in combination with adjuvant QS-21. The Safety and tolerability of HerpV plus QS-21 will also be evaluated by collecting number and severity of adverse events throughout the study.
Participants will undergo a baseline/ screening period. This is a 45 day period when the participant collects a swab of the genital area each day. In case of a recurrence, participant will be required to collect two swabs a day. If the participant collects at least 80% of the swabbing samples and meets all eligibility criteria they may enroll in the study.
Study Period 1 consists of three treatments and a 45 day swabbing period after the last treatment. The participant will collect swabs of the genital region each day for 45 days.
Participants who successfully complete Study Period 1 will proceed to Study Period 2. They will receive a booster injection of study drug or placebo according to their original randomization assignment. The participants will again enter a 45 day swabbing period, collecting swabs of the genital area each day for 45 days.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HerpV 240 μg + QS-21 50 μg Participants will receive a combination of HerpV 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 will receive a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period will be followed by a washout period of 1 week. |
Drug: HerpV and QS-21
HerpV (recombinant human heat shock protein 70 [rh-Hsc70] polyvalent peptide complex) in combination with adjuvant QS-21
Other Names:
|
| Placebo Comparator: Placebo Participants will receive a placebo injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period will be followed by a washout period of 1 week. |
Drug: Placebo
phosphate buffered saline
|
Outcome Measures
Primary Outcome Measures
- Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13) [Baseline, Weeks 6-13]
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported.
- Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33) [Baseline, Weeks 26-33]
The viral shedding rate was defined as the number of days with genital swab positive for HSV DNA, as measured by quantitative real-time PCR, relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported.
Other Outcome Measures
- Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time [Baseline through Week 26]
- Number of Participants With CD8+ Immune Response at Any Time [Baseline through Week 26]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Seropositive for herpes simplex virus type 2 (HSV-2)
-
Clinically active genital herpes defined as a history of 1-9 episodes per year for at least 1 year prior to screening or 1 year prior to beginning suppressive therapy.
-
Willing to either use an effective method of contraception or abstain from sexual intercourse throughout the 48-week study period.
-
If female of childbearing potential, have a negative serum pregnancy test.
-
Agree to not receive any other investigational drugs while enrolled in this study.
-
The above criteria must be met before participants are allowed to enter the 45-day swabbing period to be screen for the study.
-
Completion and collection of greater than or equal to 80% (36 days) of the 45-day consecutive daily genital swabs.
Exclusion Criteria:
-
Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion.
-
A history of herpes simplex virus (HSV) infection of the eye (herpes simplex interstitial keratitis or uveitis), or herpes-associated erythema multiforme.
-
A history of immune suppression or autoimmune disorder.
-
Continued use of suppressive anti-viral therapy for HSV-2; a 1 week washout of any anti-viral therapy (suppressive and episodic) is required prior to initiating the swabbing period.
-
Concomitant use of systemic corticosteroids or immune-suppressive medications. The use of nasal steroids is acceptable.
-
Human immunodeficiency virus (HIV) positive.
-
Presence of active Hepatitis B or C infection.
-
Known hypersensitivity or allergies to acyclovir or valacyclovir.
-
Pregnant or breast-feeding women.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Westover Heights Clinic | Portland | Oregon | United States | 97210 |
| 2 | Center for Clinical Studies - Texas Medical Center | Houston | Texas | United States | 77030 |
| 3 | Center for Clinical Studies - Cypress | Houston | Texas | United States | 77065 |
| 4 | Center for Clinical Studies- Webster | Houston | Texas | United States | 77598 |
| 5 | University of Washington Virology Research Clinic | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Agenus Inc.
