Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever
Sponsor
U.S. Army Medical Research and Development Command (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02116205
Collaborator
Walter Reed Army Institute of Research (WRAIR) (U.S. Fed), Ichor Medical Systems Incorporated (Industry), United States Army Medical Materiel Development Activity (U.S. Fed), US Army Medical Research Institute of Infectious Diseases (U.S. Fed)
130
1
4
35.7
3.6
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the immune responses of two different doses (1.0 mg and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a blind, participants in the two-dose group will receive one dose of normal saline placebo. All of the groups will also receive a booster dose 6 months after first vaccination. The results will help to determine which dose and vaccination schedule will be best to move forward in the vaccine development process.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The study will enroll 4 randomized groups of 30 subjects each for a total of 120 subjects. These groups will be split so that 60 individuals receive the 1.0 mg dose and the other 60 receive the 2.0 mg dose. Every subject will receive a total of 3 injections on Days 0, 28, and 56. Half of each of these groups (n = 30) will receive 2 vaccine injections at Days 0 and 56 (normal saline placebo on Day 28) while the other half will receive 3 vaccine injections at Days 0, 28, and 56. All subjects will receive a booster dose at Day 168 to help assess immunogenicity with this booster dose. All doses will be administered with the TDS-IM device. All subjects will be followed until at least Day 252 (a 12 month follow-up visit may be requested). Subjects will complete post-injection memory aids for 7 days after each injection. There will also be up to 12 alternates enrolled and used to replace any original subject who fails to complete all 3 scheduled primary injections and Day 70 follow-up visit.
Study Design
Study Type:
Interventional
Actual Enrollment
:
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase 2a Double-Blind, Dose-optimizing Study to Evaluate the Immunogenicity of Hantaan/Puumala Virus DNA Vaccine Administered to Healthy Adult Volunteers by Electroporation for Prevention of Hemorrhagic Fever With Renal Syndrome
Actual Study Start Date
:
Jul 9, 2014
Actual Primary Completion Date
:
Dec 7, 2016
Actual Study Completion Date
:
Jul 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vaccine + Placebo at 1.0 mg 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28. |
Biological: HTNV/PUUV DNA vaccine
HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Other Names:
Biological: Placebo
0.9% sodium chloride
Other Names:
Device: TriGrid Delivery System (TDS)
The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
Other Names:
|
| Experimental: Vaccine at 1.0 mg 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. |
Biological: HTNV/PUUV DNA vaccine
HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Other Names:
Device: TriGrid Delivery System (TDS)
The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
Other Names:
|
| Experimental: Vaccine + Placebo at 2.0 mg 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28. |
Biological: HTNV/PUUV DNA vaccine
HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Other Names:
Biological: Placebo
0.9% sodium chloride
Other Names:
Device: TriGrid Delivery System (TDS)
The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
Other Names:
|
| Experimental: Vaccine at 2.0 mg 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. |
Biological: HTNV/PUUV DNA vaccine
HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Other Names:
Device: TriGrid Delivery System (TDS)
The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50 [Study Days 0 to 365]
The primary endpoint will be to determine the seroconversion rates of the vaccines. Seroconversion is defined as production of neutralizing antibody titers measured using a pseudovirion neutralization assay (PsVNA). A PsVNA50 titer ≥ 20 is considered positive. Sera were collected on Days 0, 28, 56, 84, 140, 168, 196, 252, 365 and evaluated for the presence of neutralizing antibodies using PsVNA50. Percentages for seroconversion are based on the number of subjects presenting non-missing data.
Secondary Outcome Measures
- Number of Solicited Adverse Events (AEs) in Study Subjects [The time of each injection through 14 days following the procedure]
The nature, frequency, and severity of solicited adverse events (AE) occurring from the time of each injection through 14 days following the procedure. The total number of events counts all solicited adverse events for all subjects. Subjects may have more than one solicited adverse event per body system and preferred term.
- Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80 [Study Days 0 to 365]
Seroconversion is defined as production of neutralizing antibody titers measured using a pseudovirion neutralization assay (PsVNA). Sera were collected on Days 0, 28, 56, 84, 140, 168, 196, 252, 365 and evaluated for the presence of neutralizing antibodies by using PsVNA80. Percentages for seroconversion are based on the number of subjects presenting non-missing data.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 49 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy adult male or non-pregnant, non-lactating female, ages 18-49 (inclusive) at the time of screening
-
Have provided written informed consent before screening
-
Free of clinically significant health problems, as determined by pertinent medical history and clinical examination prior to entry into the study
-
Available and able to participate for all study visits and procedures
-
Females, if sexually active, are known to be at least one year post-menopausal (defined as no menses for 12 consecutive months), or willing to use an effective method of contraception (eg, hormonal contraception, diaphragm, cervical cap, intrauterine device, condom, anatomical sterility [self or partner]) from the date of screening until at least 3 months after the last injection
-
Negative hantavirus pseudovirion neutralization assay (PsVNA) test result at screening
Exclusion Criteria:
-
History or serologic evidence of prior infection with any hantavirus virus, or prior participation in a HTNV or PUUV vaccine trial
-
History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
-
Ongoing participation in another clinical trial
-
Receipt or planned receipt of any vaccination, experimental or otherwise within the period 30 days prior to the first injection through the period 60 days after Study Day 168 (booster dose; approximately 9 month period in total), with the exception of emergency use vaccinations as needed
-
Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid region) exceeds 40 mm
-
Individuals in whom the ability to observe possible local reactions at the eligible injections sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
-
Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, electrocardiogram (ECG), and/or laboratory screening test
-
Pregnant or lactating female, or female who intends to become pregnant during the study period
-
Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
-
Any serologic evidence of hepatitis B or C infection
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
-
Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of study entry
-
For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
-
Intranasal and topical steroids are allowed
-
Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child
-
Syncopal episode within 12 months of screening
-
Suspected or known current alcohol and/or illicit drug abuse
-
Unwilling to allow storage and use of blood for future hantavirus-related research
-
Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Walter Reed Army Institute of Research Clinical Trials Center | Silver Spring | Maryland | United States | 20910 |
Sponsors and Collaborators
- U.S. Army Medical Research and Development Command
- Walter Reed Army Institute of Research (WRAIR)
- Ichor Medical Systems Incorporated
- United States Army Medical Materiel Development Activity
- US Army Medical Research Institute of Infectious Diseases
Investigators
- Principal Investigator: Kristopher Paolino, MD, WRAIR Clinical Trials Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier:
NCT02116205
Other Study ID Numbers:
- S-14-01
- 2085
First Posted:
Apr 16, 2014
Last Update Posted:
Feb 12, 2021
Last Verified:
Feb 1, 2021
Keywords provided by U.S. Army Medical Research and Development Command
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 130 subjects were enrolled in the study. Ten of the 130 were enrolled as replacements for early withdrawals. The first participant was enrolled on July 9, 2014 and the last participant was enrolled in September 2015. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Vaccine + Placebo at 1.0 mg | Vaccine at 1.0 mg | Vaccine + Placebo at 2.0 mg | Vaccine at 2.0 mg |
|---|---|---|---|---|
| Arm/Group Description | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses |
| Period Title: Overall Study | ||||
