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.[1]
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.[2] 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.[2] 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.[2] 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.[2] Almost all vaccine study participants achieved this antibody level.[2]
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.[4] The applicant for this medicinal product is Valneva Austria GmbH.[4] Ixchiq was reviewed under EMA's accelerated assessment program.[4][5] It contains the live attenuated chikungunya virus (CHIKV) Δ5nsP3 strain of the ECSA/IOL genotype.[4]
Aphase-IIvaccine 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.[6] However, 8% of people reported transient joint pain, and attenuation was found to be due to only two mutations in the E2 glycoprotein.[7] Alternative vaccine strategies have been developed, and show efficacy in mouse models.[8][9]
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.[11] In 2021, two vaccine manufacturers, one in France, the other in the United States, reported successful completion of phase II clinical trials.[12][13]
^ abc"Ixchiq". U.S. Food and Drug Administration. 9 November 2023. Archived from the original on 9 November 2023. Retrieved 10 November 2023. This article incorporates text from this source, which is in the public domain.
^ abcd"Ixchiq EPAR". European Medicines Agency. 30 May 2024. Retrieved 1 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
This article incorporates text from this source, which is in the public domain.
Viruses
