Vaccinia immune globulin

Vaccinia immune globulin (VIG) is made from the pooled blood of individuals who have been inoculated with the smallpox vaccine. The antibodies these individuals developed in response to the smallpox vaccine are removed and purified. This results in VIG. It can be administered intravenously. It is used to treat individuals who have developed progressive vaccinia after smallpox vaccination.

It was also used along with cidofovir for the 2003 Midwest monkeypox outbreak as concomitant therapy to reduce the serious side effects of smallpox vaccine.[1][2] In addition, CDC states that use of VIGIV may be considered for postexposure prophylaxis of monkeypox in exposed individuals who cannot receive postexposure vaccination with smallpox vaccine because of severe T-cell function immunodeficiency.[3][4]

## Contents

* 1 Adverse effects of smallpox vaccine
* 2 Development of immune globulin
* 3 Orthopoxvirus Vaccination
* 4 See also
* 5 References
* 6 External links

## Adverse effects of smallpox vaccine

For a small percentage of the population, the smallpox vaccine either does not "take" or it produces adverse events. These include postvaccinial central nervous system disease, progressive vaccinia, eczema vaccinatum, accidental implantations, "generalized vaccinia", and the common erythematous or urticarial rashes.[5][6][7][8]

## Development of immune globulin

In the late 1940s, Henry Kempe suggested that the solution to the complications of the smallpox vaccine was to provide antibodies in the form of gamma globulin, a medical treatment known as passive immunity.[9][10] Kempe noted that for some infants, the smallpox vaccine failed to "take". Kempe believed this failure might be due to the high levels of maternal antibodies to vaccinia in the infants' blood. It appeared to Kempe that the presence of the antibodies blocked viral replication, and therefore a transfusion of antibodies from people who were immune due to vaccination would help those in whom vaccination had failed.[11]

Two intravenous formulations of VIG (VIGIV Cangene and VIGIV Dynport) have been licensed by the FDA for the management of patients with progressive vaccinia, eczema vaccinatum, severe generalized vaccinia, and extensive body surface involvement or periocular implantation following inadvertent inoculation.[12][13]

Cangene (a subsidiary of Emergent BioSolutions) brand-name VIGIV is also known by an alternate name: C-VIG; CNJ 016; NP 016 – Cangene; VIG; VIGIV – Emergent BioSolutions.[14] This type of medicine called an antiserum has been used in many treatments successfully, and some research and clinical trials for its use treating monkeypox has been completed.[15]

An initial post-marketing study was updated in 2021 to verify the clinical benefits of VIGIV (CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution) in the resolution of complications resulting from Orthopoxvirus vaccination in eligible patients treated with VIGIV named Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection.[16]

## Orthopoxvirus Vaccination

Vaccinia immune globulin intravenous (VIGIV) is recommended as the first line of therapy for treatment of adverse reactions resulting from continued vaccinia virus replication after vaccination using ACAM2000 or APSV.[17][18][19][20]

VIGIV is not commercially available but can be made available through the Strategic National Stockpile (SNS) for the treatment of smallpox vaccine complications in patients with serious clinical manifestations.

Other treatments are

* Cidofovir
* Brincidofovir (TEMBEXA)
* Tecovirimat (ST-246 or its brand name Tpoxx)

The Orthopoxvirus (Smallpox) vaccine management guidelines are available from the Centers for Disease Control and Prevention.[21]

Literature such as Progressive Vaccinia: Case Description and Laboratory-Guided Therapy With Vaccinia Immune Globulin, ST-246®, and CMX001 explains in clinical terms to the layperson (non-medical staff, or the patient and their families) what happens during this treatment when they are sick.[22]

HIV and AIDS positive people are at risk of developing reactions and side-effects when they have Orthopoxvirus. Literature such as Progressive Vaccinia Acquired through Zoonotic Transmission in a Patient with HIV/AIDS explains again in clinical terms why patients with immunodeficiency (from HIV infection, or from any other medical condition that affects the immune system) are at high risk.[23] Likewise, infants (and by extension during pregnancy), and the elderly with pre-existing medical conditions are more likely to have more serious reactions.[24] For people who have been taking serum antibodies for immunodeficiency, VIGIV has a different name and is for a specific case (if they get necrosis from a smallpox vaccine) rather than a generalized treatment for immunodeficiency.[25] These (IgG, IgA, IgM, IgD, and IgE) previously have been researched for use with Modified Vaccinia virus Ankara, more so than VIGIV as a treatment for monkeypox.[26][27]

