Immunogenicity and safety of fractional doses of 17D-213 yellow fever vaccine in HIV-infected people in Kenya (YEFE): a randomised, double-blind, non-inferiority substudy of a phase 4 trial.
Journal
The Lancet. Infectious diseases
ISSN: 1474-4457
Titre abrégé: Lancet Infect Dis
Pays: United States
ID NLM: 101130150
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
received:
07
11
2022
revised:
07
02
2023
accepted:
08
02
2023
medline:
31
7
2023
pubmed:
2
5
2023
entrez:
1
5
2023
Statut:
ppublish
Résumé
Evidence indicates that fractional doses of yellow fever vaccine are safe and sufficiently immunogenic for use during yellow fever outbreaks. However, there are no data on the generalisability of this observation to populations living with HIV. Therefore, we aimed to evaluate the immunogenicity of fractional and standard doses of yellow fever vaccine in HIV-positive adults. We conducted a randomised, double-blind, non-inferiority substudy in Kilifi, coastal Kenya to compare the immunogenicity and safety of a fractional dose (one-fifth of the standard dose) versus the standard dose of 17D-213 yellow fever vaccine among HIV-positive volunteers. HIV-positive participants aged 18-59 years, with baseline CD4 Between Jan 29, 2019, and May 17, 2019, 303 participants were screened, and 250 participants were included and vaccinated; 126 participants were assigned to the fractional dose and 124 to the standard dose. 28 days after vaccination, 112 (96%, 95% CI 90-99) of 117 participants in the fractional dose group and 115 (98%, 94-100) of 117 in the standard dose group seroconverted by PRNT Fractional doses of the 17D-213 yellow fever vaccine were sufficiently immunogenic and safe demonstrating non-inferiority to the standard vaccine dose in HIV-infected individuals with CD4 Wellcome Trust, Médecins Sans Frontières Foundation, and the UK Department for International Development.
Sections du résumé
BACKGROUND
Evidence indicates that fractional doses of yellow fever vaccine are safe and sufficiently immunogenic for use during yellow fever outbreaks. However, there are no data on the generalisability of this observation to populations living with HIV. Therefore, we aimed to evaluate the immunogenicity of fractional and standard doses of yellow fever vaccine in HIV-positive adults.
METHODS
We conducted a randomised, double-blind, non-inferiority substudy in Kilifi, coastal Kenya to compare the immunogenicity and safety of a fractional dose (one-fifth of the standard dose) versus the standard dose of 17D-213 yellow fever vaccine among HIV-positive volunteers. HIV-positive participants aged 18-59 years, with baseline CD4
FINDINGS
Between Jan 29, 2019, and May 17, 2019, 303 participants were screened, and 250 participants were included and vaccinated; 126 participants were assigned to the fractional dose and 124 to the standard dose. 28 days after vaccination, 112 (96%, 95% CI 90-99) of 117 participants in the fractional dose group and 115 (98%, 94-100) of 117 in the standard dose group seroconverted by PRNT
INTERPRETATION
Fractional doses of the 17D-213 yellow fever vaccine were sufficiently immunogenic and safe demonstrating non-inferiority to the standard vaccine dose in HIV-infected individuals with CD4
FUNDING
Wellcome Trust, Médecins Sans Frontières Foundation, and the UK Department for International Development.
Identifiants
pubmed: 37127045
pii: S1473-3099(23)00114-7
doi: 10.1016/S1473-3099(23)00114-7
pmc: PMC10371873
pii:
doi:
Substances chimiques
Antibodies, Viral
0
Yellow Fever Vaccine
0
Banques de données
ClinicalTrials.gov
['NCT02991495']
Types de publication
Clinical Trial, Phase IV
Equivalence Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
974-982Subventions
Organisme : Wellcome Trust
ID : 092654
Pays : United Kingdom
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of interests We declare no competing interests.
Références
J Travel Med. 2022 Dec 27;29(8):
pubmed: 35285913
Clin Microbiol Infect. 2021 Jul;27(7):958-967
pubmed: 33813107
Lancet. 2016 Dec 10;388(10062):2904-2911
pubmed: 27837923
J Travel Med. 2019 Sep 2;26(6):
pubmed: 30937437
PLoS Med. 2014 May 06;11(5):e1001638
pubmed: 24800812
Microbiol Resour Announc. 2019 Jan 24;8(4):
pubmed: 30701251
Nurs Stand. 2014 Sep 23;29(3):53-8
pubmed: 25227387
Biologicals. 2012 Nov;40(6):399-404
pubmed: 23034357
J Travel Med. 2019 Sep 2;26(6):
pubmed: 30850844
Lancet. 2021 Jan 9;397(10269):119-127
pubmed: 33422245
J Acquir Immune Defic Syndr. 2012 Apr 1;59(4):360-7
pubmed: 22267015
Vaccines (Basel). 2021 Jun 18;9(6):
pubmed: 34207358
Wkly Epidemiol Rec. ;92(16):193-204
pubmed: 28429585
Vaccine. 2020 Feb 5;38(6):1291-1301
pubmed: 31859201
Cochrane Database Syst Rev. 2014 Jan 23;(1):CD010929
pubmed: 24453061
J Travel Med. 2019 Jun 11;26(5):
pubmed: 31150098
CMAJ. 2008 Apr 22;178(9):1181-4
pubmed: 18427095
Lancet Infect Dis. 2001 Aug;1(1):11-20
pubmed: 11871403
Wkly Epidemiol Rec. 2013 Jul 5;88(27):269-83
pubmed: 23909008
NPJ Vaccines. 2020 Jul 6;5(1):54
pubmed: 32655896
Qual Assur. 1998 Apr-Jun;6(2):65-74
pubmed: 10386329
J Travel Med. 2023 Apr 5;30(2):
pubmed: 35947986
N Engl J Med. 2019 Aug 1;381(5):444-454
pubmed: 29443626
Wellcome Open Res. 2019 Nov 20;4:182
pubmed: 31984244
Clin Infect Dis. 2022 Dec 19;75(12):2266-2274
pubmed: 35856638
N Engl J Med. 2018 Aug 16;379(7):603-605
pubmed: 29995585