| STARTED | 31 | 33 | 33 | 33 |
| COMPLETED | 29 | 26 | 29 | 27 |
| NOT COMPLETED | 2 | 7 | 4 | 6 |
Baseline Characteristics
| Arm/Group Title | Vaccine + Placebo at 1.0 mg | Vaccine at 1.0 mg | Vaccine + Placebo at 2.0 mg | Vaccine at 2.0 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | Total of all reporting groups |
| Overall Participants | 31 | 33 | 33 | 33 | 130 |
| Age, Customized (years) [Mean (Standard Deviation) ] | |||||
| Age |
34.3
(8.8)
|
30.9
(8.9)
|
30.5
(6.6)
|
33.2
(8.5)
|
32.2
(8.3)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
15
48.4%
|
17
51.5%
|
13
39.4%
|
18
54.5%
|
63
48.5%
|
| Male |
16
51.6%
|
16
48.5%
|
20
60.6%
|
15
45.5%
|
67
51.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
2
6.5%
|
5
15.2%
|
3
9.1%
|
1
3%
|
11
8.5%
|
| Not Hispanic or Latino |
29
93.5%
|
28
84.8%
|
30
90.9%
|
32
97%
|
119
91.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
1
3%
|
1
3%
|
0
0%
|
2
1.5%
|
| Asian |
0
0%
|
1
3%
|
1
3%
|
2
6.1%
|
4
3.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
1
3%
|
0
0%
|
1
0.8%
|
| Black or African American |
20
64.5%
|
17
51.5%
|
14
42.4%
|
15
45.5%
|
66
50.8%
|
| White |
11
35.5%
|
13
39.4%
|
14
42.4%
|
13
39.4%
|
51
39.2%
|
| More than one race |
0
0%
|
1
3%
|
2
6.1%
|
3
9.1%
|
6
4.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
31
100%
|
33
100%
|
33
100%
|
33
100%
|
130
100%
|
Outcome Measures
| Title | Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50 |
|---|---|
| Description | The primary endpoint will be to determine the seroconversion rates of the vaccines. Seroconversion is defined as production of neutralizing antibody titers measured using a pseudovirion neutralization assay (PsVNA). A PsVNA50 titer ≥ 20 is considered positive. Sera were collected on Days 0, 28, 56, 84, 140, 168, 196, 252, 365 and evaluated for the presence of neutralizing antibodies using PsVNA50. Percentages for seroconversion are based on the number of subjects presenting non-missing data. |
| Time Frame | Study Days 0 to 365 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 130 subjects enrolled, 120 met the conditions for the efficacy evaluable population, that is subjects who received all three of the vaccinations on Study Days 0, 28, and 56; and who attended at least one subsequent study visit. Seroconversion is measured in the efficacy evaluable population. |
| Arm/Group Title | Vaccine + Placebo at 1.0 mg | Vaccine at 1.0 mg | Vaccine + Placebo at 2.0 mg | Vaccine at 2.0 mg |
|---|---|---|---|---|
| Arm/Group Description | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses |
| Measure Participants | 30 | 30 | 30 | 30 |
| Seroconversion |
1
3.2%
|
1
3%
|
1
3%
|
2
6.1%
|
| No Seroconversion |
29
93.5%
|
29
87.9%
|
29
87.9%
|
28
84.8%
|
| Seroconversion |
1
3.2%
|
10
30.3%
|
1
3%
|
7
21.2%
|
| No Seroconversion |
29
93.5%
|
20
60.6%
|
29
87.9%
|
23
69.7%
|
| Seroconversion |
15
48.4%
|
18
54.5%
|
14
42.4%
|
17
51.5%
|
| No Seroconversion |
15
48.4%
|
12
36.4%
|
16
48.5%
|
13
39.4%
|
| Seroconversion |
11
35.5%
|
14
42.4%
|
9
27.3%
|
12
36.4%
|
| No Seroconversion |
19
61.3%
|
14
42.4%
|
20
60.6%
|
16
48.5%
|
| Seroconversion |
12
38.7%
|
11
33.3%
|
7
21.2%
|
13
39.4%
|
| No Seroconversion |
18
58.1%
|
16
48.5%
|
22
66.7%
|
13
39.4%
|
| Seroconversion |
18
58.1%
|
23
69.7%
|
20
60.6%
|
19
57.6%
|
| No Seroconversion |
12
38.7%
|
3
9.1%
|
9
27.3%
|
8
24.2%
|
| Seroconversion |
12
38.7%
|
16
48.5%
|
19
57.6%
|
16
48.5%
|
| No Seroconversion |
17
54.8%
|
10
30.3%
|
10
30.3%
|
11
33.3%
|
| Seroconversion |
12
38.7%
|
15
45.5%
|
16
48.5%
|
14
42.4%
|
| No Seroconversion |
8
25.8%
|
7
21.2%
|
6
18.2%
|
6
18.2%
|
| Title | Number of Solicited Adverse Events (AEs) in Study Subjects |
|---|---|
| Description | The nature, frequency, and severity of solicited adverse events (AE) occurring from the time of each injection through 14 days following the procedure. The total number of events counts all solicited adverse events for all subjects. Subjects may have more than one solicited adverse event per body system and preferred term. |
| Time Frame | The time of each injection through 14 days following the procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vaccine + Placebo at 1.0 mg | Vaccine at 1.0 mg | Vaccine + Placebo at 2.0 mg | Vaccine at 2.0 mg |
|---|---|---|---|---|
| Arm/Group Description | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses |
