HIV Overview

What is a therapeutic HIV vaccine?

A therapeutic HIV vaccine is a vaccine that is designed to improve the body’s immune response to HIV in people who already have the virus.

In 2012, a therapeutic HIV vaccine called Vacc-4x showed that it may be possible to teach the immune system to control HIV in some people with HIV and reduce their viral load.

Researchers are developing and testing therapeutic HIV vaccines to achieve HIV remission or a functional cure. The goal of a therapeutic vaccine is to keep HIV at undetectable levels (known as undetectable viral load) without the need for regular antiretroviral therapy (ART).

Currently, ART is the only recommended treatment for HIV infection and involves using a combination of different HIV medicines to prevent HIV from multiplying. A person with HIV must remain on ART to keep HIV at undetectable levels.

In summary, researchers are exploring the use of therapeutic HIV vaccines to—

• Slow down the progression of HIV in people with the virus
• Achieve HIV remission, also called a functional cure (keeping viral load suppressed without the need for ART)

As an added benefit, a therapeutic HIV vaccine may also make it less likely that a person with HIV could transmit it to others.

Are there any FDA-approved therapeutic HIV vaccines?

Currently, no therapeutic HIV vaccines are approved by the FDA. However, scientists are pursuing innovative strategies to design an HIV vaccine to prevent or treat HIV infection.

To develop an effective therapeutic HIV vaccine, scientists continue creating vaccines that target different parts of the virus (such as the Env gene or Gag proteins) or components of the immune system (such as broadly neutralizing antibodies, or bNAbs). These strategies aim to improve the body’s ability to control HIV.

While previous research has shown only limited success, ongoing advancements in vaccine technology, immune-based therapies, and gene-editing approaches provide hope that a therapeutic HIV vaccine will eventually be developed. For now, you must be enrolled in a clinical trial to receive an experimental HIV vaccine.

Why is a therapeutic vaccine important?

Treatment options for HIV have continuously improved over the years by improving the number of options and ease of use, while also minimizing side effects. However, adhering to an HIV treatment regimen over a lifetime can be difficult for many people.

Many HIV medicines must be taken every day to be effective. Although some long-acting HIV medicines can be taken less often, these medicines are not appropriate for everyone with HIV and still require a strict medicine schedule to work as intended (see the HIVinfo Long-Acting HIV Medicine fact sheet for more information).

Access to HIV medicines can be difficult in some situations, and some medicines may have side effects or high costs that deter people from taking them as prescribed. Over time, missed doses can lead to drug resistance, and a treatment regimen may need to be changed.

A therapeutic HIV vaccine could help to effectively control HIV while overcoming the limitations of HIV medicines. At a minimum, a therapeutic HIV vaccine could reduce the amount of HIV in the body, reduce how often HIV medicines must be taken, and help prevent drug resistance.

How is a therapeutic HIV vaccine different from a preventive HIV vaccine?

The goal of a preventive HIV vaccine is to prevent people from getting HIV. When available, it will be given to people who do not have HIV. To learn more, read the HIVinfo What is a Preventive HIV Vaccine? fact sheet.

A therapeutic HIV vaccine is for people who already have HIV. The goal of a therapeutic HIV vaccine is to strengthen the natural immune response to the HIV that is already in people with the virus.

Where can a person get more information about clinical trials studying therapeutic HIV vaccines?

An online database of clinical trials on therapeutic HIV vaccines is available from the ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see more information about the study.

If you are interested in participating in a vaccine study, you can also contact the National Institutes of Health Vaccine Research Center by calling 866-833-LIFE (5433) or by emailing [email protected].

To learn more, read the HIVinfo fact sheet on HIV and AIDS Clinical Trials.

This fact sheet is based on information from the following sources:

From the National Institute of Allergy and Infectious Diseases:

• HIV Vaccine Development
• Sustained ART-Free HIV Remission
• Clinical trial of HIV vaccine begins in United States and South Africa (September 20, 2023)

From the International AIDS Vaccine Initiative (IAVI):

• IAVI Vaccine Literacy Library

Also see the HIV Source collection of HIV links and resources.