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Randomized Controlled Trial
. 2024 Sep 17;42(22):126197.
doi: 10.1016/j.vaccine.2024.126197. Epub 2024 Aug 15.

Adverse events following immunization (AEFI) with fractional one-fifth and one-half doses of yellow fever vaccine compared to full dose in children 9-23 months old in Uganda, 2019-2020 - Preliminary report

Rebecca M Casey  1 , Marjorie Sserunga Najjengo  2 , Irene Lubega  2 , Arthur B Sekiziyivu  2 , Ellon Twinomuhwezi-Oyet  2 , Winfred Nansozi Nakato  2 , Courtney N Sciarratta  3 , Susan Y Chu  3 , Reena H Doshi  3 , Andrew Kambugu  2 , Jane F Gidudu  3
Affiliations
Randomized Controlled Trial

Adverse events following immunization (AEFI) with fractional one-fifth and one-half doses of yellow fever vaccine compared to full dose in children 9-23 months old in Uganda, 2019-2020 - Preliminary report

Rebecca M Casey et al. Vaccine. .

Abstract

Background: In 2016, the World Health Organization recommended that a fractional dose of yellow fever (YF) vaccine could be used in persons 2 years of age or older in response to an emergency that resulted in a global shortage of available YF vaccine. However, this recommendation did not extend to the youngest age group licensed for YF vaccine because there were no published data on the use or safety of fractional dose YF vaccination in children aged 9-23 months. We conducted a single-blind randomized controlled trial, comparing the immunogenicity and safety of fractional one-fifth and one-half doses of Bio-Manguinhos 17DD YF vaccine with full dose in children aged 9-23 months old in Uganda. In this paper, we present the interim analysis on safety.

Methods: Children aged 9-23 months presenting for routine well-child services were recruited for inclusion at one of three study sites. We collected data during March 26, 2019-August 31, 2020, on all adverse events following immunization (AEFI) during active surveillance for 28 days post-vaccination using multiple collection tools including a diary card with an objective measurement of fever. An independent team from the Uganda national AEFI Committee investigated and classified serious AEFI (SAE) according to Brighton Collaboration Criteria.

Results: Among 1053 enrolled children, 672 (64%) were reported to have a non-serious AEFI (NSAE) and 17 (2%) were reported to have a SAE. The most common AEFI were diarrhoea, fever, and rash, each reported by 355 (34%), 338 (33%), and 188 (18%) participants, respectively. Among 17 participants with SAE, eight were reported to have had seizures and five were hospitalised for seizures or other causes (respiratory symptoms, gastrointestinal illness, malaria). Four SAEs (deaths) occurred >28 days after vaccination. There were no reported cases of pre-specified or vaccine-related SAEs. We observed no significant difference in frequency or severity of adverse events among the study groups.

Conclusions: Using comprehensive active surveillance monitoring, we did not identify any unexpected safety concerns among children aged <2 years receiving YF vaccination, including with the fractional doses. Although we identified a high number of both serious and non-serious AEFI, none were determined to be causally related to YF vaccination. These results provide evidence for the safety of fractional dose YF vaccination among children aged 9-23 months.

Keywords: AEFI; Adverse events following immunization; Fractional dose yellow fever vaccination; Prospective active surveillance; SAE; Uganda; Yellow fever vaccination.

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Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1.
Fig. 1.
Enrollment and Follow-up of Study Participants — The Fractional Dose Yellow Fever AEFI Study, Uganda, 2019–2020.
Fig. 2.
Fig. 2.
Description of fever among participants with completed diary card — The Fractional Dose Yellow Fever AEFI Study Uganda 2019–2020.
See this image and copyright information in PMC

References

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