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PRELIMINARY OBSERVATIONS ON THE EFFICACY OF A RECOMBINANT MULTISTAGE PLASMODIUM FALCIPARUM VACCINE IN AOTUS NANCYMAI MONKEYS

A vaccine trial was conducted to determine the efficacy of a multicomponent candidate vaccine, FALVAC-1, against Plasmodium falciparum in Aotus nancymai monkeys. After two immunizations, animals were challenged intravenously with parasites of the Vietnam Oak Knoll (FVO) strain of P. falciparum. The primary outcome was to determine the protective response of the monkeys to immunization with the FALVAC-1 antigen produced in baculovirus when combined with different adjuvants (alum, QS-21, ASO2a, CRL1005/oil, and CRL1005/saline) as compared with FALVAC-1 with FCA/FIA and antigen alone. When compared with the monkeys immunized with FALVAC-1 alone, FALVAC-1 with FCA/FIA reduced the mean parasite count (to Day 11), reduced the mean accumulated parasitemia (through Day 11), and extended the number of days to treatment. None of the other 5 antigen-adjuvant combinations were able to provide discernable levels of protection based on log(parasitemia) and log(cumulative parasitemia) to Day 11.

Received December 3, 2004. Accepted for publication June 10, 2005.

Acknowledgments: The authors thank the staff of the Animal Resources Branch, NCID, for the care of the animals and Ira Goldman for maintaining the masking. The authors thank the administrative and statistical staff of the Division of Parasitic Diseases for their assistance in the conduct of the study and preparation of the manuscript. Special thanks goes to Charlotte R. Kensil, Antigenics, Inc., and Craig Hacket, Protein Sciences Corporation, for provision of QS-21 and FLVAC-1 antigen, respectively.

Financial support: The work was supported in part by USAID IAA no. 936-6001 between the Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention.

^* Address correspondence to William E. Collins, Division of Parasitic Diseases, Mail Stop F-12, Centers for Disease Control and Prevention, 4770 Buford Highway, Chamblee, GA 30341. E-mail: wec1{at}cdc.gov

Authors’ addresses: William E. Collins, John W. Barnwell, Venkatachalam Udhayakumar, JoAnn S. Sullivan, Douglas Nace, and Ya Ping Shi, Division of Parasitic Diseases, Centers for Disease Control and Prevention, Mail Stop F-12, 4770 Buford Highway, Chamblee, GA 30341. G. Gale Galland, Scientific Resources Program, Centers for Disease Control and Prevention, Atlanta, GA 30333. Tyrone Williams, Atlanta Research & Education Foundation, Atlanta, GA, 30033. Jon Eric Tongren, London School of Tropical Medicine and Hygiene, Keppel Street, London WC1E 7HT, UK. Altaf A. Lal, U.S. Embassy, New Delhi, India.

Reprint requests: William E. Collins, Division of Parasitic Diseases, Mail Stop F-12, Centers for Disease Control and Prevention, 4770 Buford Highway, Chamblee, GA 30341.