Consumer medicine information

Jespect

Japanese encephalitis virus vaccine (inactivated)

BRAND INFORMATION

Brand name

Jespect

Active ingredient

Japanese encephalitis virus vaccine (inactivated)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Jespect.

What is in this leaflet

This leaflet answers some common questions about JESPECT®.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you having JESPECT® against the benefits they expect it will have.

If you have any concerns about this vaccine, talk to your doctor, nurse or pharmacist.

Keep this leaflet. You might need to read it again.

What JESPECT® is used for

JESPECT® is a vaccine. It helps prevent Japanese encephalitis (en-kef-al-i-tis), a severe and often fatal infection of the brain. Some of those who recover from the disease are often left with brain damage.

Japanese encephalitis is caused by the Japanese encephalitis virus that mainly occurs in Asia. The virus is transmitted to humans by infected mosquitoes that feed on human blood.

JESPECT® is used to vaccinate persons 18 years and older who:

  • plan to live in or travel to areas where Japanese encephalitis is common or seasonal. Your doctor will explain your individual risk of catching the disease
  • work with Japanese encephalitis virus.

JESPECT® is given as two injections 28 days apart. The vaccination course should be completed at least one week before potential exposure to the Japanese encephalitis virus.

How JESPECT® works

JESPECT® works by getting your body to produce its own protection against the Japanese encephalitis virus.

The vaccine does not contain live virus and cannot give you the illness.

After you have been given JESPECT®, your body makes substances called antibodies. These antibodies fight the Japanese encephalitis virus. When you come into contact with the virus, your body is usually ready to destroy it.

Most people who receive both doses of the vaccine will produce enough antibodies to protect against the disease. However, as with all vaccines, 100% protection cannot be guaranteed.

JESPECT® does not protect against encephalitis caused by other viruses or bacteria.

Before you are given JESPECT®

When you must NOT be given JESPECT®

JESPECT® should not be given to any person under 18 years of age.

Do not use JESPECT® after the expiry date printed on the pack.

Do not use JESPECT® if the packaging is torn, shows signs of tampering or does not look quite right.

If you are not sure whether you should have JESPECT®, talk to your doctor or pharmacist.

Before you are given JESPECT®

Tell your doctor if you have allergies to:

  • any previous injections of JESPECT® or any of the ingredients listed at the end of this leaflet
  • any other medicines or vaccines
  • any other substances, such as foods, preservatives or dyes.

As for all vaccines, medical supervision and treatment should be available in case there is a severe allergic reaction.

Tell your doctor if you:

  • tend to bleed or bruise easily
  • are taking any other medicines including medicines you buy without prescription from a pharmacy, supermarket or health food shop
  • have a high temperature,
  • if your immune system does not work properly
  • have had any other travel vaccines.

Tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the possible risks and benefits of having JESPECT® during pregnancy.

How JESPECT® is given

JESPECT® is given by a trained health professional as an injection into the upper arm.

How much is given and when

Two doses of vaccine will be given, 28 days apart. Each dose of the vaccine is 0.5 mL.

If you miss the second dose of vaccine, talk to your doctor. It is important that you are given the second dose so that your body can produce enough antibodies to protect against the Japanese encephalitis virus.

Your doctor may decide that you need a booster dose 1–2 years after receiving the vaccine. Your doctor will tell you if a booster dose is required.

Ask your doctor or pharmacist to answer any questions you may have.

If you are given too much (overdose)

As each JESPECT® pre-filled syringe contains only one dose, overdosage is unlikely.

If you think you or anyone else may have been given too much of this medicine

  • consult your doctor immediately, or
  • telephone the Poisons Information Centre (telephone 13 11 26 in Australia or 0800 POISON (0800 764 766) in New Zealand) for advice, or
  • go to Accident and Emergency at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. Urgent medical attention may be required.

After having JESPECT®

Things you must do

Take appropriate precautions to reduce mosquito bites (wear adequate clothing, use repellents and mosquito nets).

Keep an updated record of your vaccinations.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after having JESPECT®.

All medicines, including vaccines, can have side effects. JESPECT® may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • reaction at the injection site such as temporary redness, tenderness, itching, pain, bruising, bleeding or swelling
  • a small lump at the injection site; sometimes this may last for a few weeks
  • sore throat, runny or blocked nose
  • muscle pain or stiffness
  • flu like symptoms, such as headache, fatigue, fever, chills, aching joints
  • nausea, vomiting, diarrhoea, stomach ache
  • dizziness
  • migraine
  • skin rash
  • inflammation of the glands.

