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Therapeutic Vaccine for HIV

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ClinicalTrials.gov Identifier: NCT01859325
Recruitment Status : Active, not recruiting
First Posted : May 21, 2013
Results First Posted : April 9, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Profectus BioSciences, Inc.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV
Therapeutic Vaccine
Interventions Biological: rVSV
Biological: IL-12 pDNA adjuvant
Biological: HIV-Mag pDNA
Drug: Placebo
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV-Mag/IL-12 & rVSV Vaccine Placebo Excluded
Hide Arm/Group Description HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48. Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48. Participants not meeting inclusion criteria or declined to participate.
Period Title: Overall Study
Started 15 16 2
Completed 12 12 2
Not Completed 3 4 0
Arm/Group Title HIV-Mag/IL-12 & rVSV Vaccine Placebo Total
Hide Arm/Group Description HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48. Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48. Total of all reporting groups
Overall Number of Baseline Participants 15 16 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
15
  93.8%
30
  96.8%
>=65 years
0
   0.0%
1
   6.3%
1
   3.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
15
 100.0%
16
 100.0%
31
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Hispanic or Latino
1
   6.7%
1
   6.3%
2
   6.5%
Not Hispanic or Latino
13
  86.7%
15
  93.8%
28
  90.3%
Unknown or Not Reported
1
   6.7%
0
   0.0%
1
   3.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
  33.3%
2
  12.5%
7
  22.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
  12.5%
2
   6.5%
White
7
  46.7%
11
  68.8%
18
  58.1%
More than one race
1
   6.7%
1
   6.3%
2
   6.5%
Unknown or Not Reported
2
  13.3%
0
   0.0%
2
   6.5%
1.Primary Outcome
Title The Rate of Related Adverse Events in Subjects Who Began cART During Acute or Early HIV-1 Infection.
Hide Description

The rate of occurrence of grade 3 or higher AEs, including serious adverse events (SAEs) that per standard criteria (see safety section) are:

At least possibly related to the test article, and Definitely NOT related to a factor other than the test article This is to evaluate safety and tolerability of the study vaccines.

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who received vaccine or placebo
Arm/Group Title HIV-Mag/IL-12 & rVSV Vaccine Placebo
Hide Arm/Group Description:
HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: Related Adverse Events
0 0
2.Secondary Outcome
Title HIV-1 Viral Load Following Antiretroviral Treatment Interruption (ATI).
Hide Description The difference in HIV-1 viral load at the end of the ATI between the vaccine and placebo groups. Levels of plasma viremia in the vaccine and placebo groups were compared using the Wilcoxon rank sum test at the end of treatment interruption periods to determine the antiviral efficacy of the therapeutic vaccine regimen. The limit of detection of plasma viremia was 40 copies/ml of HIV RNA.
Time Frame 72 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who received vaccine or placebo
Arm/Group Title HIV-Mag/IL-12 & rVSV Vaccine Placebo
Hide Arm/Group Description:
HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48.
Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
Overall Number of Participants Analyzed 14 15
Median (Inter-Quartile Range)
Unit of Measure: copies/ml
4932
(513 to 22577)
3170
(467 to 7025)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV-Mag/IL-12 & rVSV Vaccine, Placebo
Comments Samples size based on published data on populations of early treated patients undergoing ART interruption. The power based on a 2-sample t-test with a 2-tailed alpha of .05 and a total sample size of 30 is approximately 91% to detect a 1.25 log10 reduction in the rebound plasma viremia between vaccine and placebo groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.406
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -.36
Confidence Interval (2-Sided) 95%
-1.41 to 0.67
Estimation Comments [Not Specified]
Time Frame 96 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HIV-Mag/IL-12 & rVSV Vaccine Placebo
Hide Arm/Group Description HIV-MAG pDNA vaccine prime will be administered at a dose of 3000 g (1500 g of the HIV-1 gag/pol plasmid and 1500 g of the HIV-1 net/tat/vif, env plasmid) at week 0, 4, 12, and 36. Each construct of HIV-MAG pDNA vaccine (1500 g each) will be mixed and combined with 1000 g of the IL-12 pDNA adjuvant. The resulting mixture will be divided into 2 IM injections and administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid with EP using the TDS device. IL-12 pDNA adjuvant will be mixed with the HIV-MAG pDNA vaccine prime, as noted above, and administered at a dose of 1000 g (500 g in each IM injection) at week 0, 4, 12, and 36. rVSV HIV gag booster vaccine--The total dose, 1x107 pfu, will be administered as 1 mL (5x106 pfu) IM injection in the left deltoid and 1 mL (5x106 pfu) IM injection in the right deltoid at week 24 and 48. Placebo for the IL-12 pDNA adjuvant and HIV-MAG pDNA vaccine (sodium chloride for injection, USP 0.9%) will be administered as 0.75 mL IM injection in the left deltoid and 0.75 mL IM injection in the right deltoid at weeks 0, 4, 12, and 36 with EP using the TDS device. Placebo for the rVSV HIV gag (sodium chloride for injection, USP 0.9%) will be administered as 1 mL IM injection in the left deltoid and 1 mL IM injection in the right deltoid at week 24 and 48.