Investigators
- Study Director: Agenus Medical Monitor, Agenus Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
- C-400-02
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | HerpV + QS-21 | Placebo |
|---|---|---|
| Arm/Group Description | Participants received a combination of HerpV (recombinant human heat shock protein 70 [rh-Hsc70] polyvalent peptide complex) 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. | Participants received placebo (phosphate buffered saline [PBS]) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week. |
| Period Title: Overall Study | ||
| STARTED | 70 | 10 |
| Received at Least 1 Dose of Study Drug | 70 | 10 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 70 | 10 |
Baseline Characteristics
| Arm/Group Title | HerpV + QS-21 | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. | Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week. | Total of all reporting groups |
| Overall Participants | 70 | 10 | 80 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
35.9
(8.00)
|
33.7
(6.22)
|
35.6
(7.80)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
42
60%
|
6
60%
|
48
60%
|
| Male |
28
40%
|
4
40%
|
32
40%
|
Outcome Measures
| Title | Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13) |
|---|---|
| Description | The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported. |
| Time Frame | Baseline, Weeks 6-13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for "HerpV + QS-21" arm only. |
| Arm/Group Title | HerpV + QS-21 |
|---|---|
| Arm/Group Description | Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. |
| Measure Participants | 70 |
| Number (95% Confidence Interval) [percentage change] |
13.53
|
| Title | Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33) |
|---|---|
| Description | The viral shedding rate was defined as the number of days with genital swab positive for HSV DNA, as measured by quantitative real-time PCR, relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported. |
| Time Frame | Baseline, Weeks 26-33 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for "HerpV + QS-21" arm only. |
| Arm/Group Title | HerpV + QS-21 |
|---|---|
| Arm/Group Description | Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. |
| Measure Participants | 70 |
| Number (95% Confidence Interval) [percentage change] |
12.78
|
| Title | Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time |
|---|---|
| Description | |
| Time Frame | Baseline through Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. |
| Arm/Group Title | HerpV + QS-21 | Placebo |
|---|---|---|
| Arm/Group Description | Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. | Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week. |
| Measure Participants | 61 | 8 |
| Count of Participants [Participants] |
46
65.7%
|
1
10%
|
| Title | Number of Participants With CD8+ Immune Response at Any Time |
|---|---|
| Description | |
| Time Frame | Baseline through Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. |
| Arm/Group Title | HerpV + QS-21 | Placebo |
|---|---|---|