## See also

* Cangene
* Eczema vaccinatum
* Gamma globulin
* Immunoglobulin therapy – an overview of this topic.
* Vaccinia virus

## References

1. ↑ "CDC Smallpox | Investigational Vaccinia Immune Globulin (VIG) Information". Bt.cdc.gov. http://emergency.cdc.gov/agent/smallpox/vaccination/vig.asp.
2. ↑ Wharton, M; Strikas, RA; Harpaz, R; Rotz, LD; Schwartz, B; Casey, CG; Pearson, ML; Anderson, LJ (4 April 2003). "Recommendations for using smallpox vaccine in a pre-event vaccination program. Supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC)". MMWR. Recommendations and Reports 52 (RR-7): 1–16. PMID 12710832.
3. ↑ "Vaccinia Immune Globulin IV Monograph for Professionals". https://www.drugs.com/monograph/vaccinia-immune-globulin-iv.html.
4. ↑ "Monkeypox | Agent Fact Sheet". 17 August 2023. https://www.centerforhealthsecurity.org/our-work/publications/monkeypox.
5. ↑ Lane, J.Michael; Goldstein, Joel (July 2003). "Adverse events occurring after smallpox vaccination". Seminars in Pediatric Infectious Diseases 14 (3): 189–195. doi:10.1016/s1045-1870(03)00032-3. PMID 12913830.
6. ↑ Frelinger, JA; Garba, ML (29 August 2002). "Responses to smallpox vaccine". The New England Journal of Medicine 347 (9): 689-90; author reply 689-90. doi:10.1056/NEJM200208293470913. PMID 12201305.
7. ↑ Møller-Larsen, A; Haahr, S (January 1978). "Humoral and cell-mediated immune responses in humans before and after revaccination with vaccinia virus". Infection and Immunity 19 (1): 34–39. doi:10.1128/iai.19.1.34-39.1978. PMID 624594.
8. ↑ Cohen, Jon (2 November 2001). "Smallpox Vaccinations: How Much Protection Remains?". Science 294 (5544): 985. doi:10.1126/science.294.5544.985. PMID 11691969.
9. ↑ "Vaccinia immune globulin definition - Medical Dictionary definitions of popular medical terms easily defined on MedTerms". Medterms.com. 2012-06-14. http://www.medterms.com/script/main/art.asp?articlekey=21783.
10. ↑ "CDC Smallpox | Medical Management of Smallpox (Vaccinia) Vaccine Adverse Reactions (Info for Clinicians and Public Health Professionals)". Bt.cdc.gov. http://www.bt.cdc.gov/agent/smallpox/vaccination/mgmt-adv-reactions.asp.
11. ↑ Bray, M. (15 September 2004). "Henry Kempe and the Birth of Vaccinia Immune Globulin". Clinical Infectious Diseases 39 (6): 767–769. doi:10.1086/423005. PMID 15472805.
12. ↑ Wittek, Riccardo (May 2006). "Vaccinia immune globulin: current policies, preparedness, and product safety and efficacy". International Journal of Infectious Diseases 10 (3): 193–201. doi:10.1016/j.ijid.2005.12.001. PMID 16564720.
13. ↑ "DynPort Vaccine Company | GDIT". https://www.gdit.com/dvc/.
14. ↑ "DailyMed - CNJ-016 (Vaccinia immune globulin- human injection". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe.
15. ↑ Leendertz, Siv; Stern, Daniel; Theophil, Dennis; Anoh, Etile; Mossoun, Arsène; Schubert, Grit; Wiersma, Lidewij; Akoua-Koffi, Chantal et al. (29 September 2017). "A Cross-Sectional Serosurvey of Anti-Orthopoxvirus Antibodies in Central and Western Africa". Viruses 9 (10): 278. doi:10.3390/v9100278. PMID 28961172.
16. ↑ Clinical trial number NCT01374984 for "VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection" at ClinicalTrials.gov
17. ↑ "Medical Management of Adverse Reactions to Vaccinia Virus Vaccination | Smallpox | CDC". 2 November 2021. https://www.cdc.gov/smallpox/clinicians/vaccine-medical-management6.html.
