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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 : April 9, 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HIV-Mag/IL-12 & rVSV Vaccine 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 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.
Excluded Participants not meeting inclusion criteria or declined to participate.

Participant Flow:   Overall Study
    HIV-Mag/IL-12 & rVSV Vaccine   Placebo   Excluded
STARTED   15   16   2 
COMPLETED   12   12   2 
NOT COMPLETED   3   4   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HIV-Mag/IL-12 & rVSV Vaccine 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 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 Total of all reporting groups

Baseline Measures
   HIV-Mag/IL-12 & rVSV Vaccine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   16   31 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      15 100.0%      16 100.0%      31 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   The Rate of Related Adverse Events in Subjects Who Began cART During Acute or Early HIV-1 Infection.   [ Time Frame: 48 weeks ]

2.  Secondary:   HIV-1 Viral Load Following Antiretroviral Treatment Interruption (ATI).   [ Time Frame: 72 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: MSNELLER@niaid.nih.gov


Publications of Results:
Other Publications:

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: April 9, 2018