These side effects are usually mild.

Tell your doctor as soon as possible if you notice any of the following:

  • abnormal sensation like tingling, pricking or numbness
  • painful swelling of the arms or legs.
  • fainting

The above list includes serious side effects that may require medical attention.

Allergic reaction:

As with all vaccines given by injection, there is a very small risk of a severe allergic reaction.

If any of the following happen, tell your doctor or pharmacist immediately, or go to Accident and Emergency at your nearest hospital:

  • sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body
  • shortness of breath, wheezing or trouble breathing
  • collapse.

These are very serious side effects. If you have them, you may have had a severe allergic reaction to JESPECT®. You may need urgent medical attention or hospitalisation. This type of side effect usually occurs within the first few hours of being given the vaccine. These side effects are very rare.

Other side effects not listed above might occur in some people. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storing JESPECT®

JESPECT® is usually stored in the doctor’s surgery or clinic, or at the pharmacy. However, if you need to store JESPECT®:

  • Keep it where children cannot reach it.
  • Keep it in the original pack until it is time for it to be injected.
  • Keep it in the refrigerator, between 2°C and 8°C. DO NOT FREEZE. Freezing destroys the vaccine.

Product description

What JESPECT® looks like

JESPECT® is supplied as a single dose (0.5 mL) in a needle-less pre-filled glass syringe. The vaccine should appear as a clear liquid with a white precipitate and when shaken, it should appear as a white, cloudy suspension.

Ingredients in a single dose

Active ingredients:

  • Inactivated Japanese encephalitis virus strain SA14–14–2 produced in Vero cells: 6 AgU (antigen units).

Other ingredients:

  • aluminium hydroxide hydrate
  • sodium chloride
  • monobasic potassium phosphate
  • dibasic sodium phosphate
  • water for injections.

JESPECT® does NOT contain:

  • lactose
  • gluten
  • tartrazine or
  • any other azo dyes
  • preservatives.

JESPECT® may contain trace amounts of sucrose and protamine sulphate.

Manufacturer/Distributor

Manufacturer

JESPECT® is made by:

Valneva Scotland Ltd.
Oakbank Park Road
EH53 OTG Livingston
United Kingdom

Sponsor

JESPECT® is distributed in Australia by:

Seqirus Pty Ltd
ABN: 26 160 735 035
63 Poplar Road
Parkville, VIC 3052
Australia
Telephone: 1800 642 865
www.seqirus.com.au

JESPECT® is distributed in New Zealand by:

Seqirus (NZ) Ltd
PO Box 62 590
Greenlane, Auckland 1546
New Zealand

Registration number

Australia
AUST R 150602

New Zealand
TT50-9020

Date of preparation

June 2020

JESPECT® is a trademark of Valneva Scotland Ltd

Published by MIMS December 2020

BRAND INFORMATION

Brand name

Jespect

Active ingredient

Japanese encephalitis virus vaccine (inactivated)

Schedule

S4

 

1 Name of Medicine

Inactivated Japanese encephalitis vaccine (adsorbed).

2 Qualitative and Quantitative Composition

Jespect Japanese encephalitis (JE) virus, purified inactivated vaccine is a sterile, ready to use suspension for intramuscular (IM) injection. The vaccine is prepared by propagating Japanese encephalitis virus strain (SA14-14-2) in Vero cells. No preservatives or antibiotics are added to the formulation.
Jespect is a clear liquid with white precipitate and when shaken before use, a white/cloudy suspension forms. Jespect is supplied in pre-filled syringes without needles. Each 0.5 mL dose of vaccine contains 6 antigen units (AgU) of purified, inactivated JE virus. Each dose of vaccine also contains the following excipients: 0.1% aluminium hydroxide hydrate corresponding to 0.25 mg aluminium, and Phosphate Buffered Saline.
Phosphate Buffered Saline has the following saline composition:
sodium chloride - 9 mg/mL;
monobasic potassium phosphate - 0.144 mg/mL;
dibasic sodium phosphate - 0.795 mg/mL.

3 Pharmaceutical Form

Jespect is supplied as a 0.5 mL suspension in a pre-filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer) in a pack size of 1 needle-less syringe.
To attach needle, remove the syringe cap by gently twisting it. Do not attempt to snap or pull the tip off as this may damage the syringe.