| Arm/Group Description | Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. | Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week. |
| Measure Participants | 61 | 8 |
| Count of Participants [Participants] |
32
45.7%
|
2
20%
|
Adverse Events
| Time Frame | Baseline up to Week 76 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization. | |||
| Arm/Group Title | HerpV + QS-21 | Placebo | ||
| Arm/Group Description | Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. | Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week. | ||
All Cause Mortality |
||||
| HerpV + QS-21 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| HerpV + QS-21 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/70 (4.3%) | 0/10 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis | 1/70 (1.4%) | 0/10 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Rhabdomyolysis | 1/70 (1.4%) | 0/10 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pneumothorax | 1/70 (1.4%) | 0/10 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| HerpV + QS-21 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 67/70 (95.7%) | 10/10 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 3/70 (4.3%) | 0/10 (0%) | ||
| Lymphadenopathy | 2/70 (2.9%) | 0/10 (0%) | ||
| Ear and labyrinth disorders | ||||
| Ear discomfort | 1/70 (1.4%) | 0/10 (0%) | ||
| Hyperacusis | 1/70 (1.4%) | 0/10 (0%) | ||
| Endocrine disorders | ||||
| Thyroid mass | 1/70 (1.4%) | 0/10 (0%) | ||
| Eye disorders | ||||
| Erythema of eyelid | 1/70 (1.4%) | 0/10 (0%) | ||
| Eye pruritus | 1/70 (1.4%) | 0/10 (0%) | ||
| Eyelid edema | 1/70 (1.4%) | 0/10 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 3/70 (4.3%) | 0/10 (0%) | ||
| Abdominal pain, upper | 0/70 (0%) | 1/10 (10%) | ||
| Anorectal discomfort | 1/70 (1.4%) | 0/10 (0%) | ||
| Aphthous stomatitis | 1/70 (1.4%) | 0/10 (0%) | ||
| Constipation | 4/70 (5.7%) | 0/10 (0%) | ||
| Diarrhea | 25/70 (35.7%) | 5/10 (50%) | ||
| Dry mouth | 1/70 (1.4%) | 0/10 (0%) | ||
| Dyspepsia | 1/70 (1.4%) | 0/10 (0%) | ||
| Gastritis | 1/70 (1.4%) | 0/10 (0%) | ||
| Gastroesophageal reflux disease | 2/70 (2.9%) | 0/10 (0%) | ||
| Hemorrhoids | 1/70 (1.4%) | 0/10 (0%) | ||
| Irritable bowel syndrome | 1/70 (1.4%) | 0/10 (0%) | ||
| Nausea | 30/70 (42.9%) | 6/10 (60%) | ||
| Paresthesia, oral | 2/70 (2.9%) | 0/10 (0%) | ||
| Tongue disorder | 1/70 (1.4%) | 1/10 (10%) | ||
| Tooth impacted | 1/70 (1.4%) | 0/10 (0%) | ||
| Vomiting | 5/70 (7.1%) | 2/10 (20%) | ||
| General disorders | ||||
| Asthenia | 1/70 (1.4%) | 0/10 (0%) | ||
| Axillary pain | 1/70 (1.4%) | 0/10 (0%) | ||
| Chills | 12/70 (17.1%) | 0/10 (0%) | ||
| Fatigue | 57/70 (81.4%) | 6/10 (60%) | ||
| Feeling cold | 1/70 (1.4%) | 0/10 (0%) | ||
| Induration | 1/70 (1.4%) | 0/10 (0%) | ||
| Inflammation | 1/70 (1.4%) | 0/10 (0%) | ||
| Influenza-like illness | 1/70 (1.4%) | 0/10 (0%) | ||
| Injection-site cyst | 1/70 (1.4%) | 0/10 (0%) | ||
| Injection-site erythema | 56/70 (80%) | 0/10 (0%) | ||
| Injection-site hematoma | 6/70 (8.6%) | 1/10 (10%) | ||
| Injection-site induration | 16/70 (22.9%) | 0/10 (0%) | ||