All-Cause Mortality
HIV-Mag/IL-12 & rVSV Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
HIV-Mag/IL-12 & rVSV Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/15 (13.33%)   1/16 (6.25%) 
Infections and infestations     
Cellulitis   1/15 (6.67%)  0/16 (0.00%) 
Psychiatric disorders     
Depression   1/15 (6.67%)  0/16 (0.00%) 
Suicidal ideation   0/15 (0.00%)  1/16 (6.25%) 
Vascular disorders     
Thrombosis   1/15 (6.67%)  0/16 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV-Mag/IL-12 & rVSV Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   15/15 (100.00%)   15/16 (93.75%) 
Gastrointestinal disorders     
Abdominal distension   0/15 (0.00%)  1/16 (6.25%) 
Abdominal pain upper   0/15 (0.00%)  2/16 (12.50%) 
Diarrhoea   2/15 (13.33%)  4/16 (25.00%) 
Haemorrhoids   0/15 (0.00%)  1/16 (6.25%) 
Nausea   6/15 (40.00%)  2/16 (12.50%) 
Oral disorder   0/15 (0.00%)  1/16 (6.25%) 
Vomiting   1/15 (6.67%)  0/16 (0.00%) 
General disorders     
Chills   5/15 (33.33%)  2/16 (12.50%) 
Fatigue   11/15 (73.33%)  7/16 (43.75%) 
Injection site erythema   2/15 (13.33%)  5/16 (31.25%) 
Injection site pain   15/15 (100.00%)  15/16 (93.75%) 
Injection site swelling   0/15 (0.00%)  3/16 (18.75%) 
Non-cardiac chest pain   0/15 (0.00%)  1/16 (6.25%) 
Pyrexia   2/15 (13.33%)  1/16 (6.25%) 
Infections and infestations     
Acute sinusitis   1/15 (6.67%)  0/16 (0.00%) 
Cellulitis   1/15 (6.67%)  1/16 (6.25%) 
Conjunctivitis viral   0/15 (0.00%)  1/16 (6.25%) 
Diarrhoea infectious   1/15 (6.67%)  0/16 (0.00%) 
Folliculitis   0/15 (0.00%)  1/16 (6.25%) 
Gastroenteritis   1/15 (6.67%)  1/16 (6.25%) 
Gonorrhoea   0/15 (0.00%)  2/16 (12.50%) 
Infection   1/15 (6.67%)  0/16 (0.00%) 
Laryngitis   0/15 (0.00%)  1/16 (6.25%) 
Onychomycosis   0/15 (0.00%)  1/16 (6.25%) 
Oral herpes   1/15 (6.67%)  1/16 (6.25%) 
Osteomyelitis   1/15 (6.67%)  0/16 (0.00%) 
Pharyngitis streptococcal   0/15 (0.00%)  1/16 (6.25%) 
Pneumonia   1/15 (6.67%)  0/16 (0.00%) 
Staphylococcal infection   1/15 (6.67%)  0/16 (0.00%) 
Tinea versicolour   1/15 (6.67%)  0/16 (0.00%) 
Upper respiratory tract infection   2/15 (13.33%)  5/16 (31.25%) 
Viral infection   0/15 (0.00%)  1/16 (6.25%) 
Viral upper respiratory tract infection   1/15 (6.67%)  1/16 (6.25%) 
Injury, poisoning and procedural complications     
Contusion   0/15 (0.00%)  3/16 (18.75%) 
Injury   1/15 (6.67%)  2/16 (12.50%) 
Investigations     
Alanine aminotransferase increased   3/15 (20.00%)  4/16 (25.00%) 
Aspartate aminotransferase increased   3/15 (20.00%)  2/16 (12.50%) 
