Assessment of Myocarditis After Replication-Deficient Smallpox Immunization

NCT05513313 | Not Yet Recruiting FDA Drug

• 1 other identifier: PAMARDSI
• Study Type: observational
• Target: 2,350
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective observational phase IV study of a novel, replication-deficient smallpox vaccine that has been recently been approved by FDA. The purpose of this study is to determine if there are any abnormalities detected by electrocardiographic testing and/or blood tests within 35 days of receiving the second dose of smallpox vaccine either alone or co-administered with other vaccines that may/may not be suggestive of myopericarditis.

Conditions

Myopericarditis; Small Pox

Keywords

Small pox vaccine; ACAM2000™; Dryvax®

Outcome Measures

Primary Outcomes (2)

• Primary Objective

  Determine the number of participants with myocarditis or pericarditis defined by abnormal laboratory biomarkers (hsTn) or abnormal ECG that may or may not be accompanied by subjective reports of chest, back, shoulder or upper abdominal pain or discomfort following receipt of the 2-dose series of a novel, replication-deficient (Jynneos™) smallpox vaccination in a group of adult primary smallpox vaccines.

  Within 35 days following the 2-dose series of a novel, replication-deficient (JYNNEOS™) smallpox vaccine

• Primary Outcome

  Determine the number of participants with myocarditis or pericarditis defined by abnormal laboratory biomarkers (hsTn) or abnormal ECG that may or may not be accompanied by subjective reports of chest, back, shoulder or upper abdominal pain or discomfort following receipt of the 2-dose series of a novel, replication-deficient (Jynneos™) smallpox vaccination with co-receipt of any other ACIP recommended vaccine in a group of adult primary smallpox vaccines.

  Within 35 days following the 2-dose series of a novel, replication-deficient (JYNNEOS™) smallpox vaccine

Secondary Outcomes (3)

• Secondary Objective

  Within 35 days following the 2-dose series of a novel, replication-deficient (JYNNEOS™) smallpox vaccine

• Tertiary Objective

  Within 35 days following the 2-dose series of a novel, replication-deficient (JYNNEOS™) smallpox vaccine

• Quaternary Objective

  Within 35 days following the 2-dose series of a novel, replication-deficient (JYNNEOS™) smallpox vaccine

Study Arms (3)

Jynneos vaccine with out other vaccines

Allocated to Jynneos without any need for additional indicated/required vaccines intervention. JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection. Administer two doses (0.5 mL each) 4 weeks apart. Each dose (0.5 mL) is supplied in a singledose vial.

Biological: JYNNEOS

Jynneos vaccine with other vaccines at dose 1

Allocated to Jynneos with concomitant vaccines given at time of first dose of Jynneos intervention.

Biological: JYNNEOS

Jynneos vaccine with other vaccines at dose 2

Allocated to Jynneos with concomitant vaccines given at time of second dose of Jynneos.

Biological: JYNNEOS

Interventions

JYNNEOS BIOLOGICAL

smallpox vaccine

Jynneos vaccine with other vaccines at dose 1; Jynneos vaccine with other vaccines at dose 2; Jynneos vaccine with out other vaccines

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

2350 Active duty military personnel age 18 to 45 years meeting the eligibility criteria and having a current force health protection requirement for the smallpox vaccination.

You may qualify if:

• Active duty military personnel within the range of 18-45 years of age without limitations to gender or ethnicity.
• Primary vaccinee (receiving smallpox vaccine for the first time) with a force health protection requirement for the smallpox vaccination
• Medical screening for immunization completed and potential participant found eligible for immunization (standard of care)

You may not qualify if:

• Known contraindication to replication deficient smallpox vaccination based on FDA-approved package insert for JYNNEOS™ vaccine.
• No indication for replication deficient smallpox vaccination based on FDA-approved package insert for JYNNEOS, ACIP or DoD guidelines
• Secondary smallpox vaccinee (patients who had previously received any smallpox vaccine).
• Age less than 18 years or age greater than 45 years.
• Inability to provide informed consent.
• Presence of a moderate or severe acute illness with or without a fever
• Pregnancy: We will rely on the subject for an assessment of her pregnancy status, based on answers in the routine adult immunization screening questionnaire. (Screening by history is the current standard of care.)
• Scheduled deployment, PCS or TDY that would interfere with the respective follow-up visits. (no planned deployment, TDY or PCS for 65 days after enrollment/visit 1).

Sponsors & Collaborators

• Womack Army Medical Center: lead
• United States Naval Medical Center, San Diego: collaborator
• C.R.Darnall Army Medical Center: collaborator

Related Publications (14)

• Casey C, Vellozzi C, Mootrey GT, Chapman LE, McCauley M, Roper MH, Damon I, Swerdlow DL; Vaccinia Case Definition Development Working Group; Advisory Committee on Immunization Practices-Armed Forces Epidemiological Board Smallpox Vaccine Safety Working Group. Surveillance guidelines for smallpox vaccine (vaccinia) adverse reactions. MMWR Recomm Rep. 2006 Feb 3;55(RR-1):1-16.

