Trial Outcomes & Findings for Immunization With HIV-1 Peptides in Adjuvant for Treatment of Patients With Chronic HIV-infection (NCT NCT01009762)
NCT ID: NCT01009762
Last Updated: 2014-03-27
Results Overview
the numbers of treatment related side effects (DLT = reaction 3 or more) are registered for participants
COMPLETED
PHASE1
11 participants
up to 6 months after end of treatment
2014-03-27
Participant Flow
Participants were recruited at the infectious disease department at the University hospitals
20 participant numbers were randomised to vaccine or placebo but at the deadline for expiring of the vaccine only 11 participants were enrolled but all 11 completed the study
Participant milestones
| Measure |
Saline
Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
|
AFO-18 Vaccinated
Patients receiving the experimental therapeutic vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
10
|
|
Overall Study
Primary Outcome
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunization With HIV-1 Peptides in Adjuvant for Treatment of Patients With Chronic HIV-infection
Baseline characteristics by cohort
| Measure |
Saline
n=1 Participants
Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
|
AFO-18 Vaccinated
n=10 Participants
Patients receiving the experimental therapeutic vaccine
|
Total
n=11 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
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Clusters of Differentiation 4 (CD4) T-cells >400 cells/mm^3
|
1 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Absence of T cell reaction to all vaccine peptides
|
1 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Viral load >10^3/mm^3 plasma
|
1 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6 months after end of treatmentPopulation: Interview, questionaire, objective examination by medical doctor, blood testing for hematology, clinical chemistry, CD4 counts, HIV-1 viral load
the numbers of treatment related side effects (DLT = reaction 3 or more) are registered for participants
Outcome measures
| Measure |
Vaccinee
n=10 Participants
participants receiving the vaccine
|
Placebo
n=1 Participants
participants receiving placebo (=saline)
|
|---|---|---|
|
Numbers of Treatment Related Side Effects (DLT = Reaction 3 or More)
|
0 side effects
|
0 side effects
|
SECONDARY outcome
Timeframe: 10-14 days or 3 months or 6 months after last immunisationPopulation: Peripheral Blood Mononuclear Cells (PBMC) from blood was measured in IFNg-ELISPOT and/or Intracellular Cytokines (ICS) Flowcytometry for T cell responses. All 10 vaccinee developed a new T cell immune response to at least one vaccine epitope. The saline placebo did not develop any new t cell responses.
Number of Participants with New T Cell Response to the Vaccine Target Epitopes as Measured by Intracellular Cytokine Stain Flowcytometry (IC-FACS) and/or IFNg-ELISPOT Analysis. Criteria's for meeting anticipated secondary end-point was that \>50% of vaccinees reacted with new Clusters of differentiation 8 (CD8) T-cell and/or Clusters of differentiation 4 (CD4) T-cell response to al least one of the vaccine target epitopes as measured by IC-Facs and/or interferon-gamma (IFNg) - Enzyme-Linked ImmunoSpot (ELISPOT) assays.
Outcome measures
| Measure |
Vaccinee
n=1 Participants
participants receiving the vaccine
|
Placebo
n=10 Participants
participants receiving placebo (=saline)
|
|---|---|---|
|
Number of Participants With New T Cell Response to the Vaccine Target Epitopes
|
0 participants
|
10 participants
|
SECONDARY outcome
Timeframe: up to 6 months after treatment stopPopulation: the numbers of participants that showed changes (lowering of) in Viral load (measured as HIV-1 RNA copies/mm\^3 plasma in commercial quantitative PCR) at end of study (6 months after vaccination) relative to base-line viral-load was counted at 6 month after vaccination (end of study)
HIV-1 RNA Viral load was measured by Quantitative-PCR in plasma as numbers of virus RNA copies/mm\^3 relative to baseline viral-load for each participant. The numbers of participant with lowering of HIV RNA plasma Viral-load is counted at base-line and at 6 months (end of study) and provided in the table (analysis population description) and the number of participants that showed lowering of viral-load was counted. Criteria for this anticipated end-point was a significant lowering of HIV RNA viral-load in \>50% of responders (defined as participants with new T-cell responses).
Outcome measures
| Measure |
Vaccinee
n=1 Participants
participants receiving the vaccine
|
Placebo
n=10 Participants
participants receiving placebo (=saline)
|
|---|---|---|
|
Numbers of Participants With Lowering of HIV RNA Viral-load
|
0 participants
|
0 participants
|
Adverse Events
Vaccinee
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place