| Injection-site pain | 66/70 (94.3%) | 5/10 (50%) | ||
| Injection-site paresthesia | 0/70 (0%) | 1/10 (10%) | ||
| Injection-site pruritus | 18/70 (25.7%) | 1/10 (10%) | ||
| Injection-site rash | 2/70 (2.9%) | 0/10 (0%) | ||
| Injection-site swelling | 42/70 (60%) | 0/10 (0%) | ||
| Injection-site ulcer | 1/70 (1.4%) | 0/10 (0%) | ||
| Injection-site vesicles | 1/70 (1.4%) | 0/10 (0%) | ||
| Injection-site warmth | 4/70 (5.7%) | 0/10 (0%) | ||
| Pyrexia | 11/70 (15.7%) | 0/10 (0%) | ||
| Vaccination-site warmth | 1/70 (1.4%) | 0/10 (0%) | ||
| Hepatobiliary disorders | ||||
| Hypertransaminasemia | 1/70 (1.4%) | 0/10 (0%) | ||
| Immune system disorders | ||||
| Seasonal allergy | 0/70 (0%) | 1/10 (10%) | ||
| Infections and infestations | ||||
| Bronchitis | 2/70 (2.9%) | 0/10 (0%) | ||
| Chlamydial infection | 1/70 (1.4%) | 0/10 (0%) | ||
| Ear infection | 0/70 (0%) | 1/10 (10%) | ||
| Folliculitis | 1/70 (1.4%) | 0/10 (0%) | ||
| Furuncle | 1/70 (1.4%) | 0/10 (0%) | ||
| Gastroenteritis, viral | 3/70 (4.3%) | 0/10 (0%) | ||
| Herpes zoster | 1/70 (1.4%) | 0/10 (0%) | ||
| Influenza | 4/70 (5.7%) | 0/10 (0%) | ||
| Nasopharyngitis | 7/70 (10%) | 0/10 (0%) | ||
| Oral herpes | 0/70 (0%) | 1/10 (10%) | ||
| Otitis media | 1/70 (1.4%) | 0/10 (0%) | ||
| Perirectal abscess | 1/70 (1.4%) | 0/10 (0%) | ||
| Pharyngitis | 1/70 (1.4%) | 0/10 (0%) | ||
| Pharyngitis, streptococcal | 2/70 (2.9%) | 1/10 (10%) | ||
| Rash, pustular | 1/70 (1.4%) | 0/10 (0%) | ||
| Sinusitis | 5/70 (7.1%) | 0/10 (0%) | ||
| Tooth infection | 1/70 (1.4%) | 0/10 (0%) | ||
| Upper respiratory tract infection | 6/70 (8.6%) | 1/10 (10%) | ||
| Urinary tract infection | 1/70 (1.4%) | 0/10 (0%) | ||
| Vaginal abscess | 1/42 (2.4%) | 0/6 (0%) | ||
| Vulvovaginal candidiasis | 0/42 (0%) | 1/6 (16.7%) | ||
| Vulvovaginitis | 1/42 (2.4%) | 0/6 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Arthropod bite | 0/70 (0%) | 1/10 (10%) | ||
| Joint injury | 1/70 (1.4%) | 0/10 (0%) | ||
| Ligament sprain | 2/70 (2.9%) | 0/10 (0%) | ||
| Limb injury | 2/70 (2.9%) | 1/10 (10%) | ||
| Muscle strain | 2/70 (2.9%) | 0/10 (0%) | ||
| Procedural nausea | 1/70 (1.4%) | 0/10 (0%) | ||
| Procedural pain | 1/70 (1.4%) | 0/10 (0%) | ||
| Investigations | ||||
| Activated partial thromboplastin time prolonged | 1/70 (1.4%) | 0/10 (0%) | ||
| Alanine aminotransferase increased | 1/70 (1.4%) | 0/10 (0%) | ||
| Blood creatine phosphokinase increased | 2/70 (2.9%) | 0/10 (0%) | ||
| Blood glucose increased | 1/70 (1.4%) | 0/10 (0%) | ||
| Blood growth hormone decreased | 0/70 (0%) | 1/10 (10%) | ||
| Liver function test abnormal | 1/70 (1.4%) | 0/10 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Vitamin D deficiency | 1/70 (1.4%) | 0/10 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 2/70 (2.9%) | 1/10 (10%) | ||
| Axillary mass | 1/70 (1.4%) | 0/10 (0%) | ||
| Back pain | 1/70 (1.4%) | 0/10 (0%) | ||
| Muscle spasms | 1/70 (1.4%) | 0/10 (0%) | ||
| Muscle tightness | 1/70 (1.4%) | 0/10 (0%) | ||
| Musculoskeletal chest pain | 1/70 (1.4%) | 0/10 (0%) | ||
