A Study of V934/V935 Vaccine in Cancer Participants With... | NCT00753415 | Trialant
NCT00753415
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Mar 17, 2015Estimated
Enrollment
37Actual
Phase
Phase 1
Conditions
Non-Small Cell Lung Carcinoma
Breast Cancer
Melanoma
Upper GI Tract Carcinoma
Colon Carcinoma
Renal Cell Carcinoma
Bladder Carcinoma
Prostate Cancer
Interventions
V935
V934-EP
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00753415
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V934-002
Secondary IDs
ID
Type
Description
Link
2008_541
Other Identifier
Merck Registration Number (Telerx #)
Brief Title
A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)
Official Title
A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Feb 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2008
Primary Completion Date
Apr 2011Actual
Completion Date
Apr 2011Actual
First Submitted Date
Sep 15, 2008
First Submission Date that Met QC Criteria
Sep 15, 2008
First Posted Date
Sep 16, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 19, 2014
Results First Submitted that Met QC Criteria
May 7, 2014
Results First Posted Date
Jun 3, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 26, 2015
Last Update Posted Date
Mar 17, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a two-part study to test the safety, tolerability, and immune response for V934/V935 vaccine using a new prime-boost regimen in participants with selected solid tumors.
Detailed Description
Two vaccines will be administered: V934-electroporation (EP) either low dose (LD) or high dose (HD), and V935 either LD or HD. In Part A, participants will be assigned to V935 vaccine alone or in combination with V934-EP. Part B will be an optional part of the study, offering V934-EP vaccine booster to participants who were enrolled in Part A.
Conditions Module
Conditions
Non-Small Cell Lung Carcinoma
Breast Cancer
Melanoma
Upper GI Tract Carcinoma
Colon Carcinoma
Renal Cell Carcinoma
Bladder Carcinoma
Prostate Cancer
Keywords
Urinary Bladder Neoplasms
Breast Neoplasms
Renal Cell carcinoma
Melanoma
Prostatic Neoplasms
Colonic Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Breast Diseases
Skin Diseases
Neoplasms
Glandular and Epithelial Neoplasms by Histologic Type
Adenocarcinoma
Kidney Neoplasms
Kidney Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Genital Neoplasms
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
37Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: V935 LD
Experimental
Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
Biological: V935
Part A: V934 LD(3)+V935 LD
Experimental
Three electroporation (EP) injections of V934 (LD) , 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) will be administered, 1 given every other week over a 3-week period.
Biological: V935
Biological: V934-EP
Part A: V935 HD
Experimental
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
Biological: V935
Part A: V934 HD(3)+V935 HD
Experimental
Three EP injections of V934 (HD), 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period.
Biological: V935
Biological: V934-EP
Part A: V934 HD(5)+V935 HD
Experimental
Five EP injections of V934 (HD), 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
V935
Biological
A 0.5 mL vaccine administered IM every 2 weeks as either a LD (1 x 10^9 vector genomes/mL) or a HD (1 x 10^11 vector genomes/mL).
Part A: V934 HD(3)+V935 HD
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-Limiting Toxicity (DLT)
DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.
Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
Number of Participants With Adverse Events (AEs)
This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.
Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)
An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria Part A
Participant has one of the selected solid tumors with no distant metastases, and is more than 8 weeks from completion of definitive therapy with intention to cure. Selected Solid Tumors: Stage I to III non-small cell lung carcinoma (NSCLC); Stage III breast cancer; Stage IIB or III melanoma; Stage II or III upper gastrointestinal tract carcinoma (e.g., esophagus, stomach, gallbladder, pancreas); Stage III colon carcinoma; Stage II, III, or IV (M0 only) renal cell carcinoma; Stage II, III, or IV (M0 only) bladder carcinoma; clinically-localized prostate carcinoma
Participant has adequate organ function.
Female participant of childbearing potential has a negative serum pregnancy test within 3 days of study enrollment.
Exclusion Criteria Part A
Participant has known hypersensitivity to any component of study vaccine.
Participant has a history of clinically significant cardiac conditions, including cardiac arrhythmias which have not been controlled within the last 3 months, unstable angina, myocardial infarction (within the last 3 months), or New York Heart Association (NYHA) Class III or IV congestive heart failure. Participant must have no clinically significant electrocardiogram (ECG) abnormalities and not have a pacemaker or cardioverter/defibrillator implanted.
Participant has undergone splenectomy or has any history of autoimmune disorder.
Participant has received immunosuppressive treatment within 1 month prior to enrollment.
Participant has known acquired, inherited, or idiopathic thrombocytopenia, platelet dysfunction or coagulopathy that would contraindicate IM injections.
Participant has an acute infection requiring intravenous antibiotic, antiviral or antifungal agents within 2 weeks of study entry.
Participant is pregnant or breastfeeding, or expecting to conceive at any time during the study or within 1 year after receiving the last vaccination.
Participant is known to be Human Immunodeficiency Virus (HIV)-seropositive.
Participant has known history of Hepatitis B or C or active Hepatitis A.
Participant has been vaccinated for any disease or for prophylaxis within 1 month prior to the first vaccination.
