Public Release:  Clinical trial will test new HIV/AIDS vaccine

Phase 1 trial begins in Boston

Beth Israel Deaconess Medical Center

BOSTON - A phase 1 clinical trial to test a novel HIV/AIDS vaccine has begun at Brigham and Women's Hospital (BWH). This new vaccine aims to overcome the problem of preexisting immunity to common vaccine vectors, which is thought to be a major problem in the developing world.

"This study will involve 48 healthy volunteers who will receive either two or three immunizations and who will be followed to assess the safety and immunogenicity of the vaccine," explains Lindsey R. Baden, MD, Assistant Professor of Medicine at BWH and Harvard Medical School and Protocol Chair for the study.

The vaccine consists of a replication-incompetent, recombinant adenovirus serotype 26 (rAd26) vector encoding an HIV-1 envelope gene.

"The rAd26 vaccine vector was selected for its particularly low seroprevalence in human populations and for its potent immunogenicity and protective efficacy in preclinical studies," explains Dan H. Barouch, MD, PhD, Associate Professor of Medicine at Beth Israel Deaconess Medical Center (BIDMC) and Harvard Medical School and Principal Investigator of the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program that developed the vaccine. This program is sponsored by the Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health.

Manufactured by the Dutch biotechnology company Crucell Holland BV, the rAd26 vaccine is the first HIV-1 vaccine candidate to emerge from the IPCAVD initiative, which brings together investigators from academia and industry in an effort to accelerate the development of promising HIV/AIDS vaccine candidates. The novel strategy used in developing this vaccine enables researchers to circumvent preexisting immunity to the adenovirus serotype 5, the virus responsible for the common cold, which has recently shown limitations as an HIV-1 vaccine vector.

"The rAd26 vector does not regularly occur in the human population and human antibodies to this vector are rare," explains Jaap Goudsmit, Chief Scientific Officer at Crucell. "The rAd26 vector therefore is efficacious in eliciting good T and B cell responses."

AIDS remains one of the world's most devastating health problems, with an estimated 33.2 million people living with HIV/AIDS and 2.5 million new infections reported in 2007 alone.

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Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School, and consistently ranks in the top four in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of Dana-Farber/Harvard Cancer Care Center. BIDMC is the official hospital of the Boston Red Sox. For more information visit www.bidmc.harvard.edu.

Brigham and Women's Hospital (BWH) is a 747-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human disease, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.

Crucell N.V. is a global biotechnology company focused on research, development, production and marketing of vaccines, proteins and antibodies that prevent and treat primarily infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several product candidates based on its unique PER.C6 production technology. The Company licenses its PER.C6 technology and other technologies to the biopharmaceutical industry. Important partners and other licensees include DSM Biologics, sanofi-aventis, Novartis, Wyeth and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Switzerland, Spain, Portugal, Italy, Sweden, Korea and the US. The Company employs over 1,000 people. For more information, please visit www.crucell.com.

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