TICOVAC Clinical Studies

(tick-borne encephalitis vaccine,whole virus, inactivated)

14 CLINICAL STUDIES

14.1 Immunogenicity

Primary Immunization Course

The immunogenicity of TICOVAC described in this section is based on results from the following studies:

•
Study 209: Healthy subjects 1 through 15 years of age TBE seronegative at baseline received three vaccinations with TICOVAC. The first two vaccinations were given 1 month apart followed by the third vaccination 6 months after the first vaccination.
•
Study 213: Healthy subjects 16 to 64 years of age TBE seronegative at baseline who had received two vaccinations in Study 208 given one month apart, received a third vaccination with TICOVAC 6 months after the first vaccination in Study 208.
•
Study 690601: Healthy subjects 16 years of age and older TBE seronegative at baseline received three vaccinations with TICOVAC. The first two vaccinations were given 14 days apart followed by the third vaccination 6 months after the first vaccination.

Table 6 shows neutralization test (NT) seropositivity rates 21 days after the third vaccination in subjects 1 through 15 years of age vaccinated with TICOVAC in Study 209.

Table 6:Seropositivity Rates (NT)* by Age Group; Post Dose 3† (Study 209)
Age Group% (n/N)(95% CI)‡
Abbreviations: CI=confidence interval; NT=neutralization test.
Clinical trial identifier: NCT00161863.
*
Seropositivity was defined as NT ≥1:10 (Neudoerfl TBE strain).
†
Evaluated 21 days after Dose 3.
‡
Exact 2-sided CI calculated using the Clopper and Pearson method.

1–5 Years

99.2% (125/126)

(95.7%, 100.0%)

6–15 Years

99.6% (240/241)

(97.7%, 100.0%)

Total

99.5% (365/367)

(98.0%, 99.9%)

Table 7 shows NT seropositivity rates 21 days after the third vaccination in subjects 16 years of age and older vaccinated with TICOVAC in Study 690601 and Study 213.

Table 7:Seropositivity Rates (NT)* by Age Group; Post Dose 3† TICOVAC (Studies 213 and 690601)
Age Group
(Study Number)		% (n/N)(95% CI)‡
Abbreviations: CI=confidence interval; NT=neutralization test.
Clinical trial identifiers: NCT00161876 and NCT00460486.
*
Seropositivity was defined as NT ≥1:10 (Neudoerfl TBE strain).
†
Evaluated 21 days after Dose 3.
‡
Exact 2-sided CI calculated using the Clopper and Pearson method.

16–64 Years (Study 213)

98.8% (411/416)

(97.2%, 99.6%)

16–49 Years (Study 690601)

100.0% (144/144)

(97.5%, 100.0%)

≥50 Years (Study 690601)

98.7% (151/153)

(95.4%, 99.8%)

Seven days after the third vaccination, 90.6% of the subjects 16 years of age and older were seropositive (Study 690601).

Seropersistence and Booster Vaccination

Two open-label, multi-center, follow-up studies which enrolled subjects who were seropositive 1 month after the third vaccination from Studies 213 (N=252, ages 16 through 65 at the time of first TICOVAC dose) and 209 (N=358, ages 1 through 15 at the time of first TICOVAC dose) were conducted to assess the seropersistence of TBE antibodies after completion of the primary vaccination series and the antibody response to a booster administration. Three years after the primary series of TICOVAC , NT seropositivity in follow-up studies 223 and 700401 ranged from 82.9% to 100% depending on age. Following a booster dose the NT seropositivity rates were 100%.

14.2 Field Vaccine Effectiveness

In Austria, field effectiveness of TBE vaccines was assessed retrospectively for the period from 2000 to 2011. During this period, two TBE vaccines were available in Austria. The market coverage in Austria for TICOVAC was 95%, 90%, and 80%, in 2000, 2006, and 2011, respectively.1 The calculation of TBE vaccine effectiveness overall is based on (1) the annual numbers of serologically confirmed cases of TBE virus infections with neurological symptoms causing hospitalization (2) their vaccination history, and (3) the proportion of vaccinated and unvaccinated in the Austrian population. During the study period, the recommended vaccination schedule in Austria consisted of 2 vaccinations approximately 4 weeks apart followed by a third vaccination 5–12 months after the second dose, and a booster vaccination ≥3 years after the third dose. The TBE cases were categorized based on their vaccination status. Among the 883 TBE cases in Austria between 2000 and 2011, 45 patients did not have an accurate vaccination history. The best-case and worst-case estimates of vaccine effectiveness were calculated. For the best-case estimate, the 45 patients without an accurate vaccination history were excluded from the calculation. For the worst-case estimate, these 45 patients were assumed to have been vaccinated according to the recommended schedule. The proportions of vaccinated and unvaccinated individuals in the general population were estimated using annual postal surveys sent to 4,000 households (8,500–10,000 household members). Overall, worst-case and best-case TBE vaccine effectiveness for preventing hospitalized TBE was estimated to be 96.3% (95% CI: 95.5, 97.0) and 98.7% (95% CI: 98.2, 99.0), respectively, following at least 3 doses of TBE vaccine administered according to the recommended schedule in Austria.2

