A phase I randomised trial to evaluate the safety and immunogenicity of a recombinant human immunodeficiency virus envelope preparation (rgp120) with novel potent adjuvants
Testing the safety of a vaccine which might help to prevent HIV
What was this study about?
This trial aimed to look at the safety of a protein which might be used as a vaccine to protect against HIV. It also looked at the ability of this protein to stimulate an immune response. People who took part in this study were given the same protein substance (called rgp120) in three different types of liquid, in an injection. These were called SBAS1, SBAS2 and alum.
People who took part in this trial were followed for one year, and their immune responses were looked at through blood tests.
What difference did this study make?
Unwanted side effects were more common in the group of people who were given the SBAS2 liquid. Researchers were able to test for various antibodies and responses in the blood samples they took.
Researchers carried out a large review of information collected in this and other similar trials about safety and side effects. They concluded that these vaccines were safe, but that the unwanted side effects seemed to relate mainly to the liquids that were added to the protein substance.
Type of study
Who funded the study?
This trial was funded by the Medical Research Council and by the drugs company Smith Kline Beecham Biologicals.
When did it take place?
This study began recruiting people in 1995 and closed in 1996. The results were published in 2000.
Who was included?
30 people took part in this study. They were all healthy HIV negative volunteers.