Comparative clinical study of a new 17D thermostable yellow fever vaccine

Roche, J.C.; Jouan, A.; Brisou, B.; Rodhain, R.; Fritzell, Bernard; Hannoun, C

doi:10.1016/0264-410x(86)90004-6

Cited by 16 publications

(6 citation statements)

References 3 publications

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“…1,5,8,10,11,17,18,[20][21][22]23 The rates of systemic adverse events generated by diaries (12%-16%) were within the range reported in some studies using the same approach. 5,10 Nevertheless, figures as high as 41% and as low as 7.6% have been reported.…”

Section: Discussionmentioning

confidence: 77%

“…3 The frequency of signs and symptoms on the injection site reported in the literature varied from nil to 39%. 5,7,[9][10][11]14,15,17,18,20,22,23 In all studies, pain on the site of injection was the most frequently reported local adverse event. The highest frequencies of adverse events were based on diaries, which could inflate the frequency by stimulating reports of trivial signs/symptoms.…”

Section: Discussionmentioning

confidence: 99%

“…15 Variable frequency of predominantly mild signs and symptoms following administration of YF vaccine have been reported. 18,20 As systemic reactions are usually non-specific, the proportion of adverse events explained by vaccination can only be approximated by comparing with a reference non-vaccinated group. Severe events are rare and the association with the vaccine has been suggested by clinical and pathological evidence.…”

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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Section: Discussionmentioning

confidence: 77%

Section: Discussionmentioning

confidence: 99%

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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“…High seroconversion rates and GMT in international units were comparable to those reported in other randomized trials, 12,15 and in observational studies in adults, in which neutralization tests were used to assess immunological response and the 17D strain vaccine was used. 16,20,22,24 Comparability with previous results is limited by methodological differences, such as laboratory methods for antibody titration, vaccine dose and method of administration, and age of study subjects. That is the case of three studies involving the 17DD substrain.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial

et al. 2004

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ObjectiveTo compare the immunogenicity of three yellow fever vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots). Methods An equivalence trial was carried out involving 1,087 adults in Rio de Janeiro. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered following standardized procedures adapted to allow blocked randomized allocation of participants to coded vaccine types (double-blind). Neutralizing yellow fever antibody titters were compared in pre-and post-immunization serum samples. Equivalence was defined as a difference of no more than five percentage points in seroconversion rates, and ratio between Geometric Mean Titters (GMT) higher than 0.67. Results Seroconversion rates were 98% or higher among subjects previously seronegative, and 90% or more of the total cohort of vaccinees, including those previously seropositive. Differences in seroconversion ranged from -0.05% to -3.02%. The intensity of the immune response was also very similar across vaccines: 14.5 to 18.6 IU/mL. GMT ratios ranged from 0.78 to 0.93. Taking the placebo group into account, the vaccines explained 93% of seroconversion. Viremia was detected in 2.7% of vaccinated subjects from Day 3 to Day 7. ConclusionsThe equivalent immunogenicity of yellow fever vaccines from the 17D and 17DD substrains was demonstrated for the first time in placebo-controlled double-blind randomized trial. The study completed the clinical validation process of a new vaccine seed-lot, provided evidence for use of alternative attenuated virus substrains in vaccine production for a major manufacturer, and for the utilization of the 17DD vaccine in other countries. $ %Rev Saúde Pública 2004;38(5):671-8 www.fsp.usp.br/rsp Immunogenicity of yellow fever vaccines Camacho LAB et al Resumo Objetivo Comparar a imunogenicidade de três vacinas contra febre amarela ) das subcepas WHO-17D e 17DD brasileira (diferentes lotes-semente

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“…Media such as lactose, sorbitol, histidine and alanine have considerably improved the heat stability of lyophilized 17D yellow fever (YF) vaccine (127). These stabilized vaccines may successfully be used in different field conditions (51,118).…”

Section: Stability Of Freeze-dried Vaccinementioning

confidence: 99%