| Musculoskeletal stiffness | 2/70 (2.9%) | 0/10 (0%) | ||
| Myalgia | 56/70 (80%) | 4/10 (40%) | ||
| Neck mass | 1/70 (1.4%) | 0/10 (0%) | ||
| Neck pain | 0/70 (0%) | 1/10 (10%) | ||
| Pain in extremity | 3/70 (4.3%) | 0/10 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast cancer, in situ | 1/70 (1.4%) | 0/10 (0%) | ||
| Lung neoplasm | 1/70 (1.4%) | 0/10 (0%) | ||
| Rectal cancer, stage II | 1/70 (1.4%) | 0/10 (0%) | ||
| Nervous system disorders | ||||
| Balance disorder | 1/70 (1.4%) | 0/10 (0%) | ||
| Disturbance in attention | 0/70 (0%) | 1/10 (10%) | ||
| Dizziness | 7/70 (10%) | 0/10 (0%) | ||
| Headache | 49/70 (70%) | 7/10 (70%) | ||
| Hyperesthesia | 2/70 (2.9%) | 0/10 (0%) | ||
| Nerve compression | 0/70 (0%) | 1/10 (10%) | ||
| Paresthesia | 2/70 (2.9%) | 0/10 (0%) | ||
| Presyncope | 1/70 (1.4%) | 0/10 (0%) | ||
| Syncope | 1/70 (1.4%) | 0/10 (0%) | ||
| Tremor | 0/70 (0%) | 1/10 (10%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Pregnancy | 1/42 (2.4%) | 0/6 (0%) | ||
| Psychiatric disorders | ||||
| Anxiety | 2/70 (2.9%) | 0/10 (0%) | ||
| Depression | 2/70 (2.9%) | 0/10 (0%) | ||
| Insomnia | 1/70 (1.4%) | 1/10 (10%) | ||
| Restlessness | 1/70 (1.4%) | 0/10 (0%) | ||
| Sleep disorder | 1/70 (1.4%) | 1/10 (10%) | ||
| Renal and urinary disorders | ||||
| Bladder discomfort | 1/70 (1.4%) | 0/10 (0%) | ||
| Dysuria | 1/70 (1.4%) | 0/10 (0%) | ||
| Nephrolithiasis | 1/70 (1.4%) | 0/10 (0%) | ||
| Pyuria | 1/70 (1.4%) | 0/10 (0%) | ||
| Reproductive system and breast disorders | ||||
| Mid-cycle spotting | 1/70 (1.4%) | 0/10 (0%) | ||
| Breast mass | 1/70 (1.4%) | 0/10 (0%) | ||
| Cervical polyp | 1/42 (2.4%) | 0/6 (0%) | ||
| Menstrual disorder | 1/42 (2.4%) | 0/6 (0%) | ||
| Pelvic pain | 1/42 (2.4%) | 0/6 (0%) | ||
| Penile pain | 1/28 (3.6%) | 0/4 (0%) | ||
| Sexual dysfunction | 1/70 (1.4%) | 0/10 (0%) | ||
| Vaginal laceration | 1/42 (2.4%) | 0/6 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 1/70 (1.4%) | 0/10 (0%) | ||
| Nasal congestion | 1/70 (1.4%) | 0/10 (0%) | ||
| Oropharyngeal pain | 1/70 (1.4%) | 0/10 (0%) | ||
| Sinus congestion | 2/70 (2.9%) | 0/10 (0%) | ||
| Tonsillar hypertrophy | 1/70 (1.4%) | 0/10 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 2/70 (2.9%) | 0/10 (0%) | ||
| Cold sweat | 1/70 (1.4%) | 0/10 (0%) | ||
| Dermatitis | 1/70 (1.4%) | 0/10 (0%) | ||
| Dermatitis, contact | 1/70 (1.4%) | 0/10 (0%) | ||
| Erythema | 1/70 (1.4%) | 0/10 (0%) | ||
| Erythema, multiforme | 1/70 (1.4%) | 0/10 (0%) | ||
| Pruritis | 2/70 (2.9%) | 0/10 (0%) | ||
| Pruritis, generalized | 2/70 (2.9%) | 0/10 (0%) | ||
| Rash | 1/70 (1.4%) | 0/10 (0%) | ||
| Rash, pruritic | 1/70 (1.4%) | 0/10 (0%) | ||
| Urticaria | 1/70 (1.4%) | 0/10 (0%) | ||
| Vascular disorders | ||||
| Flushing | 0/70 (0%) | 1/10 (10%) | ||
| Hot flush | 1/70 (1.4%) | 0/10 (0%) | ||
| Hypertension | 1/70 (1.4%) | 0/10 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Agenus, Inc. Clinical Trial Information |
|---|---|
| Organization | Agenus Inc. |
| Phone | 781-674-4265 |
| clinicaltrialinfo@Agenusbio.com |
- C-400-02