A Randomized, Double-Blind, Placebo-Controlled Phase II Trial Investigating the Safety and Immunogenicity of Modified Vaccinia Ankara Smallpox Vaccine (MVA-BN®) in 56-80-Year-Old Subjects

Modified Vaccinia Ankara MVA-BN® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56-80 years old population. MVA with a viru...

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Published inPloS one Vol. 11; no. 6; p. e0157335
Main Authors Greenberg, Richard N., Hay, Christine M., Stapleton, Jack T., Marbury, Thomas C., Wagner, Eva, Kreitmeir, Eva, Röesch, Siegfried, von Krempelhuber, Alfred, Young, Philip, Nichols, Richard, Meyer, Thomas P., Schmidt, Darja, Weigl, Josef, Virgin, Garth, Arndtz-Wiedemann, Nathaly, Chaplin, Paul
Format Journal Article
LanguageEnglish
Published United States Public Library of Science 21.06.2016
Public Library of Science (PLoS)
Subjects
Aged, 80 and over
Analysis
Biology and Life Sciences
Body temperature
Clinical trials
Demography
Double-Blind Method
Double-blind studies
EKG
Enzyme-Linked Immunosorbent Assay
Erythema
Fatigue
Female
Headache
Health care
HIV
Human immunodeficiency virus
Humans
Immune response (humoral)
Immune system
Immunogenicity
Immunological memory
Infections
Injection
Lymphocytes B
Male
Medical prognosis
Medicine and Health Sciences
Middle Aged
Myalgia
Nausea
Neutralization
Pain
Placebos
Population
Product development
Pruritus
Public health
Replicating
Replication
Research and Analysis Methods
Safety
Seroconversion
Smallpox
Smallpox Vaccine - adverse effects
Smallpox Vaccine - immunology
Smallpox vaccines
Studies
Vaccination
Vaccines
Vaccines, DNA
Vaccinia
Variola major
Viral Plaque Assay
Viral Vaccines - adverse effects
Viral Vaccines - immunology
Viruses
United States
Ankara Turkey
Iowa City Iowa
Turkey
United States > US
Germany
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Abstract Modified Vaccinia Ankara MVA-BN® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56-80 years old population. MVA with a virus titer of 1 x 108 TCID50/dose was administered via subcutaneous injection to 56-80 year old vaccinia-experienced subjects (N = 120). Subjects received either two injections of MVA (MM group) or one injection of Placebo and one injection of MVA (PM group) four weeks apart. Safety was evaluated by assessment of adverse events (AE), focused physical exams, electrocardiogram recordings and safety laboratories. Solicited AEs consisted of a set of pre-defined expected local reactions (erythema, swelling, pain, pruritus, and induration) and systemic symptoms (body temperature, headache, myalgia, nausea and fatigue) and were recorded on a memory aid for an 8-day period following each injection. The immunogenicity of the vaccine was evaluated in terms of humoral immune responses measured with a vaccinia-specific enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT) before and at different time points after vaccination. Vaccinations were well tolerated by all subjects. No serious adverse event related to MVA and no case of myopericarditis was reported. The overall incidence of unsolicited AEs was similar in both groups. For both groups immunogenicity responses two weeks after the final vaccination (i.e. Visit 4) were as follows: Seroconversion (SC) rates (doubling of titers from baseline) in vaccine specific antibody titers measured by ELISA were 83.3% in Group MM and 82.8% in Group PM (difference 0.6% with 95% exact CI [-13.8%, 15.0%]), and 90.0% for Group MM and 77.6% for Group PM measured by PRNT (difference 12.4% with 95% CI of [-1.1%, 27.0%]). Geometric mean titers (GMT) measured by ELISA two weeks after the final vaccination for Group MM were 804.1 and 605.8 for Group PM (with ratio of GMTs of 1.33 with 95% CI of [0.96, 1.84]). Similarly, GMTs measured by PRNT were 210.3 for Group MM and 126.7 for Group PM (with ratio 1.66 and 95% CI [0.95, 2.90]). One or two doses of MVA were safe and immunogenic in a 56-80 years old vaccinia-experienced population. No cases of myopericarditis were observed following vaccinations with MVA. The safety, reactogenicity and immunogenicity were similar to that seen in younger (18-55 year old) healthy populations as investigated in other MVA trials. The results suggest that a single dose of MVA in a 56-80 years old population was well tolerated and sufficient to rapidly boost the long-term B cell memory response induced by a prior vaccination with a traditional smallpox vaccine. ClinicalTrials.gov NCT00857493.
