NIH GUIDE, Volume 23, Number 1, January 7, 1994


P.T. 34


  Clinical Trial 



National Institute of Allergy and Infectious Diseases

Abt Associates Inc., under Contract No. N01-AI-35176 with the Vaccine

Trials and Epidemiology Branch, Division of AIDS, National Institute

of Allergy and Infectious Diseases (NIAID), requires clinical trial

sites to conduct seroepidemiologic and other studies in preparation

for HIV vaccine efficacy trials and collaborate in potential, future

multi-center phase III trials of HIV vaccines.

Offerors must be capable of enrolling and following HIV-seronegative

volunteers at increased risk of exposure to HIV in preparatory

studies and subsequent efficacy trials.  Contractors will recruit a

cohort of at least 500 volunteers in preparatory studies, and must

demonstrate a capacity to recruit 1,000 volunteers in efficacy

trials, which may be undertaken in the future.  Offerors must provide

evidence of appropriate experience and feasible strategies for:

retaining at least 90 percent of enrolled study participants during a

two-year prospective study; reliably interviewing study participants

regarding HIV-related risk behavior; collecting, processing, storing,

and shipping of laboratory specimens; handling vaccine product that

requires refrigerated storage; providing HIV pre-test and post-test

counseling and referrals to relevant community services; assessing

participants' attitudes about enrollment in preventive vaccine

efficacy trials before and after delivery of relevant information

about clinical trials and HIV vaccines; assuring compliance with

regulations governing the protection of human research subjects

including protection of participant confidentiality; and performing

clinical assessments and documenting medical findings as required by

vaccine trial protocols.

Organizations submitting proposals must respond to Solicitation for

Proposal (SFP) requirements for both vaccine preparedness studies

(Part A) and plans for potential future phase III efficacy trials

(Part B).  Proposals that address only the requirements of Part A

will not be considered.  Plans and budgets for Part A are to be

developed for a period of performance of two years.  Plans and

budgets for Part B are to be developed for a period of performance of

five years.  Abt Associates contemplates award of cost plus fixed fee

subcontracts to successful offerors.  Initial awards will support

Part A studies only.  Award of funds for Part B trials will be

contingent upon the availability of promising vaccine candidates.

Subcontract modifications to support Part B trials and associated

budgets will be negotiated only after authorization by NIH to proceed

with the implementation of vaccine efficacy trials.  Technical

evaluation of proposals will consider offerors' experience and

approach to both components of the SFP (Part A and Part B).

It is anticipated that offerors will be invited to include, as an

optional component of their submission, proposals for the conduct of

non-vaccine HIV prevention interventions (Part C).  Results of the

technical review of proposals for non-vaccine prevention

interventions (Part C) will not be considered in the determination of

the number and size of awards for preparedness studies and efficacy

trials (Parts A and B).

This is an announcement for an anticipated SFP.  This notice does not

commit the Government or Abt Associates Inc. to award a contract.

SFP N01-AI-35176-JMEISTER1-94 will be issued on or about January 10,

1994, with a closing date for receipt of proposals tentatively set

for March 10, 1994.  To receive a copy of the SFP, supply Abt

Associates Inc. with three self-addressed mailing labels.  All

inquiries must be in writing and addressed to:

A. Walker


HPRA, Abt Associates Inc.

4800 Montgomery Lane, Suite 600

Bethesda, MD  20814


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