[Memo to CBCTN Committee Members from Ellen Cooper]

9; 05 '9 O 5PI1 SYNT.EX DR ELLEN COYD"RP. 3/3
4) The same Immutdzatkm schedule will be followed for all products, with monthly
ImhnuniZ~tlOMs for six. months followed by bimonthly IrnJectn BaQch participating site
will be asked to enroll at least 00 patients over a fairly short period of time (three to
air, months). it Is curreiny estimated that twoQ nurses per site (130 patlents/mirse) will
be required, support for whom is included in the budget. lEach participating site must
also ensure the availability of a doctor' aservkec, should the need arise, and
irastruotun~s necessary to immunIsn and evaluate the subjects per protoo.I.'S DROD will be sekt y roa participation of cliuleal research sites, prticularly community
baned sites capable of ' nrolig the targeted number of patients and of oondueting the
protocol.
6) A mbset of approximiitely 10% of the patients wilt have periodic cell and erum samples
stored for future analysis of itmnww and viral paramatars. These sites will be local to
the D)C. area to help ensure rapid, proper handling of the spwImens,
7) Thi tentative schedule leading to study start-up Inzdudes Informational mesings with
aotdv~s, potential shte participants, and other Interested parties in August, followed by
more focucd1 working meetings of site participants, government and pharhiaceutical
Sponsrs In Septmbrfteber. Actual enrollment in a final protocol isaunlikely to occur
befors 1994.
In summary, I think It's likely ibis study will be performed in the ntar ftiuwe, and interes in
CRCTN site participation Ie high. If you have any quwitleu, pleasellW.