Vaccines and Immunotherapies (VIT)
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 will see if increasing the immune response against HIV using a vaccine delivered via electroporation (or a pulse of electricity) can reduce the viral reservoir.
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.
This pilot study will test 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 will 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:
All participants will continue to take their regular cART and receive regular care. This study is open-label meaning that everyone and their doctors will know whether or not they are receiving the vaccine. Both study groups will receive regular testing periodically throughout the course of the study and during follow-up.
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)
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
If you would like more information on this clinical study, please refer to a participating site.