Orphaned Vaccines

Questions of efficacy remain unanswered when continuity of research funding lapses

by Jeannie Wraight

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red tape[dropcap type=”3″]S[/dropcap]ometimes viewing a complex issue in its most simplistic form can help us to understand where a problem lies. HIV is a virus that has spread to pandemic proportions. Medical science is employed to limit the damage done by HIV. In order to control, and eventually eliminate HIV, we need to find efficacious strategies, technologies, and therapies focused on prevention, treatment and cure. To determine what will be helpful in this process, we conduct research which (with the exception of non-medical interventions) consists of laboratory research, animal studies, and human clinical trials to test these strategies, technologies and therapies.

Funding is needed to perform medical research. Research should be continued or discontinued on the basis of efficacy and done so in a continual forward-moving process. We spend a couple hundred thousand dollars on lab tests. If the results show promise, we spend more money performing more research that will take us to animal studies. If the animal studies show promise, we move to Phase I clinical trials and so on.

If something appears to work, it moves forward in this process. If it doesn’t, we disregard it and try something else. This sounds simple but, unfortunately, this is not what actually happens. The National Institutes of Health provide research grants to assist in the cost of research but it does so sporadically, with little regard for continuity. The result of this is that therapies, vaccines, cures and technologies that show promise, die in the pipeline due to a lack of funding.

Here’s one example of a casualty of this process. In researching for this column and other articles I write, I found a 2003 press announcement that described a $357,000 grant from the NIH provided for research of a novel HIV vaccine.

In vaccine development, $357,000, isn’t a lot of money, but for a preclinical potential vaccine, it’s a decent sum of our tax payer dollars. The vaccine, made by Antigen Express, appears promising. Early pre-clinical research was performed in conjunction with Dr. Bruce Walker, a leading HIV researcher. The vaccine strategy intended to mimic immunological responses seen in long term non-progressors.

In this vaccine platform, peptides are used to stimulate antigen-specific T-helper cell responses by addition of a fragment of the Ii immuneregulatory protein to the vaccine components. Peptides are very inexpensive to manufacture, making this an option for an affordable global vaccine.

This vaccine could be studied as both a preventative and therapeutic vaccine, and as a stand-alone vaccine or one that could be used to help boost other vaccines. Extensive clinical studies have shown other vaccines designed using this platform are non-toxic. Further, the vaccine is not clade-specific so it could be used against all strains of HIV.

So what’s happened to this vaccine candidate? Development was discontinued by its makers in 2010, not on the basis of poor efficacy but due to lack of funds. Could we have lost the vaccine that would have halted the spread of HIV and/or allowed people with HIV to develop more efficient immune responses and discontinue ARVs? Who knows? Maybe, maybe not. Only more research could have determined that. Investing in vaccines or drugs here and there with no regard for what happens to the ones that show promise is a waste of money and good science, and slows the process of ending the HIV pandemic.

Many HIV activists are currently meeting with U.S. Presidential candidates to help them establish an HIV agenda. Continuity of research grants should be included in that agenda. If something works, let’s see it through by creating a holistic view of funding through government, private and Foundation sources.

Other vaccines that have received NIH funding and may be both preventative and therapeutic include Paxvax, an HIV gag protein adenovirus vector vaccine, PTcell’s HIV-V immunotherapy and HIVAX, a replication-defective HIV vaccine.
The 2017 NIH budget will consolidate the money spent on HIV research. They will be cutting a great deal of research projects, focusing only on priority issues, one of which is vaccines and other means of reducing new infections. To ensure the best interests of the HIV community are taken into account during this time of “refocused priorities,” a concerted effort must be made to determine and voice what we want to see studied.

Many researchers have stated that the only effective way to end the HIV pandemic is through a preventative vaccine. However, if that vaccine cannot also be used to control HIV in the thirty-five million-plus individuals already living with HIV, it is unlikely that further therapeutic options will be developed for treatment of a dwindling consumer market. As we advocate for vaccines, we must ensure we do so for those that can act as both a preventative and therapeutic vaccine and that funds be available to move promising ones forward.


 

Jeannie Wraight is the former editor-in-chief and co-founder of HIV and HCV Haven (www.hivhaven.com) and a blogger and writer for TheBody. com. She is a member of the Board of Directors of Health People, a community-based organization in the South Bronx and an advisor to TRW (Teach me to Read and Write), a community-based organization in Kampala, Uganda. She lives with her husband in New York City.