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Grading of Recommendations, Assessment, Development, and Evaluation (GRADE): Use of JYNNEOS® (orthopoxvirus) vaccine booster (Policy Questions 3 and 4)										Related Pages
										Table 1.1: Policy Question 3 and PICO
Table 1: Policy Question and PICO
Policy question:
**Should persons who are at continued risk for occupational exposure to more virulent orthopoxviruses such as variola virus or monkeypox virus receive a booster dose of JYNNEOS® every two years after the primary JYNNEOS® series?**Population
Persons who are at risk for occupational exposure to variola virus or monkeypox virusIntervention
Booster with JYNNEOS® 2 years after primary seriesComparison
No vaccine booster after JYNNEOS® primary seriesOutcomes
Prevention of disease
Severity of disease
Serious adverse events
Myo-/ peri- carditisTable 1.2: Policy Question 4 and PICO
Table 1: Policy Question and PICO
Policy question:
**Should persons who are at continued risk for occupational exposure to replication-competent orthopoxviruses like vaccinia virus or cowpox virus receive a booster dose of JYNNEOS® at least every 10 years after the primary JYNNEOS® series?**Population
Persons who are at risk for occupational exposure to replication competent orthopoxviruses like vaccinia virus or cowpox virusIntervention
Booster with JYNNEOS® at least every 10 yearsComparison
No vaccine booster after JYNNEOS® primary seriesOutcomes
Prevention of disease
Severity of disease
Serious adverse events
Myo-/ peri- carditisTable 2: Outcomes and Rankings
Table 2: Outcomes and Rankings
Outcome
Importance*
Included in evidence profilePrevention of disease
Critical
YesSeverity of disease
Critical
YesSerious adverse events**
Critical
YesMyo-/ peri- carditis
Important
YesMinor adverse events
Not important
No
*Three options: 1. Critical; 2. Important but not critical; 3. Not important for decision making
**Serious adverse events were defined according to the standard FDA definition. In addition, data was collected about any smallpox vaccine-specific adverse event: postvaccinial encephalitits, eczema vaccinatum, progressive vaccinia, and generalized vaccinia.
Appendix 1: Studies Included in the Review of Evidence
Appendix 1: Studies Included in the Review of Evidence
Last name first author, Publication year
Study design
Country (or more detail, if needed)
Age (measure central tendency – mean/SD; median/IQR; range)
Total population
N Intervention
N comparison
Outcomes
Funding sourceRCT dataNCT02038881
Overton3
Overton et al. 2020
Phase II, Randomized, Open-label
USA
Mean 35
SD 6.7
87
31
27
Safety and immunogenicity in HIV+ patients
Bavarian NordicObservational data for the interventionNCT00686582
Von Sonnenburg 3
Phase II, non-randomized, open-label
Germany
Mean 34.6
SD 10.2
304
92
NA
Safety and immunogenicity
Bavarian NordicObservational data for the comparisonVRC 201
Parrino1
Parrino 2007
Phase I/Ib randomized, placebo controlled, double-blinded trial
USA
Mean and
SD NR,
adults
77
NA
19
Immunogenicity, safety, Dryvax challenge, cell mediated/humoral immune responses
NIAIDNCT00437021
Frey 2
Frey et al. 2013
Troy et al. 2015
Phase II, Double-blind, Randomized, Dose-finding Study
USA
Mean 24.7
SD 4.2
208
NA
67
Safety and immunogenicity
NIAIDNCT01668537
Greenburg4
2014
Phase II, Randomized, Double-blind, Multicenter
USA
Mean 27.7
SD 6.28
651
NA
327
Safety and immunogenicity
Bavarian NordicNCT00879762
Frey3
Troy et al. 2015
Frey et al. 2014
Phase II, randomized, double blinded
USA
Mean 26.5
SD NR
91
NA
45
Safety and immunogenicity
NIAIDNCT00316602
Greenburg2
Greenberg 2015
Phase II, non-randomized, open-label
USA and Mexico
Mean 27.7
SD 6.11
632
NA
632
Safety and immunogenicity in people with atopic dermatitis
NIAID and Bavarian NordicNCT00914732
Frey4
Troy et al. 2015
Frey et al. 2015
Phase II, randomized, triple blinded
USA
Mean 27.2
SD 4.6
523
NA
167
Safety and immunogenicity
NIAID and Bavarian NordicNCT00189904
Greenburg1
Greenberg et al. 2013
Phase I/II, non-randomized, open-label
USA
Mean 37.9
SD NR
151
NA
60