4 Clinical Particulars

4.1 Therapeutic Indications

Jespect is indicated for active immunisation against Japanese encephalitis (JE) virus for persons 18 years of age and older.
Jespect should be considered for use in persons who plan to reside in or travel to areas where JE is endemic (common) or epidemic (seasonal), especially during the transmission season.
Jespect is indicated for persons who work with JE virus in laboratories and in industry.

4.2 Dose and Method of Administration

Primary vaccination.

The primary vaccination series consists of a total of two doses of 0.5 mL each according to the following schedule.
First dose at Day 0 (elected date).
Second dose: 28 days after first dose.
It is recommended that persons who receive the first dose of Jespect complete the 2-dose primary vaccination course.
If the primary immunisation schedule of 2 doses is not completed, sufficient protection against Japanese encephalitis virus might not be achieved. Clinical trial data indicates that administration of the second dose up to 11 months after the first dose results in high seroconversion rates (see Section 5.1 Pharmacodynamic Properties, Clinical trials, Incomplete primary immunisation).

Booster dose.

See Section 5.1 Pharmacodynamic Properties, Clinical trials for clinical trial data for potential booster doses.
The vaccine should be inspected visually for presence of particulate matter and discolouration prior to administration. Discard the product if particulates are present, if it appears discoloured or if the syringe appears to be physically damaged. Any unusual product or waste material should be disposed of in accordance with local requirements.
Jespect should be well shaken before administration to obtain a homogenous suspension. Once shaken, the vaccine should appear as a white cloudy suspension.
Jespect should be administered by IM injection into the deltoid muscle. It should never be injected IV.
In exceptional circumstances, for those patients with thrombocytopenia or bleeding disorders where bleeding may occur following IM administration, Jespect may be administered subcutaneously. Subcutaneous administration could lead to a suboptimal response to the vaccine.
Jespect pre-filled syringe is for single use only in one individual only. Inject the entire contents of the syringe.

4.3 Contraindications

Jespect should not be administered to individuals who have previously experienced a serious reaction (e.g. anaphylaxis) to this vaccine or who are known to be hypersensitive to any of the vaccine components or to the residues protamine sulphate, formaldehyde, bovine serum albumin, host cell DNA, sodium metabisulphite or host cell protein. Individuals who show hypersensitivity reactions after receiving the first dose of the vaccine should not be given the second dose.

4.4 Special Warnings and Precautions for Use

As with other injectable vaccines, appropriate medical treatment and supervision should always be available in the event of anaphylactic reaction. Adrenaline should always be readily available whenever the injection is given.
Jespect will not protect against encephalitis caused by other organisms. As with any other vaccine, vaccination with Jespect may not result in protection in all cases. The primary vaccination series (2 doses) should be completed at least one week prior to potential exposure to Japanese encephalitis virus. Seroconversion rates after one dose are limited (see Section 5.1 Pharmacodynamic Properties, Clinical trials, Table 3).
Jespect should be administered by IM injection into the deltoid muscle. It should never be injected IV. In exceptional circumstances, for those patients with thrombocytopenia or bleeding disorders where bleeding may occur following IM administration, Jespect may be administered subcutaneously. Subcutaneous administration could lead to a suboptimal response to the vaccine (see Section 4.2 Dose and Method of Administration).
As with other vaccines, Jespect should not be administered in persons with acute severe febrile illness.
Safety and efficacy of Jespect have not been established in persons with a history of flavivirus (including JE virus, yellow fever virus, Dengue virus and Murray Valley encephalitis virus) infection and/or vaccination against JE or yellow fever (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Paediatric use.

The safety and efficacy of Jespect in persons under 18 years of age have not been established.

Use in the elderly.

