A ‘dance’ before a trial begins

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Col. Nelson L. Michael, MD, PhD

Nelson L. Michael is a medical doctor, has a doctorate in molecular biology, holds the rank of colonel in the U.S. Medical Corps and his day job is huge: He is in charge of the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research in Rockville, Md. He oversees 750 people and his budget this year was $180 million.

But Michael is low-key to the core, and much of his job escapes public notice, even if he now is following multiple leads that resulted from a Thailand HIV vaccine study, which showed in 2009 for the first time that a preventive HIV vaccine was possible.

Often his job is figuring out how to make things work for research, and that has led him to Mozambique a couple of times in recent months to talk about starting a clinical trial site for HIV vaccine research.  His approach, which he described in an interview with Science Speaks, is telling in the great caution he takes on such missions, even if he is well aware of the great demand for new sites in areas with high HIV prevalence.

“We’re really impressed with them,” Michael said of the research team at Mozambique’s National Institute of Health (NIH). The director is Dr. Ilesh Jani, an immunologist and a physician “who is 38 years old and that makes him the old man in the group. It’s a young, motivated, and excited group, and they have developed a good research site in Maputo.”

But Michael was concerned. Would an HIV clinical trial overwhelm Mozambique’s 104-person NIH? He talked to many people there, asked tough questions, and came away believing that they could do it.

They are now jointly planning a clinical trial to begin in 2014. It might be a spinoff of Michael’s RV 144 HIV prime-boost vaccine study, a collaboration which involved more than 16,000 Thai volunteers. Or it might be something completely different, such as a microbicides trial.

In some ways, it doesn’t matter to Michael. He is more concerned about building the capacity of research scientists in another sub-Saharan African country.

“Our network would like to bring Mozambique into the fold and build a strong partnership,” he said. “We want them to be part of vaccine development activities in Africa that will move at a much more accelerated pace.”

After agreeing to form a partnership, he said the next job – and one that remains through the end of the project – is to engage the community in the trial. “It has to be true engagement,” he said. “It’s a daily job.”

At the same time, Michael said, the researchers from different cultures enter into a type of “marriage,” planning for a long-lasting relationship.

“You have a long dance in developing the scientific capabilities,” Michael said. “What we don’t want to do is go into Mozambique and bring our own scientists in, do the studies, and helicopter out. What we want is for Mozambique scientists to do the work.”

Where does the relationship stand today in Mozambique?

“It’s not a first date by any means, we’re much further along,” he said. “Mozambique already has a core of strong physician-researchers. We think by 2014, we can conceive a large-scale efficacy trial. It will be exciting.”

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