| Measure Participants | 31 | 33 | 33 | 33 |
| Total Number of Events |
144
|
148
|
173
|
182
|
| Mild |
131
|
136
|
147
|
155
|
| Moderate |
13
|
9
|
25
|
24
|
| Severe |
0
|
3
|
1
|
3
|
| Life Threatening |
0
|
0
|
0
|
0
|
| Title | Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80 |
|---|---|
| Description | Seroconversion is defined as production of neutralizing antibody titers measured using a pseudovirion neutralization assay (PsVNA). Sera were collected on Days 0, 28, 56, 84, 140, 168, 196, 252, 365 and evaluated for the presence of neutralizing antibodies by using PsVNA80. Percentages for seroconversion are based on the number of subjects presenting non-missing data. |
| Time Frame | Study Days 0 to 365 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 130 subjects enrolled, 120 met the conditions for the efficacy evaluable population, that is subjects who received all three of the vaccinations on Study Days 0, 28, and 56; and who attended at least one subsequent study visit. Seroconversion is measured in the efficacy evaluable population. |
| Arm/Group Title | Vaccine + Placebo at 1.0 mg | Vaccine at 1.0 mg | Vaccine + Placebo at 2.0 mg | Vaccine at 2.0 mg |
|---|---|---|---|---|
| Arm/Group Description | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses |
| Measure Participants | 30 | 30 | 30 | 30 |
| Seroconversion |
0
0%
|
1
3%
|
0
0%
|
2
6.1%
|
| No Seroconversion |
30
96.8%
|
29
87.9%
|
30
90.9%
|
28
84.8%
|
| Seroconversion |
0
0%
|
6
18.2%
|
0
0%
|
1
3%
|
| No Seroconversion |
30
96.8%
|
24
72.7%
|
30
90.9%
|
29
87.9%
|
| Seroconversion |
5
16.1%
|
13
39.4%
|
8
24.2%
|
9
27.3%
|
| No Seroconversion |
25
80.6%
|
17
51.5%
|
22
66.7%
|
21
63.6%
|
| Seroconversion |
2
6.5%
|
8
24.2%
|
4
12.1%
|
5
15.2%
|
| No Seroconversion |
28
90.3%
|
20
60.6%
|
25
75.8%
|
23
69.7%
|
| Seroconversion |
4
12.9%
|
8
24.2%
|
3
9.1%
|
3
9.1%
|
| No Seroconversion |
26
83.9%
|
19
57.6%
|
26
78.8%
|
23
69.7%
|
| Seroconversion |
14
45.2%
|
19
57.6%
|
17
51.5%
|
16
48.5%
|
| No Seroconversion |
16
51.6%
|
7
21.2%
|
12
36.4%
|
11
33.3%
|
| Seroconversion |
6
19.4%
|
13
39.4%
|
9
27.3%
|
10
30.3%
|
| No Seroconversion |
23
74.2%
|
13
39.4%
|
20
60.6%
|
17
51.5%
|
| Seroconversion |
5
16.1%
|
9
27.3%
|
4
12.1%
|
9
27.3%
|
| No Seroconversion |
15
48.4%
|
13
39.4%
|
18
54.5%
|
11
33.3%
|
Adverse Events
| Time Frame | Study Days 0 to 365 | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported | |||||||
| Arm/Group Title | Vaccine + Placebo at 1.0 mg | Vaccine at 1.0 mg | Vaccine + Placebo at 2.0 mg | Vaccine at 2.0 mg | ||||
| Arm/Group Description | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) Placebo: 0.9% sodium chloride TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | 2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168. HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2) TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses | ||||
All Cause Mortality |
||||||||
| Vaccine + Placebo at 1.0 mg | Vaccine at 1.0 mg | Vaccine + Placebo at 2.0 mg | Vaccine at 2.0 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
Serious Adverse Events |
||||||||
| Vaccine + Placebo at 1.0 mg | Vaccine at 1.0 mg | Vaccine + Placebo at 2.0 mg | Vaccine at 2.0 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Enteritis | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Vaccine + Placebo at 1.0 mg | Vaccine at 1.0 mg | Vaccine + Placebo at 2.0 mg | Vaccine at 2.0 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 29/31 (93.5%) | 33/33 (100%) | 31/33 (93.9%) | 33/33 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Lymphadenopathy | 0/31 (0%) | 3/33 (9.1%) | 4/33 (12.1%) | 3/33 (9.1%) | ||||
| Anaemia | 0/31 (0%) | 0/33 (0%) | 2/33 (6.1%) | 4/33 (12.1%) | ||||
| Leukocytosis | 1/31 (3.2%) | 1/33 (3%) | 1/33 (3%) | 0/33 (0%) | ||||
| Lymphadenopathy | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 1/33 (3%) | ||||
| Neutropenia | 0/31 (0%) | 0/33 (0%) | 2/33 (6.1%) | 0/33 (0%) | ||||
| Neutrophilia | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Thrombocytopenia | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Eye disorders | ||||||||
| Scleral discolouration | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Vision blurred | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Nausea | 1/31 (3.2%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Abdominal discomfort | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Abdominal distension | 1/31 (3.2%) | 1/33 (3%) | 1/33 (3%) | 0/33 (0%) | ||||
