WASHINGTON — The National Institute of Allergy and Infectious Diseases said Friday that it is having trouble recruiting participants for the first human tests of an experimental AIDS vaccine and issued a nationwide plea for volunteers.
The outcome of the recruitment effort, which includes an around-the-clock toll-free telephone number and an offer of reimbursement for travel expenses, will determine whether the AIDS vaccine development program suffers a serious setback.
In the nearly three months since the vaccine tests were announced, only about 45 suitable volunteers have been found, all from the Washington area, said Patricia Randall, an institute spokeswoman. Seventy-five homosexual men and six heterosexual men are needed for the initial phase of the study.
Many Change Their Minds
The federal agency was flooded with hundreds of phone calls from potential volunteers after the initial Aug. 18 test announcement. But many potential volunteers subsequently changed their minds or were disqualified because of medical problems, Randall said.
"The study has begun, people have been vaccinated with no short-term side effects, but more subjects are needed to complete the study," said Dr. Robert E. Windom, assistant secretary for health.
The first phase of the trial tests the potential vaccine--made from a protein on the outer coat of the AIDS virus--for safety to determine whether it causes any toxic side effects. A subsequent study to determine whether the experimental vaccine is effective in preventing AIDS infection will be conducted only if the vaccine has been determined safe.
The vaccine contains no live or killed virus, so it will not produce infection with the virus or cause the disease itself.
Will Test Positive
However, because the vaccine will stimulate the body's natural defense system to produce antibodies, vaccinated individuals will test positive for exposure to the virus in the standard blood test, known as an ELISA. Thus, concerns have been raised that individuals who volunteer for vaccine trials may in fact be subject to the same types of discrimination that AIDS patients experience.
To participate, volunteers must have had a negative antibody test and be in good health, agency officials said. They also said volunteers "must have avoided risk behaviors that could have exposed them to (the virus) for three months prior to entering the study, and be willing to abstain from risk behaviors for three months following administration of the vaccine."
The National Institute of Allergy and Infectious Diseases said that interested volunteers should call (301) 496-7196 or 1-800-634-3027.
$44.5 Million in Grants
In another federal AIDS development Friday, the Health and Human Services Department announced $44.5 million in new grants to states, local governments and organizations for AIDS information and education activities.
The awards include $4.5 million to establish a national AIDS information clearinghouse; $7 million for school health education, including $325,000 to the Los Angeles School District and $342,607 to the California Department of Education, and $7 million for a minority education project.
An additional $19.3 million will supplement the $24.4 million already awarded for acquired immune deficiency syndrome prevention projects in states and municipalities that support counseling and testing programs and health education risk-reduction projects, the department announced.
Health officials said they do not expect the grants to be delayed by an amendment to the Labor Department-HHS appropriations bill, sponsored by Sen. Jesse Helms (R-N.C.) and recently passed by both houses of Congress. The amendment forbids the use of HHS funds for AIDS education materials that "promote or encourage, directly or indirectly, homosexual sexual activities."
Marlene Cimons reported from Washington and Robert Steinbrook from Los Angeles.