Serious adverse events associated with yellow fever 17DD vaccine in Brazil: a report of two cases

Vasconcelos, Pedro F.C.; Luna, Expedito; Galler, Ricardo; Silva, Luiz J.; Coimbra, Terezinha Lisieux Moraes; Barros, Vera Lúcia Reis Souza de; Monath, Thomas P.; Rodigues, Sueli G; Laval, Cristina Aparecida Borges; Costa, Zouraide Guerra Antunes; Vilela, Maria F. G; Santos, C.; Papaiordanou, Cristina M. O; Alves, Venâncio Avancini Ferreira; Andrade, L; Sato, Helena Keico; Rosa, E. S. Travassos da; Froguas, Gustavo B; Lacava, Ethel; Almeida, Leda M R; Cruz, Ana C. R.; Rocco, Iray Maria; Santos, Raimunda T. M.; Oliva, Otávio Pinheiro; Yellow, Brazilian

doi:10.1016/s0140-6736(01)05326-0

Cited by 256 publications

(155 citation statements)

References 13 publications

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“…12,24 Safety was an essential element of the performance of vaccines in this investigation and is reported separately so as to cover aspects which have remained scanty in the literature.…”

Section: Discussionmentioning

confidence: 99%

“…Severe events are rare and the association with the vaccine has been suggested by clinical and pathological evidence. 6,12,24 Although those reports did not lead to changes in immunization policies for YF, the WHO called for a revision of the safety of the vaccines. 26 The study assessed the immunogenicity and reactogenicity of a new seed lot prepared from one additional passage at Fundação Oswaldo Cruz (Fiocruz) in Brazil to replace the working seed.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2005

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OBJECTIVE: To compare the reactogenicity of three yellow fever (YF) vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots) and placebo. METHODS: The study involved 1,087 adults eligible for YF vaccine in Rio de Janeiro, Brazil. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered ("day 0") following standardized procedures adapted to allow blinding and blocked randomization of participants to coded vaccine types. Adverse events after immunization were ascertained in an interview and in diary forms filled in by each participant. Liver enzymes were measured on days 0, 4-20 and 30 of the study. Viremia levels were measured on days 4 to 20 of follow-up. The immune response was verified through serologic tests. RESULTS: Participants were mostly young males. The seroconversion rate was above 98% among those seronegative before immunization. Compared to placebo, the excess risk of any local adverse events ranged from 0.9% to 2.5%, whereas for any systemic adverse events it ranged from 3.5% to 7.4% across vaccine groups. The excess risk of events leading to search for medical care or to interruption of work activities ranged from 2% to 4.5%. Viremia was detected in 3%-6% of vaccinees up to 10 days after vaccination. Variations in liver enzyme levels after vaccination were similar in placebo and vaccine recipients. CONCLUSIONS: The frequency of adverse events post-immunization against YF, accounting for the background occurrence of nonspecific signs and symptoms, was shown for the first time to be similar for vaccines from 17D and 17DD substrains. The data also provided evidence against viscerotropism of vaccine virus.

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“…12,24 Safety was an essential element of the performance of vaccines in this investigation and is reported separately so as to cover aspects which have remained scanty in the literature.…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2005

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“…It was a shock when several cases of visceral dissemination of YFV 17D virus were reported, with high lethality, with the United States and Brazil 7,8 being the first countries to identify the new syndrome. The clinical picture is similar to wild yellow fever.…”

Section: Vaccine-associated Viscerotropicmentioning

confidence: 99%

Serious adverse events associated with yellow fever vaccine

Martins

Leal²,

Homma³

2015

Human Vaccines & Immunotherapeutics

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“…Cases of encephalitis and other severe reactions including fatal cases of multiple organ system failure and hepatitis have been reported 1 8 . In Brazil, two fatal cases of haemorragic fever associated with yellow fever vaccine, suggesting idiosyncratic reaction have recently been reported 13 .…”

Section: Discussionmentioning

confidence: 99%

Low frequency of side effects following an incidental 25 times concentrated dose of yellow fever vaccine

Rabello¹,

Orsini²,

Disch³

et al. 2002

Rev. Soc. Bras. Med. Trop.

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In August/1999, a group of 14 adults from the staff of a private hospital in Contagem -- Minas Gerais State, Brazil, received unintentionally a 25 times concentrated dose of the 17-DD yellow fever vaccine (Bio-Manguinhos), due to a mistake at the reconstitution step. All patients were clinically and laboratorially evaluated at days 5, 13 and 35 post vaccination. Frequency of side effects and clinical observations of this group of individuals were not different from the observed in recipients immunized with normal doses of the vaccine. At the second and third evaluation none of the subjects reported symptoms. None of the patients presented abnormalities at the physical examination at none of the time points and in all cases the blood examination was normal, except for a reduced number of platelets that was detected in one subject at the first and second evaluation and reverted to normal at third evaluation. At the first evaluation point, 8 subjects were serum negative and 6 serum positive for yellow fever at the plaque reduction neutralization test. In 5 subjects the observed titre was 10 times higher as the baseline of 2.36 Log10 mUI/ml. The samples collected at second and third evaluation (13th and 35th days) demonstrated that all subjects responded to the vaccination with the exception of one that did not present a positive result in any of the samples collected. This evaluation confirms the safety of the 17-DD yellow fever vaccine.

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Serious adverse events associated with yellow fever 17DD vaccine in Brazil: a report of two cases

Cited by 256 publications

References 13 publications

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

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

Serious adverse events associated with yellow fever vaccine

Low frequency of side effects following an incidental 25 times concentrated dose of yellow fever vaccine

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