Safety and immunogenicity in HIV positive patients
NIAIDNCT01144637
Overton2
Overton et al. 2018
Randomized, Double-Blind, Placebo-Controlled Phase III Trial
USA
Mean 27.7
SD 6.3
4005
NA
4005
immunogenicity, safety, and tolerability
Bavarian Nordic and BARDANCT00189917
von Sonnenburg2
Darsow et al. 2016
Von Sonnenburg et al. 2014
Open-label, Controlled Phase I Pilot Study
Germany
Mean NR
SD NR
60
NA
60
Safety and immunogenicity
NIAID and Bavarian NordicNCT00133575
Seaman/Wilck
Seaman et al. 2010
Wilck et al. 2010
Phase I/II, randomized, double blinded, placebo-controlled
USA
Mean 25.2, SD=3.7
72
NA
10
Safety and immunogenicity and surrogate efficacy (Dryvax challenge)
NIAIDNCT01913353
Pittman
Pittman 2019
Phase 3, open-label,
randomized clinical trial
U.S. military, stationed in Korea
Mean 23.5
SD 4.67
433
NA
220
Immunogenicity,
Surrogate efficacy (ACAM2000 challenge),
Adverse events
Bavarian Nordic, US Army Medical Research Institute of Infectious DiseasesNCT01827371
Frey5
Anderson et al. 2020
Jackson et al. 2017
Phase II, Randomized, Open-Label
USA
Mean 27.4
SD 5.3
435
NA
115
Safety and immunogenicity
NIAIDNCT00082446
Frey1
Frey 2007
Sano 2009
Phase I, randomized, partially blinded,
placebo controlled clinical trial
USA
Mean 24.8
SD 3.8
90
NA
30
Immunogenicity, Cell-mediated immunity, Surrogate efficacy (Dryvax challenge),
Adverse events
NIAIDNCT00316589
Overton1
Overton et al. 2015
Phase II, Multicenter, Open-label, Controlled
USA
Mean 37.5
SD 8.0
579
NA
439
Safety and immunogenicity
HHS and NIAIDNCT00189959
Pokorny
Von Kremplehuber et al. 2010
Phase II, Double-blind, randomized, Dose-finding Study
Switzerland
Mean 23.3
SD 3.0
165
NA
55
Safety and immunogenicity
NIAID and Bavarian NordicVollmar
Vollmar et al. 2005
Phase 1, randomized, double-blinded and open-label
Germany
Mean 32.8
68
NA
16
Safety and immunogenicity
Bavarian Nordic
Table 3a: Summary of Studies Reporting Outcome A – Prevention of Disease
Table 3a: Summary of Studies Reporting Outcome A – Prevention of Disease
Authors last name, pub year
Age or other characteristic of importance
N intervention
N comparison
Comparator vaccine
Absolute difference/effect estimate
Study limitations (Risk of Bias)RCT dataNCT00316589
Overton3
Overton et al. 2015
Age: Mean 35
SD 6.7
**HIV positive vaccinia naïve adults**
31
27
No vaccine booster after MVA-BN primary series
Geometric mean titer:
Mean 3.56 titer units more (1.84 more to 6.89 more)
Seroconversion rate: RR = 1.00 (0.94 to 1.06); 0 fewer per 1,000 (from 60 fewer to 60 more)
Serious risk of bias due to high attrition rate in the per protocol populationObservational data for the interventionNCT00686582
Von Sonnenburg 3
Mean 34.6
SD 10.2
Healthy vaccinia naïve adults
75
NA
NA
From pooled all observational studies (comparison and intervention):
Among intervention: 74/75 (99%) seroconverted
Among Comparison: 3326/3539 (94%) seroconverted
Seroconversion rate: RR 1.05 (1.02 to 1.08); 47 more per 1,000 (from 19 more to 75 more)Observational for the comparisonNCT00437021
Frey 2
Frey et al. 2013
Troy et al. 2015
Mean 24.7
SD 4.2
Healthy vaccinia naïve adults
NA
63
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.NCT01668537
Greenburg4
2014
Mean 27.7
SD 6.28
Healthy vaccinia naïve adults
NA
297
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.NCT00316602
Greenburg2
Greenberg 2015
Mean 26.5
SD NR
Healthy vaccinia naïve adults and **vaccinia naïve adults with atopic dermatitis**
NA
451
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.NCT00914732
Frey4
Troy et al. 2015
Frey et al. 2015
Mean 27.7
SD 6.11
Healthy vaccinia naïve adults
NA
148
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.NCT00189904
Greenburg1
Greenberg et al. 2013
Mean 37.9
SD NR
Healthy vaccinia naïve adults and **HIV + vaccinia naïve adults**
NA
60
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.NCT01144637
Overton2
Overton et al. 2018
Mean 27.7
SD 6.3
Healthy vaccinia naïve adults
NA
1906
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.NCT00189917
von Sonnenburg2
Darsow et al.  2016
Von Sonnenburg et al. 2014
Mean NR
SD NR