AbstractList Modified Vaccinia Ankara MVA-BN.sup.® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN.sup.® (MVA) was assessed in a 56-80 years old population. MVA with a virus titer of 1 x 10.sup.8 TCID.sub.50 /dose was administered via subcutaneous injection to 56-80 year old vaccinia-experienced subjects (N = 120). Subjects received either two injections of MVA (MM group) or one injection of Placebo and one injection of MVA (PM group) four weeks apart. Safety was evaluated by assessment of adverse events (AE), focused physical exams, electrocardiogram recordings and safety laboratories. Solicited AEs consisted of a set of pre-defined expected local reactions (erythema, swelling, pain, pruritus, and induration) and systemic symptoms (body temperature, headache, myalgia, nausea and fatigue) and were recorded on a memory aid for an 8-day period following each injection. The immunogenicity of the vaccine was evaluated in terms of humoral immune responses measured with a vaccinia-specific enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT) before and at different time points after vaccination. Vaccinations were well tolerated by all subjects. No serious adverse event related to MVA and no case of myopericarditis was reported. The overall incidence of unsolicited AEs was similar in both groups. For both groups immunogenicity responses two weeks after the final vaccination (i.e. Visit 4) were as follows: Seroconversion (SC) rates (doubling of titers from baseline) in vaccine specific antibody titers measured by ELISA were 83.3% in Group MM and 82.8% in Group PM (difference 0.6% with 95% exact CI [-13.8%, 15.0%]), and 90.0% for Group MM and 77.6% for Group PM measured by PRNT (difference 12.4% with 95% CI of [-1.1%, 27.0%]). Geometric mean titers (GMT) measured by ELISA two weeks after the final vaccination for Group MM were 804.1 and 605.8 for Group PM (with ratio of GMTs of 1.33 with 95% CI of [0.96, 1.84]). Similarly, GMTs measured by PRNT were 210.3 for Group MM and 126.7 for Group PM (with ratio 1.66 and 95% CI [0.95, 2.90]). One or two doses of MVA were safe and immunogenic in a 56-80 years old vaccinia-experienced population. No cases of myopericarditis were observed following vaccinations with MVA. The safety, reactogenicity and immunogenicity were similar to that seen in younger (18-55 year old) healthy populations as investigated in other MVA trials. The results suggest that a single dose of MVA in a 56-80 years old population was well tolerated and sufficient to rapidly boost the long-term B cell memory response induced by a prior vaccination with a traditional smallpox vaccine.
Background Modified Vaccinia Ankara MVA-BN registered is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN registered (MVA) was assessed in a 56-80 years old population. Methods MVA with a virus titer of 1 x 108 TCID50/dose was administered via subcutaneous injection to 56-80 year old vaccinia-experienced subjects (N = 120). Subjects received either two injections of MVA (MM group) or one injection of Placebo and one injection of MVA (PM group) four weeks apart. Safety was evaluated by assessment of adverse events (AE), focused physical exams, electrocardiogram recordings and safety laboratories. Solicited AEs consisted of a set of pre-defined expected local reactions (erythema, swelling, pain, pruritus, and induration) and systemic symptoms (body temperature, headache, myalgia, nausea and fatigue) and were recorded on a memory aid for an 8-day period following each injection. The immunogenicity of the vaccine was evaluated in terms of humoral immune responses measured with a vaccinia-specific enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT) before and at different time points after vaccination. Results Vaccinations were well tolerated by all subjects. No serious adverse event related to MVA and no case of myopericarditis was reported. The overall incidence of unsolicited AEs was similar in both groups. For both groups immunogenicity responses two weeks after the final vaccination (i.e. Visit 4) were as follows: Seroconversion (SC) rates (doubling of titers from baseline) in vaccine specific antibody titers measured by ELISA were 83.3% in Group MM and 82.8% in Group PM (difference 0.6% with 95% exact CI [-13.8%, 15.0%]), and 90.0% for Group MM and 77.6% for Group PM measured by PRNT (difference 12.4% with 95% CI of [-1.1%, 27.0%]). Geometric mean titers (GMT) measured by ELISA two