IXIARO® JESPECT® Japanese Encephalitis Vaccine Clinical Trials, Dosage, Indication, Side Effects
Valneva SE's IXIARO® JESPECT® is an inactivated, adsorbed Vero cell culture-derived vaccine targeted against the Japanese encephalitis virus (JEV). It is prepared by propagating JEV strain SA14-14-2 in Vero cells. Multiple viral harvests are pooled, clarified, and concentrated. The virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins. The partially purified virus is processed and fractionated through a sucrose density gradient centrifugation. Each fraction is analyzed for the presence of the virus, and fractions with the highest virus activity are pooled to give a purified virus suspension. The purified virus is then inactivated by treatment with formaldehyde. IXIARO's final preparation is adjusted to a specified protein concentration and formulated by adding aluminum hydroxide.
The IXIARO JEV was developed through a cooperative research and development agreement with the Walter Reed Army Institute of Research. In 2018, the U.S. FDA issued STN: BL 125280, Statistical Review, Clinical Review, Toxicology Review, and an Approval Letter was issued on October 4, 2018.
The U.S. Department of Defense (DoD) has relied on IXIARO since 2010 to help protect personnel deployed to JE-endemic areas for whom JE vaccination is recommended. Under a new one-year contract announced on September 25, 2023, the DoD will buy a minimum of $32 million worth of IXIARO® vaccines and can purchase additional doses during twelve months. Vaccine deliveries will commence in 2023.
A study estimated that between 2000 and 2015, 307,774 JE cases (95% CI: 167,442–509,583) were averted due to vaccination globally. The U.K. Health Security Agency published new guidance on JE vaccination in the 'Green Book' (Chapter 20) in February 2024.
France-based Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) is a specialty vaccine company focused on preventing diseases with significant unmet needs. For more information, visit www.valneva.com. Valneva USA, Inc. is located at 910 Clopper Road, Suite 160S, Gaithersburg, MD 20878, USA.
IXIARO Vaccine Availability 2024
IXIARO is the only Japanese encephalitis vaccine approved by the U.S. Food and Drug Administration (FDA) against JEV. On March 8, 2020, Valneva announced that the FDA approved an extension of the shelf life of IXIARO from 24 months to 36 months. IXIARO / JESPECT® is licensed for adults in the U.S., Australia, New Zealand, Europe, Canada, Switzerland, Hong Kong, Singapore, Israel, Norway, Liechtenstein, Iceland, Singapore, Japan, the United Kingdom, and the Republic of Korea. In all other licensed territories, IXIARO®/JESPECT® is indicated for use by adults. Visit PreventJE.com, a website for travel health professionals and their patients focusing on the risk and prevention of Japanese encephalitis in travelers to Asia.
IXIARO Vaccine Approvals
In March 2009, the U.S. Food and Drug Administration (FDA) licensed JE-VC for adults aged ≥17 years. In June 2009, the CDC's Advisory Committee on Immunization Practices (ACIP) approved recommendations for using JE-VC in adults. In September 2010, the FDA approved a JE-VC booster dose for adults. In May 2013, FDA approval for JE-VC was extended to include children aged two months through 16 years. ACIP recommendations for pediatric use of JE-VC were approved in June 2013. In April 2018, FDA approval for a booster dose was extended to include the pediatric age group.
IXIARO Indication
IXIARO is indicated for active immunization to prevent disease caused by the JEV, the leading cause of vaccine-preventable encephalitis, and is approved by the U.S. CDC for use in individuals two months of age and older. The CDC says travelers to areas at risk for Japanese encephalitis should discuss the need for vaccination with their healthcare provider. JE is a deadly infectious disease occurring throughout most of Asia and parts of the western Pacific. JE is fatal in approximately 30% of those who show symptoms, leaving half of the survivors with permanent brain damage.
