In Process Interventional Clinical Trials
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, which has already been completely enrolled, has determined the optimal dose. Part B will test whether EnvSeq-1 can start the process of bnAb development in uninfected people. You can read more about the HVTN 115 trial here.
HVTN 121 is a trial being performed at Duke and at the University of Alabama at Birmingham that is examining the safety of the alum-adjuvanted vaccine AIDSVAX B/E in participants who have systemic lupus erythematosus (SLE). This study will test how AIDSVAX B/E affects the immune system of people with SLE and will also determine the quality of their response. 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. You can read more about the HVTN 121 trial here .
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.
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 participants.
A phase 1 clinical trial to evaluate the safety and immunogenicity of the HIV-1 CH505 transmitted/founder (TF) gp120 adjuvanted with GLA-SE in healthy, HIV-exposed infants.
The Duke CHAVI ID program is partnering with HVTN to develop a clinical trial of Duke-developed vaccines in infants. This study will use the CH505TF protein that has been tested in adults in the HVTN 115 trial. The purpose of this study will be to determine if this vaccine is safe in infants and if infants make a different response to the vaccine than adults. Determining whether infants can make a different response than adults is an important step in designing vaccine strategies that could protect infants from infection by breastfeeding and could help establish whether vaccination in infancy can produce immunity that can protect in later life.
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.