NEW YORK -- Researchers reported what is said to be the
first test on humans of a vaccine produced through genetic
Scientists at Merck & Co. said the vaccine, for use against a
type of hepatitis, proved completely safe in a study of 37
healthy adults, all Merck employees who volunteered for the
test. The report of the study, published in today's Journal of
the American Medical Association, said the vaccine produced
antibodies against hepatitis B in the test subjects' blood, an
indication the vaccine would protect against the illness.
The new vaccine is the first of what is expected to be a host
of vaccines produced through biotechnology. Vaccines against
herpes, malaria, gonorrhea and other illnesses are currently
A vaccine against hepatitis B already exists, but it is
produced from the blood of hepatitis B carriers and is
difficult, expensive and potentially dangerous to make. That
vaccine, also developed by Merck and marketed under the name
Heptavax-B since 1982, has run into resistance from potential
users because of its high cost and the fear that the donors'
blood might be contaminated. The new vaccine, which Merck
hopes to have generally available in two-to-three years, is
expected to overcome many problems associated with its
Heptavax-B product. The company still must conduct tests to
ensure that the vaccine protects those most at risk of getting
"This is an important hurdle for the vaccine. We believe it
will prove to be the vaccine of choice against hepatitis B,"
said Edward M. Scolnick, senior vice president of Merck's Merck
Sharp & Dohme Research Laboratories and principal researcher of
Today is the second day in a row Merck's vaccine researchers
made news. A research team reported earlier that a vaccine
against chicken pox had been tested successfully. The company's
common stock closed at $85.375, up $1.875, in composite trading
yesterday on the New York Stock Exchange.
Hepatitis B can be transmitted through blood transfusions,
hypodermic needles, or sexually and is common among homosexual
males, health care workers, and some Third World populations.
Symptoms of the disease vary from flu-like illness to liver
failure. It is believed to cause liver cancer among some Third
Merck is the first out of the gate in a race among a number of
companies to produce a less-expensive and more easily produced
hepatitis B vaccine. Biogen, a Dutch-American biotechnology
concern with U. S. headquarters in Boston, also is deep into
research on a similar vaccine made through genetic engineering.
Last year Biogen announced that its vaccine was effective in
chimpanzees. A spokesman for the company said it has licensed
a major pharmaceutical company to conduct human tests on the
vaccine, expected to begin sometime this year. Biogen declined
to name the drug company.
In April, researchers at the New York Blood Center and
California Institute of Technology jointly reported the
production of a vaccine produced through a completely different
synthetic technique. This vaccine is composed of chemicals
that make up a small part of the antigen, or molecule that
stimulates the body to produce antibodies against hepatitis B.
In April, the scientists said they successfully produced the
chemicals in a way expected to be less costly than those used
in genetic engineering.
That synthetic vaccine is expected to be tested soon on
animals, but is some years away from human usage.
Both the genetically engineered and synthetic versions will
solve a major roadblock to widespread use of a hepatitis B
vaccine. Merck's Heptavax-B is produced from the blood of
hepatitis B carriers, many of whom are homosexuals. Many
potential recipients of Heptavax-B worry that the vaccine might
contain the agent suspected of causing acquired immune
deficiency syndrome, or AIDS, even though Merck has argued
strongly that its purification process eliminates any such
The new vaccines would also avoid the production difficulties
associated with Heptavax-B, the making of which involves the
handling of blood containing live hepatitis virus.
Merck's Heptavax-B is also expensive, costing about $100 for a
three-shot dosage. Many hospitals and health institutions say
the price is too high for widespread innoculation. Because of
this, only 400,000 people have received the vaccine, far fewer
than Merck first expected.
Researchers also are seeking a hepatitis B vaccine that, if
inexpensive enough, could be distributed widely among Third
World nations. Some suggest that such a vaccine should cost as
little as $1 a shot. Officials at Merck said they weren't sure
how much the new vaccine might cost, or whether it would be
less expensive than Heptavax-B.
Merck's new vaccine was produced from material first developed
by Chiron Corp., a small biotechnology company based in
Emeryville, Calif. Merck paid for the research under which
Chiron developed the vaccine and is negotiating a licensing
arrangement with Chiron.
Cetus Corp. of Emeryville, Calif., has already brought to
market a vaccine for use in animals that was developed through
genetic engineering. The vaccine is licensed to the Norden
Laboratories unit of SmithKline Beckman Corp. and prevents a
fatal diarrheal disease of newborn pigs. It is believed to be
the first recombinant vaccine to make it to market, a Cetus