Reactogenecity of yellow fever vaccines in a randomized, placebo-controlled trial

Revista de Saude Publica

Volumn 39, Issue 3, 2005, Pages 413-420

  Camacho, Luiz Antonio Bastos ^a   Gomes de Aguiar, Savitri ^a   da Silva Freire, Marcos ^a   da Luz Fernandes Leal, Maria ^a   do Nascimento, Jussara Pereira ^a   Iguchi, Takumi ^a   Azevedo Lozana, José ^a   Guedes Farias, Roberto Henrique ^b  

^a INSTITUTO OSWALDO CRUZ   (Brazil)

^b Inst de Biologia do Exército   (Brazil)

Author keywords

Adverses effects; Brazil; Randomized controlled trials; Yellow fever vaccine

Indexed keywords

LIVER ENZYME; PLACEBO; YELLOW FEVER VACCINE; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; VIRUS ANTIBODY;

ABNORMAL SUBSTRATE CONCENTRATION IN BLOOD; ADULT; ARTICLE; BRAZIL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG FEVER; ENZYME BLOOD LEVEL; ERYTHEMA; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; IMMUNE RESPONSE; IMMUNIZATION; INJECTION SITE REACTION; INTERVIEW; MAJOR CLINICAL STUDY; MALE; MYALGIA; NAUSEA AND VOMITING; PAIN; RANDOMIZED CONTROLLED TRIAL; RECIPIENT; RISK ASSESSMENT; SEROCONVERSION; SOMNOLENCE; STRAIN DIFFERENCE; SYSTEMIC DISEASE; URINARY TRACT DISEASE; VACCINATION REACTION; VIREMIA; VIRUS STRAIN; YELLOW FEVER; YELLOW FEVER FLAVIVIRUS; BLOOD; COMPARATIVE STUDY; ENZYMOLOGY; IMMUNOLOGY; LIVER;

ADULT; ALANINE TRANSAMINASE; ANTIBODIES, VIRAL; ASPARTATE AMINOTRANSFERASES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; LIVER; MALE; VIREMIA; YELLOW FEVER; YELLOW FEVER VACCINE; YELLOW FEVER VIRUS;

EID: 23944444472     PISSN: 00348910     EISSN: None     Source Type: Journal    
DOI: 10.1590/s0034-89102005000300012     Document Type: Article

References (26)

