Evidence map›Paper›PMID 39970397›Full record

Trial reportThe New England journal of medicine2025

Low-Dose Yellow Fever Vaccine in Adults in Africa.

Derick Kimathi, Aitana Juan-Giner, Ndeye S Bob, Benedict Orindi, Maria L Namulwana, Antoine Diatta, Stanley Cheruiyot, Gamou Fall, Moussa Dia, Mainga M Hamaluba and 31 more

Registry-linked trialAbstract readClinical Trial, Phase IVEquivalence TrialMulticenter Study
In one paragraph

Trial report in The New England journal of medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04059471 (Non- Inferiority Fractional-doses Trial for Yellow Fever Vaccine), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04059471 phase4completednot on this map

Non- Inferiority Fractional-doses Trial for Yellow Fever Vaccine

TypeinterventionalSponsorUniversity of OxfordRan2019 to 2023Enrolled900ConditionsYellow FeverArmsYellow fever vaccine, Institut Pasteur
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Article
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  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

41 authors.

Derick KimathiKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Aitana Juan-GinerEpicentre, Paris.
Ndeye S BobInstitut Pasteur de Dakar, Dakar, Senegal.
Benedict OrindiKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Maria L NamulwanaEpicentre Mbarara Research Centre, Mbarara, Uganda.
Antoine DiattaInstitut Pasteur de Dakar, Dakar, Senegal.
Stanley CheruiyotKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Gamou FallInstitut Pasteur de Dakar, Dakar, Senegal.
Moussa DiaInstitut Pasteur de Dakar, Dakar, Senegal.
Mainga M HamalubaKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Dan NyehanganeEpicentre Mbarara Research Centre, Mbarara, Uganda.
Henry K KaranjaKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
John N GitongaKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Daisy MugoKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Donwilliams O OmuoyoKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Mwatasa HusseinKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Elizaphan OlooKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Naomi KamauKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Jackline WafulaKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Josephine BenderaKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Namanya SilvesterEpicentre Mbarara Research Centre, Mbarara, Uganda.
James MwavitaKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Musiimenta JoshuaEpicentre Mbarara Research Centre, Mbarara, Uganda.
Jane MwendwaKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Collins AgababyonaEpicentre Mbarara Research Centre, Mbarara, Uganda.
Caroline NgetsaKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Nalusaji AishaEpicentre Mbarara Research Centre, Mbarara, Uganda.
Felix MokiKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Titus BulukuKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Marianne MuneneKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Juliet Mwanga-AmumpaireEpicentre Mbarara Research Centre, Mbarara, Uganda.
Julius LutwamaUganda Virus Research Institute (UVRI), Entebbe.
John KayiwaUganda Virus Research Institute (UVRI), Entebbe.
Eunice KamaaraMoi University, Eldoret, Kenya.
Alan D BarrettSealy Institute for Vaccine Sciences, University of Texas Medical Branch, Galveston.
Pontiano KaleebuUganda Virus Research Institute (UVRI), Entebbe.
Philip BejonKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Amadou A SallInstitut Pasteur de Dakar, Dakar, Senegal.
Rebecca F GraisEpicentre, Paris.
George M WarimweKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
NIFTY Investigators

Funding

European and Developing Countries Clinical Trials Partnership EDCTP- RIA2016V-1633Wellcome Trust 203077Wellcome Trust 203077_Z_16_Z
6 · The paper itself

Abstract

backgroundYellow fever vaccine is highly effective with a single dose, but vaccine supply is limited. The minimum dose requirements for seroconversion remain unknown.

methodsIn this double-blind, randomized, noninferiority trial in Uganda and Kenya, we assigned adults with no history of yellow fever vaccination or infection to receive vaccination with the Institut Pasteur de Dakar 17D-204 yellow fever vaccine at a standard dose (13,803 IU) or at a fractional dose of 1000 IU, 500 IU, or 250 IU. The primary outcome was seroconversion at 28 days after vaccination with each fractional dose as compared with the standard dose, evaluated in a noninferiority analysis. Seroconversion was defined as an antibody titer at day 28 that was at least four times as high as the antibody titer before vaccination, as measured by a plaque reduction neutralization test. We conducted noninferiority analyses in the per-protocol and intention-to-treat populations. Noninferiority was shown if the lower boundary of the 95% confidence interval for the difference in the incidence of seroconversion between the fractional dose and the standard dose was higher than -10 percentage points.

resultsA total of 480 participants underwent randomization (120 participants in each group). The incidence of seroconversion was 98% (95% confidence interval [CI], 94 to 100) with the standard dose. The difference in the incidence of seroconversion between the 1000-IU dose and the standard dose was 0.01 percentage points (95% CI, -5.0 to 5.1) in the intention-to-treat population and -1.9 percentage points (95% CI, -7.0 to 3.2) in the per-protocol population; the corresponding differences between the 500-IU dose and the standard dose were 0.01 percentage points (95% CI, -5.0 to 5.1) and -1.8 percentage points (95% CI, -6.7 to 3.2), and those between the 250-IU dose and the standard dose were -4.4 percentage points (95% CI, -9.4 to 0.7) and -6.7 percentage points (95% CI, -11.7 to 1.6). A total of 111 vaccine-related adverse events were reported: 103 were mild in severity, 7 were moderate, and 1 was severe. The incidence of adverse events was similar in the four groups.

conclusionsA yellow fever vaccination dose as low as 500 IU was noninferior to the standard dose of 13,803 IU for producing seroconversion within 28 days. (Funded by the European and Developing Countries Clinical Trials Partnership and the Wellcome Trust; NIFTY ClinicalTrials.gov number, NCT04059471.).

Indexed as

Antibodies, ViralSeroconversionYellow FeverYellow Fever VaccineYellow fever virusAdultDouble-Blind MethodFemaleHumansImmunogenicity, VaccineIntention to Treat AnalysisKenyaMaleMiddle AgedUgandaAntibodies, ViralYellow Fever Vaccine

Identifiers

PMID39970397
PMCPMC7617464

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.