The participant has been diagnosed with Systemic Lupus Erythematosus (SLE)
Inclusion Criteria Part B
Participant must have completed their respective vaccination Treatment Group regimen for Part A of this study.
Participant must have completed a ≥12 week safety observation period prior to receiving their first V934-EP boost.
Exclusion Criteria Part B
Participant has new or metastatic tumor lesions since enrollment in Part A.
Participant has developed any significant cardiac conditions since enrollment in Part A including cardiac arrhythmias which have not been controlled within the last 3 months, unstable angina, myocardial infarction (within the last 3 months), or NYHA Class III or IV congestive heart failure.
Participant has undergone a splenectomy, or has developed any autoimmune disorders, since enrollment in Part A.
Participant has received immunosuppressive treatment within 1 month prior to enrollment in Part B
Participant has developed any acquired, inherited, or idiopathic thrombocytopenia, platelet dysfunction or coagulopathy that would contraindicate IM injections
Participant has an acute infection requiring intravenous antibiotic, antiviral or antifungal agents within 2 weeks of entry to Part B.
Aurisicchio L, Fridman A, Mauro D, Sheloditna R, Chiappori A, Bagchi A, Ciliberto G. Safety, tolerability and immunogenicity of V934/V935 hTERT vaccination in cancer patients with selected solid tumors: a phase I study. J Transl Med. 2020 Jan 30;18(1):39. doi: 10.1186/s12967-020-02228-9.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Of the 37 participants who were enrolled in Part A, 32 participants completed and were eligible to enroll in the optional extension study Part B. There were 28 participants who elected to enroll in Part B.
Recruitment Details
V935 alone or in combination with V934 was administered to 37 participants with selected solid tumors in Part A.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: V935 LD
Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
FG001
Part A: V934 LD(3)+V935 LD
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
Periods
Title
Milestones
Reasons Not Completed
Part A
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Male Genital Diseases
Male, Prostatic Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: V935
Biological: V934-EP
Part B: V935 LD/V934 Booster
Experimental
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Biological: V934-EP
Part B: V934 LD(3)+V935 LD/V934 Booster
Experimental
Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.
Biological: V934-EP
Part B: V935 HD/V934 Booster
Experimental
Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.
Biological: V934-EP
Part B: V934 HD(3)+V935 HD/V934 Booster
Experimental
Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.
Biological: V934-EP
Part B: V934 HD(5)+V935 HD/V934 Booster
Experimental
Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.
Biological: V934-EP
Part A: V934 HD(5)+V935 HD
Part A: V934 LD(3)+V935 LD
Part A: V935 HD
Part A: V935 LD
V934-EP
Biological
A 0.5 mL vaccine administered by EP as either a LD (0.5 mg plasmid/mL) or a HD (5.0 mg plasmid/mL).
Part A: V934 HD(3)+V935 HD
Part A: V934 HD(5)+V935 HD
Part A: V934 LD(3)+V935 LD
Part B: V934 HD(3)+V935 HD/V934 Booster
Part B: V934 HD(5)+V935 HD/V934 Booster
Part B: V934 LD(3)+V935 LD/V934 Booster
Part B: V935 HD/V934 Booster
Part B: V935 LD/V934 Booster
From pre-vaccination to Week 69
FG002
Part A: V935 HD
Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.
FG003
Part A: V934 HD(3)+V935 HD
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
FG004
Part A: V934 HD(5)+V935 HD
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
FG005
Part B: V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.
FG006
Part B: V934 LD(3)+V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
FG007
Part B: V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
FG008
Part B: V934 HD(3)+V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
FG009
Part B: V934 HD(5)+V934 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
FG0003 subjects
FG0013 subjects
FG00210 subjects
FG00311 subjects
FG00410 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0002 subjects
FG0013 subjects
FG0028 subjects
FG0039 subjects
FG00410 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Disease progression
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Part B
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjectsOf 2 eligible participants who completed Part A, 1 chose to enter Part B
FG0062 subjectsOf 3 eligible participants who completed Part A, 2 chose to enter Part B
FG0077 subjectsOf 8 eligible participants who completed Part A, 7 chose to enter Part B
FG0089 subjects9 participants who completed Part A were eligible and enrolled in Part B
FG0099 subjectsOf 10 eligible participants who completed Part A, 9 chose to enter Part B
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: V935 LD
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
BG001
Part A: V934 LD(3)+V935 LD
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
BG002
Part A: V935 HD
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
BG003
Part A: V934 HD(3)+V935 HD
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
BG004
Part A: V934 HD(5)+V935 HD
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG00210
BG00311
BG00410
BG00537
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00070.0± 9.5
BG00170.0± 6.2
BG00263.8± 10.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose-Limiting Toxicity (DLT)
DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.
Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.
Posted
Number
Participants
Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
ID
Title
Description
OG000
Part A: V935 LD
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
OG001
Part A: V934 LD(3)+V935 LD
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
OG002
Part A: V935 HD
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
OG003
Part A: V934 HD(3)+V935 HD
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
OG004
Part A: V934 HD(5)+V935 HD
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
OG005
Part B: V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
OG006
Part B: V934 LD(3)+V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
OG007
Part B: V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
OG008
Part B: V934 HD(3)+V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
OG009
Part B: V934 HD(5)+V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Adverse Events (AEs)
This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.