Special studies in the geriatric population have not been performed; however, Jespect has been administered to 118 subjects ≥ 65 years of age. No overall differences in safety and effectiveness were observed between these subjects and younger subjects.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant administration of Jespect with inactivated hepatitis A vaccine (Havrix 1440) has been explored in one clinical trial (study IC51-308). There was no interference with the immune response to the JE virus and HAV, respectively (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
Vaccination with Jespect in persons with vaccine induced tick born encephalitis (TBE) antibodies resulted in comparable SCR and GMT at Day 56 compared to TBE naive persons.
Vaccination with Jespect concurrently with or after administration of other flavivirus vaccines (including yellow fever vaccine) has not been assessed.
If co-administration with other vaccines is indicated, injections should be given into separate limbs. It should be noted that adverse reactions might be intensified.
In patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immune response may be diminished.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No significant effects on mating performance or fertility were observed in vaccine treated rats administered with IM Jespect prior to mating (3 weeks (regimen 1 only) and 1 week) during gestation (day 6). The effect of Jespect administration on male fertility has not been evaluated (see Use in pregnancy).
(Category B1)
In a three phase reproductive study of female rats administered approximately the clinical IM dose of Jespect (5 microgram) prior to mating (3 weeks (regimen 1 only) and 1 week) and during gestation (day 6), there were no significant toxicological effects in the dams. High JEV-specific antibody titres were detected in maternal blood during gestation (day 5 and 20) in fetal cord blood and at the end of gestation (day 20), and in pups at weaning (lactation day 21).
In a reproductive and pre-/post-natal toxicity study, no vaccine-related effects were detected on reproduction, foetal weight, survival and development of the off-springs. However, incomplete ossification of parts of the skeleton was observed in the group receiving 2 doses, but not in the group receiving 3 doses. There is currently no evidence that this phenomenon is treatment related.
There are limited data from the use of Jespect in pregnant women. The vaccine should be used during pregnancy only when clearly needed and the possible advantages outweigh the possible risks for the fetus.
It is not known whether vaccine antigens or antibodies induced by the vaccine are excreted in human milk. Therefore, caution should be exercised when Jespect is administered to a nursing woman.
In a three phase reproductive study of maternal treatment of rats with IM Jespect prior to mating and during gestation, assessed to lactation day 21, high JEV-specific antibody titres were detected in maternal blood during gestation, in fetal cord blood at the end of gestation and in pups at weaning (see Use in pregnancy).
Adequate human data on Jespect use during lactation are not available. Jespect should be administered to women who are breastfeeding only when clearly needed.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Adverse Effects (Undesirable Effects)

The safety of Jespect has been assessed in different controlled clinical trials in which more than 5,405 healthy adults were included of which 4,248 healthy adults received the vaccine.
Approximately 40% of treated subjects can be expected to experience adverse reactions. They usually occur within the first three days after vaccination, are usually mild and disappear within a few days. No increase in the number of undesirable reactions was noted between first and second doses. The incidence of systemic and local symptoms was less prominent after the second vaccination.
Most commonly reported adverse reactions included headache and myalgia occurring in approximately 20% and 13% of subjects, respectively. The treatment-related, treatment-emergent adverse events seen in clinical trials are described in Table 1.
The incidence of local symptoms from a pooled safety population is described in Table 2. Please note the results are from subject diary cards on the day of first and second vaccination.

Post marketing experience.

The following adverse events have been reported during post marketing use of Jespect. Because these events are reported voluntarily, it is not possible to estimate frequency.

Nervous system disorders.

Paraesthesia, neuritis, syncope.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

There have been no cases of overdosage reported.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

No data available.

Clinical trials.

Efficacy (immunogenicity) of Jespect has been studied in approximately 2,228 healthy, adult subjects in 10 multi-centre clinical trials conducted in the US and Europe.
Immunogenicity of the vaccine was evaluated in a randomized, active-controlled, observer-blinded, multicenter Phase 3 clinical trial (trial IC51-301) conducted in the US, Germany and Austria in healthy male and female subjects ≥ 18 years of age (mean age: 41.3 years; 60.8% female; race: Caucasian 80.8%, Asian 0.8%, Black/African American 13.1%, and Other 5.3%). Subjects were randomised to receive either two separate doses of 6 microgram/0.5 mL of Jespect (on a 0, 28-day schedule by IM injection) (n = 430) or three separate doses of 1.0 mL of the JE vaccine JE-Vax (on a 0, 7 and 28 day schedule by subcutaneous injection) (n = 437). The co-primary endpoint was seroconversion rate (anti-JE virus antibody titer ≥ 1:10) and geometric mean titer (GMT) at Day 56 as assessed by a Plaque Reduction Neutralisation Test (PRNT) for the entire study population.
By Day 56, the proportion of subjects who had seroconverted was similar for both treatment groups (96.4% vs. 93.8% for Jespect and JE-Vax, respectively) (see Table 3). Geometric mean titers increased by Day 56 to 243.6 for Jespect and to 102.0 for JE-Vax, respectively. The immune responses elicited by Jespect were non-inferior to those induced by JE-Vax (see Table 3).
The effect of age on the immune response to Jespect and JE-Vax was assessed as a secondary endpoint (trial IC51-301), comparing subjects 50 years of age or older (N = 262, mean age 59.8) with those below 50 years of age (N = 605, mean age 33.9). There was no significant difference between seroconversion rates of Jespect and JE-Vax in subjects aged < 50 years compared to those aged ≥ 50 years at Day 28 or Day 56 following vaccination. Geometric mean titers were significantly higher at Day 28 in subjects aged < 50 years than those aged ≥ 50 years in the JE-Vax group (80.9 vs. 46.9, p = 0.0236) but there was no significant difference at Day 56 for this treatment group. In addition there were no significant effects of age on GMT in the group receiving Jespect and no significant difference between seroconversion rates in subjects aged < 50 years compared to those aged ≥ 50 years at Day 28 or Day 56 for either treatment group.