weeks after the final vaccination for Group MM were 804.1 and 605.8 for Group PM (with ratio of GMTs of 1.33 with 95% CI of [0.96, 1.84]). Similarly, GMTs measured by PRNT were 210.3 for Group MM and 126.7 for Group PM (with ratio 1.66 and 95% CI [0.95, 2.90]). Conclusions One or two doses of MVA were safe and immunogenic in a 56-80 years old vaccinia-experienced population. No cases of myopericarditis were observed following vaccinations with MVA. The safety, reactogenicity and immunogenicity were similar to that seen in younger (18-55 year old) healthy populations as investigated in other MVA trials. The results suggest that a single dose of MVA in a 56-80 years old population was well tolerated and sufficient to rapidly boost the long-term B cell memory response induced by a prior vaccination with a traditional smallpox vaccine. Trial Registration ClinicalTrials.gov NCT00857493
Background Modified Vaccinia Ankara MVA-BN.sup.® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN.sup.® (MVA) was assessed in a 56-80 years old population. Methods MVA with a virus titer of 1 x 10.sup.8 TCID.sub.50 /dose was administered via subcutaneous injection to 56-80 year old vaccinia-experienced subjects (N = 120). Subjects received either two injections of MVA (MM group) or one injection of Placebo and one injection of MVA (PM group) four weeks apart. Safety was evaluated by assessment of adverse events (AE), focused physical exams, electrocardiogram recordings and safety laboratories. Solicited AEs consisted of a set of pre-defined expected local reactions (erythema, swelling, pain, pruritus, and induration) and systemic symptoms (body temperature, headache, myalgia, nausea and fatigue) and were recorded on a memory aid for an 8-day period following each injection. The immunogenicity of the vaccine was evaluated in terms of humoral immune responses measured with a vaccinia-specific enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT) before and at different time points after vaccination. Results Vaccinations were well tolerated by all subjects. No serious adverse event related to MVA and no case of myopericarditis was reported. The overall incidence of unsolicited AEs was similar in both groups. For both groups immunogenicity responses two weeks after the final vaccination (i.e. Visit 4) were as follows: Seroconversion (SC) rates (doubling of titers from baseline) in vaccine specific antibody titers measured by ELISA were 83.3% in Group MM and 82.8% in Group PM (difference 0.6% with 95% exact CI [-13.8%, 15.0%]), and 90.0% for Group MM and 77.6% for Group PM measured by PRNT (difference 12.4% with 95% CI of [-1.1%, 27.0%]). Geometric mean titers (GMT) measured by ELISA two weeks after the final vaccination for Group MM were 804.1 and 605.8 for Group PM (with ratio of GMTs of 1.33 with 95% CI of [0.96, 1.84]). Similarly, GMTs measured by PRNT were 210.3 for Group MM and 126.7 for Group PM (with ratio 1.66 and 95% CI [0.95, 2.90]). Conclusions One or two doses of MVA were safe and immunogenic in a 56-80 years old vaccinia-experienced population. No cases of myopericarditis were observed following vaccinations with MVA. The safety, reactogenicity and immunogenicity were similar to that seen in younger (18-55 year old) healthy populations as investigated in other MVA trials. The results suggest that a single dose of MVA in a 56-80 years old population was well tolerated and sufficient to rapidly boost the long-term B cell memory response induced by a prior vaccination with a traditional smallpox vaccine. Trial Registration ClinicalTrials.gov NCT00857493
Background Modified Vaccinia Ankara MVA-BN® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56–80 years old population. Methods MVA with a virus titer of 1 x 108 TCID50/dose was administered via subcutaneous injection to 56–80 year old vaccinia-experienced subjects (N = 120). Subjects received either two injections of MVA (MM group) or one injection of Placebo and one injection of MVA (PM group) four weeks apart. Safety was evaluated by assessment of adverse events (AE), focused physical exams, electrocardiogram recordings and safety laboratories. Solicited AEs consisted of a set of pre-defined expected local reactions (erythema, swelling, pain, pruritus, and induration) and systemic symptoms (body temperature, headache, myalgia, nausea and fatigue) and were recorded on a memory aid for an 8-day period following each injection. The immunogenicity