Melanoma, Metastatic Melanoma, Mucosal Melanoma
Conditions
Keywords
melanoma, neoplasms, Poly ICLC, Freund's Adjuvant, Metastatic melanoma, resiquimod, adjuvants, peptide vaccine
Brief summary
The purpose of this study is to learn what effects (good and bad) an experimental vaccine (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine and these drugs cause any changes in your immune system.
Interventions
BIOLOGICALPeptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.
OTHERPolyICLC
1 mL administered half intradermally and half subcutaneously
OTHERResiquimod
500 mg applied to vaccine site after vaccine administration
OTHERIFA
2 mL administered half intradermally and half subcutaneously
Sponsors
University of Virginia
Craig L Slingluff, Jr
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven Stage IIB - IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration. * Patients may have had melanoma from a cutaneous, mucosal or unknown primary site * Patients with small radiologic or clinical findings may be eligible * Patients with treated brain metastases may be eligible if the following are true: * Total number of brain metastases ever is less than or equal to 3 * The brain metastases have been completely removed by surgery or have been treated completely with stereotactic radiotherapy * There has been no evident growth of any brain metastases since treatment * No treated brain metastases is greater than 2 cm at the time of protocol entry * Patients must have at least 1 intact axillary and/or inguinal lymph node basin * ECOG performance status of 0-1 * Lab parameters as follows: * HLA-A1, A2, A3, B35, or B51 * ANC \> 1000/mm3 and Platelets \> 100,000/mm3 and Hemoglobin \> 9 g/dL * AST and ALT up to 2.5 x ULN * Bilirubin up to 2.5 x ULN * Alkaline Phosphatase up to 2.5 x ULN * Creatinine up to 1.5 x ULN * HGBA1C level ≤ 7.5%
Exclusion criteria
* Patients with melanoma from a uveal or ocular primary site * Patients currently receiving any systemic therapy within 4 weeks of study registration. Gamma knife or stereotactic radiosurgery must not be administered within 1 week prior to study registration. Patients who are currently receiving nitrosoureas within the preceding 6 weeks. * Patients who have received CTLA-4, PD-1, PD-L1, CD137, or CD27 within the prior 12 months. * Patients with known or suspected allergy to any component of the vaccine * HIV positive or active Hepatitis C virus * Patients receiving any of the following medications within 4 weeks are excluded: * Agents with immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids) * Allergy desensitization injections * Systemic corticosteroids, administered parenterally or orally. Inhaled steroids (e.g. Advair, Flovent, Azmacort) are not permitted. Topical corticosteroids are acceptable including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex) * Any growth factors (e.g. GM-CSF, G-CSF, erythropoietin). * Interferon therapy * Interleukin-2 or other interleukins * Other investigational drugs or investigational therapy if currently receiving or have received within 1 month * Pregnancy or the possibility of becoming pregnant during the study. And women who are breastfeeding. * Must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. The following are not exclusionary: * Presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms * Clinical evidence of vitiligo * Other forms of depigmenting illness * Mild arthritis requiring NSAID medications * Patients with a medical contradiction or potential problem with complying with the protocol, in the opinion of the investigator * Patients with Class III or IV heart disease (according to NYHA classification) * Patients with a body weight \< 110 lbs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events Per Study Arm | 6 months | Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists. Patients are evaluated by safety labs and physical exams to assess for toxicity. |
| T Cell Response in Peripheral Blood Over Duration of Study Participation | 6 months | Levels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T Cell Response and Function in Peripheral Blood | 6 months | CD4+ T cell responses to peptides in the vaccine, and their function |
Countries
United States
Participant flow
Pre-assignment details
After enrolling 49 participants across all 7 arms in accord with the study objectives, the study was amended to allow enrollment of an additional cohort on arm E (part 2) as a neoadjuvant vaccine with biopsies pre- and post-vaccine. However, only 1 patient enrolled on part 2 arm E; thus, we closed the study. Analysis of 1 patient would not satisfy the goals of that neoadjuvant component; so, we include data for the part 2 Arm E participant in Arm E for reporting purposes.
Participants by arm
| Arm | Count |
|---|---|
| Arm A (Part 1) Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
IFA: 2 mL administered half intradermally and half subcutaneously | 5 |
| Arm B (Part 1) Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously | 7 |
| Arm C (Part 1) Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after the vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration | 4 |
| Arm D (Part 1) Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration | 6 |
| Arm E (Part 1 + 2) Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
IFA: 2 mL administered half intradermally and half subcutaneously.
