NCT03758625

Comparison of Dendritic Cell-Based Therapeutic Vaccine Strategies for HIV Functional Cure

A Phase I Study to Evaluate the Safety, Tolerability and Immunogenicity of a Therapeutic HIV Vaccine Composed of Autologous Dendritic Cells Loaded With Autologous Inactivated Whole Virus or Conserved Peptides in ART-treated HIV-infected Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sharon Riddler · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will be done in people living with HIV to see if an investigational vaccine made from a person's own white blood cells is safe and tolerated. This study will also look at the body's immune response to the vaccine and evaluate four different methods of making the vaccine to see which method may result in better immune responses.

Detailed description

Despite the availability of strong medicines for HIV infection, there is no cure for the infection. The current anti-HIV drugs, used in combination, are effective in slowing the growth of the virus and delaying the progression of the infection. There is increasing information to suggest that a vigorous immune response (a strong response of the body to fight infection) to HIV may also result in improved control of the HIV infection. Such strong immune responses are found in a small number of HIV-infected individuals, but not in the majority. Dendritic cells, or DCs, are a type of white blood cell that works together with other immune cells to fight infection. The DCs role is to bring substances foreign to the body, such as viruses including HIV or cancer cell proteins, to the body's immune system. Large numbers of DCs can be made from blood samples and administered back to the same person as an individualized vaccine. Vaccines made from DCs have been studied in HIV and numerous types of cancer. The vaccines will be created by two different laboratory methods, standard or improved, using an individual's own DCs and either an individual's own inactive HIV that has been killed with heat or manmade HIV proteins called peptides. The peptides have not been studied for this use in humans, and these vaccines are not approved by the Food and Drug Administration (FDA) to prevent or treat HIV infection. This study will be done in two steps. During Step 1 (Entry-Week 12), participants will have 4 study visits for tests, procedures and exams. At Week 4, participants will be randomized by chance into one of six study groups, like rolling dice. Four of the study groups will receive a DC-HIV vaccine while two of the study groups will receive a "control" vaccine with only DCs. Participants will have a 4:1 chance of receiving a DC-HIV study vaccine. * Group 1: enhanced DC-HIV vaccine with inactive HIV * Group 2: enhanced DC-HIV vaccine with HIV peptides * Group 3: enhanced DCs only (control) * Group 4: classic DC-HIV vaccine with inactive HIV * Group 5: classic DC-HIV vaccine with HIV peptides * Group 6: classic DCs only (control) Each participant will receive 6 study vaccinations at 4-week intervals beginning at Week 12. Researchers will compare the results from participants who get the active study vaccines with results from participants who get the control vaccines. Participants, the researchers and the clinic staff will not know which vaccine participants are getting. In Step 2 (Weeks 12 - 80), participants will have 18 study visits to receive the 6 study vaccinations and for tests to monitor health and safety and to see how the study vaccine affects the immune system and the virus.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	a1DC + inactivated whole autologous HIV	Investigational vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) and loaded with autologous -inactivated HIV
BIOLOGICAL	a1DC + conserved HIV peptides	Investigational vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) and loaded with a conserved HIV gag and pol peptide pool
BIOLOGICAL	a1DC + no antigen	Control vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) but without an antigen
BIOLOGICAL	pgDC + inactivated whole autologous HIV	Investigational vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) and loaded with autologous -inactivated HIV
BIOLOGICAL	pgDC + conserved HIV peptides	Investigational vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) and loaded with a conserved HIV gag and pol peptide pool
BIOLOGICAL	pgDC + no antigen	Control vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) but without an antigen

Timeline

• Start date: 2019-01-02
• Primary completion: 2025-02-19
• Completion: 2025-02-19
• First posted: 2018-11-29
• Last updated: 2025-10-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study