Blood bicarbonate abnormal   1/15 (6.67%)  2/16 (12.50%) 
Blood creatine phosphokinase increased   1/15 (6.67%)  0/16 (0.00%) 
Blood creatinine increased   1/15 (6.67%)  3/16 (18.75%) 
C-reactive protein increased   0/15 (0.00%)  1/16 (6.25%) 
Neutrophil count decreased   0/15 (0.00%)  1/16 (6.25%) 
Platelet count decreased   3/15 (20.00%)  0/16 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia   6/15 (40.00%)  6/16 (37.50%) 
Hypernatraemia   1/15 (6.67%)  4/16 (25.00%) 
Hypocalcaemia   1/15 (6.67%)  1/16 (6.25%) 
Hypoglycaemia   1/15 (6.67%)  2/16 (12.50%) 
Hypokalaemia   1/15 (6.67%)  0/16 (0.00%) 
Hyponatraemia   2/15 (13.33%)  0/16 (0.00%) 
Hypophosphataemia   3/15 (20.00%)  4/16 (25.00%) 
Vitamin D deficiency   1/15 (6.67%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   5/15 (33.33%)  5/16 (31.25%) 
Back pain   1/15 (6.67%)  1/16 (6.25%) 
Intervertebral disc degeneration   1/15 (6.67%)  0/16 (0.00%) 
Musculoskeletal pain   1/15 (6.67%)  0/16 (0.00%) 
Musculoskeletal stiffness   1/15 (6.67%)  1/16 (6.25%) 
Myalgia   10/15 (66.67%)  7/16 (43.75%) 
Nervous system disorders     
Headache   6/15 (40.00%)  5/16 (31.25%) 
Migraine   1/15 (6.67%)  0/16 (0.00%) 
Sciatica   0/15 (0.00%)  1/16 (6.25%) 
Psychiatric disorders     
Anxiety   1/15 (6.67%)  0/16 (0.00%) 
Depression   1/15 (6.67%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion   0/15 (0.00%)  3/16 (18.75%) 
Oropharyngeal pain   2/15 (13.33%)  1/16 (6.25%) 
Productive cough   1/15 (6.67%)  0/16 (0.00%) 
Rhinorrhoea   1/15 (6.67%)  0/16 (0.00%) 
Sleep apnoea syndrome   0/15 (0.00%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders     
Alopecia   0/15 (0.00%)  1/16 (6.25%) 
Dermatitis acneiform   1/15 (6.67%)  0/16 (0.00%) 
Dermatitis contact   0/15 (0.00%)  1/16 (6.25%) 
Hidradenitis   1/15 (6.67%)  0/16 (0.00%) 
Hyperhidrosis   0/15 (0.00%)  1/16 (6.25%) 
Night sweats   1/15 (6.67%)  1/16 (6.25%) 
Rash   1/15 (6.67%)  2/16 (12.50%) 
Skin lesion   1/15 (6.67%)  1/16 (6.25%) 
Surgical and medical procedures     
Toe amputation   1/15 (6.67%)  0/16 (0.00%) 
Vascular disorders     
Hypertension   0/15 (0.00%)  1/16 (6.25%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sneller, Michael
Organization: National Institute of Allergy and Infectious Diseases
Phone: +1 301 496 0491
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01859325     History of Changes
Other Study ID Numbers: 130141
13-I-0141
First Submitted: May 16, 2013
First Posted: May 21, 2013
Results First Submitted: March 9, 2018
Results First Posted: April 9, 2018
Last Update Posted: September 18, 2018