Except that the last patient, on Part 2 received all 6 vaccines in the same site and did not receive tetanus peptide. | 16 |
| Arm F (Part 1) Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously | 6 |
| Arm G(Part 1) Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously | 6 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | disease progression | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Arm B (Part 1) | Total | Arm G(Part 1) | Arm F (Part 1) | Arm E (Part 1 + 2) | Arm D (Part 1) | Arm C (Part 1) | Arm A (Part 1) |
|---|---|---|---|---|---|---|---|---|
| Age, Customized Median Age | 64 years | 58 years | 59 years | 56 years | 60 years | 53 years | 64 years | 52 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 50 Participants | 6 Participants | 6 Participants | 16 Participants | 6 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 49 Participants | 6 Participants | 6 Participants | 15 Participants | 6 Participants | 4 Participants | 5 Participants |
| Region of Enrollment United States | 7 participants | 50 participants | 6 participants | 6 participants | 16 participants | 6 participants | 4 participants | 5 participants |
| Sex: Female, Male Female | 3 Participants | 20 Participants | 3 Participants | 0 Participants | 9 Participants | 1 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 30 Participants | 3 Participants | 6 Participants | 7 Participants | 5 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 1 / 7 | 1 / 4 | 2 / 6 | 1 / 16 | 0 / 6 | 2 / 6 |
| other Total, other adverse events | 5 / 5 | 7 / 7 | 4 / 4 | 6 / 6 | 16 / 16 | 6 / 6 | 6 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 7 | 0 / 4 | 0 / 6 | 0 / 16 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants With Treatment-related Adverse Events Per Study Arm
Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists. Patients are evaluated by safety labs and physical exams to assess for toxicity.
Time frame: 6 months
Population: All participants enrolled and treated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | EAR/LABYRINTH - Tinnitus | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INJURY/POISONING/PROCEDURAL - Bruising | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Weight loss | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | METABOLISM/NUTRITION - Anorexia | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Generalized muscle weakness | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Pain in extremity | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Dyspnea | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pruritus | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Rash maculo-papular | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin ulceration | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Other | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | BLOOD/LYMPHATIC - Other | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Constipation | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Diarrhea | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Mucositis oral | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Nausea | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Other | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Vomiting | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Chills | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fatigue | 4 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fever | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Flu like symptoms | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Injection site reaction | 5 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Localized edema | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Other | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Pain | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | IMMUNE SYSTEM - Autoimmune disorder | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Lymphocyte count decreased | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - White blood cell decreased | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Arthralgia | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Myalgia | 3 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Other | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dizziness | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dysgeusia | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Headache | 2 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | PSYCHIATRIC - Anxiety | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Allergic rhinitis | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Cough | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Sore throat | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Hyperhidrosis | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pain of skin | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Scalp pain | 1 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hyperpigmentation | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hypopigmentation | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin induration | 4 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Flushing | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Hot flashes | 0 Participants |
| Arm A (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | DLTs | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin ulceration | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Localized edema | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | DLTs | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Arthralgia | 2 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | METABOLISM/NUTRITION - Anorexia | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Other | 2 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INJURY/POISONING/PROCEDURAL - Bruising | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - White blood cell decreased | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Weight loss | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Lymphocyte count decreased | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Flushing | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | IMMUNE SYSTEM - Autoimmune disorder | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Constipation | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Pain | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Flu like symptoms | 1 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | EAR/LABYRINTH - Tinnitus | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Diarrhea | 1 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Scalp pain | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Rash maculo-papular | 1 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Mucositis oral | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pruritus | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pain of skin | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Hyperhidrosis | 1 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Nausea | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Sore throat | 1 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hypopigmentation | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Other | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Cough | 1 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Allergic rhinitis | 1 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin induration | 2 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Vomiting | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | BLOOD/LYMPHATIC - Other | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | PSYCHIATRIC - Anxiety | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Chills | 2 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Other | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Headache | 2 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Generalized muscle weakness | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fatigue | 5 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Dyspnea | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dysgeusia | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dizziness | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fever | 1 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Other | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hyperpigmentation | 0 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Pain in extremity | 1 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Myalgia | 2 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Injection site reaction | 6 Participants |
