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VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE. ALVAC-vCP1521 plus AIDSVAX B/E CRF01_AE (Clade E) -based HIV vaccines Phase 3 Trial in Thailand Sponsor: Office of the Surgeon General, U.S. Army Joseph Toerner, M.D., M.P.H.: FDA, CBER September 23, 2004.

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VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

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  1. VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE ALVAC-vCP1521 plus AIDSVAX B/E CRF01_AE (Clade E) -based HIV vaccines Phase 3 Trial in Thailand Sponsor: Office of the Surgeon General, U.S. Army Joseph Toerner, M.D., M.P.H.: FDA, CBER September 23, 2004

  2. PHASE 3 TRIAL IN THAILAND ALVAC vCP1521 prime plus AIDSVAX B/E boost in Thai young adults Differing scientific opinions • For example, Science 2004 vol. 303, 305 Purpose of today’s VRBPAC is to provide an update on the ongoing study for committee members • Decision to allow trial to proceed under US IND • Regulatory challenges

  3. HIV GENETIC DIVERSITY • Complicated global diversity • Clades: short sequences of env • New circulating recombinants identified • Recharacterization of clades (Clade E) • Potential obstacle HIV vaccine dev. • Superinfection with different clade HIV • NEJM 2002;347:731-6 • Broad immunological responses? • How much cross-clade recognition? • Much of HIV vaccine development is clade-specific

  4. Vaccine Development, GCP & the Global Challenge • Jesse L. Goodman, MD, MPH • Director, Center for Biologics Evaluation and Research (CBER) • US FDA • Presentation to the 2004 ICDRA • Madrid, Spain

  5. HIV Vaccine: Interesting Issues • Is US approval possible for an HIV vaccine that incorporates only non-US prevalent clades? • What about any approval of a vaccine of limited efficacy (what do we think of 10 v. 20 v. 40 v. 60 v 80% v. 90+ % condoms)? • Behavioral issues, risks to pt and contacts? • High vs. low incidence areas • Actions based on interim analyses? • Would the “right” response differ between high/low risk areas?

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