| Abdominal pain | 1/31 (3.2%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Abdominal pain upper | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Diarrhoea | 0/31 (0%) | 1/33 (3%) | 1/33 (3%) | 0/33 (0%) | ||||
| Food poisoning | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Gastrointestinal inflammation | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Gastrooesophageal reflux disease | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Haematochezia | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Nausea | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Odynophagia | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Toothache | 1/31 (3.2%) | 1/33 (3%) | 0/33 (0%) | 3/33 (9.1%) | ||||
| Vomiting | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| General disorders | ||||||||
| Axillary pain | 2/31 (6.5%) | 2/33 (6.1%) | 4/33 (12.1%) | 4/33 (12.1%) | ||||
| Fatigue | 9/31 (29%) | 4/33 (12.1%) | 13/33 (39.4%) | 12/33 (36.4%) | ||||
| Injection site bruising | 3/31 (9.7%) | 2/33 (6.1%) | 1/33 (3%) | 3/33 (9.1%) | ||||
| Injection site erythema | 3/31 (9.7%) | 3/33 (9.1%) | 6/33 (18.2%) | 6/33 (18.2%) | ||||
| Injection site pain | 29/31 (93.5%) | 33/33 (100%) | 30/33 (90.9%) | 33/33 (100%) | ||||
| Injection site reaction | 1/31 (3.2%) | 4/33 (12.1%) | 4/33 (12.1%) | 2/33 (6.1%) | ||||
| Injection site swelling | 1/31 (3.2%) | 1/33 (3%) | 0/33 (0%) | 2/33 (6.1%) | ||||
| Local swelling | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Asthenia | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Axillary pain | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Fatigue | 1/31 (3.2%) | 4/33 (12.1%) | 1/33 (3%) | 2/33 (6.1%) | ||||
| Immune system disorders | ||||||||
| Allergy to chemicals | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Infections and infestations | ||||||||
| Upper respiratory tract infection | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Bacterial vaginosis | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Furuncle | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Gastroenteritis | 2/31 (6.5%) | 2/33 (6.1%) | 1/33 (3%) | 1/33 (3%) | ||||
| Labyrinthitis | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Laryngitis | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Localised infection | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Pharyngitis | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 1/33 (3%) | ||||
| Pneumonia | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Rhinitis | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Sinusitis | 0/31 (0%) | 2/33 (6.1%) | 0/33 (0%) | 0/33 (0%) | ||||
| Tooth infection | 1/31 (3.2%) | 1/33 (3%) | 1/33 (3%) | 1/33 (3%) | ||||
| Upper respiratory tract infection | 4/31 (12.9%) | 6/33 (18.2%) | 7/33 (21.2%) | 10/33 (30.3%) | ||||
| Urinary tract infection | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Vulvovaginal candidiasis | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Muscle strain | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Ankle fracture | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Arthropod bite | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Concussion | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Contusion | 1/31 (3.2%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Joint dislocation | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Muscle strain | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 1/33 (3%) | ||||
| Procedural pain | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Skin abrasion | 2/31 (6.5%) | 1/33 (3%) | 1/33 (3%) | 1/33 (3%) | ||||
| Investigations | ||||||||
| Respiratory rate increased | 1/31 (3.2%) | 0/33 (0%) | 2/33 (6.1%) | 0/33 (0%) | ||||
| Alanine aminotransferase increased | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 5/33 (15.2%) | ||||
| Aspartate aminotransferase increased | 0/31 (0%) | 3/33 (9.1%) | 0/33 (0%) | 2/33 (6.1%) | ||||
| Blood creatinine increased | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Blood glucose decreased | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Blood pressure diastolic increased | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Blood pressure increased | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Blood urea increased | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Grip strength decreased | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Haemoglobin decreased | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 1/33 (3%) | ||||