of the vaccine was evaluated in terms of humoral immune responses measured with a vaccinia-specific enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT) before and at different time points after vaccination. Results Vaccinations were well tolerated by all subjects. No serious adverse event related to MVA and no case of myopericarditis was reported. The overall incidence of unsolicited AEs was similar in both groups. For both groups immunogenicity responses two weeks after the final vaccination (i.e. Visit 4) were as follows: Seroconversion (SC) rates (doubling of titers from baseline) in vaccine specific antibody titers measured by ELISA were 83.3% in Group MM and 82.8% in Group PM (difference 0.6% with 95% exact CI [-13.8%, 15.0%]), and 90.0% for Group MM and 77.6% for Group PM measured by PRNT (difference 12.4% with 95% CI of [-1.1%, 27.0%]). Geometric mean titers (GMT) measured by ELISA two weeks after the final vaccination for Group MM were 804.1 and 605.8 for Group PM (with ratio of GMTs of 1.33 with 95% CI of [0.96, 1.84]). Similarly, GMTs measured by PRNT were 210.3 for Group MM and 126.7 for Group PM (with ratio 1.66 and 95% CI [0.95, 2.90]). Conclusions One or two doses of MVA were safe and immunogenic in a 56–80 years old vaccinia-experienced population. No cases of myopericarditis were observed following vaccinations with MVA. The safety, reactogenicity and immunogenicity were similar to that seen in younger (18–55 year old) healthy populations as investigated in other MVA trials. The results suggest that a single dose of MVA in a 56–80 years old population was well tolerated and sufficient to rapidly boost the long-term B cell memory response induced by a prior vaccination with a traditional smallpox vaccine. Trial Registration ClinicalTrials.gov NCT00857493
BackgroundModified Vaccinia Ankara MVA-BN® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56-80 years old population.MethodsMVA with a virus titer of 1 x 108 TCID50/dose was administered via subcutaneous injection to 56-80 year old vaccinia-experienced subjects (N = 120). Subjects received either two injections of MVA (MM group) or one injection of Placebo and one injection of MVA (PM group) four weeks apart. Safety was evaluated by assessment of adverse events (AE), focused physical exams, electrocardiogram recordings and safety laboratories. Solicited AEs consisted of a set of pre-defined expected local reactions (erythema, swelling, pain, pruritus, and induration) and systemic symptoms (body temperature, headache, myalgia, nausea and fatigue) and were recorded on a memory aid for an 8-day period following each injection. The immunogenicity of the vaccine was evaluated in terms of humoral immune responses measured with a vaccinia-specific enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT) before and at different time points after vaccination.ResultsVaccinations were well tolerated by all subjects. No serious adverse event related to MVA and no case of myopericarditis was reported. The overall incidence of unsolicited AEs was similar in both groups. For both groups immunogenicity responses two weeks after the final vaccination (i.e. Visit 4) were as follows: Seroconversion (SC) rates (doubling of titers from baseline) in vaccine specific antibody titers measured by ELISA were 83.3% in Group MM and 82.8% in Group PM (difference 0.6% with 95% exact CI [-13.8%, 15.0%]), and 90.0% for Group MM and 77.6% for Group PM measured by PRNT (difference 12.4% with 95% CI of [-1.1%, 27.0%]). Geometric mean titers (GMT) measured by ELISA two weeks after the final vaccination for Group MM were 804.1 and 605.8 for Group PM (with ratio of GMTs of 1.33 with 95% CI of [0.96, 1.84]). Similarly, GMTs measured by PRNT were 210.3 for Group MM and 126.7 for Group PM (with ratio 1.66 and 95% CI [0.95, 2.90]).ConclusionsOne or two doses of MVA were safe and immunogenic in a 56-80 years old vaccinia-experienced population. No cases of myopericarditis were observed following vaccinations with MVA. The safety, reactogenicity and immunogenicity were similar to that seen in younger (18-55 year old) healthy populations as investigated in other MVA trials. The results suggest that a single dose of MVA in a 56-80 years old population was well tolerated and sufficient to rapidly boost the long-term B cell memory response induced by a prior vaccination with a traditional smallpox vaccine.Trial registrationClinicalTrials.gov NCT00857493.