Antibody persistence.

Antibody persistence was assessed in an uncontrolled Phase 3 follow-up clinical trial (trial IC51-303) of subjects who completed the pivotal immunogenicity study (trial IC51-301) or the pivotal safety study (trial IC51-302), and who received at least one dose of Jespect. The primary objective of the study was the evaluation of the immune response (seroconversion rate) to Jespect 24 months after the first vaccination. Secondary objectives included the evaluation of the immune response to Jespect 6, 12, 24 and 36 months after the first vaccination and to evaluate the safety of Jespect during the respective study period (see Section 4.8 Adverse Effects (Undesirable Effects)). A total of 3,258 healthy male and female subjects were enrolled (mean age: 35.6 years, 56.5% female, race: Caucasian 90.2%, Asian 1.7%, Black/African American 4.9%, Other 3.2%) of which 2,283 subjects received Jespect, 338 subjects received JE-Vax, and 637 subjects received placebo in the respective previous study. Long-term immunogenicity to Jespect was assessed in a subset of 181 subjects up to 24 months, and a subset of 152 subjects at 36 months (ITT population). Immunogenicity data covering a period up to 36 months after the first vaccination are described below.
Seroconversion rates for anti-JE virus antibodies at Months 2, 6, 12, 24 and 36 are summarized in Table 4 for the ITT population. At Month 2, 98.9% of subjects had seroconverted (95% CI: 96.06, 99.70), at Month 6, 95.0% of subjects had seroconverted (95% CI: 90.82, 97.36). By Month 12, the percentage of subjects who had seroconverted was 83.4% (95% CI: 77.33, 88.14). Seroconversion at 24 months and 36 months was 81.8% (95% CI: 75.50, 86.71) and 84.9% (95% CI: 78.32, 89.70) respectively.
In the ITT2 population, which is a subset of the ITT population with positive PRNT results at Month 2, per definition, 100% of the subjects (N = 179) had seroconverted at Month 2 (95% CI: 97.90%, 100.00%). By Month 6 and Month 12, the number of subjects of the ITT2 population who had seroconverted was 95.5% (95% CI: 91.43, 97.72) and 83.8% (95% CI: 77.70, 88.48) respectively (see Table 4). The number of subjects of the ITT2 population who had seroconverted at 24 months was 82.1% (95% CI: 75.85, 87.04) and at 36 months was 84.8% (95% CI: 78.18, 89.63).
Geometric mean titers at Months 2, 6, 12, 24 and 36 after vaccination with Jespect are summarized in Table 5. At Month 2, the GMT was 310.8 (95% CI: 268.76, 359.44) which decreased to 83.5 (95% CI: 70.89, 98.38) at Month 6 and to 41.2 (95% CI: 34.39, 49.33) at Month 12 after vaccination with Jespect. At Month 24 and 36, the GMT was 44.3 (95% CI: 36.72, 53.44) and 43.8 (95% CI: 36.49, 52.56) respectively.
The results were confirmed in the ITT2 population.
Vaccination with inactivated JE vaccine is known to produce antibodies that decline with time in a proportion of the vaccinated population. The observed decline in GMT is therefore as expected and compares well with data from other inactivated JE vaccines.
Results of another Phase 3 follow-up clinical trial (trial IC51-305) support these findings. In this study, 58.3% and 48.3% of subjects who received the recommended primary vaccination series (see Section 4.2 Dose and Method of Administration) showed persisting protective antibodies 12 and 24 months (respectively) after completion of primary vaccination. See Incomplete primary immunisation.