| Arm B (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Hot flashes | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Pain in extremity | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Arthralgia | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Cough | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Localized edema | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fatigue | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Generalized muscle weakness | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | METABOLISM/NUTRITION - Anorexia | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Other | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - White blood cell decreased | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hypopigmentation | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Other | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dysgeusia | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Allergic rhinitis | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Weight loss | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Pain | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Injection site reaction | 1 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Lymphocyte count decreased | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dizziness | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Myalgia | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Vomiting | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | IMMUNE SYSTEM - Autoimmune disorder | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Flushing | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INJURY/POISONING/PROCEDURAL - Bruising | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin ulceration | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Constipation | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | DLTs | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Other | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Flu like symptoms | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | PSYCHIATRIC - Anxiety | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fever | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin induration | 1 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Diarrhea | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pruritus | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Scalp pain | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hyperpigmentation | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Rash maculo-papular | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Chills | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | BLOOD/LYMPHATIC - Other | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Mucositis oral | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Other | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pain of skin | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Headache | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Hyperhidrosis | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | EAR/LABYRINTH - Tinnitus | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Hot flashes | 1 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Nausea | 1 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Dyspnea | 0 Participants |
| Arm C (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Sore throat | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Cough | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Flushing | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | BLOOD/LYMPHATIC - Other | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | EAR/LABYRINTH - Tinnitus | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hypopigmentation | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Constipation | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Diarrhea | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Mucositis oral | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Nausea | 2 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | DLTs | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Other | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Vomiting | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Chills | 3 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin induration | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fatigue | 3 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fever | 2 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Flu like symptoms | 3 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin ulceration | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Injection site reaction | 6 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Localized edema | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Other | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Pain | 1 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | IMMUNE SYSTEM - Autoimmune disorder | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INJURY/POISONING/PROCEDURAL - Bruising | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Lymphocyte count decreased | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Weight loss | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - White blood cell decreased | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | METABOLISM/NUTRITION - Anorexia | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Arthralgia | 1 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Generalized muscle weakness | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Myalgia | 2 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Pain in extremity | 1 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Other | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Hot flashes | 2 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dizziness | 2 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dysgeusia | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Headache | 3 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | PSYCHIATRIC - Anxiety | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Other | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Hyperhidrosis | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pain of skin | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Rash maculo-papular | 1 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Scalp pain | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hyperpigmentation | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Allergic rhinitis | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Dyspnea | 1 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Sore throat | 0 Participants |
| Arm D (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pruritus | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin induration | 14 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | METABOLISM/NUTRITION - Anorexia | 2 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Localized edema | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin ulceration | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Arthralgia | 6 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Generalized muscle weakness | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Injection site reaction | 15 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Sore throat | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Myalgia | 7 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Flu like symptoms | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fever | 8 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Other | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Hyperhidrosis | 7 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dizziness | 2 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Hot flashes | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fatigue | 12 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dysgeusia | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Headache | 6 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Chills | 12 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | PSYCHIATRIC - Anxiety | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Vomiting | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Other | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Dyspnea | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Other | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Nausea | 5 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Mucositis oral | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Flushing | 5 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pain of skin | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Rash maculo-papular | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Diarrhea | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pruritus | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hypopigmentation | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Constipation | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Scalp pain | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | EAR/LABYRINTH - Tinnitus | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Pain in extremity | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Allergic rhinitis | 2 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | IMMUNE SYSTEM - Autoimmune disorder | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Cough | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INJURY/POISONING/PROCEDURAL - Bruising | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | DLTs | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Lymphocyte count decreased | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Pain | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hyperpigmentation | 2 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Weight loss | 0 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Other | 6 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | BLOOD/LYMPHATIC - Other | 1 Participants |
