1. Are these vaccines expected to cause injuries?

   No. These studies have had a good safety profile thus far and it is expected that injuries due to these vaccines will be very rare. However, the primary purpose of the is study is to see if these vaccines are safe.

2. What are the study staff's responsibilities?

   Staff are required to (1) remind participants that they are participating in safety trials, (2) educate participants about the potential risks so that participants can have a thorough explanation of the process regarding reimbursement for costs of medical care for vaccine-related injuries in the vaccine study 202 / 014.

3. If I participate in the trials, what are my responsibilities?

   Study participants are instructed to keep appointments and report any symptoms to the local site as soon as possible.

4. What can you tell me about the manufactureres of these vaccines?

   Chiron Vaccines (Chiron)of California and Pasteur Merieux Connaught (PMC) (which has divisions in the U.S., Canada, and Europe) are large, established companies with excellent reputations in the field of vaccine manufaccture. Both companies carry insurance coverage in case their vaccines cause injuries and both have signed the protocol document which states that they will cover medical expenses for a serious vaccine injury in this protocol.

5. What if no one can tell for sure which manufacturer's vaccine caused the injury?

   In the study, one group of volunteers receives bothe the PMC vaccine and the Chiron vaccine; a second group receives PMC vaccine and saline (placebo); and a third group receives the PMC placebo control and saline. If a volunteer receives both vaccines, both manufactureres will ensure coverage for medical care. If a volunteer receives only the PMC vaccine, only PMC will provide coverage for medical care. No volunteeres will receive the Chiron vaccine alone.

6. Are there limitations on the coverage?

   Coverage is for adverse events which are vaccine-related. Neither company compensates for pain and suffering. Also, the manufactureres do not cover injuries which are due to malpractice of the site staff.

7. What if I have an injury due to malpractice by the site staff?

   Sites are required to have malpractice insurance which would pay for medical care.

8. Who decides that an adverse event is vaccine-related?

   The determination that an adverse event is vaccine-related is made independently by the clinical investigator at the local site and the NIAID Division of AIDS (DAIDS) Medical Officer, and is reviewed by the Vaccine and Prevention Data and Safety Monitoring Board (VPDSMB).

9. What is the Vaccine and Prevention DSMB?

   The Vaccine and Prevention DSMB is an independent group of professionals with a long history in the clinical trials arena. Among the members are physicians who specialize in the care of persons with AIDS, community advocates, and ethicists.

10. When does the Vaccine and Prevention DSMB get involved?

    The Vaccine and Prevention DSMB routinely reviews the safety fo the vaccine trials. The DSMB meets approximately three times per year; however, conference calls with DSMB members can be arranged quickly if a emergent need arises.

    If the site physician or the DAIDS Medical Officer thinks that an adverse event is likely to be related to the vaccine(s), DAIDS will hold a DSMB meeting or conference call. If the DSMB members also think that the adverse event is likely to be related to the vaccine, they will inform DIADS, DAIDS will notify the vaccine manufacturers of the adverse event related to vaccine administration and provide the manufacturers with the information about the event.

11. How is it determined that a medical injury is vaccine related?

    The Determination of whether an injury is vacccine-related is based on several factors; for example, the timing of the reaction in relationship to the vaccination; the location (e.g., anaphylaxis is a known, but rare reaction to vaccines); the biological plausibility that the vaccine caused the injury; and statistical patterns, such as the rate in vaccinated compared to similar, no-vaccinated populations or patterns of repeated injuries occuring in vaccinated volunteers but not in placebo recipients.

12. What would happen if an injury occurs?

    If an injury occurs, the site clinical investigator will make an initial, and independent determinatino of whether the event is vaccine-related. In addition, the DAIDS Medical Officer reviews all serious adverse events in depth, and constantly looks at patterns of non-serious events as well.

    It will probably take several weeks to assess the injury, obtain laboratory tests, if needed, and gather the necesssary information to determine if the adverse event is likely to be related to the vaccine.

13. If a volunteer is injured by the vaccine, will the study site bill the volunteer's health insurance company for the medical care?

    The study site will provide immediate care free of charge but some sites may bill the volunteer's health insurance sompany for the cost of any additional care. The vaccine manufactureres will cover the costs of the medical care.

14. What if a participant becomes infected with HIV during the trial?

    The vaccines cannot cause HIV infection. Accordingly, HIV infection occurring during the trial is not a vaccine-induced injury. In addition, volunteers are counseled that it is unknown whether the vaccine will protect them, and that they may receive the placebo, not the vaccine. Also volunteers are educated in how to prevent becoming infected with HIV.

15. What's the bottom line?

    If the injury is clearly and directly related to the vaccine(s), the manufactureres that supply the vaccines will pay the reasonable costs of the medical treatment. The site will cover any injuries caused by the site staff.

You will be provided the name and telephone number of the appointed person at the your institution for additional information about other payment for research-related injuries and other compensation that may be available to you through the pharmaceutical companies.

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