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Safety and immunogenicity of IMVAMUNE® smallpox vaccine using different strategies for a post event scenario.

Publication ,  Journal Article
Frey, SE; Winokur, PL; Salata, RA; El-Kamary, SS; Turley, CB; Walter, EB; Hay, CM; Newman, FK; Hill, HR; Zhang, Y; Chaplin, P; Tary-Lehmann, M ...
Published in: Vaccine
June 24, 2013

INTRODUCTION: Reintroduction of Variola major as an agent of bioterrorism remains a concern. A shortened dosing schedule of Bavarian Nordic's (BN) IMVAMUNE(®) (modified vaccinia Ankara vaccine against smallpox) was compared to the currently recommended 0- and 28-day schedule for non-inferiority by evaluating the magnitude and kinetics of the immune responses. METHODS: Subjects were assigned to receive IMVAMUNE or placebo administered subcutaneously on Days 0 and 7, Days 0 and 28, or Day 0. Blood was collected for antibody and cell-mediated immune assays. Subjects were followed for safety for 12 months after last vaccination. RESULTS: The primary endpoint of this study was the geometric mean antibody titers (GMT) at 14 days post last vaccination. Of 208 subjects enrolled, 191 received vaccine (Group: 0+7, Group: 0+28 and Group: 0) and 17 received placebo. Moderate/severe systemic reactogenicity after any vaccination were reported by 31.1%, 25.4%, and 28.6% of the subjects for Group: 0+7, Group: 0+28, and Group: 0, respectively (Chi-square test, P=0.77). Based on BN's Plaque Reduction Assay GMTs, Group: 0+7 was non-inferior to Group: 0+28 at Day 4, 180, and 365 after the second vaccination. On Day 14, Group: 0+7 and Group: 0+28 GMT were 10.8 (CI: 9.0, 12.9) and 30.2 (CI: 22.1, 41.1), respectively. Based on BN's Enzyme-linked immunosorbent assay, the proportion of subjects with positive titers for Group: 0+28 was significantly greater than that for Group: 0+7 after second vaccination at Days 4 and 180. By Day 14 after the second dose, the IFN-γ enzyme-linked immunosorbent spot (ELISPOT) responses were similar for Group: 0+28 and Group: 0+7. CONCLUSION: Overall, a standard dose of IMVAMUNE (0.5 mL of 1 x 10(8) TCID/mL) administered subcutaneously was safe and well tolerated. A second dose of IMVAMUNE at Day 28 compared to Day 7 provided greater antibody responses and the maximal number of responders. By Day 14 after the second dose, IFN-γ ELISPOT responses were similar for Group: 0+28 and Group: 0+7.

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Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

June 24, 2013

Volume

31

Issue

29

Start / End Page

3025 / 3033

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Virology
  • Variola virus
  • Vaccines, Attenuated
  • Vaccination
  • Smallpox Vaccine
  • Smallpox
  • Male
  • Immunity, Cellular
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
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Frey, S. E., Winokur, P. L., Salata, R. A., El-Kamary, S. S., Turley, C. B., Walter, E. B., … Belshe, R. B. (2013). Safety and immunogenicity of IMVAMUNE® smallpox vaccine using different strategies for a post event scenario. Vaccine, 31(29), 3025–3033. https://doi.org/10.1016/j.vaccine.2013.04.050
Frey, Sharon E., Patricia L. Winokur, Robert A. Salata, Samer S. El-Kamary, Christine B. Turley, Emmanuel B. Walter, Christine Mhorag Hay, et al. “Safety and immunogenicity of IMVAMUNE® smallpox vaccine using different strategies for a post event scenario.Vaccine 31, no. 29 (June 24, 2013): 3025–33. https://doi.org/10.1016/j.vaccine.2013.04.050.
Frey SE, Winokur PL, Salata RA, El-Kamary SS, Turley CB, Walter EB, et al. Safety and immunogenicity of IMVAMUNE® smallpox vaccine using different strategies for a post event scenario. Vaccine. 2013 Jun 24;31(29):3025–33.
Frey, Sharon E., et al. “Safety and immunogenicity of IMVAMUNE® smallpox vaccine using different strategies for a post event scenario.Vaccine, vol. 31, no. 29, June 2013, pp. 3025–33. Pubmed, doi:10.1016/j.vaccine.2013.04.050.
Frey SE, Winokur PL, Salata RA, El-Kamary SS, Turley CB, Walter EB, Hay CM, Newman FK, Hill HR, Zhang Y, Chaplin P, Tary-Lehmann M, Belshe RB. Safety and immunogenicity of IMVAMUNE® smallpox vaccine using different strategies for a post event scenario. Vaccine. 2013 Jun 24;31(29):3025–3033.
Journal cover image

Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

June 24, 2013

Volume

31

Issue

29

Start / End Page

3025 / 3033

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Virology
  • Variola virus
  • Vaccines, Attenuated
  • Vaccination
  • Smallpox Vaccine
  • Smallpox
  • Male
  • Immunity, Cellular
  • Humans