For us it would be in the area of vaccines first.

The approval of the first cancer therapeutic vaccine from Dendreon in prostate cancer establishes the concept that immunotherapy is a conceptually achievable and clinically useful approach for treating cancer. This allows us and others to develop novel concepts of immunotherapy for cancer.

On another vein is the approval of GlaxoSmithKline’s human papillomavirus (HPV) vaccine both for the continued demonstration of the importance of infectious disease-related cancer and the ability to intervene with a vaccine to prevent such a cancer. The GSK HPV vaccine also includes the first novel adjuvant in a vaccine in the U.S. in the last 30 years and thus allowing the ability of novel adjuvants to enhance immune responses for candidate cancer vaccines or vaccines that are directed at infections in the elderly.

Lastly is the discussion of the complexities that rapid emergence of resistance to cancer therapies is being increasingly noted. There is an ongoing discussion about allowing combination chemotherapy to be utilized early on in the clinical development pathway of cancer therapies as well as complex infectious diseases such as multi-drug resistant tuberculosis.

[Editor's Note: This is part of a series of posts from Xconomists and other technology and life sciences leaders from around the U.S. who are weighing in with the top surprises they've seen in their respective fields in the past year, or the major things to watch for in 2011.]

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The HIV vaccine field received exciting news Thursday from an HIV vaccine trial conducted in Thailand, where the vaccines tested appeared to reduce the acquisition of HIV by about 30 percent. This milestone is the first sign from a study in humans that it is possible to develop an effective HIV vaccine.

The trial, conducted by a consortium of partners, including the Thai Ministry of Health and the U.S. Military HIV Research Program, used two vaccines (ALVACr HIV and AIDSVAXr B/E) that were matched to the strain of HIV that is predominant in Thailand (Clade E). The study was the first community-based trial of an HIV vaccine and involved more than 16,000 people from two provinces in Thailand. The vaccines reduced the acquisition of HIV-1 by 31.2 percent. Although this level of effectiveness did not reach the degree of protection specified in the protocol for potential licensure as a vaccine, it was statistically significant.

Thus, while the vaccine’s effectiveness is not at the level needed to control the AIDS pandemic, it is an indication that scientists will reach the goal of developing an effective HIV vaccine. By examining and analyzing the blood samples from participants, they will develop a greater understanding of how these vaccines protected some people from infection. They will build on that knowledge to create future vaccine candidates that are able to produce a greater protective effect.

Historically in vaccine development, a study will first show a modest effect at preventing disease, and then changes are made so that subsequent vaccine candidates demonstrate a more robust effect. Some of the most effective vaccines can reduce infection by as much as 95 percent, while others, like the seasonal influenza vaccine, are in the range of 50-60 percent effective. It is far easier to double the effectiveness of a vaccine from 30 to 60 percent than it is to find the vaccine with that first effect.

Moving forward toward an effective HIV vaccine will require more clinical trials in humans. Some of them will be successful, and some of them not. Hopefully, a concerted scientific effort to define the correlate of this success will lead to rapid improvements on these initial results, and bring us to an effective HIV vaccine.

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…is coming soon.

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