Chikungunya Vaccine Live (Monograph)

Brand name: Ixchiq
Drug class: Vaccines

Introduction

Chikungunya vaccine live is a preparation of live, attenuated chikungunya virus.

Uses for Chikungunya Vaccine Live

Chikungunya vaccine live has the following uses:

Chikungunya vaccine live is indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.

This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody titers. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies.

Chikungunya Vaccine Live Dosage and Administration

General

Chikungunya vaccine live is available in the following dosage form(s) and strength(s):

Supplied in a carton containing one single-dose vial of lyophilized antigen component live and one prefilled ungraduated syringe of sterile water diluent component. After reconstitution, a single dose is approximately 0.5 mL.

Dosage

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

For IM use only.

Reconstitute the lyophilized antigen component live (a white to slightly yellowish powder) only with the accompanying sterile water diluent component. After reconstitution, a single dose of chikungunya vaccine live is approximately 0.5 mL.

Administer a single dose by IM injection.

Cautions for Chikungunya Vaccine Live

Contraindications

• Immunocompromised individuals.

• Individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of chikungunya vaccine live.

Warnings/Precautions

Management of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic reactions must be available in the event an acute anaphylactic reaction occurs following administration of chikungunya vaccine live.

Risk of Severe or Prolonged Chikungunya-like Adverse Reactions

Vaccination with chikungunya vaccine live may cause severe or prolonged chikungunya-like adverse reactions. Severe chikungunya-like adverse reactions that prevented daily activity and/or required medical intervention occurred in 1.6% of 3,082 chikungunya vaccine live recipients and no placebo recipients. Two chikungunya vaccine live recipients required hospitalization for severe myalgia and for hypovolemic hyponatremia and atrial fibrillation, respectively. Fourteen chikungunya vaccine live recipients had prolonged (duration at least 30 days) chikungunya-like adverse reactions.

Potential for Vertical Transmission of Vaccine Virus and Fetal/Neonatal Adverse Reactions

Vertical transmission of wild-type CHIKV to neonates from pregnant individuals with viremia at delivery is common and can cause severe, potentially fatal CHIKV disease in neonates. Vertical transmission of wild-type CHIKV and fetal death attributable to CHIKV in the context of antepartum infection has been reported to occur infrequently.

Vaccine viremia occurs in the first week following administration of chikungunya vaccine live, with resolution of viremia by 14 days after vaccination. It is not known if the vaccine virus can be transmitted from a pregnant individual to the fetus or neonate and cause fetal or neonatal adverse reactions.

Decisions to administer chikungunya vaccine live during pregnancy should take into consideration the individual’s risk of exposure to wild-type CHIKV, gestational age, and risks to the fetus or neonate from vertical transmission of wild-type CHIKV.

Closely monitor neonates for 7 days after birth for potential disease due to vaccine virus if they are born within 14 days of their mother receiving chikungunya vaccine live.

Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines including chikungunya vaccine live. Procedures should be in place to avoid injury from fainting.

Limitations of Vaccine Effectiveness

Vaccination with chikungunya vaccine live may not protect all individuals.

Specific Populations

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to chikungunya vaccine live during pregnancy. Individuals who receive the vaccine during pregnancy are encouraged to contact directly, or have their healthcare professional contact OXON Epidemiology at 1-855-417-6214 to enroll in or obtain information about the registry.

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There are no adequate and well-controlled studies of chikungunya vaccine live in pregnant individuals, and human data available from clinical trials with the vaccine are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy.

A developmental study was conducted in female rats. Animals were administered a single human dose of chikungunya vaccine live on 2 occasions, once prior to mating and once during gestation. This study revealed no evidence of harm to the fetus and no adverse effects on post-natal development due to the vaccine.

Vertical transmission of wild-type CHIKV to neonates from pregnant individuals with viremia at delivery is common and can cause severe, potentially fatal CHIKV disease in neonates, with neurologic (e.g., encephalopathy, intracranial hemorrhage) and myocardial manifestations. Vertical transmission of wild-type CHIKV and fetal death attributable to CHIKV in the context of antepartum infection has been reported to occur infrequently.

Vaccine viremia occurred in the first week following administration of a vaccine containing the same attenuated CHIKV as in chikungunya vaccine live, with resolution of viremia by 14 days after vaccination. It is not known if the vaccine virus can be transmitted from a pregnant individual to the fetus or neonate and cause fetal or neonatal adverse reactions.

Decisions to administer chikungunya vaccine live during pregnancy should take into consideration the individual’s risk of exposure to wild-type CHIKV, gestational age, and risks to the fetus or neonate from vertical transmission of wild-type CHIKV.

Closely monitor neonates for 7 days after birth for potential disease due to vaccine virus if they are born within 14 days of their mother receiving chikungunya vaccine live.

Lactation

Human data are not available to assess the impact of chikungunya vaccine live on milk production, its presence in breast milk, or its effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for chikungunya vaccine live and any potential adverse effects on the breastfed child from the vaccine or from the underlying maternal condition. For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine.

Vaccine viremia occurs after vaccination. In a clinical trial, vaccine virus was not detectable at 14 days after vaccination. The potential for transmission of the vaccine virus from mother to infant through breastmilk is unknown.

Pediatric Use

The safety and effectiveness of chikungunya vaccine live in individuals younger than 18 years of age have not been established.

Geriatric Use

Of the total number of participants in clinical studies of chikungunya vaccine live, 9.6% (n=346) were 65 years of age and older, while 1.6% (n=59) were 75 and older. In Study 1, no overall difference in effectiveness was observed between participants 65 years of age and older and younger participants. Study 1 did not include sufficient numbers of participants 65 years of age and older to determine if there was an overall difference in safety between these participants and younger participants.

Common Adverse Effects

In clinical studies, the most common solicited injection site reaction (>10%) was tenderness (10.6%). The most common solicited systemic adverse reactions (>10%) were headache (31.6%), fatigue (28.5%), myalgia (23.9%), arthralgia (17.2%), fever (13.5%), and nausea (11.2%).

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

Chikungunya vaccine live contains live, attenuated chikungunya virus (generated by reverse genetics from La Réunion strain LR-CHIKV clone LR2006 OPY1). The attenuated virus has a deletion in non-structural protein 3, which encodes a component of the viral replicase complex, and replicates less efficiently than the wild-type CHIKV. The vaccine virus is propagated in Vero cells (a continuous line of monkey kidney cells) in media containing amino acids, vitamins, minerals and fetal bovine serum. The exact mechanism of protection of the vaccine has not been determined. Chikungunya vaccine live elicits CHIKV-specific immune responses.

Advice to Patients

• Advise the vaccine recipient to read the FDA-approved patient labeling (Patient Information).

• Question the vaccine recipient about reactions to previous vaccines.

• Inform the vaccine recipient of the benefits and risks of chikungunya vaccine live, including the potential for severe or prolonged chikungunya-like adverse reactions and the potential for vertical transmission of vaccine virus from pregnant individuals and potential fetal/neonatal adverse reactions.

• Advise the recipient that chikungunya vaccine live may not protect everyone who gets the vaccine and that personal precautions should be taken to reduce exposure to mosquito bites (e.g., adequate clothing, use of repellents, mosquito nets).

• There is a pregnancy exposure registry for chikungunya vaccine live. Encourage individuals exposed to the vaccine around the time of conception or during pregnancy to register by calling 1-855-417-6214 or by visiting www.valneva-oxon.com/IXCHIQPregnancyRegistry.

• Advise vaccine recipient to report any adverse reactions to their healthcare provider or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 and www.vaers.hhs.gov.

Additional Information

AHFSfirstRelease^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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