- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Journal: Acral Papulovesicular Eruption in a Soldier Following Smallpox Vaccination. (Pubmed Central) - Jun 8, 2022
Acral papulovesicular eruption is a distinct presentation that has been described in US Military service members following vaccination with the second-generation smallpox vaccine (ACAM2000, Sanofi Pasteur Biologics Co). We describe a case of this unique cutaneous eruption and review previously described cutaneous adverse events associated with smallpox vaccination.
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions, TPOXX (tecovirimat) / SIGA Technologies
Journal: Monkeypox in a Traveler Returning from Nigeria - Dallas, Texas, July 2021. (Pubmed Central) - Apr 14, 2022
Whole genome sequencing showed that the virus was consistent with a strain of Monkeypox virus known to circulate in Nigeria, but the specific source of the patient's infection was not identified. No epidemiologically linked cases were reported in Nigeria; no contact received postexposure prophylaxis (PEP) with the orthopoxvirus vaccine ACAM2000.
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Journal: Proteomic assessment of humoral immune responses in smallpox vaccine recipients. (Pubmed Central) - Jan 27, 2022
In this cohort, which consisted of both ACAM2000 and Dryvax recipients, we noted minute differences in the antibody responses to a restricted number of viral proteins, providing additional support for the use of ACAM2000 as a replacement smallpox vaccine. Furthermore, our data indicate that poxvirus proteome microarrays can be valuable for screening and monitoring smallpox vaccine-induced humoral immune responses in large-scale serologic surveillance studies and prove useful in the guidance of developing novel smallpox candidate vaccines.
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Clinical, Journal: Enhanced safety surveillance study of ACAM2000 smallpox vaccine among US military service members. (Pubmed Central) - Aug 31, 2021
P=N/A
Furthermore, our data indicate that poxvirus proteome microarrays can be valuable for screening and monitoring smallpox vaccine-induced humoral immune responses in large-scale serologic surveillance studies and prove useful in the guidance of developing novel smallpox candidate vaccines. Electronic records surveillance of the entire vaccinated SM population over a ten-year period found rates of myopericarditis, of defined neurological events, and of overall cardiac events that were consistent with those of prior passive surveillance studies involving Dryvax or ACAM2000 smallpox vaccines.
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions, CNJ-016 (vaccinia immune globulin intravenous (human)) / Emergent Biosolutions
Trial completion, Trial completion date, Trial primary completion date: VA-008 ACAM2000 (clinicaltrials.gov) - Aug 18, 2021
P4, N=3032, Completed,
Electronic records surveillance of the entire vaccinated SM population over a ten-year period found rates of myopericarditis, of defined neurological events, and of overall cardiac events that were consistent with those of prior passive surveillance studies involving Dryvax or ACAM2000 smallpox vaccines. Recruiting --> Completed | Trial completion date: Feb 2022 --> Aug 2021 | Trial primary completion date: Dec 2021 --> May 2021
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Clinical, Journal: Prospective safety surveillance study of ACAM2000 smallpox vaccine in deploying military personnel. (Pubmed Central) - Apr 28, 2021
P=N/A
Recruiting --> Completed | Trial completion date: Feb 2022 --> Aug 2021 | Trial primary completion date: Dec 2021 --> May 2021 In this carefully screened, generally young and healthy service-member population, ACAM2000 vaccination was associated with modest non-significant increases in the risk of myopericarditis (adjusted OR, 1.3; unadjusted OR, 1.8); all but seven cases were subclinical.
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions, CNJ-016 (vaccinia immune globulin intravenous (human)) / Emergent Biosolutions
Trial completion date, Trial primary completion date: VA-008 ACAM2000 (clinicaltrials.gov) - Feb 25, 2021
P4, N=3000, Recruiting,
In this carefully screened, generally young and healthy service-member population, ACAM2000 vaccination was associated with modest non-significant increases in the risk of myopericarditis (adjusted OR, 1.3; unadjusted OR, 1.8); all but seven cases were subclinical. Trial completion date: Feb 2021 --> Feb 2022 | Trial primary completion date: Feb 2021 --> Dec 2021
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
[VIRTUAL] Oops, I Didn't Follow My Post Vaccinaton Instructions () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_1765;
Hence, the vaccine recipients should be well educated about proper care of the vaccination site for preventing possible contact transmission of the virus. These include covering the vaccination site, proper hand washing after bandage changes, and avoiding skin-to-skin contact.
