Duration of post-vaccination immunity to yellow fever in volunteers eight years after a dose-response study

Reinaldo de Menezes Martins, Maria de Lourdes S Maia, Sheila Maria Barbosa de Lima, Tatiana Guimarães de Noronha, Janaina Reis Xavier, Luiz Antonio Bastos Camacho, Elizabeth Maciel de Albuquerque, Roberto Henrique Guedes Farias, Thalita da Matta de Castro, Akira Homma, Collaborative Group for Studies on Duration of Immunity from Yellow Fever Vaccine, Reinaldo de Menezes Martins, Maria de Lourdes S Maia, Sheila Maria Barbosa de Lima, Tatiana Guimarães de Noronha, Janaina Reis Xavier, Luiz Antonio Bastos Camacho, Elizabeth Maciel de Albuquerque, Roberto Henrique Guedes Farias, Thalita da Matta de Castro, Akira Homma, Collaborative Group for Studies on Duration of Immunity from Yellow Fever Vaccine

Abstract

In 2009, Bio-Manguinhos conducted a dose-response study with the yellow fever vaccine, administering the vaccine in the usual mean dose of 27,476 IU (full dose, reference) and in tapered doses (10,447 IU, 3013 IU, 587 IU, 158 IU, and 31 IU) by the usual subcutaneous route and usual volume (0.5 mL). Tapered doses were obtained by dilution in the manufacturer's laboratory, and the test batches presented industrial quality. Doses down to 587 IU showed similar immunogenicity to the full dose (27,476, reference), while the 158 IU and 31 IU doses displayed lower immunogenicity. Seropositivity was maintained at 10 months, except in the group that received the 31 IU dose. The current study aims to determine whether yellow fever seropositivity was maintained eight years after YF vaccination in non-revaccinated individuals. According to the current study's results, seropositivity was maintained in 85% of 318 participants and was similar across groups. The findings support the use of the yellow fever vaccine in fractional doses during outbreaks, but each fractional dose should have at least 587 IU. This study also supports the minimum dose required by WHO, 1000 IU.

Clinical trials registration: Clinicaltrials.gov NCT 03338231.

Trial registration: ClinicalTrials.gov NCT03338231.

Keywords: Dose-response study; Duration of immunity; Fractionated vaccine; Immunogenicity; Yellow fever vaccine.

Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Figures

Fig. 1
Fig. 1
Study inclusion steps.
Fig. 2
Fig. 2
Scatterplot of log10 neutralizing antibody titers by dose group. 8 years after vaccination.

References

    1. Shearer F.M., Moyes C.L., Pigott D.M., Brady O.J., Marinho F., Deshpande A. Lancet Infect Dis. 2017 Nov;17(11):1209–1217. Epub 2017 Aug 16.
    1. Wilder-Smith A. Yellow fever vaccination: estimating coverage. Lancet Infect Dis. 2017 Nov;17(11):1109–1111.
    1. Monath T.P., Woodall J.P., Gubler D.J., Yuill T.M., Mackenzie J.S., Martins R.M. Yellow fever vaccine supply: a possible solution. The Lancet. 2016 Apr;387(10028):1599–1600.
    1. WHO. Fractional dose yellow fever vaccine as a dose-sparing option for outbreak response. WHO Secretariat information paper. WHO; 20 July 2016.
    1. .
    1. Yellow fever vaccine: WHO position on the use of fractional doses – June 2017. Wkly Epidemiol Rec. 2017 23;92(25):345–50.
    1. de S Lopes O., Guimarães S.S., de Carvalho R. Studies on yellow fever vaccine. III–Dose response in volunteers. J Biol Stand. 1988 Apr;16(2):77–82.
    1. Martins R.M., Maia de M.L.S., Farias R.H.G., Camacho L.A.B., Freire M.S., Galler R. 17DD yellow fever vaccine: a double-blind, randomized clinical trial of immunogenicity and safety in a dose-response study. Human Vaccines Immunother. 2013 Apr;9(4):879–888.
    1. Campi-Azevedo AC, de Almeida Estevam P, Coelho-dos-Reis JG, Peruhype-Magalhães V, Villela-Rezende G, Quaresma PF, et al. Subdoses of 17DD yellow fever vaccine elicit equivalent virological/immunological kinetics timeline. BMC Inf Dis [Internet]. 2014 Dec [cited 2018 Jan 30];14(1). Available from: <>.
    1. Gotuzzo E., Yactayo S., Cordova E. Review article: efficacy and duration of immunity after yellow fever vaccination: systematic review on the need for a booster every 10 years. Am J Trop Med Hyg. 2013;89:434–444.
    1. Ahuka-Mundeke S., Casey R.M., Harris J.B., Dixon M.G., Nsele P.M., Kizito G.M. Immunogenicity of fractional-dose vaccine during a yellow fever outbreak – preliminary report. N Engl J Med. 2018 Feb;14
    1. Campi-Azevedo A.C., Costa-Pereira C., Antonelli L.R., Fonseca C.T., Teixeira-Carvalho A., Villela-Rezende G. Booster dose after 10 years is recommended following 17DD-YF primary vaccination. Human Vaccines Immunotherapeutics. 2016 Feb;12(2):491–502.
    1. Collaborative group for studies on yellow fever vaccines Duration of post-vaccination immunity against yellow fever in adults. Vaccine. 2014;32:4977–4984.
    1. SAGE Working Group. Background paper on yellow fever vaccine. Version: 2013, March, 19th. Obtained at <> [2018/02/04], at 3:19 PM.
    1. WHO. Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines. Replacement of the annex 2 of WHO Technical Report series, N° 872 and of the amendment to the annex in WHO Technical Report series, N° 2012;944.

Source: PubMed

3
Abonneren