Diary Prequel Package — page 169

my resident when I was an intern. Very moving evening with many of merle's old friends from NY Hospital, SF, Utah and Uganda. Feb. 14, 2008 -- Had meeting with Carl Dieffenbach, Peggy Johnston, Larry Corey, Scott Hammer (Chair, PAVE 100 clinical trial), JJ. McGowan, Hugh Auchincloss, Cliff Lane, Carole Hudgings, Patty Conrad, Ralph Tate, Gary Nabel to discuss the great dilemma about proceeding or not with PAVE 100 in light of the failure of the recent Merck STEP trial of a somewhat similar T cell based vaccine for HIV (see reports of STEP study failure). STEP trial was performed within the HVTN (by Larry Corey's operation). It used an adenovirus (Ad) 5 vector prime and 2 boosts with gag, pol, nef. DSMB stopped study because of "futility" in that the vaccine did not protect against acquisition of infection (not expected to since it is a T cell vaccine) and also did not alter set point of virus. Importantly, for reasons that no one can figure out, vaccinees (not placebos) who had high pre-existing titer of antibody against Ad5, did worse than unvaccinated in acquisition of infection. The PAVE 100 trial (VRC-Gary Nabel) is also using a T cell vaccine approach with 3 DNA-gag, pol, nef, env prime/boost followed by an Ad5-gal pol env 4" shot. Question is whether we should go ahead with the PAVE 100. Basic researchers in AIDS (Ron Desrosiers, Doug Richman, Dennis Burton, etc.) want to stop all vaccine clinical trials until we figure out the "basic science". We should actually probably tilt the balance more towards discovery rather than development of vaccine candidates since we still have no idea what a protective immune response is or even how or if we can elicit it. However, the "basic" people have their own whining agenda since they feel that any money towards a trial is money away from their grants. Also, they are very jealous of Bart Haynes who got a lot of money for CHAVI (which is actually more basic than applied). I am holding a "Summit" on March 25, 2008 to examine this balance between basic and applied in HIV vaccine research. Feb. 16, 2008 -- Another trip to the White House (EEOB) to visit with Bob Kadlec concerning the Global Health Initiatives that we are working on. Everyone is actively engaged in "sprinting to the finish line" of the administration with various transforming initiatives (see above). Bob (who is with HSC) is emphasizing more the Global Security issue, which includes things that I am involved in such as pandemic flu, biodefense, etc. We are working on initiatives to present to the POTUS. Feb. 19, 2008 -- Briefed VP Cheney in his West Wing office at 10:00 AM (crisp, sunny day). This was one of several briefings that he has requested of me over the past 7 years. T updated him on pandemic flu threat, seasonal flu, AIDS, emerging IDs, malaria, TB, biodefense. Bruce Miller (VP's chief of Homeland Security) told me before the lecture that yesterday when he was flying back from the long weekend with the VP on Marine 2, the VP spontaneously said "Isn't Tony Fauci going to be briefing me tomorrow. I am really looking forward to his briefing; I always learn a lot from them". Bruce said that this was the first time that the VP has made such a comment about an upcoming briefing the day before the briefing in the 7 years that Bruce has been with the VP. The briefing went very well and the VP was very engaged, particularly about flu and about the dire