A Phase 4 interventional study of FSME-IMMUN Vaccine in Tick-borne Encephalitis and Vaccine, sponsored by Region Örebro County. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Region Örebro County · Phase 4, Interventional, and Prevention
Tick-borne Encephalitis (TBE) can be prevented by vaccine. Vaccine failure, defined as a case of TBE regardless of previous vaccination, has been described and seems to be more predominant with increasing age, suggesting a less effective immune response following with increasing age. In fact previous studies has shown a reduced antibody response in elderly individuals compared to younger when vaccinated against TBE. As a result, in Sweden, an extra vaccine dose has been recommended during the primary vaccine schedule to individuals > 50 years of age. This alternative vaccine schedule has not been tested. The investigator aim to test if an extra vaccine dose in the primary vaccine schedule for those > 50 years of age improves the immune response and offers a corresponding immunity to younger individuals following TBE vaccination.
51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.
This study's planned enrollment of 90 is below the median of 192 across 32 interventional studies indexed under Encephalitis, Tick-Borne.
Browse Encephalitis, Tick-Borne studies →Region Örebro County is the lead sponsor of 124 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy individuals \> 50 years of age divided into age groups 50-59 years, 60-69 years and \>70 years, approximately 20 participants in each group. Vaccinated with 4 doses FSME immune Adult intramuscular injection according to the recommended primary vaccine Schedule in Sweden for individuals \> 50 years of age, at time 0, 1, 2 and 7 months.
Drug: FSME-IMMUN Vaccine
Healthy individuals \< 40 years of age. Vaccinated with 3 doses FSME immune Adult intramuscular injection according to the standard recommended primary vaccine at time 0, 1, and 7 months.
Drug: FSME-IMMUN Vaccine
0.5 ml intramuscular injection scheduled in the two different arms
Serological response to vaccination with TBE vaccine following primary vaccination
The proportion of individuals \> 50 years that achieves protective levels following the extra primary vaccine dose compared to the proportion of individuals tha achieve protective levels of neutralizing antibodies following the second vaccine dose in those \< 40 years.
Time frame: NT measured 1 months after vaccination
Serological response to vaccination with TBE vaccine following the full vaccine scehdule
The proportion of individuals \> 50 years that achieves protective levels of neutralizing antibodies following the final primary schedule ( dose 4), compared to those \< 40 years ( 3 doses).
Time frame: NT measured 1 months after vaccination
Cellular immunity in young and elderly ( immune cell expression)
T and B cell populations (flow cytometry) 7 days after TBE vaccination
Time frame: Measured 7 days after vaccination
Cellular immunity in young and elderly ( cytokine production)
Cytokine production ( Luminex) 7 days after TBE vaccination
Time frame: Measured 7 days after vaccination
Plan to share: Undecided
Start is estimated for Jan 2024; primary completion for Jan 2024, 0 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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