Participants were given postcards at their final study visit to be completed and mailed on or after January 1 , 1996
Disease assessment was completed every 3 weeks or at the start of each treatment cycle until the final study visit.
At the final study visit, no volunteers tested HIV positive.
These included 7 PBMC-derived sequences, 5 from the first and 2 from the final study visit, and 1 anorectal-derived sequence from the final study visit.
One Group A volunteer acquired HIV about 2 years after receipt of rAd5 alone, i.e., one year after final study visit.
The 6 sequences from F10 included 4 anorectal-derived sequences from 3 time points after the first study visit and 1 PBMC-derived sequence from the final study visit.
At the 48-week time point (final study visit) there were 4/13 (31%) and 5/13 (38%) responders in Groups A and B, respectively, all but one of whom were also positive at 6 weeks.
A gap region ranging from 3 9 nucleotides in length was also present in a majority of F10 and in 4 PBMC-derived sequences from F9, 1 from the first study visit and 3 from the final study visit.
The peak geometric mean concentration (GMC) of anti-rPA antibodies was observed 2 weeks after the second vaccination and diminished over time to low, but detectable, levels by the final study visit.
After enrollment, one participant traveled outside the study area two days after his second immunization and missed all subsequent visits, and one participant missed the final study visit on day 364 due to travel.
Volunteers who had a positive HIV ELISA test results due to vaccine-induced antibodies at the final study visit are being followed in a long-term follow up study until serological test results return to negative.