Healthy vaccinia naïve adults and **vaccinia naïve adults with a history of atopic dermatitis, active atopic dermatitis or allergic rhinitis**
NA
56
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.NCT01913353
Pittman
Pittman 2019
Mean 23.5
SD 4.67
Healthy vaccinia naïve adults
NA
185
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.NCT00082446
Frey1
Frey 2007
Sano 2009
Mean 24.8
SD 3.8
Healthy vaccinia naïve adults
NA
15
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.NCT00316589
Overton1
Overton et al. 2015
Mean 37.5
SD 8.0
Healthy vaccinia naïve adults and **HIV + vaccinia naïve adults**
NA
298
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.NCT00189959
Pokorny
Von Kremplehuber et al. 2010
Mean 23.3
SD 3.0
Healthy vaccinia naïve adults
NA
52
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.Vollmar
Vollmar et al. 2005
Mean 32.8
Healthy vaccinia naïve adult males
NA
16
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.
Table 3b: Summary of Studies Reporting Outcome B – Severity of Disease
Table 3b: Summary of Studies Reporting Outcome B – Severity of Disease
Authors last name, pub year
Age or other characteristic of importance
N intervention
N comparison
Comparator vaccine
Absolute difference/effect estimate
Study limitations (Risk of Bias)No data available for this outcome.
Table 3c: Summary of Studies Reporting Outcome C – Serious Adverse Events (SAE)
Table 3c: Summary of Studies Reporting Outcome C – Serious Adverse Events (SAE)
Authors last name, pub year
Age or other characteristic of importance
N intervention
N comparison
Comparator vaccine
Absolute difference/effect estimate
Study limitations (Risk of Bias)RCTNCT00316589
Overton3
Overton et al. 2015
Age: Mean 35
SD 6.7
**HIV positive vaccinia naïve adults**
31
27
No vaccine booster after MVA-BN primary series
Not estimable
No serious adverse events were recorded among the intervention or comparison groups
Serious risk of bias due to high attrition rate in the per protocol populationObservational interventionNCT00686582
Von Sonnenburg 3
Mean 34.6
SD 10.2
Healthy vaccinia naïve adults
751
NA
NA
Not estimable
Among intervention: 0/75 (0%) had vaccine-related SAEs
Among comparison: 3/5265 (0.1%) had vaccine related SAEsObservational comparisonParrino 1
Mean and
SD NR
Healthy vaccinia naïve adults
NA
19
No vaccine booster after **TBC-MVA** primary series
Pooled studies. See observational intervention for effect estimate.Frey 2
Mean 24.7
SD 4.2
Healthy vaccinia naïve adults
NA
67
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.Greenburg 4
Mean 27.7
SD 6.28
Healthy vaccinia naïve adults
NA
327
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.Frey 3
Mean 26.5
SD NR
Healthy vaccinia naïve adults
NA
45
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.Greenburg 2
Mean 26.5
SD NR
Healthy vaccinia naïve adults and **vaccinia naïve adults with atopic dermatitis**
NA
632
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.
**1 SAE2** was recorded for a participant, a healthy vaccinia naïve adult, in this comparison groupFrey 4
Mean 27.7
SD 6.11
Healthy vaccinia naïve adults
NA
167
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.Greenburg 1
Mean 37.9
SD NR
Healthy vaccinia naïve adults and **HIV + vaccinia naïve adults**
NA
60
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.Overton 2
Mean 27.7
SD 6.3
Healthy vaccinia naïve adults
NA
3003
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.Von Sonnenburg 2
Mean NR
SD NR
Healthy vaccinia naïve adults and **vaccinia naïve adults with a history of atopic dermatitis, active atopic dermatitis or allergic rhinitis**
NA
60
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.Seaman/Wilck
Mean 25.2, SD=3.7
Healthy vaccinia naïve adults
NA
10
No vaccine booster after **Acambis MVA** primary series
Pooled studies. See observational intervention for effect estimate.Pittman
Mean 23.5
SD 4.67
Healthy vaccinia naïve US military soldiers
NA
220
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.Frey 5
Mean 27.4
SD 5.3
Healthy vaccinia naïve adults
NA
1163
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.
