About The Study

Though combination antiretroviral therapy (cART) can eliminate most of the HIV in a person living with HIV, small amounts of the virus persist, known as a viral reservoir. This pilot trial sought to understand if increasing the immune response against HIV using a vaccine delivered via electroporation (or a pulse of electricity) can reduce the viral reservoir.

About The Disease

Viral reservoirs are made up of HIV that is able to avoid eradication by cART. Typically, viral reservoirs are contained within immune cells (CD4 T cells) in the blood and gut. Recent studies have suggested that the immune response while on cART can become defective which could be another reason for the persistence of HIV within the body.

To combat the formation and persistence of these viral reservoirs researchers have begun searching for strategies to enhance the effectiveness of the immune system specifically for HIV. One of these approaches is using therapeutic vaccines. By introducing a small amount of HIV DNA directly into cells, these vaccines trigger an increase in immune response specific to that virus. This increase in HIV-specific immune response may help the body attack the remaining HIV in the system and reduce the viral reservoir.

Study Approach

This pilot study tested whether an experimental therapeutic vaccine (known as Pennvax®-GP in combination with interleukin-12 (IL-12)) administered via an electroporation device (CELLECTRA®– 5P) can help the immune system reduce the amount of HIV in the viral reservoirs.

This study planned to take place over 18 months and include 18 participants who began cART within 6 months of infection. Study participants will be randomized into one of two groups:

  • Treatment group (12 participants): will receive an HIV vaccine at 0, 4, 8, and 16 weeks
  • Control group (6 participants): will not receive the vaccine

All participants would continue to take their regular cART and receive regular care. This study was open-label meaning that everyone and their doctors will know whether or not they are receiving the vaccine. Both study groups would receive regular testing periodically throughout the course of the study and during follow-up.

Results

This study was terminated early due to futility analysis.

Eligibility Requirements

Required

  • Ability to provide informed consent
  • 18 years or older
  • Treated with cART within 6 months of infection
  • Detectable HIV viral reservoir
  • Good general health and lab results
  • Consistent use of effective contraception by either participant or their sexual partner(s)

Not Allowed

  • Non-adherence to cART
  • Laboratory test results deemed abnormal
  • Pregnant or planning on becoming pregnant, or breastfeeding
  • Serious illness, disease, or syndrome deemed to interfere with study requirements
  • Hepatitis C co-infection
  • Surgery or radiation therapy within 30 days of participation
  • Receipt of other vaccine or blood product before participation
  • Anything that may interfere with injection of vaccine (implants, bruises, scars, rashes near injection site)
  • Alcohol or drug dependency that could interfere with study requirements

Additional Information

If you would like more information on this clinical study, please refer to a participating site.

Principal Investigators

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@ctnplus.ca.

Participating Sites

Here’s where this study is being conducted.

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