Modified Vaccinia Ankara MVA-BN® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56-80 years old population. MVA with a virus titer of 1 x 108 TCID50/dose was administered via subcutaneous injection to 56-80 year old vaccinia-experienced subjects (N = 120). Subjects received either two injections of MVA (MM group) or one injection of Placebo and one injection of MVA (PM group) four weeks apart. Safety was evaluated by assessment of adverse events (AE), focused physical exams, electrocardiogram recordings and safety laboratories. Solicited AEs consisted of a set of pre-defined expected local reactions (erythema, swelling, pain, pruritus, and induration) and systemic symptoms (body temperature, headache, myalgia, nausea and fatigue) and were recorded on a memory aid for an 8-day period following each injection. The immunogenicity of the vaccine was evaluated in terms of humoral immune responses measured with a vaccinia-specific enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT) before and at different time points after vaccination. Vaccinations were well tolerated by all subjects. No serious adverse event related to MVA and no case of myopericarditis was reported. The overall incidence of unsolicited AEs was similar in both groups. For both groups immunogenicity responses two weeks after the final vaccination (i.e. Visit 4) were as follows: Seroconversion (SC) rates (doubling of titers from baseline) in vaccine specific antibody titers measured by ELISA were 83.3% in Group MM and 82.8% in Group PM (difference 0.6% with 95% exact CI [-13.8%, 15.0%]), and 90.0% for Group MM and 77.6% for Group PM measured by PRNT (difference 12.4% with 95% CI of [-1.1%, 27.0%]). Geometric mean titers (GMT) measured by ELISA two weeks after the final vaccination for Group MM were 804.1 and 605.8 for Group PM (with ratio of GMTs of 1.33 with 95% CI of [0.96, 1.84]). Similarly, GMTs measured by PRNT were 210.3 for Group MM and 126.7 for Group PM (with ratio 1.66 and 95% CI [0.95, 2.90]). One or two doses of MVA were safe and immunogenic in a 56-80 years old vaccinia-experienced population. No cases of myopericarditis were observed following vaccinations with MVA. The safety, reactogenicity and immunogenicity were similar to that seen in younger (18-55 year old) healthy populations as investigated in other MVA trials. The results suggest that a single dose of MVA in a 56-80 years old population was well tolerated and sufficient to rapidly boost the long-term B cell memory response induced by a prior vaccination with a traditional smallpox vaccine. ClinicalTrials.gov NCT00857493.
Background Modified Vaccinia Ankara MVA-BN ® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN ® (MVA) was assessed in a 56–80 years old population. Methods MVA with a virus titer of 1 x 10 8 TCID 50 /dose was administered via subcutaneous injection to 56–80 year old vaccinia-experienced subjects (N = 120). Subjects received either two injections of MVA (MM group) or one injection of Placebo and one injection of MVA (PM group) four weeks apart. Safety was evaluated by assessment of adverse events (AE), focused physical exams, electrocardiogram recordings and safety laboratories. Solicited AEs consisted of a set of pre-defined expected local reactions (erythema, swelling, pain, pruritus, and induration) and systemic symptoms (body temperature, headache, myalgia, nausea and fatigue) and were recorded on a memory aid for an 8-day period following each injection. The immunogenicity of the vaccine was evaluated in terms of humoral immune responses measured with a vaccinia-specific enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT) before and at different time points after vaccination. Results Vaccinations were well tolerated by all subjects. No serious adverse event related to MVA and no case of myopericarditis was reported. The overall incidence of unsolicited AEs was similar in both groups. For both groups immunogenicity responses two weeks after the final vaccination (i.e. Visit 4) were as follows: Seroconversion (SC) rates (doubling of titers from baseline) in vaccine specific antibody titers measured by ELISA were 83.3% in Group MM and 82.8% in Group PM (difference 0.6% with 95% exact CI [-13.8%, 15.0%]), and 90.0% for Group MM and 77.6% for Group PM measured by PRNT (difference 12.4% with 95% CI of [-1.1%, 27.0%]). Geometric mean titers (GMT) measured by ELISA two weeks after the final vaccination for Group MM were 804.1 and 605.8 for Group PM (with ratio of GMTs of 1.33 with 95% CI of [0.96, 1.84]). Similarly, GMTs measured by PRNT were 210.3 for Group MM and 126.7 for Group PM (with ratio 1.66 and 95% CI [0.95, 2.90]). Conclusions One or two doses of MVA were safe and immunogenic in a 56–80 years old vaccinia-experienced population. No cases of myopericarditis were observed following vaccinations with MVA. The safety, reactogenicity and immunogenicity were similar to that seen in younger (18–55 year old) healthy populations as investigated in other MVA trials. The results suggest that a single dose of MVA in a 56–80 years old population was well tolerated and sufficient to rapidly boost the long-term B cell memory response induced by a prior vaccination with a traditional smallpox vaccine. Trial Registration ClinicalTrials.gov NCT00857493
Audience Academic
Author Hay, Christine M.