**1 SAE3** was recorded for a participant in this comparison groupFrey 1
Mean 24.8
SD 3.8
Healthy vaccinia naïve adults
NA
30
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.Overton 1
Mean 37.5
SD 8.0
Healthy vaccinia naïve adults and **HIV + vaccinia naïve adults**
NA
439
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.
**1 SAE4** was recorded for a participant, an HIV positive vaccinia naïve adult, in this comparison groupPokorny
Mean 23.3
SD 3.0
Healthy vaccinia naïve adults
NA
545
No vaccine booster after MVA-BN primary series
Pooled studies. See observational intervention for effect estimate.Vollmar
Vollmar et al. 2005
Mean 32.8
Healthy vaccinia naïve adult males
NA
16
MVA-BN
Pooled studies. See observational intervention for effect estimate.
N=75 is the reported number at risk for those at risk for serious adverse events. Reasons for attrition not reported
**Extra ocular muscle paresis** event in one person 8 days after second MVA-BN vaccination; deemed probably related by investigators.
**Acute myocardial infarction** event in one person 117 days after the first MVA-BN dose. Deemed related to vaccination because no other reasonable etiology was found. Number at risk is 116 because one subject was initially randomized to study arm C but was vaccinated out of the window and was analyzed in study arm A.
**Pneumonia and pleurisy** event in one person 1 day after second MVA-BN dose. Deemed “possibly but unlikely” to be associated with vaccination.
One person missing all symptom data.
Table 3d: Summary of Studies Reporting Outcome D – Myo/pericarditis
Table 3d: Summary of Studies Reporting Outcome D – Myo/pericarditis
Authors last name, pub year
Age or other characteristic of importance
N intervention
N comparison
Comparator vaccine
Absolute difference/effect estimate
Study limitations (Risk of Bias)RCTNCT00316589
Overton3
Overton et al. 2015
Age: Mean 35
SD 6.7
**HIV positive vaccinia naïve adults**
31
27
No vaccine booster after MVA-BN primary series
Not estimable
No myopericarditis events were recorded among the intervention or comparison groups
Serious risk of bias due to high attrition rate in the per protocol population
Table 4: GRADE Summary of Findings
Policy Question 2: Should JYNNEOS® be recommended for healthcare personnel who administer ACAM2000 or care for patients after vaccination with replication-competent orthopoxviruses?
Certainty assessment
No of patients
Effect
Certainty
ImportanceNo of studies
Study design
Risk of bias
Inconsistency
Indirectness
Imprecision
Other considerations
JYNNEOS® OPXV vaccine primary series followed by a JYNNEOS® booster every 2 years
JYNNEOS® OPXV vaccine primary series
Relative
(95% CI)
Absolute
(95% CI)A. Prevention of disease (assessed with: Geometric mean titer)11,2
randomized trials
seriousa
not serious
very seriousb,c
not seriousd
none
26
20
–
mean **3.56 titer units more**
(1.84 more to 6.89 more)
Level 4
VERY LOW
CRITICALA. Prevention of disease (assessed with: seroconversion rate)11,2
randomized trials
seriousa
not serious
very seriousb,c
seriousd,e
none
26/26 (100.0%)
20/20 (100.0%)
**RR 1.00**
(0.94 to 1.06)
**0 fewer per 1,000**
(from 60 fewer to 60 more)
Level 4
VERY LOW
CRITICALA. Prevention (assessed with: seroconversion rate)123,4,5,6,7,8,9,10,11,12,13,14,15,16,
17,18,19,20,21,22,23,24,25,26,27,28,29,30,
31,32,33, 39
observational studies
very seriousf
seriousg
PQ3: serioush
PQ4: very serioush
seriousi
none
74/75 (98.7%)
3326/3539 (94.0%)
**RR 1.05**
(1.02 to 1.08)
**47 more per 1,000**
(from 19 more to 75 more)
Level 4
VERY LOW
CRITICALC. Serious adverse events (assessed with: vaccine related SAE rate)11,2
randomized trials
not serious
not serious
seriousc
very seriousj
none
0/31 (0.0%)
0/27 (0.0%)
not estimable

Level 4
VERY LOW
CRITICALC. Serious adverse events (assessed with: vaccine related SAE rate)173,4,5,6,7,8,9,10,11,12,13,14,15,16,
17,18,19,20,21,22,23,24,25,26,27,28,29,30,
31,32,33,34,35,36,37,38,39
observational studies