All Participants as Treated (APaT) population; all participants who received at least one vaccination.
Posted
Number
Participants
Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
ID
Title
Description
OG000
Part A: V935 LD
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
OG001
Part A: V934 LD(3)+V935 LD
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
Secondary
Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)
An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.
Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.
Posted
From pre-vaccination to Week 69
ID
Title
Description
OG000
Part A: V935 LD
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
OG001
Part A: V934 LD(3)+V935 LD
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
OG002
Part A: V935 HD
Time Frame
SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Description
Participants who completed Part A had the option to enter Part B.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: V935 LD
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
1
3
3
3
EG001
Part A: V934 LD(3)+V935 LD
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
0
3
3
3
EG002
Part A: V935 HD
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
2
10
8
10
EG003
Part A: V934 HD(3)+V935 HD
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
2
11
11
11
EG004
Part A: V934 HD(5)+V935 HD
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1
10
10
10
EG005
Part B: V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
0
1
1
1
EG006
Part B: V934 LD(3)+V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
0
2
1
2
EG007
Part B: V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
0
7
3
7
EG008
Part B: V934 HD(3)+V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
0
9
8
9
EG009
Part B: V934 HD(5)+V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
0
9
7
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pericardial effusion
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG0031 events1 affected11 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected9 at risk
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG0031 events1 affected11 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected9 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Chest discomfort
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Chills
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Fatigue
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Feeling hot
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Feeling jittery
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Influenza like illness
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Injection site erythema
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Injection site haematoma
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Injection site induration
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Injection site pain
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Injection site paraesthesia
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Injection site reaction
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Injection site scab
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Injection site scar
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Injection site swelling
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Nodule
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Oedema
General disorders
MedDra 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Oedema peripheral
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Pain
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Celllulitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Ear lobe infection
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Influenza
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Skin infection
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Blood amylase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Blood lactic acid increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Blood potassium increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Blood urine
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Blood urine present
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Glomerular filtration rate increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Lipase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Platelet count decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Protein total increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
White blood cells urine
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected10 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Soft tissue disorder
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Headache
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Hirsutism
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Hot flush
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Eye irritation
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Injection site mass
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Mountain sickness acute
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected10 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected10 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharpe & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D002289
Carcinoma, Non-Small-Cell Lung
D001943
Breast Neoplasms
D008545
Melanoma
D003110
Colonic Neoplasms
D002292
Carcinoma, Renal Cell
D001749
Urinary Bladder Neoplasms
D011471
Prostatic Neoplasms
D014571
Urologic Neoplasms
D014565
Urogenital Neoplasms
D001745
Urinary Bladder Diseases
D014570
Urologic Diseases
D001941
Breast Diseases
D012871
Skin Diseases
D009369
Neoplasms
D000230
Adenocarcinoma
D007680
Kidney Neoplasms
D007674
Kidney Diseases
D018358
Neuroendocrine Tumors
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009380
Neoplasms, Nerve Tissue
D018326
Nevi and Melanomas
D005832
Genital Diseases, Male
D011469
Prostatic Diseases
D015179
Colorectal Neoplasms
D007414
Intestinal Neoplasms
Ancestor Terms
ID
Term
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D009371
Neoplasms by Site
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D017437
Skin and Connective Tissue Diseases
D009370
Neoplasms by Histologic Type
D012878
Skin Neoplasms
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D004066
Digestive System Diseases
D005767
Gastrointestinal Diseases
D003108
Colonic Diseases
D007410
Intestinal Diseases
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D005834
Genital Neoplasms, Male
D000091662
Genital Diseases
D012002
Rectal Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0051 subjects
FG0062 subjects
FG0076 subjects
FG0086 subjects
FG0098 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0083 subjects
FG0091 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
Disease progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
58.8
± 11.7
BG00460.2± 11.7
BG00562.4± 11.0
4
BG0034
BG0041
BG00510
Male
BG0003
BG0012
BG0026
BG0037
BG0049
BG00527
11
OG00410
OG0051
OG0062
OG0077
OG0089
OG0099
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG002
Part A: V935 HD
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
OG003
Part A: V934 HD(3)+V935 HD
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
OG004
Part A: V934 HD(5)+V935 HD
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
OG005
Part B: V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
OG006
Part B: V934 LD(3)+V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
OG007
Part B: V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
OG008
Part B: V934 HD(3)+V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
OG009
Part B: V934 HD(5)+V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG00311
OG00410
OG0051
OG0062
OG0077
OG0089
OG0099
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0028
OG00311
OG00410
OG0051
OG0061
OG0073
OG0088
OG0097
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
OG003
Part A: V934 HD(3)+V935 HD
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
OG004
Part A: V934 HD(5)+V935 HD
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
OG005
Part B: V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
OG006
Part B: V934 LD(3)+V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
OG007
Part B: V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, V934-EP booster was administered, 1 given every 2 weeks for 3 doses.
OG008
Part B: V934 HD(3)+V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
OG009
Part B: V934 HD(5)+V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.