Posted by: blog4globalhealth | 05/04/2011


John Donnelly talked to Dr. Nelson L. Michael, MD, PhD, and Colonel in the US Army Medical Corps about US MRHP.

Nelson L. Michael, MD, PhD, a Colonel in the US Army Medical Corps, is the director of the US Military HIV Research Program at the Department of Defense’s Walter Reed Army Institute of Research in Rockville, Maryland. He guided the program through the completion of the RV 144 HIV prime-boost vaccine study, a collaboration which involved more than 16,000 Thai volunteers and provided the world’s first demonstration that a preventive HIV vaccine was possible.

John Donnelly talked to Dr. Michael from his Rockville office. This is the third of five pieces on the importance of global health research and development that coincides with the Global Health Technologies Coalition‘s (GHTC) annual report, and GHTC’s May 3 Hill briefing.

Q: Not many people know the extent of the US military’s work in infectious diseases. Could you describe it?

A: The Walter Reed Army Research Program is the military’s infectious disease research center. It was grounded in the late 1800s. The Army has had a long success in working in global health because so many of our servicemen served in places where there were infectious diseases-like yellow fever when the Panama Canal was built, or the scourge of malaria in the Second World War. We are all about building relationships for a long time. In Thailand and Kenya, our partnerships there are almost three generations long-they can be described as a marriage, not a date.

Q: Can you give some idea of the scope of the work?

A: We have 750 people who are doing research in six countries, including four in Africa. In our last calendar year, our budget was $180 million, although that was skewed somewhat and we generally have around $150 million a year. We receive about $30 million from the US Army, a range from the National Institutes of Health (NIH), and $70 million from the President’s Emergency Plan for AIDS Relief (PEPFAR). We also receive money from the Bill & Melinda Gates Foundation and the NIH Office of AIDS Research. Half of the money we receive from PEPFAR goes into service delivery. Over 100,000 people in Africa received antiretroviral treatment as a result of our program.

Q: Why does a research organization do so much service delivery?

A: You have some responsibility to provide care. We use an ethical framework to provide service delivery in an area where we do research. The rationale to do this is to provide an ethical and non-coercive environment to do research.

Q: For the HIV vaccine trial, can you put the finding of 31 percent efficacy in some context?

A: If you look at time period between 2003 and 2009, we had three major concepts for HIV vaccine research for advance clinical testing. Two were shown not to be efficacious. It took away enthusiasm for HIV vaccines. It came as a delightful surprise that when we unblinded our trial that we showed modest success for our vaccine.

In the first year, we had 60 percent efficacy, but the study was designed for 42 months and the efficacy waned over time. But the consequence of that finding energized the field again. It turned some people’s opinions around completely whether we should purse HIV vaccines. [Still] we have 31 percent efficacy for a vaccine that requires four visits and six shots and is very difficult to roll out. We want to show how it works in certain risk populations, and show it can be replicated elsewhere in the world. All these things mean a lot more work needs to be done for this vaccine, or one like it, in order to indicate we have a public health success.

Q: What are the next steps?

A: We have two major approaches for next steps. One is that we have 150 scientists in more than 30 labs working around the world doing secondary studies on the Thai results. We are looking for something we can measure in the lab that would correlate a positive sign. It could mean any development of an HIV vaccine would be simpler. We should have an answer sometime in the middle of the summer. If that points the way forward, it would be wonderful, because a lot of vaccines are being tested worldwide, and it would allow more clarity on which vaccine candidates should be tested.

Another approach is more empirical. We are doing additional studies of doing an additional boost to the vaccine, similar to what you do with an influenza booster. That would mean we would work on study designs, and go back to Thailand. It means we would have to tailor the vaccine to the subtype of the region. In Southern Africa, it’s subtype C. The rate of HIV infection is nine people out of 100 per year in Southern Africa. In Thailand, in contrast, it’s 0.3 per 100. Southern Africa is a much, much hotter epidemic.

Q: The process even to start a vaccine trial seems like a long dance, well before a marriage begins.

A: It’s a very long dance. Some people describe it like baseball. You can’t do anything until you can throw a ball, catch a ball and hit a ball. You have to be goodat all three. Job one in starting a discussion about a trial is community engagement. If the community doesn’t trust you, you can’t start. Imagine: the U.S. army is testing experimental vaccines in Africa, and in some of the areas along the coastal region, the major religion is Islam. So it has to be a marriage. You go into communities, have true community engagement, and you work with civil society. It’s a daily job.

Q: What motivates you to do this work?

A: I have a moral compass. I adore what I do. I’m trained as a MD and PhD, and I wanted to work at the intersection of science and medicine. My PhD is in molecular biology, and I still run a lab here in my own program, and I still see patients. I want to do something that has a public health impact. My father, who was in public health, still has students at George Washington University at age 82. I got some of this from my old man. I grew up in an environment of public service and some of that rubbed off on me.

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