Nichols, Richard
Meyer, Thomas P.
Röesch, Siegfried
Greenberg, Richard N.
Wagner, Eva
Schmidt, Darja
Weigl, Josef
von Krempelhuber, Alfred
Virgin, Garth
Marbury, Thomas C.
Young, Philip
Arndtz-Wiedemann, Nathaly
Kreitmeir, Eva
Chaplin, Paul
Stapleton, Jack T.
AuthorAffiliation 4 Orlando Clinical Research Center, 5055 South Orange Avenue, Orlando, FL, 32809, United States of America
5 Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany
1 University of Kentucky School of Medicine, MN663 Medical Science Bldg., 800 Rose Street, Lexington, KY, 40536, United States of America
2 University of Iowa, SW54, GH, 200 Hawkins Drive, UHC, Iowa City, IA, 52242, United States of America
3 University of Rochester Medical Center School of Medicine and Dentistry, 601 Elmwood Avenue, Box 689, Rochester, NY, 14642, United States of America
The George Washington University School of Medicine and Health Sciences, UNITED STATES
AuthorAffiliation_xml – name: 3 University of Rochester Medical Center School of Medicine and Dentistry, 601 Elmwood Avenue, Box 689, Rochester, NY, 14642, United States of America
– name: 4 Orlando Clinical Research Center, 5055 South Orange Avenue, Orlando, FL, 32809, United States of America
– name: 5 Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany
– name: 1 University of Kentucky School of Medicine, MN663 Medical Science Bldg., 800 Rose Street, Lexington, KY, 40536, United States of America
– name: 2 University of Iowa, SW54, GH, 200 Hawkins Drive, UHC, Iowa City, IA, 52242, United States of America
– name: The George Washington University School of Medicine and Health Sciences, UNITED STATES
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  givenname: Christine M.
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  givenname: Jack T.
  surname: Stapleton
  fullname: Stapleton, Jack T.
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  surname: Marbury
  fullname: Marbury, Thomas C.
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  givenname: Eva
  surname: Wagner
  fullname: Wagner, Eva
– sequence: 6
  givenname: Eva
  surname: Kreitmeir
  fullname: Kreitmeir, Eva
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  givenname: Siegfried
  orcidid: 0000-0002-6206-091X
  surname: Röesch
  fullname: Röesch, Siegfried
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  fullname: von Krempelhuber, Alfred
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  surname: Nichols
  fullname: Nichols, Richard
– sequence: 11
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  surname: Meyer
  fullname: Meyer, Thomas P.