very seriousf
seriousg
serioush
seriousk
none
0/75 (0.0%)
3/5265 (0.1%)
not estimable

Level 4
VERY LOW
CRITICALD. Myo-/pericarditis (assessed with: myo-/pericarditis event rate)11,2
randomized trials
seriousl
not serious
seriousc
very seriousj
none
0/31 (0.0%)
0/27 (0.0%)
not estimable

Level 4
VERY LOW
IMPORTANT
Table 5: Summary of Evidence for Outcomes of Interest
Table 5: Summary of Evidence for Outcomes of Interest
Outcome
Importance
Included in profile
CertaintyPrevention of disease
Critical
Yes
Very lowSeverity of disease
Important
Yes
NA (No data available)Serious adverse events
Critical
Yes
Very lowMyo-/pericarditis
Critical
Yes
Very lowMinor adverse events
Not important
No
N/A
Explanations
High attrition rate in per protocol population.
Immunogenicity as assessed with GMT is an indirect measure of efficacy.
Available intervention data gives a booster at day 84. Indirect evidence for 2 year booster.
There is one study with a small sample size.
95% CI suggests there may be the potential for benefit or harm.
Many studies have serious concerns for risk of bias. Observational data has a higher risk for bias there were some concerns in a few studies for attrition and timing of outcome ascertainment.
Only one study contributes data to the intervention. Others contribute data to the comparison. Can’t assess inconsistency for intervention.
PQ3: Downgrade for indirectness because the comparisons are between studies. PQ4: h. Downgrade for indirectness because the comparisons are between studies. Further downgrade for indirectness because 2-year booster data is indirect data for 10-year booster data.
Though the confidence interval is small, the number of participants in the intervention group is small and therefore may not provide a precise estimate.
Study population is very small and would be poor at estimating the rate of rare outcomes.
Few people in the intervention group. Wide confidence interval.
High attrition rate and unclear information about randomization procedure.References
Overton, E. T., Lawrence, S. J., Stapleton, J. T., Weidenthaler, H., Schmidt, D., Koenen, B., Silbernagl, G., Nopora, K., Chaplin, P.. A randomized phase II trial to compare safety and immunogenicity of the MVA-BN smallpox vaccine at various doses in adults with a history of AIDS. Vaccine; Mar 4 2020.
Bavarian Nordic, . Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection. 2014.
Bavarian Nordic, , and, National,Institute,of,Allergy, Diseases, Infectious. An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees. 2008.
Frey, S. E., Winokur, P. L., Salata, R. A., El-Kamary, S. S., Turley, C. B., Walter, E. B.,Jr., Hay, C. M., Newman, F. K., Hill, H. R., Zhang, Y., Chaplin, P., Tary-Lehmann, M., Belshe, R. B.. Safety and immunogenicity of IMVAMUNE R smallpox vaccine using different strategies for a post event scenario. Vaccine; 2013.
Troy, J. D., Hill, H. R., Ewell, M. G., Frey, S. E.. Sex difference in immune response to vaccination: A participant-level meta-analysis of randomized trials of IMVAMUNE smallpox vaccine. Vaccine; 2015.
MVA Post-Event: administration Timing and Boost Study. https://clinicaltrials.gov/show/NCT00437021; 2007.
Bavarian Nordic, . A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects. 2013.
A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects. https://clinicaltrials.gov/show/NCT01668537; 2012.
Bavarian Nordic, , National Institute of Allergy and Infectious Diseases, . A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNETM) Smallpox Vaccine in Subjects With Atopic Dermatitis. 2006.
Greenberg, R. N., Hurley, Y., Dinh, D. V., Mraz, S., Vera, J. G., Von Bredow, D., Von Krempelhuber, A., Roesch, S., Virgin, G., Arndtz-Wiedemann, N., Meyer, T. P., Schmidt, D., Nichols, R., Young, P., Chaplin, P.. A multicenter, open-label, controlled phase II study to evaluate safety and immunogenicity of MVA smallpox vaccine (IMVAMUNE) in 18-40 year old subjects with diagnosed atopic dermatitis. PLoS ONE; 2015.
