» Chikungunya: Valneva announces positive 12-month antibody persistence data with its MyPharma editions single-dose vaccine candidates

Posted on Monday, December 5, 2022

Valneva, a vaccine company, today announced positive antibody persistence data twelve months after vaccination with a single dose of its chikungunya vaccine candidate, VLA1553.

Following the announcement of positive immunogenicity and safety data for the Phase 3 study VLA1553-301 in March 2022 (1), Valneva initiated an antibody persistence study (VLA1553-303) intended to follow a subset of participants for a period of at least five years and to confirm the long-term durability of the antibody response after a single vaccination.

This antibody persistence trial enrolled 363 healthy adult participants who were followed between six and 12 months after vaccination. 99% of participants retained neutralizing antibody titers above the 150(2) sero-response threshold twelve months after a single vaccination. These antibody levels confirm the antibody persistence profile already observed in a previous study(3). Antibody persistence was similar in adults aged ≥65 years, who maintained neutralizing antibody titers comparable to younger adults during study follow-up. These results follow the completion of the pivotal study VLA1553-301, for which a 96% sero-response rate was reported six months after vaccination1. As part of the study, antibody persistence will continue to be monitored annually.

No safety issues were identified during the follow-up study, confirming the safety profile observed in previous studies.

Juan Carlos Jaramillo MD, Chief Medical Officer at Valneva, commented, “We are very pleased with these twelve-month data, which corroborate those we saw during our previous six-month follow-up and which confirm the possibility of inducing a long-term antibody response with our chikungunya vaccine candidate. We look forward to finalizing the submission of the FDA marketing authorization application and potentially being able to make a difference in people’s lives. If our vaccine candidate is approved, we are confident that it can help combat this huge , growing and unmet threat to public health. »

Valneva expects to finalize submission of the marketing authorization application dossier to the FDA by the end of 2022. Once all elements of the authorization application are submitted and if the application dossier is accepted, the FDA will decide whether the candidate vaccine is eligible for priority review, which will determine the date by which the FDA intends to complete its evaluation. The program received Fast Track and Breakthrough Therapy status from the FDA in 2018 and 2021, respectively. VLA1553 also received ‘PRIority MEdicine’ (PRIME) status from the European Medicines Agency in 2020. Valneva currently expects to file further marketing authorization applications for VLA1553 in 2023. Valneva has also initiated a Phase 3 study in adolescents, conducted in Brazil by Instituto Butantan, to support the expansion of the indication in this age group after obtaining, if necessary, initial authorization in adults .

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1 Valneva successfully completes crucial Phase 3 testing of its single-shot chikungunya vaccine candidate
2 A neutralizing antibody titer of ≥150 as determined by µPRNT50, ie the level of antibodies agreed with regulators as an evaluation criterion under the accelerated authorization procedure.
3 Valneva reports excellent final Phase 1 results for its Chikungunya vaccine candidate, confirms plans – Valneva
4 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas. https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed on October 13, 2020.
5 CDC 2022, Puntasecca CJ 2021
6 VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 2020
7 Valneva and Instituto Butantan sign final agreement on a single vaccine against chikungunya for low- and middle-income countries
8 CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine

Source: Valneva

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