Chikungunya vaccine

The chikungunya vaccine is indicated for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at high risk of exposure to the chikungunya virus.

The safety of the chikungunya vaccine was evaluated in two clinical studies conducted in North America in which about 3,500 participants 18 years of age and older received a dose of the vaccine with one study including about 1,000 participants who received a placebo. The effectiveness of the chikungunya vaccine is based on immune response data from a clinical study conducted in the United States in individuals 18 years of age and older. In this study, the immune response of 266 participants who received the vaccine was compared to the immune response of 96 participants who received placebo. The level of antibody evaluated in study participants was based on a level shown to be protective in non-human primates that had received blood from people who had been vaccinated. Almost all vaccine study participants achieved this antibody level.

The US Food and Drug Administration (FDA) granted the application for the chikungunya vaccine fast track, breakthrough therapy, and priority review designations. The FDA granted approval of Ixchiq to Valneva Austria GmbH.{{Cite news |last=Malhi |first=Sabrina |date=10 November 2023 |title=FDA approves first vaccine against mosquito-borne virus chikungunya |url=https://www.washingtonpost.com/health/2023/11/10/chikungunya-vaccine-approved-mosquito-bites/ |access-date=13 November 2023 |newspaper=The Washington Post |archive-date=11 November 2023 |archive-url=https://web.archive.org/web/20231111001243/https://www.washingtonpost.com/health/2023/11/10/chikungunya-vaccine-approved-mosquito-bites/ |url-status=live }}

In May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ixchiq, intended for the prevention of chikungunya disease in adults. The applicant for this medicinal product is Valneva Austria GmbH.{{cite press release | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024 | website=European Medicines Agency (EMA) | date=31 May 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-may-2024 | access-date=13 June 2024 | archive-date=13 June 2024 | archive-url=https://web.archive.org/web/20240613053159/https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-may-2024 | url-status=live }} Ixchiq was reviewed under EMA's accelerated assessment program. It contains the live attenuated chikungunya virus (CHIKV) Δ5nsP3 strain of the ECSA/IOL genotype. Ixchiq was authorized for medical use in the European Union in June 2024.{{cite web | title=Ixchiq PI | website=European Medicines Agency (EMA) | date=30 May 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ixchiq | access-date=2 July 2024 | archive-date=1 June 2024 | archive-url=https://web.archive.org/web/20240601045534/https://www.ema.europa.eu/en/medicines/human/EPAR/ixchiq | url-status=live }}

In January 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vimkunya (chikungunya vaccine (recombinant, adsorbed)), a vaccine intended for the prevention of chikungunya disease in individuals aged twelve years of age and older. The applicant for this medicinal product is Bavarian Nordic A/S.{{cite press release | title=New Chikungunya vaccine for adolescents from 12 and adults | website=European Medicines Agency (EMA) | date=31 January 2025 | url=https://www.ema.europa.eu/en/news/new-chikungunya-vaccine-adolescents-12-adults | access-date=16 February 2025}} Vimkunya was authorized for medical use in the European Union in February 2025.{{cite web | title=Vimkunya PI | website=Union Register of medicinal products | date=28 February 2025 | url=https://ec.europa.eu/health/documents/community-register/html/h1916.htm | access-date=4 March 2025}}