  PMID: 16456528 BACKGROUND

• Halsell JS, Riddle JR, Atwood JE, Gardner P, Shope R, Poland GA, Gray GC, Ostroff S, Eckart RE, Hospenthal DR, Gibson RL, Grabenstein JD, Arness MK, Tornberg DN; Department of Defense Smallpox Vaccination Clinical Evaluation Team. Myopericarditis following smallpox vaccination among vaccinia-naive US military personnel. JAMA. 2003 Jun 25;289(24):3283-9. doi: 10.1001/jama.289.24.3283.

  PMID: 12824210 BACKGROUND

• Godreuil S, Delhaume O, Besset-Prat L, Blayac JP, Peyriere H, Bonnet P. [Acute haemorrhagic pericarditis following influenza vaccination]. Presse Med. 2003 Feb 15;32(6):258-9. French.

  PMID: 12610454 BACKGROUND

• Boccara F, Benhaiem-Sigaux N, Cohen A. Acute myopericarditis after diphtheria, tetanus, and polio vaccination. Chest. 2001 Aug;120(2):671-2. doi: 10.1378/chest.120.2.671.

  PMID: 11502677 BACKGROUND

• Peyriere H, Hillaire-Buys D, Pons M, Navarre C, Davy JM, Blayac JP. [Acute pericarditis after vaccination against hepatitis B: a rare effect to be known]. Rev Med Interne. 1997;18(8):675-6. doi: 10.1016/s0248-8663(97)82474-5. No abstract available. French.

  PMID: 9365747 BACKGROUND

• Helle EP, Koskenvuo K, Heikkila J, Pikkarainen J, Weckstrom P. Myocardial complications of immunisations. Ann Clin Res. 1978 Oct;10(5):280-7.

  PMID: 736507 BACKGROUND

• Cono J, Casey CG, Bell DM; Centers for Disease Control and Prevention. Smallpox vaccination and adverse reactions. Guidance for clinicians. MMWR Recomm Rep. 2003 Feb 21;52(RR-4):1-28.

  PMID: 12617510 BACKGROUND

• de Meester A, Luwaert R, Chaudron JM. Symptomatic pericarditis after influenza vaccination: report of two cases. Chest. 2000 Jun;117(6):1803-5. doi: 10.1378/chest.117.6.1803.

  PMID: 10858422 BACKGROUND

• Feldman AM, McNamara D. Myocarditis. N Engl J Med. 2000 Nov 9;343(19):1388-98. doi: 10.1056/NEJM200011093431908. No abstract available.

  PMID: 11070105 BACKGROUND

• Engler RJ, Nelson MR, Collins LC Jr, Spooner C, Hemann BA, Gibbs BT, Atwood JE, Howard RS, Chang AS, Cruser DL, Gates DG, Vernalis MN, Lengkeek MS, McClenathan BM, Jaffe AS, Cooper LT, Black S, Carlson C, Wilson C, Davis RL. A prospective study of the incidence of myocarditis/pericarditis and new onset cardiac symptoms following smallpox and influenza vaccination. PLoS One. 2015 Mar 20;10(3):e0118283. doi: 10.1371/journal.pone.0118283. eCollection 2015.

  PMID: 25793705 BACKGROUND

• Grabenstein JD, Winkenwerder W Jr. US military smallpox vaccination program experience. JAMA. 2003 Jun 25;289(24):3278-82. doi: 10.1001/jama.289.24.3278.

  PMID: 12824209 BACKGROUND

• Bonini M, Braido F, Baiardini I, Del Giacco S, Gramiccioni C, Manara M, Tagliapietra G, Scardigno A, Sargentini V, Brozzi M, Rasi G, Bonini S. AQUA: Allergy Questionnaire for Athletes. Development and validation. Med Sci Sports Exerc. 2009 May;41(5):1034-41. doi: 10.1249/MSS.0b013e318193c663.

  PMID: 19346984 BACKGROUND

• Silverberg JI. Atopic disease and cardiovascular risk factors in US children. J Allergy Clin Immunol. 2016 Mar;137(3):938-40.e1. doi: 10.1016/j.jaci.2015.09.012. Epub 2015 Dec 8. No abstract available.

  PMID: 26679356 BACKGROUND

• Xu RY, Zhu XF, Yang Y, Ye P. High-sensitive cardiac troponin T. J Geriatr Cardiol. 2013 Mar;10(1):102-9. doi: 10.3969/j.issn.1671-5411.2013.01.015.

  PMID: 23610580 BACKGROUND

Related Links

• JYNNEOS package insert

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Smallpox

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSN, FNP-C

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: August 24, 2022
• Study Start (Estimated): March 1, 2029
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): October 1, 2033
• Last Updated: December 14, 2023

Record last verified: 2023-12