Minutes of the November 16, 2000 FMVCC Meeting
Venue: WRAIR/NMRC
Participants:
Bill Collins (Phone)
Carter Diggs
Judy Epstein
Nicole Freydberg
Dan Gordon
Gray Heppner
Steve Hoffman
Rick Kenney
Carole Long
Alan Magill
Tonu Wali
NVPO Unmet Needs Awards Program
Eight proposals submitted to FMVCC by the NVPO for discussion and prioritization were distributed to members attending in person; they will be faxed to CDC.
Proposals were presented by proponents in attendance and discussed by the group at large.
Members were also provided with review and score sheets provided by the NVPO and were asked to fill them out. According to FMVCCs agreed upon operational mode, each agency will exercise two votes; i.e. two representatives of each agency will submit a review ad score sheet for each proposal to the Chairman, except that agencies will obstain from voting on their own proposals.
A deadline of 1 December was set for receipt of scored forms by the Chairman; score sheets received after this date may not be considered.
NOTE ADDED POST MEETING: IT IS PROPOSED THAT THE RANKING PROCEDURE DISCUSSED DURING THE MEETING NOT BE USED SINCE IT WOULD INTRODUCE BIAS. IT IS ONLY NECESSARY TO COMPLETE THE SCORE SHEETS AS PREPARED BY THE NVPO. A FMVCC MEAN AND RANGE OF THE TOTAL SCORES (A+B) WILL BE CALCULATED FOR EACH PROPOSAL AND REPORTED TO THE NVPO. THE INDIVIDUAL SCORE SHEETS WILL ALSO BE PROVIDED TO THE NVPO ON REQUEST WITH THE NAME OF THE REVIEWER DELETED.
Reports of the Agencies
Carole Long (MVDU, NIH) provided further information on recent studies on protection of Autos monkeys immunized with MSP-1 (42kDa C terminus) produced in transgenic mice. Glycosylated MSP-1 did not induce protection whereas MSP-1 from mice with transgenes modified to remove gycosylation sites provided complete protection. Antibody from the latter group of animals was shown to have a higher avidity for antigen. Studies of antibody fine specificity and in vitro growth inhibition of antibodies and are in progress to investigate other possible differences in the immune response in the two groups of animals. Preparations are being made to repeat the protection experiment.
Gray Heppner (WRAIR) reported that all volunteers in the ongoing MSP-1 (42kDa C terminus) vaccine Phase I have received the second dose without incident. Preparations are under way for a Phase IIa trial in the spring and plans are being made for field trials in Kenya to include age de-escalation and a phase IIb trial in the target population.
Tonu Wali (DMID, NIH) indicated that DMID is deeply involved in the infrastructure development contracts in Mali and Ghana and in the newly awarded SAIC management and vaccine production contract. Prospects for vaccine development by the groups include candidates under development by the MVDU as well as Hep (core) CSP and MSP-1 constructs which are a part of the extramural effort.
Rick Kenney (CBER) announced the arrival of Dr. Richard Walker as the new Director of the Division of Bacterial, Parasitic, and Allergenic Products.
Next Meeting 18 January 2001 at WRAIR/NMRC, room to be announced