A phase-II vaccine trial used a live, attenuated virus, to develop viral resistance in 98% of those tested after 28 days and 85% still showed resistance after one year.{{cite journal | vauthors = Edelman R, Tacket CO, Wasserman SS, Bodison SA, Perry JG, Mangiafico JA | title = Phase II safety and immunogenicity study of live chikungunya virus vaccine TSI-GSD-218 | journal = The American Journal of Tropical Medicine and Hygiene | volume = 62 | issue = 6 | pages = 681–5 | date = June 2000 | pmid = 11304054 | doi = 10.4269/ajtmh.2000.62.681 | url = http://www.ajtmh.org/cgi/pmidlookup?view=long&pmid=11304054 | doi-access = free }} However, 8% of people reported transient joint pain, and attenuation was found to be due to only two mutations in the E2 glycoprotein.{{cite journal | vauthors = Gorchakov R, Wang E, Leal G, Forrester NL, Plante K, Rossi SL, Partidos CD, Adams AP, Seymour RL, Weger J, Borland EM, Sherman MB, Powers AM, Osorio JE, Weaver SC | title = Attenuation of Chikungunya virus vaccine strain 181/clone 25 is determined by two amino acid substitutions in the E2 envelope glycoprotein | journal = Journal of Virology | volume = 86 | issue = 11 | pages = 6084–96 | date = June 2012 | pmid = 22457519 | pmc = 3372191 | doi = 10.1128/JVI.06449-11 }} Alternative vaccine strategies have been developed, and show efficacy in mouse models.{{cite journal | vauthors = Plante K, Wang E, Partidos CD, Weger J, Gorchakov R, Tsetsarkin K, Borland EM, Powers AM, Seymour R, Stinchcomb DT, Osorio JE, Frolov I, Weaver SC | title = Novel chikungunya vaccine candidate with an IRES-based attenuation and host range alteration mechanism | journal = PLOS Pathogens | volume = 7 | issue = 7 | pages = e1002142 | date = July 2011 | pmid = 21829348 | pmc = 3145802 | doi = 10.1371/journal.ppat.1002142 | doi-access = free }} {{open access}}{{cite journal | vauthors = Hallengärd D, Kakoulidou M, Lulla A, Kümmerer BM, Johansson DX, Mutso M, Lulla V, Fazakerley JK, Roques P, Le Grand R, Merits A, Liljeström P | title = Novel attenuated Chikungunya vaccine candidates elicit protective immunity in C57BL/6 mice | journal = Journal of Virology | volume = 88 | issue = 5 | pages = 2858–66 | date = March 2014 | pmid = 24371047 | pmc = 3958085 | doi = 10.1128/JVI.03453-13 }}

In August 2014, researchers at the National Institute of Allergy and Infectious Diseases in the USA tested an experimental vaccine using virus-like particles (VLPs) instead of attenuated virus. All of the 25 people participating in this phase I trial developed strong immune responses.{{cite news|title=Experimental chikungunya vaccine passes first test|url=https://www.npr.org/blogs/goatsandsoda/2014/08/18/341360645/experimental-vaccine-for-chikungunya-passes-first-test|date=15 August 2014|access-date=15 August 2014|publisher=NPR|url-status=live|archive-url=https://web.archive.org/web/20140819075049/http://www.npr.org/blogs/goatsandsoda/2014/08/18/341360645/experimental-vaccine-for-chikungunya-passes-first-test|archive-date=19 August 2014}}

As of 2015, a phase II trial was planned, using 400 adults aged 18 to 60 and to take place at six locations in the Caribbean.{{cite web|url=http://www.fiercevaccines.com/story/niaid-bring-chikungunya-vaccine-phase-ii/2015-12-02|title=NIAID to bring Chikungunya vaccine into Phase II|author=Al Idrus, Amirah|publisher=fiercevaccines.com|date=2 December 2015|access-date=24 March 2016|url-status=usurped|archive-url=https://web.archive.org/web/20160410115003/http://www.fiercevaccines.com/story/niaid-bring-chikungunya-vaccine-phase-ii/2015-12-02|archive-date=10 April 2016}} In 2021, two vaccine manufacturers, one in France, the other in the United States, reported successful completion of phase II clinical trials.{{cite web |last1=Hackett |first1=Karen McClory |title=Chikungunya Vaccine Candidate Approaches Authorization |url=https://www.precisionvaccinations.com/2021/06/10/chikungunya-vaccine-candidate-approaches-authorization |website=www.precisionvaccinations.com |date=10 June 2021 |access-date=10 November 2023 |archive-date=4 September 2023 |archive-url=https://web.archive.org/web/20230904005848/https://www.precisionvaccinations.com/2021/06/10/chikungunya-vaccine-candidate-approaches-authorization |url-status=live }}{{cite web |last1=Keown |first1=Alex |title=Emergent Enjoys Some Good News, Posting Positive Results for Chikungunya Vaccine |url=https://www.biospace.com/article/halting-mosquito-borne-illnesses-emergent-biosolutions-posts-positive-chikungunya-vaccine-data-/ |website=BioSpace |location=Urbandale IA |date=26 May 2021 |access-date=10 November 2023 |archive-date=4 September 2023 |archive-url=https://web.archive.org/web/20230904005845/https://www.biospace.com/article/halting-mosquito-borne-illnesses-emergent-biosolutions-posts-positive-chikungunya-vaccine-data-/ |url-status=live }}

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Category:Vaccines