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Minutes of the December 19, 2000 FMVCC Meeting

VENUE: WRAIR/NMRC

PARTICIPANTS: Carter Diggs
Stephen Hoffman
Rick Kenney
Allan Saul
Alan Magill
Grey Heppner
Carole Long

  1. Discussion of dissemination of minutes

    Four options were considered

    a. No minutes

    b. Emailed minutes

    c. Web minutes with password

    d. Web minutes publically available

    The issue is to ensure that minutes are made as widely available as possible without compromising confidentiality on specific issues.

    Decision: Draft minutes will be agreed before the end of each meeting and then these will be posted publically. Allan Saul agreed to prepare the minutes during each meeting.

  2. Unmet needs program

    NVPO has asked FMVCC to evaluate malaria related proposals. FMVCC agreed to do continue to do this. Some clarification on process has been sought but further improvement is required.

    Carter will submit a proposal for a study to evaluate the economics of malaria vaccines and their potential impact.

  3. Combo strategy

    Issues for testing multiple antigenic components were discussed. Where products are available, there is a strong rationale for proceeding with immunizations with individual components in separate sites to evaluate additive or synergistic impact on efficacy, without waiting for the process required to develop co-formulation.

  4. Institute reports

    WRAIR: Volunteers in the RTSS 3 dose trial with 0, 7, 28 day or 0 ,1 and 3 months vaccinations are now being challenged.

    The first vaccinations in the NVPO funded safety and immunogenicity study or MSP142 are now complete. Volunteers in groups of 5 were given 1/5, _ or full doses of vaccine.

    A booster vaccination of RTSS has been given to volunteers in the RTSS Gambian vaccine trial conducted in 1999. Results of the booster are expected to be presented at the American Society of Tropical Medicine and Hygiene (ASTHM) meeting late this month.

    NIH An Aotus trial with 3 version of MSP142 is close to completion. Results will be presented at the ASTHM meeting.

    Saccharomyces pvs25 is now in clinical development with a phase I safety and immungenicity trial planned for mid 2001.

    NMRC A prime boost RTSS trial is underway. MustDo5 is going forward with challenges starting in November. MustDo8: pre-IND package submitted. In collaboration with NIH, an aotus trial with MSP142 and EBA using DNA vaccination with various combinations of rec antigen boost, and with rec protein immunization and boost is underway.

    A new clinical trial center has been opened for malaria trials at the National Naval Medical Center campus at Bethesda.

  5. Upcoming meetings

    MSP1 meeting. To b e held at the Pooks Hill Marriot Dec 4 and 5, 2000. Limited space means this is by invitation only. For details contact Carole Long (301) 496 3655 or Jeff Lyons (301) 319 9904

    Keystone meeting. "The challenge of malaria from infants to genomics to vaccines" March 3 to 8 2002. Contact Carole Long (Clong@niaid.nih.gov) or Steve Hoffman (hoffmans@nmrc.navy.mil).

  6. Next FMVCC meeting

    16th November 2000. CDC may participate by video conference. Grey Heppner to arrange a room at WRAIR/NMRC with video conference facilities.