Frey, S. E., Wald, A., Edupuganti, S., Jackson, L. A., Stapleton, J. T., El Sahly, H., El-Kamary, S. S., Edwards, K., Keyserling, H., Winokur, P., Keitel, W., Hill, H., Goll, J. B., Anderson, E. L., Graham, I. L., Johnston, C., Mulligan, M., Rouphael, N., Atmar, R., Patel, S., Chen, W., Kotloff, K., Creech, C. B., Chaplin, P., Belshe, R. B.. Comparison of lyophilized versus liquid modified vaccinia Ankara (MVA) formulations and subcutaneous versus intradermal routes of administration in healthy vaccinia-naive subjects. Vaccine; 2015.
Lyophilized IMVAMUNE® (1×10^8 TCID50) Versus Liquid IMVAMUNE® (1×10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2×10^7 TCID50) Administered Intradermally. https://clinicaltrials.gov/show/NCT00914732; 2009.
National Institute of Allergy and Infectious Diseases, . Lyophilized IMVAMUNE® (1×10^8 TCID50) Versus Liquid IMVAMUNE® (1×10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2×10^7 TCID50) Administered Intradermally. 2010.
Greenberg, R. N., Overton, E. T., Haas, D. W., Frank, I., Goldman, M., von Krempelhuber, A., Virgin, G., Bädeker, N., Vollmar, J., Chaplin, P.. Safety, immunogenicity, and surrogate markers of clinical efficacy for modified vaccinia Ankara as a smallpox vaccine in HIV-infected subjects. J Infect Dis; Mar 1 2013.
Bavarian Nordic, , National Institute of Allergy and Infectious Diseases, . Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in HIV Infected Patients. 2005.
Overton, E. T., Lawrence, S. J., Wagner, E., Nopora, K., Rosch, S., Young, P., Schmidt, D., Kreusel, C., De Carli, S., Meyer, T. P., Weidenthaler, H., Samy, N., Chaplin, P.. Immunogenicity and safety of three consecutive production lots of the non replicating smallpox vaccine MVA: A randomised, double blind, placebo controlled phase III trial. PLoS ONE [Electronic Resource]; 2018.
Bavarian Nordic, . A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects. 2013.
A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects. https://clinicaltrials.gov/show/NCT01144637; 2010.
Darsow, U., Sbornik, M., Rombold, S., Katzer, K., von Sonnenburg, F., Behrendt, H., Ring, J.. Long-term safety of replication-defective smallpox vaccine (MVA-BN) in atopic eczema and allergic rhinitis. Journal of the European Academy of Dermatology and Venereology; 2016.
von Sonnenburg, F., Perona, P., Darsow, U., Ring, J., von Krempelhuber, A., Vollmar, J., Roesch, S., Baedeker, N., Kollaritsch, H., Chaplin, P.. Safety and immunogenicity of modified vaccinia Ankara as a smallpox vaccine in people with atopic dermatitis. Vaccine; 2014.
Bavarian Nordic, , United States Army Medical Research Institute of Infectious Diseases, . A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®. 2015.
Pittman, P. R., Hahn, M., Lee, H. S., Koca, C., Samy, N., Schmidt, D., Hornung, J., Weidenthaler, H., Heery, C. R., Meyer, T. P. H., Silbernagl, G., Maclennan, J., Chaplin, P.. Phase 3 Efficacy Trial of Modified Vaccinia Ankara as a Vaccine against Smallpox. New England Journal of Medicine; 2019.
Sano, J., Chaitman, B. R., Swindle, J., Frey, S. E.. Electrocardiography screening for cardiotoxicity after modified Vaccinia Ankara vaccination. American Journal of Medicine; 2009.
Hughes, C. M., Newman, F. K., Davidson, W. B., Olson, V. A., Smith, S. K., Holman, R. C., Yan, L., Frey, S. E., Belshe, R. B., Karem, K. L., Damon, I. K.. Analysis of variola and vaccinia virus neutralization assays for smallpox vaccines. Clinical & Vaccine Immunology: CVI; 2012.
Frey, S. E., Newman, F. K., Kennedy, J. S., Sobek, V., Ennis, F. A., Hill, H., Yan, L. K., Chaplin, P., Vollmar, J., Chaitman, B. R., Belshe, R. B.. Clinical and immunologic responses to multiple doses of IMVAMUNE (Modified Vaccinia Ankara) followed by Dryvax challenge. Vaccine; 2007.