– sequence: 12
  givenname: Darja
  orcidid: 0000-0001-8559-1302
  surname: Schmidt
  fullname: Schmidt, Darja
– sequence: 13
  givenname: Josef
  surname: Weigl
  fullname: Weigl, Josef
– sequence: 14
  givenname: Garth
  surname: Virgin
  fullname: Virgin, Garth
– sequence: 15
  givenname: Nathaly
  surname: Arndtz-Wiedemann
  fullname: Arndtz-Wiedemann, Nathaly
– sequence: 16
  givenname: Paul
  surname: Chaplin
  fullname: Chaplin, Paul
BackLink https://www.ncbi.nlm.nih.gov/pubmed/27327616$$D View this record in MEDLINE/PubMed
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Current address: GlaxoSmithKline GmbH & Co. KG, Prinzregentenplatz 9, 81675 München, Germany
Conceived and designed the experiments: AK EW PY PC. Performed the experiments: RNG CMH JTS TM. Analyzed the data: PY SR. Contributed reagents/materials/analysis tools: RN TPM DS. Wrote the paper: EW EK PY TPM DS JW GV NA PC RNG. Review of safety information (adverse events): GV.
Current address: NewLink Genetics / BioProtection Systems, Mendelssohnstr 34, 81245 München, Germany
Current address: Public Health Institute Ploen, Hamburger Str 17/18, 24306 Ploen, Germany
Current address: Vifor Pharma Ltd, Flughofstrasse 61, 8152 Glattbrugg, Switzerland
Competing Interests: The trial was funded by the National Institute of Allergy and Infectious Diseases US (NIAID) (N01-AI-40072). Bavarian Nordic was the sponsor receiving the fund (N01-AI-40072). Bavarian Nordic reimbursed the Clinical Trial Investigators and the design and conduct of the trial were managed by Bavarian Nordic A/S. Eva Wagner, Eva Kreitmeir, Siegfried Rösch, Alfred von Krempelhuber, Philip Young, Richard Nichols, Thomas P. Meyer, Darja Schmidt, Josef Weigl, Garth Virgin, Nathaly Arndtz-Wiedemann and Paul Chaplin are employed by Bavarian Nordic GmbH, the manufacturer of MVA-BN. Patents relevant to this study are part of the supporting information as there are too many to list. The Statistical Analysis Plan was written by Philip Young (PY, Bavarian Nordic). Data collection, data management and analysis were performed by Kendle International (Cincinnati, OH). Kendle International is now part of INC Research (Raleigh, NC). The specific roles of the authors are articulated in the ‘author contributions’ section. There are no further patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.
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Snippet Modified Vaccinia Ankara MVA-BN® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II...
Background Modified Vaccinia Ankara MVA-BN.sup.® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine....
Modified Vaccinia Ankara MVA-BN.sup.® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this...
Background Modified Vaccinia Ankara MVA-BN® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In...
Background Modified Vaccinia Ankara MVA-BN registered is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox...
BackgroundModified Vaccinia Ankara MVA-BN® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In...
Background Modified Vaccinia Ankara MVA-BN ® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In...
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SubjectTerms Aged, 80 and over
Analysis
Biology and Life Sciences
Body temperature
Clinical trials
Demography
Double-Blind Method
Double-blind studies
EKG
Enzyme-Linked Immunosorbent Assay
Erythema
Fatigue
Female
Headache
Health care
HIV
Human immunodeficiency virus
Humans
Immune response (humoral)
Immune system
Immunogenicity
Immunological memory
Infections
Injection
Lymphocytes B
Male
Medical prognosis
Medicine and Health Sciences
Middle Aged
Myalgia
Nausea
Neutralization
Pain
Placebos
Population
Product development
Pruritus
Public health
Replicating
Replication
Research and Analysis Methods
Safety
Seroconversion
Smallpox
Smallpox Vaccine - adverse effects
Smallpox Vaccine - immunology
Smallpox vaccines
Studies
Vaccination
Vaccines
Vaccines, DNA
Vaccinia
Variola major
Viral Plaque Assay
Viral Vaccines - adverse effects
Viral Vaccines - immunology
Viruses
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Title A Randomized, Double-Blind, Placebo-Controlled Phase II Trial Investigating the Safety and Immunogenicity of Modified Vaccinia Ankara Smallpox Vaccine (MVA-BN®) in 56-80-Year-Old Subjects
URI https://www.ncbi.nlm.nih.gov/pubmed/27327616
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https://pubmed.ncbi.nlm.nih.gov/PMC4915701
https://doaj.org/article/fc2b41725d244487b4da1c0519dc89df
http://dx.doi.org/10.1371/journal.pone.0157335
Volume 11
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