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Clinical Studies

14 CLINICAL STUDIES

14.1 Immunogenicity

Primary Immunization Course

The immunogenicity of TICOVAC described in this section is based on results from the following studies:

•
Study 209: Healthy subjects 1 through 15 years of age TBE seronegative at baseline received three vaccinations with TICOVAC. The first two vaccinations were given 1 month apart followed by the third vaccination 6 months after the first vaccination.
•
Study 213: Healthy subjects 16 to 64 years of age TBE seronegative at baseline who had received two vaccinations in Study 208 given one month apart, received a third vaccination with TICOVAC 6 months after the first vaccination in Study 208.
•
Study 690601: Healthy subjects 16 years of age and older TBE seronegative at baseline received three vaccinations with TICOVAC. The first two vaccinations were given 14 days apart followed by the third vaccination 6 months after the first vaccination.

Table 6 shows neutralization test (NT) seropositivity rates 21 days after the third vaccination in subjects 1 through 15 years of age vaccinated with TICOVAC in Study 209.

Table 6:Seropositivity Rates (NT)* by Age Group; Post Dose 3† (Study 209)
Age Group% (n/N)(95% CI)‡
Abbreviations: CI=confidence interval; NT=neutralization test.
Clinical trial identifier: NCT00161863.
*
Seropositivity was defined as NT ≥1:10 (Neudoerfl TBE strain).
†
Evaluated 21 days after Dose 3.
‡
Exact 2-sided CI calculated using the Clopper and Pearson method.

1–5 Years

99.2% (125/126)

(95.7%, 100.0%)

6–15 Years

99.6% (240/241)

(97.7%, 100.0%)

Total

99.5% (365/367)

(98.0%, 99.9%)

Table 7 shows NT seropositivity rates 21 days after the third vaccination in subjects 16 years of age and older vaccinated with TICOVAC in Study 690601 and Study 213.

Table 7:Seropositivity Rates (NT)* by Age Group; Post Dose 3† TICOVAC (Studies 213 and 690601)
Age Group
(Study Number)		% (n/N)(95% CI)‡
Abbreviations: CI=confidence interval; NT=neutralization test.
Clinical trial identifiers: NCT00161876 and NCT00460486.
*
Seropositivity was defined as NT ≥1:10 (Neudoerfl TBE strain).
†
Evaluated 21 days after Dose 3.
‡
Exact 2-sided CI calculated using the Clopper and Pearson method.

16–64 Years (Study 213)

98.8% (411/416)

(97.2%, 99.6%)

16–49 Years (Study 690601)

100.0% (144/144)

(97.5%, 100.0%)

≥50 Years (Study 690601)

98.7% (151/153)

(95.4%, 99.8%)

Seven days after the third vaccination, 90.6% of the subjects 16 years of age and older were seropositive (Study 690601).

Seropersistence and Booster Vaccination

Two open-label, multi-center, follow-up studies which enrolled subjects who were seropositive 1 month after the third vaccination from Studies 213 (N=252, ages 16 through 65 at the time of first TICOVAC dose) and 209 (N=358, ages 1 through 15 at the time of first TICOVAC dose) were conducted to assess the seropersistence of TBE antibodies after completion of the primary vaccination series and the antibody response to a booster administration. Three years after the primary series of TICOVAC , NT seropositivity in follow-up studies 223 and 700401 ranged from 82.9% to 100% depending on age. Following a booster dose the NT seropositivity rates were 100%.

14.2 Field Vaccine Effectiveness

In Austria, field effectiveness of TBE vaccines was assessed retrospectively for the period from 2000 to 2011. During this period, two TBE vaccines were available in Austria. The market coverage in Austria for TICOVAC was 95%, 90%, and 80%, in 2000, 2006, and 2011, respectively.1 The calculation of TBE vaccine effectiveness overall is based on (1) the annual numbers of serologically confirmed cases of TBE virus infections with neurological symptoms causing hospitalization (2) their vaccination history, and (3) the proportion of vaccinated and unvaccinated in the Austrian population. During the study period, the recommended vaccination schedule in Austria consisted of 2 vaccinations approximately 4 weeks apart followed by a third vaccination 5–12 months after the second dose, and a booster vaccination ≥3 years after the third dose. The TBE cases were categorized based on their vaccination status. Among the 883 TBE cases in Austria between 2000 and 2011, 45 patients did not have an accurate vaccination history. The best-case and worst-case estimates of vaccine effectiveness were calculated. For the best-case estimate, the 45 patients without an accurate vaccination history were excluded from the calculation. For the worst-case estimate, these 45 patients were assumed to have been vaccinated according to the recommended schedule. The proportions of vaccinated and unvaccinated individuals in the general population were estimated using annual postal surveys sent to 4,000 households (8,500–10,000 household members). Overall, worst-case and best-case TBE vaccine effectiveness for preventing hospitalized TBE was estimated to be 96.3% (95% CI: 95.5, 97.0) and 98.7% (95% CI: 98.2, 99.0), respectively, following at least 3 doses of TBE vaccine administered according to the recommended schedule in Austria.2
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