Trial Outcomes & Findings for Single DermaVir Immunization in HIV-1 Infected Patients on HAART (NCT NCT00712530)
NCT ID: NCT00712530
Last Updated: 2013-03-26
Results Overview
Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and clinical events possibly, probably or definitely related to study treatment as judged by the Principal Investigator or the site investigators during the 28 days after DermaVir administration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
28 days
Results posted on
2013-03-26
Participant Flow
Nine subjects were sequentially enrolled into each cohort. Participants were recruited from the Szent László Hospital, Budapest, Hungary.
The first three subjects received a single low-dose DermaVir immunization. Further enrolment of subjects into the medium and high dose cohorts began only after the safety data for cohorts low and medium doses, respectively were available, and the criteria for enrolling into the next cohort were met.
Participant milestones
| Measure |
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization
Single low-dose DermaVir immunization
* 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
* Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
|
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization
Single medium-dose DermaVir immunization
* 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
* Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
|
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization
Single high-dose DermaVir immunization
* 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
* Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single DermaVir Immunization in HIV-1 Infected Patients on HAART
Baseline characteristics by cohort
| Measure |
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single low-dose DermaVir immunization
* 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
* Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
|
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single medium-dose DermaVir immunization
* 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
* Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
|
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single high-dose DermaVir immunization
* 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
* Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
45 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
34 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
36 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
38 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysOccurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and clinical events possibly, probably or definitely related to study treatment as judged by the Principal Investigator or the site investigators during the 28 days after DermaVir administration.
Outcome measures
| Measure |
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single low-dose DermaVir immunization
* 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
* Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
|
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single medium-dose DermaVir immunization
* 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
* Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
|
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single high-dose DermaVir immunization
* 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
* Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
|
|---|---|---|---|
|
Grade 3 Adverse Event Related to DermaVir Treatment
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single low-dose DermaVir immunization
* 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
* Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
|
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single medium-dose DermaVir immunization
* 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
* Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
|
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single high-dose DermaVir immunization
* 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
* Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
|
|---|---|---|---|
|
CD4+ T Cell Counts/mm3
|
893 CD4+ T cell counts/mm3
Standard Deviation 461
|
845 CD4+ T cell counts/mm3
Standard Deviation 68
|
621 CD4+ T cell counts/mm3
Standard Deviation 185
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single low-dose DermaVir immunization
* 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
* Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
|
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single medium-dose DermaVir immunization
* 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
* Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
|
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single high-dose DermaVir immunization
* 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
* Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
|
|---|---|---|---|
|
Number of Subjects With Detectable Anti-ds Antibody and ANA
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single low-dose DermaVir immunization
* 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
* Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
|
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single medium-dose DermaVir immunization
* 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
* Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
|
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single high-dose DermaVir immunization
* 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
* Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
|
|---|---|---|---|
|
Number of Subjects Having More Than 50 Copies/mL HIV RNA
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 28 daysHIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier \[Calarota et al. J Immunol 2008\]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.
Outcome measures
| Measure |
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single low-dose DermaVir immunization
* 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
* Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
|
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single medium-dose DermaVir immunization
* 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
* Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
|
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single high-dose DermaVir immunization
* 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
* Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
|
|---|---|---|---|
|
Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline
|
325 PHPC count
Standard Deviation 266
|
136202 PHPC count
Standard Deviation 162287
|
50759 PHPC count
Standard Deviation 44792
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksHIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier \[Calarota et al. J Immunol 2008\]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir. Note, group Single low-dose was measured at 24 weeks, for this group the 48 weeks data is not available
Outcome measures
| Measure |
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single low-dose DermaVir immunization
* 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
* Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
|
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single medium-dose DermaVir immunization
* 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
* Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
|
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization
n=3 Participants
Single high-dose DermaVir immunization
* 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
* Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
|
|---|---|---|---|
|
Change in HIV-specific Memory T Cell Responses at Week 48
|
3899 PHPC count
Standard Deviation 869
|
9878 PHPC count
Standard Deviation 10257
|
18382 PHPC count
Standard Deviation 21477
|
Adverse Events
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization
n=3 participants at risk
Single low-dose DermaVir immunization
* 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
* Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
|
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization
n=3 participants at risk
Single medium-dose DermaVir immunization
* 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
* Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
|
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization
n=3 participants at risk
Single high-dose DermaVir immunization
* 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
* Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
LUMBALGY
|
33.3%
1/3 • Number of events 1 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
|
Immune system disorders
FEVER
|
66.7%
2/3 • Number of events 2 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
33.3%
1/3 • Number of events 1 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
|
Musculoskeletal and connective tissue disorders
MYALGIAS
|
33.3%
1/3 • Number of events 1 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
|
Immune system disorders
CHILLS
|
33.3%
1/3 • Number of events 1 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
|
General disorders
FATIGUE
|
0.00%
0/3 • From start of study vaccination to study closure
|
33.3%
1/3 • Number of events 2 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
|
Skin and subcutaneous tissue disorders
HYPERESTHESY ON THE SITES
|
0.00%
0/3 • From start of study vaccination to study closure
|
33.3%
1/3 • Number of events 2 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
|
Blood and lymphatic system disorders
HYPERBILIRUBINAEMY
|
0.00%
0/3 • From start of study vaccination to study closure
|
33.3%
1/3 • Number of events 1 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
|
Blood and lymphatic system disorders
ELEVATED SE BILIRUBIN
|
0.00%
0/3 • From start of study vaccination to study closure
|
33.3%
1/3 • Number of events 1 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
|
Skin and subcutaneous tissue disorders
MACULAR ERYTHEMA
|
0.00%
0/3 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
33.3%
1/3 • Number of events 1 • From start of study vaccination to study closure
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/3 • From start of study vaccination to study closure
|
0.00%
0/3 • From start of study vaccination to study closure
|
33.3%
1/3 • Number of events 1 • From start of study vaccination to study closure
|
Additional Information
Dr. Denes Banhegyi
Szent Laszlo Hospital, Budapest, Hungary
Phone: +3614558152
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60