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions, CNJ-016 (vaccinia immune globulin intravenous (human)) / Emergent Biosolutions
Trial completion date, Trial primary completion date: VA-008 ACAM2000 (clinicaltrials.gov) - Mar 18, 2020
P4, N=3000, Recruiting,
Trial registration Retrospectively registered (ISRCTN#10201650) on October 22, 2018. Trial completion date: Aug 2019 --> Feb 2021 | Trial primary completion date: Feb 2019 --> Feb 2021
- |||||||||| JYNNEOS (live modified vaccinia virus ankara) / Bavarian Nordic
Trial completion, Head-to-Head: A Non-inferiority Trial to Compare MVA-BN (clinicaltrials.gov) - Dec 5, 2019
P3, N=440, Completed,
Trial completion date: Aug 2019 --> Feb 2021 | Trial primary completion date: Feb 2019 --> Feb 2021 Active, not recruiting --> Completed
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: ACAM2000 (clinicaltrials.gov) - Mar 14, 2019
P=N/A, N=24, Completed,
Development of vaccinia antibodies was rapid and broad. Active, not recruiting --> Completed | N=200 --> 24 | Trial completion date: Apr 2024 --> Feb 2019 | Trial primary completion date: Apr 2024 --> Feb 2019
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions, CNJ-016 (vaccinia immune globulin intravenous (human)) / Emergent Biosolutions
Trial completion date, Trial primary completion date: VA-008 ACAM2000 (clinicaltrials.gov) - Feb 19, 2018
P4, N=3000, Recruiting,
Active, not recruiting --> Completed | N=200 --> 24 | Trial completion date: Apr 2024 --> Feb 2019 | Trial primary completion date: Apr 2024 --> Feb 2019 Trial primary completion date: Jul 2017 --> Feb 2019 | Trial completion date: Jan 2018 --> Aug 2019
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Phase classification: Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000 (clinicaltrials.gov) - Jan 30, 2018
P=N/A, N=14108, Completed,
Trial primary completion date: Jul 2017 --> Feb 2019 | Trial completion date: Jan 2018 --> Aug 2019 Phase classification: P4 --> P=N/A
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Trial completion, Enrollment change: Safety Surveillance Study of ACAM2000 (clinicaltrials.gov) - Jan 30, 2018
P=N/A, N=897227, Completed,
Phase classification: P4 --> P=N/A Active, not recruiting --> Completed | N=200000 --> 897227
- |||||||||| JYNNEOS (live modified vaccinia virus ankara) / Bavarian Nordic
Trial primary completion date, Head-to-Head: A Non-inferiority Trial to Compare MVA-BN (clinicaltrials.gov) - Jul 21, 2017
P3, N=440, Active, not recruiting,
Active, not recruiting --> Completed | N=200000 --> 897227 Trial primary completion date: Mar 2017 --> Aug 2017
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Trial primary completion date: ACAM2000 (clinicaltrials.gov) - May 17, 2017
P=N/A, N=200, Active, not recruiting,
Trial primary completion date: Mar 2017 --> Aug 2017 Trial primary completion date: Apr 2016 --> Apr 2024
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Enrollment closed, Phase classification, Trial primary completion date: Safety Surveillance Study of ACAM2000 (clinicaltrials.gov) - May 17, 2017
P=N/A, N=200000, Active, not recruiting,
Trial primary completion date: Apr 2016 --> Apr 2024 Recruiting --> Active, not recruiting | Phase classification: P4 --> PN/A | Trial primary completion date: Apr 2016 --> Dec 2017
- |||||||||| JYNNEOS (live modified vaccinia virus ankara) / Bavarian Nordic
Enrollment closed, Trial primary completion date, Head-to-Head: A Non-inferiority Trial to Compare MVA-BN (clinicaltrials.gov) - Nov 27, 2016
P3, N=440, Active, not recruiting,
Recruiting --> Active, not recruiting | Phase classification: P4 --> PN/A | Trial primary completion date: Apr 2016 --> Dec 2017 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Mar 2017
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Enrollment closed: ACAM2000 (clinicaltrials.gov) - Jul 20, 2016
P=N/A, N=200, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Mar 2017 Recruiting --> Active, not recruiting
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Trial completion, Enrollment change: Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000 (clinicaltrials.gov) - Feb 21, 2016
P4, N=14108, Completed,
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | N=20000 --> 14108
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions, CNJ-016 (vaccinia immune globulin intravenous (human)) / Emergent Biosolutions
Enrollment open, Trial initiation date: VA-008 ACAM2000 (clinicaltrials.gov) - Dec 22, 2015
P4, N=3000, Recruiting,
Active, not recruiting --> Completed | N=20000 --> 14108 Not yet recruiting --> Recruiting | Initiation date: Jun 2015 --> Sep 2015
- |||||||||| JYNNEOS (live modified vaccinia virus ankara) / Bavarian Nordic
Trial primary completion date, Head-to-Head: A Non-inferiority Trial to Compare MVA-BN (clinicaltrials.gov) - Oct 29, 2015
P3, N=440, Recruiting,
Not yet recruiting --> Recruiting | Initiation date: Jun 2015 --> Sep 2015 Trial primary completion date: Nov 2015 --> Dec 2016
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions, CNJ-016 (vaccinia immune globulin intravenous (human)) / Emergent Biosolutions
New P4 trial: VA-008 ACAM2000 (clinicaltrials.gov) - May 14, 2015
P4, N=3000, Not yet recruiting,
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Enrollment closed: Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000 (clinicaltrials.gov) - Mar 18, 2015
P4, N=20000, Active, not recruiting,
Trial primary completion date: Nov 2015 --> Dec 2016 Recruiting --> Active, not recruiting
- |||||||||| JYNNEOS (live modified vaccinia virus ankara) / Bavarian Nordic
Enrollment open, Head-to-Head: A Non-inferiority Trial to Compare MVA-BN (clinicaltrials.gov) - Mar 7, 2015
P3, N=440, Recruiting,
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||||||| JYNNEOS (live modified vaccinia virus ankara) / Bavarian Nordic
Trial primary completion date, Head-to-Head: A Non-inferiority Trial to Compare MVA-BN (clinicaltrials.gov) - Jan 22, 2015
P3, N=440, Not yet recruiting,
Not yet recruiting --> Recruiting Trial primary completion date: Jul 2015 --> Nov 2015
- |||||||||| ACAM2000 (smallpox (vaccinia) live vaccine) / Emergent Biosolutions
Enrollment change: ACAM2000 (clinicaltrials.gov) - Nov 17, 2013
P=N/A, N=200, Recruiting,
No longer recruiting --> Completed N=150 --> 200
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