Elizaga, M. L., Vasan, S., Marovich, M. A., Sato, A. H., Lawrence, D. N., Chaitman, B. R., Frey, S. E., Keefer, M. C.. Prospective Surveillance for Cardiac Adverse Events in Healthy Adults Receiving Modified Vaccinia Ankara Vaccines: A Systematic Review. PLoS ONE; 2013.
National Institute of Allergy and Infectious Diseases, . Combination Study With MVA BN and Dryvax. 2004.
Overton, E. T., Stapleton, J., Frank, I., Hassler, S., Goepfert, P. A., Barker, D., Wagner, E., von Krempelhuber, A., Virgin, G., Meyer, T. P., Muller, J., Badeker, N., Grunert, R., Young, P., Rosch, S., Maclennan, J., Arndtz-Wiedemann, N., Chaplin, P.. Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial. Open Forum Infectious Diseases; 2015.
Bavarian Nordic, , National Institutes of Health, . Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients. 2006.
von Krempelhuber, A., Vollmar, J., Pokorny, R., Rapp, P., Wulff, N., Petzold, B., Handley, A., Mateo, L., Siersbol, H., Kollaritsch, H., Chaplin, P.. A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE. Vaccine; 2010.
Wilck, M. B., Seaman, M. S., Baden, L. R., Walsh, S. R., Grandpre, L. E., Devoy, C., Giri, A., Kleinjan, J. A., Noble, L. C., Stevenson, K. E., Kim, H. T., Dolin, R.. Safety and immunogenicity of modified vaccinia Ankara (ACAM3000): effect of dose and route of administration. Journal of Infectious Diseases; 2010.
Seaman, M. S., Wilck, M. B., Baden, L. R., Walsh, S. R., Grandpre, L. E., Devoy, C., Giri, A., Noble, L. C., Kleinjan, J. A., Stevenson, K. E., Kim, H. T., Dolin, R.. Effect of vaccination with modified vaccinia Ankara (ACAM3000) on subsequent challenge with Dryvax. Journal of Infectious Diseases; 2010.
ACAM 3000 MVA at Harvard Medical School. https://clinicaltrials.gov/show/NCT00133575; 2005.
Parrino, J., McCurdy, L. H., Larkin, B. D., Gordon, I. J., Rucker, S. E., Enama, M. E., Koup, R. A., Roederer, M., Bailer, R. T., Moodie, Z., Gu, L., Yan, L., Graham, B. S.. Safety, immunogenicity and efficacy of modified vaccinia Ankara (MVA) against Dryvax<sup></sup> challenge in vaccinia-naive and vaccinia-immune individuals. Vaccine; 2007.
Frey, S. E., Winokur, P. L., Hill, H., Goll, J. B., Chaplin, P., Belshe, R. B.. Phase II randomized, double-blinded comparison of a single high dose (5×10(8) TCID50) of modified vaccinia Ankara compared to a standard dose (1×10(8) TCID50) in healthy vaccinia-naive individuals. Vaccine; 2014.
Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®. https://clinicaltrials.gov/show/NCT01827371; 2013.
Anderson, E. J., Lai, L., Wrammert, J., Kabbani, S., Xu, Y., Priyamvada, L., Hill, H., Goll, J. B., Jensen, T. L., Kao, C., Yildirim, I., Rouphael, N., Jackson, L., Mulligan, M. J.. Plasmablast, Memory B Cell, CD4+ T Cell, and Circulating Follicular Helper T Cell Responses to a Non-Replicating Modified Vaccinia Ankara Vaccine. 2020.
Jackson, L. A., Frey, S. E., El Sahly, H. M., Mulligan, M. J., Winokur, P. L., Kotloff, K. L., Campbell, J. D., Atmar, R. L., Graham, I., Anderson, E. J., Anderson, E. L., Patel, S. M., Fields, C., Keitel, W., Rouphael, N., Hill, H., Goll, J. B.. Safety and immunogenicity of a modified vaccinia Ankara vaccine using three immunization schedules and two modes of delivery: A randomized clinical non-inferiority trial. Vaccine; 2017.
Vollmar J, Arndtz N, Eckl KM, et al. Safety and immunogenicity of IMVAMUNE, a promising candidate as a third generation smallpox vaccine. Vaccine. 2006;24(12):2065-70.Top of Page
							
					
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