NIAID Launches Three New AIDS Vaccine Trials

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"In addition, an influenza vaccine manufactured using recombinant DNA technology might
help to increase our preparedness for influenza outbreaks by allowing a more rapid response to
shortages of vaccine or changes in the circulating strain of influenza virus," he adds. "Currently, there
is no alternative to egg-produced influenza vaccine."
The volunteers in the study were healthy adults aged 18 to 45, enrolled at NIAID-sponsored
Vaccine and Treatment Evaluation Units at St. Louis University and the University of Rochester in the
winter of 1993-1994. The patients were randomly assigned to receive intramuscular injections of one
of three preparations of the new vaccine (15 micrograms, 15 micrograms plus alum or 90 micrograms),
a licensed trivalent inactivated vaccine, or a saline placebo. Alum is frequently used in vaccines as an
adjuvant to enhance the immune-stimulating properties of the vaccine.
The study was done in a double-blind fashion -- that is, neither the investigators nor the patients
knew which vaccine a patient received until the study was over. Patients filled out a daily report card
of adverse reactions during the first six days after vaccination, and were instructed to contact the clinic
if they developed flu-like symptoms.
Blood samples were taken at the time of vaccination, three weeks after vaccination, and again
in late March/April 1994 after influenza viruses were no longer circulating in local communities. The
investigators found that patients receiving the lowest dose of the new vaccine had levels of
hemagglutinin-specific neutralizing antibodies similar to those seen in patients who received the
licensed vaccine. The production of these antibodies was not enhanced in patients who received the
low-dose vaccine plus alum, but were significantly increased in patients receiving the higher dose of the
new vaccine. Even at the highest dose tested, the new vaccine caused no more side effects than a saline
placebo.
Authors of the paper include Douglas C. Powers, M.D., of the St. Louis VA Medical Center

and St. Louis University; Robert B. Belshe, M.D., Edwin L Anderson, M.D., and Donald J. Kennedy,
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