| Transaminases increased | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 3/33 (9.1%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Hyperglycaemia | 0/31 (0%) | 0/33 (0%) | 3/33 (9.1%) | 1/33 (3%) | ||||
| Hypoglycaemia | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Muscle contracture | 1/31 (3.2%) | 1/33 (3%) | 1/33 (3%) | 4/33 (12.1%) | ||||
| Muscle tightness | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Musculoskeletal pain | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Myalgia | 3/31 (9.7%) | 4/33 (12.1%) | 8/33 (24.2%) | 8/33 (24.2%) | ||||
| Neck pain | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Arthralgia | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Arthritis | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Back pain | 0/31 (0%) | 0/33 (0%) | 2/33 (6.1%) | 0/33 (0%) | ||||
| Costochondritis | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Muscle tightness | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Musculoskeletal chest pain | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 1/33 (3%) | ||||
| Musculoskeletal pain | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Myalgia | 3/31 (9.7%) | 0/33 (0%) | 1/33 (3%) | 4/33 (12.1%) | ||||
| Neck pain | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Pain in extremity | 0/31 (0%) | 1/33 (3%) | 1/33 (3%) | 0/33 (0%) | ||||
| Pain in jaw | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Patellofemoral pain syndrome | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 1/31 (3.2%) | 1/33 (3%) | 1/33 (3%) | 0/33 (0%) | ||||
| Headache | 7/31 (22.6%) | 7/33 (21.2%) | 9/33 (27.3%) | 8/33 (24.2%) | ||||
| Hypoaesthesia | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Dizziness | 0/31 (0%) | 5/33 (15.2%) | 0/33 (0%) | 1/33 (3%) | ||||
| Headache | 3/31 (9.7%) | 3/33 (9.1%) | 2/33 (6.1%) | 2/33 (6.1%) | ||||
| Hypoaesthesia | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Neuropathy peripheral | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Paraesthesia | 0/31 (0%) | 0/33 (0%) | 2/33 (6.1%) | 0/33 (0%) | ||||
| Presyncope | 0/31 (0%) | 0/33 (0%) | 2/33 (6.1%) | 1/33 (3%) | ||||
| Tremor | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Psychiatric disorders | ||||||||
| Insomnia | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Libido increased | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Dysuria | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Vaginal inflammation | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Tachypnoea | 1/31 (3.2%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Cough | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 1/33 (3%) | ||||
| Epistaxis | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Oropharyngeal pain | 0/31 (0%) | 1/33 (3%) | 1/33 (3%) | 2/33 (6.1%) | ||||
| Sinus congestion | 0/31 (0%) | 1/33 (3%) | 1/33 (3%) | 1/33 (3%) | ||||
| Throat tightness | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Blister | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
| Dermatitis allergic | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Dermatitis contact | 0/31 (0%) | 0/33 (0%) | 1/33 (3%) | 0/33 (0%) | ||||
| Miliaria | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Pain of skin | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Rash | 0/31 (0%) | 0/33 (0%) | 2/33 (6.1%) | 0/33 (0%) | ||||
| Skin mass | 0/31 (0%) | 1/33 (3%) | 0/33 (0%) | 0/33 (0%) | ||||
| Vascular disorders | ||||||||
| Hot flush | 1/31 (3.2%) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) | ||||
| Hypertension | 2/31 (6.5%) | 1/33 (3%) | 1/33 (3%) | 2/33 (6.1%) | ||||
| Orthostatic hypotension | 0/31 (0%) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Kristin Mills, Principal Investigator |
|---|---|
| Organization | WRAIR Clinical Trials Center |
| Phone | 301-319- 2039 |
| Kristin.t.mills.ctr@mail.mil |
Responsible Party:
U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier:
NCT02116205
Other Study ID Numbers:
- S-14-01
- 2085
First Posted:
Apr 16, 2014
Last Update Posted:
Feb 12, 2021
Last Verified:
Feb 1, 2021