Booster immunisation.

The effect of booster vaccination of Jespect on long-term immunogenicity was investigated in an uncontrolled, open label, Phase 3 clinical trial in healthy male and female adults (trial IC51-311). Subjects (n = 198) were administered one 6 microgram/0.5 mL dose of Jespect 15 months after their first dose (Day 0) of the recommended primary vaccination series (see Section 4.2 Dose and Method of Administration). The primary endpoint was assessment of the effect of booster vaccination on immunogenicity in terms of seroconversion rate 12 months after administration of the booster dose (equivalent to 27 months after first dose (Day 0) of the recommended primary vaccination series). Secondary endpoints included assessment of seroconversion 28 days and 6 months after administration of the booster dose, and GMT 28 days, 6 months and 12 months after booster vaccination (equivalent to 16, 21 and 27 months after first dose (Day 0) of the recommended primary vaccination series).
Pre-booster vaccination, 69.2% of subjects had seroconverted and GMT was 22.5 (95% CI: 19.0, 26.7).
Seroconversion was 100% at 28 days after administration of the booster vaccination and remained high (98.5%) to 12 months after administration of the booster vaccination (equivalent to 27 months after first dose (Day 0) of the recommended primary vaccination series) (see Table 6).
Geometric mean titers were highest 28 days after receiving the booster vaccination and declined to 361.4 after 12 months (equivalent to 27 months after first dose (Day 0) of the recommended primary vaccination series) (see Table 6).

Incomplete primary immunisation.

Immunogenicity following incomplete primary vaccination was investigated in a non-randomized, open label, multicenter Phase 3 clinical trial (trial IC51-305) conducted in healthy male and female adults (n = 349). Subjects received either the recommended primary vaccination schedule (see Section 4.2 Dose and Method of Administration); one 6 microgram/0.5 mL dose of Jespect on Day 0 and a second 6 microgram/0.5 mL dose of Jespect on Day 28) (n = 116), or one single dose of 6 microgram/0.5 mL dose of Jespect (on Day 0) (n = 117), or one 12 microgram/0.5 mL dose of Jespect (on Day 0) (n = 116). Those subjects that were seronegative (PRNT50 titers < 1:10) at Month 6 received a single 6 microgram/0.5 mL booster dose at 11 months after the first dose (Day 0). Those subjects that were seronegative at Month 12 received a single 6 microgram/0.5 mL booster dose at 23 months after the first dose (Day 0).
Administration of the second injection of the primary immunisation series up to 11 months after the first dose results in 99% seroconversion and GMT of 504.3 (95% CI 367.3, 692.3) (see Table 7).

Concomitant use.

The concomitant use of Jespect with inactivated hepatitis A virus (HAV) vaccine (Havrix 1440) has been explored in one clinical trial (study IC51-308). There was no interference with the immune response to the JE virus and HAV, respectively. Concomitant administration of Jespect and inactivated hepatitis A vaccine was shown to be non-inferior to single vaccinations with regard to GMT of anti-JE virus neutralising antibody and HAV antibody, and for seroconversion rates of both antibody types.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Animal studies in mice, rats and rabbits have shown that the Jespect vaccine induces the immune system to produce neutralising antibodies against Japanese encephalitis virus which correlate with protection and survival. Mice treated with Jespect vaccine or human Jespect antisera demonstrated protection against lethal Japanese encephalitis challenge from several different strains (SA14, Beijing and KE-093) in a generally dose- or titre-dependent manner, respectively.

Genotoxicity.

Jespect has not been evaluated for genotoxic potential.

Carcinogenicity.

Jespect has not been evaluated for carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store in a refrigerator at 2° to 8°C. Do not freeze. Store in the original package in order to protect from light.
Do not use if the package is torn or damaged.
Do not use the vaccine after the expiration date shown on the label.
Upon storage, a fine white deposit with a clear colourless supernatant can be observed. Shake well before use.

6.5 Nature and Contents of Container

Packed in a pre-filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer).
Jespect is available in a pack size of 1 needle-less syringe containing 0.5 mL dose.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

No data available.

CAS number.

Not applicable.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes