RANDOMIZED, DOUBLE-BLIND, PHASE III, PIVOTAL FIELD TRIAL OF THE COMPARATIVE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF TWO YELLOW FEVER 17D VACCINES (ARILVAX™ AND YF-VAX®) IN HEALTHY INFANTS AND CHILDREN IN PERU

VIVIAN E. BELMUSTO-WORN Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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JOSE L. SANCHEZ Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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KAREN McCARTHY Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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RICHARD NICHOLS Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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CHRISTIAN T. BAUTISTA Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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ALAN J. MAGILL Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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GIOVANNA PASTOR-CAUNA Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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CARLOS ECHEVARRIA Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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VICTOR A. LAGUNA-TORRES Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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BILLEY K. SAMAME Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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MARIA E. BALDEON Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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JAMES P. BURANS Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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JAMES G. OLSON Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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PHILIP BEDFORD Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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SCOTT KITCHENER Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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THOMAS P. MONATH Sutter Institute for Medical Research, Sutter Health, Sacramento, California: Divisions of Retrovirology and Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, District of Columbia; U.S. Naval Medical Research Detachment, Lima, Peru; Acambis Research Limited, Cambridge, United Kingdom; Acambis Inc., Cambridge, Massachusetts; Ministry of Health, Sullana, Peru

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We conducted a randomized, double-blind, phase III yellow fever (YF) vaccine trial among 1,107 healthy children in Sullana in northern Peru. The safety and efficacy (by measurement of geometric mean neutralizing antibody titer responses) were determined for two YF vaccines, ARILVAX™ (n = 738) and YF-VAX® (n = 369). Serocon-version rates were higher (94.9%) in ARILVAX™ than in YF-VAX® (90.6%) recipients. The two-sided 95% confidence interval (YF-VAX®–ARILVAX™) was (-12.8% to -2.5%), indicating that the higher seroconversion rate for Arilvax™ was significant. Post-vaccination (30-day) mean log10 neutralization indices were found to be similar for both products: 1.32 for ARILVAX™ and 1.26 for YF-VAX® (P = 0.1404, by analysis of variance). A similar number of subjects in each group reported at least one adverse event (AE); 441 (59.8%) for ARILVAX™ versus 211 (59.9%) for YF-VAX®. Most (591; 96.7%) of these were of a mild nature and resolved without treatment. There were no treatment-related serious AEs. This is the first randomized, double-blind comparison of two YF vaccines in a pediatric population; both vaccines were shown to be highly immunogenic and well-tolerated.

Author Notes

Reprint requests: Administrative Assistant, Research Support Section, U.S. Naval Medical Research Center Detachment, Lima, Peru, American Embassy-Lima, Unit 3800, APO AA 34031-3800, Telephone: 51-1-561-2882/3848, Fax: 51-1-561-3042, E-mail: rlescano@nmrcd.med.navy.mil.
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