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The first step of testing a brand new type of HIV vaccine began this week using a vaccine candidate designed in an antibody center located at Scripps Research in La Jolla.
Early Human Testing is sponsored by the International AIDS Vaccine Initiative, or IAVI, which operates the Scripps Research Center. It will assess the safety, as well as the ability of the vaccine candidate to begin the first steps of a potent antibody reaction to neutralize a broad spectrum of HIV strains.
During the trial, 48 healthy adult volunteers will receive placebos or two injections of the candidate vaccine, two months apart. It takes place at George Washington University in Washington, D.C., and the Fred Hutchinson Cancer Research Center in Seattle. The results are expected by the end of 2019, says IAVI.
Many more steps will be needed before a complete HIV vaccine can be created, said Schripps Research researcher William Schief. His laboratory designed the candidate vaccine. This is why it is called a vaccine candidate and not a vaccine.
The largely neutralizing antibodies needed to protect against HIV infection can not be manufactured in a single pass, Schief said via email. The immune system must be guided on a complicated path, which means that multiple immunizations will be needed.
The initial dose is intended to start the manufacturing process of so-called neutralizing antibodies class VRC01, he said. These physically interfere with the infection by preventing HIV from binding to the cells that it infects.
Among the assistants, Schief has appointed many other scientists in San Diego, IAVI and elsewhere in the country. GlaxoSmithKline has provided a particularly effective immune stimulant or adjuvant to administer with the vaccine candidate, he said.
The success of this program depends on the ability of most people's immune systems to make these antibodies by vaccination.
The answer is yes, according to a study published in January in the journal Immunity. Shane Crotty of the La Jolla Institute of Allergy and Immunology, who worked with Schief and the others on neutralizing antibodies, was one of the people in charge of the study.
Several attempts to produce effective HIV vaccines have failed in recent decades, including a program from The Immune Response Co, a company now extinct in Carlsbad. This is because the virus has many tips in its molecular sheaths to escape detection by the immune system.
HIV is undergoing a ferocious mutation allowing it to bypass the antibodies directed against a particular strain. The virus that causes AIDS has vulnerabilities, but these are protected by sugar molecules, called glycans, stolen from its host. As a natural part of the body, these glycans are ignored by the immune system.
This glycan shield is not totally effective. Large neutralizing antibodies can recognize the shield and penetrate it to reach vulnerable areas. But these antibodies are usually produced after years of infection, when HIV is too well established to be eradicated.
Schief and his colleagues at Scripps Research, including Dennis Burton, David Nemazee, Rich Wyatt, Ian Wilson and Andrew Ward have been collecting and studying these powerful antibodies for years. The goal is to do reverse engineering, how they were made. They do their work at IAVI's Neutralizing Antibody Center at Scripps Research. Schief is the director of vaccine design at the center.
A rare beginning
Schief and his collaborators have discovered that a rare group of immune cells is starting the process of making large neutralizing antibodies. The vaccine candidate is intended to activate these cells, to "teach" them to develop, from beginner to former, into an experienced veteran producing these specialized antibodies, Schief said.
The Crotty study found that under good conditions the human immune system should be able to produce enough of these rare cells.
"This first step is a protein designed specifically to start the process," said Schief. "The other vaccines in the sequence will provide other proteins, each designed to advance the production process of these protective antibodies."
This concept is called "the design of a germ line vaccine," said Schief. This is because the targeted cells produce "primitive primitive antibodies derived from what is called germline DNA".
Antibody-producing immune cells actually mutate their DNA from the baseline germinal state, allowing them to differentiate along pathways capable of producing more specialized antibodies.
"These early antibodies require a lot of processing to become neutralizing protective antibodies, and this maturation will ultimately be guided by our complete sequence of vaccines," said Schief.
This project is one of many projects that Schief and his colleagues hope to associate with an HIV vaccine.
"In order to make an HIV vaccine of the highest efficiency, we believe that we will have to induce at least two different classes of largely neutralizing antibodies, since no type of antibody can neutralize 100% of the strains of HIV, "said Schief.
"We are also developing other candidate vaccines to produce neutralizing antibodies against other HIV sites, and we are aiming for a combined vaccine in the long term."
The long-term goal of this work is to save millions of lives around the world. Schief said.
"All this work will be worth it if we can make a vaccine to protect people from this virus, because 5,000 people a day are infected with HIV and most of them do not get anti-HIV drugs. . "
Related reading
San Diego researchers say neutralizing response to HIV is possible for most people
New Investigators on Making an Effective HIV Vaccine Discovered by Scripps Research Scientists
Are we getting closer to HIV?
VRC01 antibody delays but does not prevent HIV from rebounding after antiretroviral therapy is discontinued
A potent anti-HIV antibody found
New weakness found in HIV
HIV low point found in a study by Scripps
Scripps scientists determine the structure of a largely neutralizing antibody against HIV
Discovery of HIV to help hunt for vaccine
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