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

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^TM (n = 738) and YF-VAX® (n = 369). Serocon-version rates were higher (94.9%) in ARILVAX^TM than in YF-VAX® (90.6%) recipients. The two-sided 95% confidence interval (YF-VAX®–ARILVAX^TM) was (-12.8% to -2.5%), indicating that the higher seroconversion rate for Arilvax^TM was significant. Post-vaccination (30-day) mean log₁₀ neutralization indices were found to be similar for both products: 1.32 for ARILVAX^TM 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^TM 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.

Received June 9, 2004. Accepted for publication August 17, 2004.

Acknowledgement: We thank Dr. Nancy Rivera (PRA International) for her continued and superb monitoring of this study. We express our sincere appreciation to Eppie Chang (Sutter Institute for Medical Research, Sutter Health) for her generous support of Vivian E. Bel-musto-Worn in this study. We also express our sincere appreciation to the innumerable staff at the U.S. Naval Medical Research Detachment-Lima laboratory for their excellent support in all aspects of this study. Lastly, we are indebted to all study participants and field workers in the city of Sullana, Peru, who with their commitment and hard work made this study possible.

Financial support: This study was supported by a Cooperative Research and Development Agreement between Acambis Research Limited (Cambridge, United Kingdom) and the U.S. Naval Medical Research Center (Silver Spring, MD), NCRADA-NMR-01-1233 (September 2001).

Disclaimer: The opinions and assertions made by the authors do not reflect the official position or opinion of the U.S. Department of the Navy or Army or the Peruvian Ministry of Health.

Disclosure: Some of the authors of this paper wish to disclose that they are Acambis employees and may hold stock in Acambis. This statement is made in the interest of full disclosure and not because the authors consider this to be a conflict of interest.

Authors’ addresses: Vivian E. Belmusto-Worn, 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: worn{at}nmrcd.med.navy.mil. Jose L. Sanchez, Department of Epidemiology and Threat Assessment, U.S. Military HIV Research Program, Division of Retrovirology, Walter Reed Army Institute of Research, 13 Taft Court, Suite 200, Rockville, MD 20850, Telephone: 301-251-5000, Fax: 301-762-4177, E-mail: jsanchez{at}hivresearch.org. Karen McCarthy, Clinical Operations, Acambis Research Limited, Peterhouse Technology Park, 100 Fulbourn Road, Cambridge CB1 9PT, United Kingdom, Telephone: 44-1223-275-300, Fax: 44-1223-416-300, E-mail: karen.mccarthy{at}acambis.com. Richard Nichols, Acambis Inc., 38 Sidney Street, Cambridge, MA 02139, Telephone: 617-761-4200, Fax: 617-494-1741, E-mail: rick.nichols{at}acambis.com. Christian Bautista, Data Center, 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: cbautista{at}nmrcd.med.navy.mil. Alan J. Magill, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910, Telephone: 301-319-9959, Fax: 301-319-9227, E-mail: Alan.Magill{at}na.amedd.army.mil. Giovanna Pastor-Cauna, PRA International, Jr. Incahuasi 539, Urbanizacion Mangomarca, Lima, Peru, Telephone/Fax: 51-1-459-2943, E-mail: 14742{at}upch.edu.pe. Carlos Echevarria, PRA International, Pasaje San Jose 120, Magdalena, Lima, Peru, Telephone: 51-1- 263-7231, Cell Phone: 51-1-9992-4422, E-mail: 06082{at}upch.edu.pe. Victor A. Laguna-Torres, HIV Program, 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: alaguna{at}nmrcd.med.navy.mil. Billey K. Samame, Sullana, Peru, Telephone: 51-74-93-5324, E-mail: bikusa{at}hotmail.com. Maria E. Baldeon, Ministry of Health, Direccion de Salud Lima-Este, El Agustino, Lima, Peru, Telephone: 51-1-363-0909 (Annex 200), Fax: 51-1-362-7056, E-mail: mebe4{at}latinmail.com. James P. Burans, National Biodefense Analysis and Countermeasures Center, U.S. Army Medical Research and Materiel Command, Attn: MCMR/ZT, 504 Scott Street, Building 810, Suite 204, Fort Detrick, Frederick, MD 21702-5012, Telephone: 301-619-7363, E-mail: james.burans{at}det.amedd.army.mil. James G. Olson, Virology Department, 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: olson{at}nmrcd.med.navy.mil. Philip Bedford, Clinical Operations and Regulatory Affairs, Acambis Research Limited, Peterhouse Technology Park, 100 Fulbourn Road, Cambridge CB1 9PT, United Kingdom, Telephone: 44-1223-275-300, Fax: 44-1223-416-300, E-mail: philip.bedford{at}acambis.com. Scott Kitchener, Centre for Military and Veterans’ Health, Mayne Medical School, Herston, Brisbane, Queensland 4006, Australia, Telephone: 61-407-366733, E-mail: scott.kitchener{at}tropmed.org. Thomas P. Monath, Acambis Inc., 38 Sidney Street, Cambridge, MA 02139, Telephone: 617-761-4200, Fax: 617- 494-1741, E-mail: thomas.monath{at}acambis.com.

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{at}nmrcd.med.navy.mil.

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