| Arm E (Part 1 + Part 2) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - White blood cell decreased | 2 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Weight loss | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Localized edema | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Dyspnea | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Headache | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | METABOLISM/NUTRITION - Anorexia | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | IMMUNE SYSTEM - Autoimmune disorder | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | DLTs | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Nausea | 2 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Constipation | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Hot flashes | 2 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Other | 3 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Arthralgia | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Other | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Injection site reaction | 6 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Scalp pain | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Chills | 3 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Generalized muscle weakness | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Other | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Pain | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Flushing | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Flu like symptoms | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Allergic rhinitis | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Cough | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Myalgia | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | EAR/LABYRINTH - Tinnitus | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin induration | 2 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Sore throat | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Mucositis oral | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pain of skin | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fever | 2 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Lymphocyte count decreased | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - White blood cell decreased | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin ulceration | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Other | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hypopigmentation | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hyperpigmentation | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Vomiting | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INJURY/POISONING/PROCEDURAL - Bruising | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Hyperhidrosis | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Rash maculo-papular | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dizziness | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pruritus | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Pain in extremity | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fatigue | 3 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | BLOOD/LYMPHATIC - Other | 0 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Diarrhea | 2 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | PSYCHIATRIC - Anxiety | 1 Participants |
| Arm F (Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dysgeusia | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Injection site reaction | 6 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Chills | 3 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Headache | 1 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Lymphocyte count decreased | 1 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Vomiting | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pain of skin | 1 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | PSYCHIATRIC - Anxiety | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Cough | 2 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Other | 1 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Allergic rhinitis | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Pruritus | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Nausea | 2 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin induration | 5 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Flushing | 1 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Dyspnea | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | IMMUNE SYSTEM - Autoimmune disorder | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hypopigmentation | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Mucositis oral | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Other | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin ulceration | 2 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Diarrhea | 1 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Scalp pain | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Rash maculo-papular | 1 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | DLTs | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INJURY/POISONING/PROCEDURAL - Bruising | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | VASCULAR - Hot flashes | 2 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Pain | 2 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | METABOLISM/NUTRITION - Anorexia | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GASTROINTESTINAL - Constipation | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Skin hyperpigmentation | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dysgeusia | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Other | 1 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Generalized muscle weakness | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Flu like symptoms | 2 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | EAR/LABYRINTH - Tinnitus | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Pain in extremity | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fever | 2 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | RESPIRATORY/THORACIC/MEDIASTINAL - Sore throat | 2 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - Weight loss | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Other | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | INVESTIGATIONS - White blood cell decreased | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Localized edema | 1 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | GENERAL AND ADMINISTRATION SITE - Fatigue | 4 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | BLOOD/LYMPHATIC - Other | 0 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | NERVOUS SYSTEM - Dizziness | 1 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Arthralgia | 4 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | SKIN/SUBCUTANEOUS TISSUE - Hyperhidrosis | 1 Participants |
| Arm G(Part 1) | Number of Participants With Treatment-related Adverse Events Per Study Arm | MUSCULOSKELETAL/CONNECTIVE TISSUE - Myalgia | 0 Participants |
Primary
T Cell Response in Peripheral Blood Over Duration of Study Participation
Levels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A (Part 1) | T Cell Response in Peripheral Blood Over Duration of Study Participation | 2 Participants |
| Arm B (Part 1) | T Cell Response in Peripheral Blood Over Duration of Study Participation | 1 Participants |
| Arm C (Part 1) | T Cell Response in Peripheral Blood Over Duration of Study Participation | 0 Participants |
| Arm D (Part 1) | T Cell Response in Peripheral Blood Over Duration of Study Participation | 0 Participants |
| Arm E (Part 1 + Part 2) | T Cell Response in Peripheral Blood Over Duration of Study Participation | 4 Participants |
| Arm F (Part 1) | T Cell Response in Peripheral Blood Over Duration of Study Participation | 1 Participants |
| Arm G(Part 1) | T Cell Response in Peripheral Blood Over Duration of Study Participation | 1 Participants |
Secondary
T Cell Response and Function in Peripheral Blood
CD4+ T cell responses to peptides in the vaccine, and their function
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A (Part 1) | T Cell Response and Function in Peripheral Blood | 4 Participants |
| Arm B (Part 1) | T Cell Response and Function in Peripheral Blood | 3 Participants |
| Arm C (Part 1) | T Cell Response and Function in Peripheral Blood | 0 Participants |
| Arm D (Part 1) | T Cell Response and Function in Peripheral Blood | 1 Participants |
| Arm E (Part 1 + Part 2) | T Cell Response and Function in Peripheral Blood | 8 Participants |
| Arm F (Part 1) | T Cell Response and Function in Peripheral Blood | 1 Participants |
| Arm G(Part 1) | T Cell Response and Function in Peripheral Blood | 3 Participants |