IXIARO Side Effects
IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Therefore, severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO®, any other Japanese encephalitis vaccine, or any component of IXIARO®, including protamine sulfate ─ a compound known to cause hypersensitivity reactions in some individuals ─ is a contraindication to administration of IXIARO®. Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO® might be considered. The most common ( > 10%) adverse reactions were fever, irritability, diarrhea, and injection site redness in infants two months to < 1 year of age; fever in children 1 to < 12 years of age; pain and tenderness in adolescents 12 to < 18 years of age; and, headache, myalgia, and injection site pain and tenderness in adults.
IXIARO Dosage
IXIARO is administered as an intramuscular injection and is approved for use in individuals two months and older. In 2019, the U.S. CDC's ACIP committee strengthened its language on booster doses to say they should be given at least one year after the primary series if the person is experiencing ongoing exposure or re-exposure to the JE virus.
Primary Series: Children 2 months to <3 years of age: Primary immunization with IXIARO consists of two (2) 0.25 mL doses, administered 28 days apart; Individuals 3 years of age and older: Primary immunization with IXIARO consists of two (2) 0.5 mL doses, administered 28 days apart; Complete the primary immunization series at least one week before potential exposure to JEV.
Booster Dose: Individuals 17 years of age and older: If the primary series of two doses was completed more than one year previously, a booster dose might be given if ongoing exposure or re-exposure to JEV is expected; Infants, children, and adolescents two months to <17 years of age: The safety and immunogenicity of a booster dose have not been evaluated.
Immunocompromised individuals may have a diminished immune response to IXIARO.
U.S. CDC Japanese Encephalitis Vaccine Recommendations
The U.S. CDC developed Japanese Encephalitis vaccine recommendations using an explicit evidence-based method based on the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.
Japanese Encephalitis Outbreaks
The World Health Organization (WHO) says JE outbreaks intensify during the rainy (monsoon) season in Asia and the Pacific, during which vector populations increase.
IXIARO Vaccine Sales
In the first nine months of 2024, Valneva SE stated IXIARO®/JESPECT® sales increased by 31% to €66.0 million, compared to €50.3 million in the first nine months of 2023. Sales to travelers and the U.S. military showed double-digit growth compared to the first nine months of 2023. Valneva has been supplying additional doses of IXIARO® to the U.S. DoD under the current contract, signed in September 2023.
IXIARO Vaccine News
November 7, 2024 - Valneva expects to receive new vaccine orders in 2025.
October 31, 2024 - Victoria's Minister for Health Mary-Anne Thomas stated, "Following expert advice from the Chief Health Officer, we're expanding this important program to ensure more Victorians can access the free JEV vaccine and protect themselves and their loved ones this summer."
May 15, 2024 - The U.S. CDC published Japanese Encephalitis Vaccine Information for Healthcare Providers.
September 25, 2023 - Dipal Patel, Chief Commercial Officer of Valneva SE, commented, "We are excited to continue our long-term relationship with the DoD. The U.S. military has trusted IXIARO® for over ten years to help protect military personnel, their families, civilian government service personnel, and government contractors from this potentially deadly disease."
September 21, 2023 - Valneva SE confirmed it distributes IXIARO® directly to the U.S. DoD.
July 11, 2022 - A non-peer-reviewed study: Safety and immunogenicity following co-administration of Yellow fever vaccine with Tick-borne encephalitis or Japanese encephalitis vaccines concluded: Inactivated TBEV or JEV vaccines can be co-administered with the live attenuated YFV vaccine without an increased risk of adverse events and reduced development of nAbs to the respective viruses.
September 3, 2021 - Valneva SE announced that the U.S. Department of Defense had exercised the first option of the contract signed in September 2020 to purchase a further supply of its Japanese encephalitis vaccine, IXIARO®.
July 19, 2019 - The CDC's Advisory Committee on Immunization Practices (ACIP) Recommendations for Japanese Encephalitis Vaccine were updated.
June 5, 2019: The European Medicines Agency approved the extension of the shelf life of the Japanese encephalitis vaccine IXIARO from 24 months to 36 months.
March 1, 2019 – According to unanimous votes by the U.S. CDC's ACIP at its February 27, 2019 meeting, the JEV vaccination recommendations have been expanded.
Ixiaro Clinical Trials
Ixiaro Japanese Encephalitis vaccine has been involved in over 60 clinical trials.
