THIS INFORMATION IN THIS MODULE IS FUNDED AND CREATED BY BAVARIAN NORDIC AND IT CONTAINS PROMOTIONAL CONTENT ABOUT BAVARIAN NORDIC PRODUCTS.
VACCINATION OPTIONS
The Joint Committee on Vaccination and Immunisation (JCVI) advises that vaccination may be considered for UK travellers in addition to bite avoidance measures.22
CHIKUNGUNYA VACCINES MAY BE CONSIDERED FOR:22
Travellers visiting regions with active CHIKV outbreaks
Frequent or long-term travellers to areas with transmission in the past 5 years
Laboratory staff working with the virus.
TWO VACCINES ARE APPROVED FOR USE BY UK TRAVELLERS; BOTH PROVIDE PROTECTION AGAINST INFECTION, BUT THEIR USE REQUIRES CAREFUL CONSIDERATION.22
The table below summarises the properties of each vaccine.
|
VIMKUNYA®▼CHIKUNGUNYA VACCINE(Recombinant, adsorbed) |
IXCHIQ®▼CHIKUNGUNYA VACCINE(Live) |
|---|---|---|
| Type |
Adjuvanted virus-like particle (VLP) recombinant protein vaccine The vaccine does not contain a live or weakened form of the virus and therefore cannot infect cells, reproduce or cause disease.23 |
Live attenuated vaccine, using a weakened form of the virus24 Vaccine virus was detected in blood and urine after administration, therefore, individuals vaccinated with IXCHIQ® should not donate blood for at least 4 weeks post-vaccination.24 |
| Therapeutic indication |
Vimkunya® is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. The use of this vaccine should be in accordance with official recommendations. |
IXCHIQ® is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals aged 18-59. The use of this vaccine should be in accordance with official recommendations. |
| Presentation |
Single-dose pre-filled syringe (without needle).23 |
One single-dose vial containing lyophilized powder of the vaccine and 0.5 mL sterile water for injection in a prefilled syringe for reconstitution.24 |
| Administration and shelf life |
To be administered by intramuscular injection within 4 hours after removal from the refrigerator (2 to 8°C).23 |
To be administered intramuscularly within 2 hours of reconstitution.24 |
| Mode of action |
It is thought that protection results from inducing neutralising antibodies against CHIKV proteins contained in Vimkunya®, resulting in neutralisation of live virus. An adjuvant is added to increase the magnitude of vaccine-mediated immune responses.23 |
The weakened form of the virus elicits neutralising antibodies against CHIKV to help prevent disease.25 |
| Pregnancy |
There is limited data from use in pregnant women. Consult each product’s SmPC for further information.23,24 |
|
| Breastfeeding |
For both vaccines, it is unknown if they are excreted in human milk, therefore a risk to the breastfed child cannot be excluded. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vaccination and any potential adverse effects on the breastfed child from the vaccine.23,24 |
|
| Joint Committee on Vaccination and Immunisation (JCVI) advice |
May be offered to individuals aged 12 years and over.22 The vaccine may be considered for:22
|
May be offered to immunocompetent individuals aged 18 to 59 years. The vaccine should not be used in people aged 60 or over, and in individuals of any age who have high blood pressure, heart disease, diabetes or chronic kidney disease or are immunodeficient or immunosuppressed as a result of disease or medical therapy. This includes IgA deficiency, history of thymus disorder or thymectomy.22,26 The Commission on Human Medicines (CHM) further recommends:27
Patients who have received the vaccine and subsequently develop signs or symptoms suggestive of viraemia, such as arthralgia, or neurological features that may indicate encephalitis, should be advised to seek urgent medical attention. |
*UK HSA and NaTHNaC have reviewed chikungunya epidemiology and the recommendations for individual countries are available on the Country Information pages at travelhealthpro.org.uk
THIS TABLE PROVIDES A HIGH-LEVEL SUMMARY OF SELECTED CHARACTERISTICS OF THE LISTED VACCINES FOR INFORMATIONAL PURPOSES ONLY.
It is not intended to replace the Summary of Product Characteristics (SmPC), prescribing information, or the clinical judgement of healthcare professionals. For full details on indications, contraindications, warnings, use in pregnancy and breastfeeding and administration, please refer to the approved prescribing information.
INFORMATION ABOUT VIMKUNYA®
Click the headings to learn more about the Vimkunya® vaccine.
VIMKUNYA® is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older.
The use of this vaccine should be in accordance with official recommendations.
A single dose of 0.8mL
The pre-filled syringe should be vigorously shaken immediately before use to obtain a homogeneous suspension
Administer by intramuscular injection in the deltoid muscle
The clinical efficacy of Vimkunya was inferred from post-vaccination levels of CHIKV-specific neutralising antibodies.
Regulators, including the MHRA, FDA and EMA, accepted a serum neutralising antibody (SNA) titre of ≥100 (corresponding to 80% neutralisation of CHIKV) as a surrogate endpoint for protection.
-
Two Phase 3 clinical studies evaluated immunogenicity of Vimkunya.
The co-primary endpoints were:- Difference in anti-CHIKV SNA seroresponse rate (Vimkunya vaccine minus placebo)
- Anti-CHIKV SNA geometric mean titre (GMT) at 21 days post-vaccination (study visit day 22).
A geometric mean titre (GMT) of at least 100 was agreed as threshold for adequate immune response.
Neutralising antibodies were detectable as early as Day 8 following vaccination; all co-primary and key secondary endpoints were met.
STUDY 1: 12 TO 64-YEAR-OLD GROUP (N=3258)
Seroresponse rates:
- At Day 8: 1169/2510 (47%)
- At Day 22: 2 503/2 559 (98%)
- At Day 183, i.e. 6 months: 1 967/2 301 (86%).
GMT at 6 months: 338
STUDY 2: ADULTS OVER 65 YEARS OF AGE (N=413)
Seroresponse rates:
- At Day 22: 165/189 (87%)
- At Day 183, i.e. 6 months: 139/184 (76%)
GMT at 6 months: 233
A long-term follow up durability study in paediatric participants (under 12 years of age) is ongoing, with a Phase 3b study ready to recruit in the event of a chikungunya outbreak.
There are no contraindications to the vaccine beyond hypersensitivity to the vaccine components
Injection site pain was the most common local adverse reaction after vaccine administration
The most common systemic adverse reactions observed after vaccination were fatigue, headache and myalgia
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. Adverse events should also be reported to Bavarian Nordic: drug.safety@bavarian-nordic.com