Drug Database: Vaccinia Immune Globulin (Human)

What is vaccinia immune globulin (human)?

Vaccinia immune globulin (human) (also known as VIGIV) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of complications resulting from smallpox vaccination. (Smallpox is a disease caused by the variola virus, a member of the orthopoxvirus group of viruses. Since 1980, smallpox has been considered eradicated worldwide.)

Although VIGIV is FDA-approved only for the treatment of complications due to smallpox vaccination, it may also be used for the treatment or post-exposure prophylaxis (PEP) of orthopoxvirus infections, including mpox. VIGIV can be used for mpox treatment or PEP through an expanded access program (also known as compassionate use).

Mpox can be an opportunistic infection (OI) of HIV. An OI is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as people with HIV—than in people with healthy immune systems. To learn more about OIs, read the HIVinfo What is an Opportunistic Infection? fact sheet.

How is vaccinia immune globulin (human) used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV include recommendations on the use of VIGIV for mpox treatment or post-exposure prophylaxis (PEP).

Additionally, the Guidelines for the Prevention and Treatment of Opportunistic Infections in Children with and Exposed to HIV reference the Centers for Disease Control and Prevention's (CDC) Clinical Guidance webpage, which includes information on the use of VIGIV for mpox treatment or PEP in children and in people with HIV.

The recommended uses may not always be consistent with FDA-approved uses of VIGIV. See the Adult Guidelines and the CDC’s Clinical Guidance for complete information on recommended uses of VIGIV in adults and children with HIV. VIGIV may have other recommended uses not listed above.

What should I tell my health care provider before receiving vaccinia immune globulin (human)?

Before receiving VIGIV, tell your health care provider:

• If you are allergic to VIGIV or any other medicines. 
• About any medical conditions you have or have had, including:
• History of anaphylactic reaction or a severe systemic allergic reaction to a previous dose of VIGIV or any other human immune globulin preparations
• Immunoglobulin A (IgA) deficiency
• Keratitis (inflammation of the cornea of the eye)
• Kidney problems
• Diabetes
• Atherosclerosis or heart problems
• If you use a blood glucose monitoring system. (VIGIV can interfere with certain types of blood glucose monitoring systems.)
• If you have recently received any type of vaccination or plan to receive a vaccination. 
• About any health conditions that may prevent you from receiving medicine by injection or infusion.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of receiving VIGIV during pregnancy.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. VIGIV may affect the way other medicines or products work, and other medicines or products may affect how VIGIV works. Ask your health care provider if there are interactions between VIGIV and the other medicines you take.

Ask your health care provider about possible side effects from VIGIV. Your health care provider will tell you what to do if you have side effects.

How is vaccinia immune globulin (human) given?

VIGIV is given by a health care provider as an intravenous infusion. The dose of VIGIV is based on a person’s body weight. VIGIV is usually given as a single dose. However, your health care provider will determine if you need additional VIGIV dosing. Read any printed information that your health care provider gives you about VIGIV.

Where can I find more information about vaccinia immune globulin (human)?

• Recommendations on the HIV-related uses of VIGIV, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. 
• CDC webpage Clinical Considerations for Treatment and Prophylaxis of Mpox Infection in People Who are Immunocompromised.
• This Patient Version drug summary is based on the Expanded Access IND Protocol: Use of Vaccinia Immune Globulin Intravenous (VIGIV, CNJ-016) for Treatment of Human Orthopoxvirus Infection in Adults and Children.
• VIGIV-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)