18. ↑ "VIGIV (Vaccinia immune globulin intravenous) dosing, indications, interactions, adverse effects, and more". https://reference.medscape.com/drug/vigiv-vaccinia-immune-globulin-intravenous-343271.
19. ↑ Eggleton, J. S.; Nagalli, S. (2022). "Highly Active Antiretroviral Therapy (HAART)". StatPearls. StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK554533/.
20. ↑ Izzedine, Hassane; Launay-Vacher, Vincent; Baumelou, Alain; Deray, Gilbert (August 2004). "Antiretroviral and immunosuppressive drug-drug interactions: An update". Kidney International 66 (2): 532–541. doi:10.1111/j.1523-1755.2004.00772.x. PMID 15253704.
21. ↑ "Medical Management of Adverse Reactions to Vaccinia Virus Vaccination | Smallpox | CDC". 2 November 2021. https://www.cdc.gov/smallpox/clinicians/vaccine-medical-management6.html.
22. ↑ Lederman, E. R.; Davidson, W.; Groff, H. L.; Smith, S. K.; Warkentien, T.; Li, Y.; Wilkins, K. A.; Karem, K. L. et al. (November 2012). "Progressive Vaccinia: Case Description and Laboratory-Guided Therapy With Vaccinia Immune Globulin, ST-246, and CMX001". Journal of Infectious Diseases 206 (9): 1372–1385. doi:10.1093/infdis/jis510. PMID 22904336.
23. ↑ Laiton-Donato, Katherine; Ávila-Robayo, Paola; Páez-Martinez, Andrés; Benjumea-Nieto, Paula; Usme-Ciro, José A.; Pinzón-Nariño, Nicole; Giraldo, Ivan; Torres-Castellanos, Diego et al. (March 2020). "Progressive Vaccinia Acquired through Zoonotic Transmission in a Patient with HIV/AIDS, Colombia". Emerging Infectious Diseases 26 (3): 601–605. doi:10.3201/eid2603.191365. PMID 32091366.
24. ↑ Bray, Mike; Wright, Mary E. (15 March 2003). "Progressive Vaccinia". Clinical Infectious Diseases 36 (6): 766–774. doi:10.1086/374244. PMID 12627361.
25. ↑ "Specific Antibody Deficiency | Immune Deficiency Foundation". https://primaryimmune.org/about-primary-immunodeficiencies/specific-disease-types/specific-antibody-deficiency.
26. ↑ Earl, Patricia L.; Americo, Jeffrey L.; Wyatt, Linda S.; Anne Eller, Leigh; Montefiori, David C.; Byrum, Russ; Piatak, Michael; Lifson, Jeffrey D. et al. (15 September 2007). "Recombinant modified vaccinia virus Ankara provides durable protection against disease caused by an immunodeficiency virus as well as long-term immunity to an orthopoxvirus in a non-human primate". Virology 366 (1): 84–97. doi:10.1016/j.virol.2007.02.041. PMID 17499326.
27. ↑ Berger, Melvin (May 2008). "Principles of and Advances in Immunoglobulin Replacement Therapy for Primary Immunodeficiency". Immunology and Allergy Clinics of North America 28 (2): 413–437. doi:10.1016/j.iac.2008.01.008. PMID 18424340.

## External links

* Maurer, Douglas M; Harrington, Brian; Lane, J Michael (September 2003). "Smallpox vaccine: contraindications, administration, and adverse reactions". American Family Physician 68 (5): 889–896. ProQuest 73658843. PMID 13678138. https://www.aafp.org/link_out?pmid=13678138.
* CDC Smallpox Home
* Quick Guide to Preexposure Smallpox Vaccination
* U.S. Food and Drug Administration – Vaccinia Immune Globulin Intravenous (Human) Supporting Documents older than three years
* Vaccinia Immune Globulin Intravenous Product Information (this pamphlet is included with the medicine)

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