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. 2022 Dec 19;7(1):170.
doi: 10.1038/s41541-022-00595-6.

A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine

Sajjad Desai  1 , K Anil  2 , Anirudha Vyankatesh Potey  1 , Y Sindhu  2 , Silvia Grappi  3 , Giulia Lapini  3 , Satyaprasad Manney  1 , Parikshit Tyagi  1 , Emanuele Montomoli  3 , Cyrus S Poonawalla  1 , Prasad S Kulkarni  4
Affiliations

A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine

Sajjad Desai et al. NPJ Vaccines. .

Abstract

Yellow fever, a mosquito-borne flavivirus infection, is an important public health problem in Africa and Latin America. A Yellow Fever vaccine (YFV) was developed and tested in a study in India. This was a Phase I, open-label, randomized, controlled study where healthy adults received SII YFV intramuscularly (SII YFV IM), SII YFV subcutaneously (SII YFV SC) or STAMARIL® (Sanofi-Pasteur) in 1:1:1 ratio. They were followed for solicited reactions for 10 days and unsolicited events for 28 days and serious adverse events for 3 months. YF-neutralizing antibodies were measured at baseline and on Days 10, 14, 28. A total of 60 adults were enrolled in the study. The proportion of participants with solicited reactions was 10%, 40%, and 25% in SII YFV SC, SII YFV IM, and STAMARIL® arms, respectively. No causally related unsolicited events or any serious adverse event was reported. After vaccination, the seroconversion was 94.44%, 100%, and 100%, in the three arms respectively. The post-vaccination geometric mean titers were similar in the study arms. The new YFV was found safe and immunogenic by IM as well as SC routes. The vaccine can be tested in further phases of clinical studies.

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Conflict of interest statement

S.D., A.V.P., S.M., P.T., and P.S.K are employees of Serum Institute of India Pvt. Ltd. (SIIPL). C.S.P. is the chairman and managing director of SIIPL. A.K., S.Y., S.G., G.L., and E.M. 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. Flow diagram of trial participants.
Screening, randomization and follow-up of enrolled participants. Twenty participants were randomized to each group. All participants received a single dose of the study vaccine as per allocated vaccine group. Nineteen participants in each group completed the Day 90 follow-up.
See this image and copyright information in PMC

References

    1. World Health Organization. Yellow Fever Factsheet. Available at: https://www.who.int/news-room/fact-sheets/detail/yellow-fever. (Accessed: 5th December 2019).
    1. Centers for Disease Control and Prevention (CDC). Global Health - Newsroom - Yellow Fever. (2018). Available at: https://www.cdc.gov/globalhealth/newsroom/topics/yellowfever/index.html. (Accessed: 2nd July 2022).
    1. World Health Organization. Immunization coverage. (2022). Available at: https://www.who.int/news-room/fact-sheets/detail/immunization-coverage. (Accessed: 29th July 2022).
    1. European Center for Disease Prevention and Control. Yellow fever: Annual Epidemiological Report. (2019).
    1. World Health Organization. 2019, Yellow fever, ICG annual meeting report. (2020). Available at: https://www.who.int/publications/i/item/9789240008236. (Accessed: 29th July 2022).