The introduction of highly active antiretroviral therapy has significantly impacted the management of HIV disease.
To assess the current state of HIV therapeutic vaccine development and potential barriers for moving vaccines forward especially through the regulatory process.
The introduction of highly active antiretroviral therapy has significantly impacted the management of HIV disease. This treatment modality has had a significant effect on patient mortality by its ability to effectively suppress plasma HIV RNA to undetectable levels and sustained increases in CD4 T cells. Even with these significant advances we now recognize the limitation of HAART based on development of viral resistance, metabolic complications, and patient compliance for complex regimens. This has lead to the combining of immune based therapies with current antiretroviral regimens to allow for the long-term management of HIV infection. Even though the introduction of HAART has demonstrated immune reconstitution to opportunistic pathogens (e.g. CMV) and reduced patient morbidity to these infectious chronically infected HIV+ subjects still do not demonstrate restoration of HIV specific immune responses. The ability to restore HIV specific responses would potentially allow for control of viral replication off antiretroviral therapy. The specific approaches taken to achieve this have included "autoimmunization" with the subjects own virus which has shown limited success and exogenous immunogens including inactivated whole virus, live viral vectors, and DNA strategies. The development of the HIV therapeutic vaccine field has been hampered by lack of defined correlates of protection that can be used as outcome measures and access to promising agents for evaluation. This meeting will bring together appropriate individuals from academia, government and industry that can help in identifying potential new vaccines for evaluation and help in defining their development pathways and evaluation criteria.
Dr. Alan Landay (USA)
Dr. David Cooper (Australia)
Ben Cheng
Materials and LinksPresentations: Alan Landay Michael Lederman Susan Barnett Roy Gulick Rick Koup Carol Weiss Kent Weinhold Wayne Koff Nature Article: AIDS researchers seek criteria for vaccines |
Goal:
To assess the current state of HIV therapeutic vaccine development and potential barriers for moving vaccines forward especially through the regulatory process.
Background:
The introduction of highly active antiretroviral therapy has significantly impacted the management of HIV disease. This treatment modality has had a significant effect on patient mortality by its ability to effectively suppress plasma HIV RNA to undetectable levels and sustained increases in CD4 T cells. Even with these significant advances we now recognize the limitation of HAART based on development of viral resistance, metabolic complications, and patient compliance for complex regimens. This has lead to the combining of immune based therapies with current antiretroviral regimens to allow for the long-term management of HIV infection. Even though the introduction of HAART has demonstrated immune reconstitution to opportunistic pathogens (e.g. CMV) and reduced patient morbidity to these infectious chronically infected HIV+ subjects still do not demonstrate restoration of HIV specific immune responses. The ability to restore HIV specific responses would potentially allow for control of viral replication off antiretroviral therapy. The specific approaches taken to achieve this have included "autoimmunization" with the subjects own virus which has shown limited success and exogenous immunogens including inactivated whole virus, live viral vectors, and DNA strategies. The development of the HIV therapeutic vaccine field has been hampered by lack of defined correlates of protection that can be used as outcome measures and access to promising agents for evaluation. This meeting will bring together appropriate individuals from academia, government and industry that can help in identifying potential new vaccines for evaluation and help in defining their development pathways and evaluation criteria.
Objectives:
- To identify potential new leads for HIV therapeutic vaccines.
- What products have been developed in the cancer vaccine field.
- What are the new lead compounds that investigators are developing
- What are new compounds that the Pharmaceutical Industry is developing
- What new areas of vaccine development are there
- To identify barriers to the process of vaccine development
- How do investigators get their vaccines evaluated in a timely manner in both nonhuman primate and human studies.
- How can NIH facilitate the process of therapeutic vaccine evaluation.
- What barriers are there in industry for developing therapeutic HIV vaccine.
- To establish criteria for endpoints in phase I, II, and III trials
- What will be an acceptable endpoint
- What is the role of surrogate markers
- What is the role of analytic treatment interruption
- To establish dialogue with FDA on criteria for licensing an HIV therapeutic vaccine.
- Will all endpoints have to be clinical?
- Can markers of HIV specific immunity be utilized as endpoint?
- Will time to virologic rebound off on an antiretroviral therapy or durability of virologic suppression be acceptable?
Scientific chairs:
Dr. Alan Landay (USA)
Dr. David Cooper (Australia)
Project Manager:
Ben Cheng
