- Doctors in Cincinnati are among those planning an unprecedented
clinical trial in which the smallpox vaccine will be tested in a small
number of children, federal health officials confirmed yesterday.
- The idea is to establish vaccine dosages suitable for
children in the event that mass vaccination is needed because of a bioterrorist
- Tests, which will be conducted at Cincinnati's Children's
Hospital Medical Center and Harbor-UCLA Medical Center in Southern California,
will mark the first time the vaccine has ever been tested in children,
using the rigors of modern science.
- Though doctors administered the vaccine successfully
in children for two centuries before the disease's eradication, a formal
controlled clinical trial had not been performed even in the 1960s, a period
well within the era of evidence-based medicine.
- Doctors involved in the design of the trial hope testing
will begin before the end of the year. Fewer than 50 children are expected
to be entered into the trial in both states.
- "We're just waiting for the final word, to hear
that it's a go. All of the pieces seem to be in place," said Dr. David
Bernstein, director of the division of infectious diseases at Cincinnati
Children's Hospital and Medical Center. Bernstein will be the chief investigator
of the study's Ohio arm.
- He does not foresee trouble enrolling children into the
trial and is discussing the test with Cincinnati pediatricians. Because
test subjects must be closely monitored and wear special bandages after
their inoculation, neither site will accept enrollees from out of state.
- "This is a good vaccine and millions of children
have been safely immunized with it," said Dr. Michael Lane, a smallpox
expert now retired from the Centers for Disease Control and Prevention.
- Medical researchers plan to test the Dryvax vaccine,
Bernstein said, which was the same one used to eradicate smallpox in an
aggressive global campaign in the 1960s and '70s. It is also the same vaccine
administered in a nationwide adult clinical trial that began late last
year. Findings announced in March showed that Dryvax could be diluted and
still maintain its effectiveness.
- But Dryvax is not problem-free. Although doctors think
current medical knowledge may make the vaccine safer, it is a live-virus
vaccine that has caused encephalitis and potential brain damage in some
recipients. It also carries a 1 in 1 million chance of death, a ratio worked
out by Lane and colleagues in a series of groundbreaking studies on the
vaccine conducted at the CDC in the 1960s.