1. Ambrosch F, Fritzel B, Gregor J, Jonas S, Kollaritsch H, Teulieres L et al. Combined vaccination against yellow fever and typhoid fever: a comparative trial. Vaccine 1994;12:625-8.
2. Armitage P, Berry G. Statistical methods in medical research. 3rd ed. Oxford: Blackwell Science; 1994.
3. Camacho LAB, Freire MS, Leal MLF, Aguiar SG, Nascimento JP, Iguchi T et al. Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial. Rev Saúde Pública 2004;38(5):671-678.
4. Dean AG, Dean JA, Coulombier D, Burton AH, Brendel KA, Smith DC et al. Epi Info, Version 6. Atlanta, GA: Centers for Disease Control and prevention; 1994.
5. Freestone DS, Ferris RD, Weinberg AL, Kelly A. Stabilized 17D strain yellow fever vaccine: dose response studies, clinical reactions and effects on hepatic function. J Biol Stand 1977;5:181-6.
6. Galler R, Pugachev KV, Santos CLS, Ocran SW, Jabor AV, Rodrigues SG, et al. Phenotypic and a molecular analyses of yellow fever 17DD vaccine viruses associated with serious adverse events in Brazil. Virology 2001;290:309-19.
7. Gil A, González A, Dal-ré R, Calero JR. Interference assessment of yellow fever vaccine with the immune response to a single-dose inactivated hepatitis A vaccine (144 EL.U.). A controlled study in adults. Vaccine 1996;14:1028-30.
8. Hussain AI, Johnson JA, Freire MS, Heneine W. Identification and characterization of avian retroviruses in chicken embryo-derived yellow fever vaccines: investigations of transmission to vaccine recipients. J Virol 2003;77:1105-11.
9. Kouwenaar W. The reaction to yellow fever vaccine (17D), particularly in allergic individuals. Doc Med Geogr Trop 1953;5:75-84.
10. Lang J, Zuckerman J, Clarke P, Barret P, Kirkpatrick C, Blondeau C. Comparison of the immunogenicity and safery fo two 17D yellow fever vaccines. Am J Trop Med Hyg 1999;60:1045-50.
11. Lhuillier M, Mazzariol MJ, Zadi S, Le Cam N, Bentejac MC, Adamowicz L et al. Study of combined vaccination against yellow fever and measles in infants from six to nine months. J Biol Stand 1989;17:9-15.
12. Martin M, Tsai TF, Cropp B, Chang GJ, Holmes DA, Tseng J et al. Fever and multisystem organ failure associated with 17D-204 yellow fever vacination: a report of four cases. Lancet 2001;358:98-104.
13. Ministério da Saúde. Fundação Nacional de Saúde. Piano de intensificação das ações de prevenção e controle da febre amarela [Plan for intensification of yellow fever prevention and Control activities]. Disponível em URL: http://www.funasa.gov.br/epi/fa/faO.htm [20 jun 2002]
14. Monath TP, Nichols R, Archambault WT, Moore L, Marchesani R, Tian J et al. Comparative safety and immunogenicity of two yellow fever 17D vaccines (Arilvax and IF-Vax) in a Phase III Multicenter, double-blind clinical trial. Am J Trop Med Hyg 2002;66:533-41.
15. Monath TP. Yellow fever. In: Plotkin AS, Orenstein WA, editors. Vaccines. 3rd ed. Philadelphia: W. B. Saunders; 1999. p. 815-79.
16. Moss-Blundell AJ, Bernstein S, Shepherd WM, Langford DT, Ferris R, Kelly A. A clinical study of stabilized 17D strain live attenuated yellow fever vaccine. J Biol Stand 1981;9:445-52.
17. Mouchon D, Pignon D, Vicens R. Thanh TH, Tekaia F, Teulières L et al. Étude de la vaccination combinée rougeole-fièvre jaune chez l'énfant Africaine agé de 6 a 10 mois. Bull Soc Pathol Exot 1990;83:537-51.
18. Pivetaud JP, Raccurt CP, M'Bailara L, Le Vigouroux A, Le Bras M. Réactions post-vaccinales a la vaccination anti-amarile. Bull Soc Pathol Exot 1986;79:772-6.
19. Reinhardt B, Jaspert R, Niedrig M, Kostner C, L'age-Stehr J. Development of Viremia and humoral and cellular parameters of immune activation after vaccination with yellow fever virus strain 17D: a model of human flavivirus infection. J Med Virol 998;56:159-67.
20. Roche JC, Jouan A, Brisou B, Rodhain R, Fritzell B, Hannoun C. Comparative clinical study of a new 17D thermostable yellow fever vaccine. Vaccine 1986;4:163-5.
21. Smith HH, Pena HA, Paoliello A. Yellow fever vaccination with cultured virus (17D) without immune serum. Am J Trop Med 1938;18:437-68.
22. Soula G, Sylla A, Pichard E, Kodio B, Bentejac MC, Teulières L et al. Étude d'un nouveau vaccin combiné contre la fièvre jaune et la rougeole chez des enfants agés de 6 a 24 mois au Mali. Bull Soc Pathol Exot 1991;84:885-97.
23. Tauraso NM, Coultrip RL, Legters LJ, Richman AV, Rosenberg DM, Savadge TO et al. Yellow fever vaccine. IV. Reactogenicity and antibody response in volunteers inoculated with a vaccine free from contaminating avian leukosis viruses. Proc Soc Exp Biol Med 1972;139:439-46.
24. Vasconcelos PFC, Luna EJ, Galler R, Silva LJ, Coimbra TL, Barros VLRS et al. Serious adverse events associated with yellow fever 17DD vaccine in Brazil: a report of two cases. Lancet 2001;358:91-7.
25. Wheelock EF, Sibley WA. Circulating virus, interferon and antibody after vaccination with the 17-D strain of yellow-fever virus. N Engl J Med 1965;273:194-8.
26. World Health Organization -WHO. Adverse events following yellow fever vaccination. Wkly Epidemiol Rec 2001;76:217-8.