In Process Interventional Clinical Trials

HVTN 115

A phase 1 clinical trial to evaluate the safety and immunogenicity of EnvSeq-1 Envs adjuvanted with GLA-SE, administered alone or with DNA Mosaic-Tre env, in healthy, HIV-uninfected adult participants

An effective HIV-1 vaccine will need to generate broadly neutralizing antibodies (bnAbs) that can prevent infection by the diverse HIV-1 strains circulating in the world. One clue that suggests a strategy to do this is that some HIV-1-infected patients eventually develop bnAbs after many months of infection—we have studied this process and now understand how the battle between the virus and immune response have allowed bnAbs to develop in infected persons. The goal of the HVTN 115 trial is to recreate this process in uninfected people by sequential immunization using EnvSeq-1, a sequence of four gp120 Env proteins isolated from an HIV-1-infected patient who eventually developed CD4-binding site specific bnAbs, combined with the adjuvant GLA-SE. Part A of this study will determine the optimal dose. Part B will test whether EnvSeq-1 can start the process of bnAb development in uninfected people. In addition, Part B will test whether the addition of a DNA vaccine, DNA Mosaic-Tre Env, can improve the immune response even further.

AVAIL

AVAIL (Alum-adjuvanted Vaccine Assessment In Lupus) is a planned single site trial that will be performed at Duke examining the safety of alum-adjuvanted vaccines in participants who are diagnosed with systemic lupus erythematosus (SLE). This study will test how alum-adjuvanted vaccines affect the immune system of people with SLE and will also determine the quality of their response. The study will examine a licensed 9-valent human papillomavirus (HPV) vaccine and a two component vaccine against HIV-1, AIDSVAX B/E. This study will ask the question, “Do people who have SLE respond to an HIV vaccine in a manner that is different than people without SLE?” The answer to this question will guide the development of vaccine candidates for HIV-1, and the data obtained on immune system stimulation by alum-adjuvanted vaccines in people with SLE will help guide the design of future vaccines for this population of people who are at risk for vaccine-preventable diseases.

Transient 

Phase I clinical trial to compare the safety and immunogenicity of CH505TF gp120 produced from stably transfected cells to CH505TF gp120 produced from transiently transfected cells in healthy, HIV-1 uninfected adult participants

The goal of this study is to compare two different methods of HIV-1 vaccine production. HIV-1-uninfected people will be immunized with an HIV-1 vaccine candidate Env protein (CH505TF gp120) manufactured with either stably transfected or transiently transfected cells. If we can show that the two methods give similar vaccine responses, we can pursue manufacture of future vaccine candidates by transient transfection, and this may help to accelerate the development process of future HIV-1 vaccines.

MPER 

A Phase I clinical trial to evaluate the safety and immunogenicity of an HIV-1 MPER peptide liposome vaccine in healthy, HIV-uninfected adult participants

On the HIV-1 Envelope is a highly conserved and well-studied area called the membrane proximal external region (MPER). Antibodies against this region can block infection by many different strains of HIV-1 circulating in the world. This study will use a vaccine that presents MPER peptides anchored in synthetic liposomes to evaluate the safety and immunogenicity of liposome-anchored MPER peptides in healthy subjects.

CERES 

There is an urgent need to prevent mother to child transmission (MTCT) of HIV-1 from infected pregnant mothers to their infants. A study performed at Duke showed that MTCT was lower when pregnant women had a higher level of antibodies against their own virus. The purpose of this study is to evaluate whether immunization of chronically HIV-1 infected women with an alum-adjuvanted clade B/C bivalent gp120 HIV-1 envelope vaccine can increase the level of plasma antibodies that can neutralize the virus in those women.  Successful outcomes in this trial will pave the way for a vaccine trial that would evaluate MTCT outcomes in HIV-1 infected pregnant women. 

HVTN 106 

The purpose of this study is to evaluate the safety and immune response to three DNA vaccines and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in healthy, HIV-uninfected adults. You can read more about the HVTN 106 trial here.