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October 12, 1994

International Disunity on HIV Vaccine Efficacy Trials

JAMA. 1994;272(14):1090-1091. doi:10.1001/jama.1994.03520140020009

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THE WORLD MAY not wait for the United States to test human immunodeficiency virus (HIV) vaccines.

Phase 3 trials of two experimental HIV vaccines were indefinitely postponed by the National Institute of Allergy and Infectious Diseases (NIAID) this summer.

NIAID Director Anthony Fauci, MD, explained at the 10th International Conference on AIDS in Yokohama, Japan, that he made the ruling for two reasons. First is the lack of correlates of protection, or clear markers, to tell when someone is indeed immunized against HIV infection.

The second reason is that potential study subjects in the community may not understand that the vaccine is only experimental and instead "assume that they are now protected and so go out and have unsafe sex," resulting in an increased infection rate, the opposite effect of that desired, says Fauci. These concerns were underscored by higher than expected new infection rates among subjects in phase 1

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