Mpox Resources for Clinical Research Sites and the Community

HANC maintains and updates this page focused on information about the 2022 Mpox (monkeypox) outbreak and its intersection with the HIV pandemic.

Mpox Terminology and Guidelines

Mpox (monkeypox) is a viral zoonosis (a virus transmitted to humans from animals) with symptoms similar to those seen in the past in smallpox patients, although it is clinically less severe. With the eradication of smallpox in 1980 and subsequent cessation of smallpox vaccination, Mpox has emerged as the most important orthopoxvirus for public health. Mpox primarily occurs in central and west Africa, often in proximity to tropical rainforests, and has been increasingly appearing in urban areas. Animal hosts include a range of rodents and non-human primates. Source: WHO

2022 Mpox Outbreak

Since early May 2022, cases of Mpox have been reported from countries where the disease is not endemic, and continue to be reported in several endemic countries. Most confirmed cases with travel history reported travel to countries in Europe and North America, rather than West or Central Africa where the Mpox virus is endemic. This is the first time that many Mpox cases and clusters have been reported concurrently in non-endemic and endemic countries in widely disparate geographical areas. Most reported cases so far have been identified through sexual health or other health services in primary or secondary health-care facilities and have involved mainly, but not exclusively, men who have sex with men. Source: WHO

2022 U.S. Map & Case Counts

WHO Director-General declares the ongoing Mpox outbreak a Public Health Emergency of International Concern

Signs & Symptoms

Mpox is a rare disease caused by infection with the Mpox virus. Mpox virus is part of the same family of viruses as smallpox. Mpox symptoms are similar to smallpox symptoms, but milder; and Mpox is rarely fatal. Mpox is not related to chickenpox. Symptoms of Mpox can include:

  • Fever
  • Headache
  • Muscle aches and backache
  • Swollen lymph nodes
  • Chills
  • Exhaustion
  • A rash that can look like pimples or blisters that appears on the face, inside the mouth, and on other parts of the body, like the hands, feet, chest, genitals, or anus.

The rash goes through different stages before healing completely. The illness typically lasts 2-4 weeks. Sometimes, people get a rash first, followed by other symptoms. Others only experience a rash. Source: CDC

Vaccines

NIAID provided significant support in the development of the JYNNEOS™ (also known as Imvamune or Imvanex) vaccine to prevent Mpox and smallpox. The vaccine was developed for people with weakened immune systems who were at risk for severe side effects from the existing smallpox vaccines. The JYNNEOS vaccine is an attenuated (weakened) live virus vaccine approved by the U.S. Food and Drug Administration in 2019 for individuals at high risk for smallpox or Mpox infection. Source: NIAID

Treatment

Currently, there is no specific treatment approved for Mpox virus infection. However, there are antiviral medications that can be used to treat smallpox and other conditions that may help patients with Mpox infection. NIAID supported the development of two of these smallpox treatments—tecovirimat or ST-246 (TPOXX), made by SIGA Technologies, New York, and brincidofovir (Tembexa), manufactured by Chimerix, based in Durham, N.C. NIAID is screening other novel compounds to find potential antiviral candidates to treat Mpox and is working to conduct larger clinical testing of tecovirimat specifically to treat patients with Mpox virus disease. Source: NIAID

Note: MPX is an emerging, rapidly evolving situation.

Resources

Centers for Disease Control and Prevention

Access the latest public health information from the CDC and explore resources for health professionals and communication resources, including Reducing Stigma in Communication and Community Engagement.

National Institutes of Health

The U.S. National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) played a key role in the development of the current vaccine and antiviral treatments for Mpox. Learn more about the latest research, testing, treatments & vaccines for Mpox.

World Health Organization

View the latest in public advice and technical guidance from the World Health Organization. The public site contains situation reports, global trends, fact sheets, FAQs, and the Research & Development blueprint for Mpox. 

NIAID-funded Mpox Research

The National Institute of Allergy and Infectious Diseases (NIAID) is conducting and supporting research focused on developing and evaluating treatments and vaccines for Mpox, understanding disease transmission and spillover, evaluating immunological characteristics of Mpox, and bolstering the critical research resources foundational to support the ongoing public health response. 

NIAID is planning for a JYNNEOS vaccine dose-sparing trial to compare immune response data for a range of doses of JYNNEOS and compare alternative inoculation routes. In addition, NIAID is conducting animal studies to understand the human-animal interface with Mpox virus and suspected reservoir hosts, as well as developing animal models to evaluate vaccine-induced immune responses to MPX virus. NIAID researchers also are isolating antibodies against Mpox virus that may be useful for the evaluation of vaccine-induced immune responses and as probes for immune assays.

NIAID is collaborating with Institut National de Recherche Biomédicale of the Democratic Republic of the Congo (DRC) to support the evaluation of the small molecule drug tecovirimat (TPOXX) for the treatment of adult and pediatric patients diagnosed with Mpox virus disease in the DRC.  The planned double-blind, randomized controlled trial is currently undergoing scientific review.

STOMP Trial (A5418)

NIAID has opened a Phase 3 double-blind, randomized controlled trial of tecovirimat (TPOXX) for the treatment of Mpox virus in the outpatient setting in the United States that will be conducted through the AIDS Clinical Trials Group (ACTG).  The study will include an open-label cohort to ensure that certain high-risk populations (e.g., pregnant or breastfeeding women, those with severe immune-deficiency) do not get randomized to placebo while also providing a means to collect important data on the safety and pharmacokinetics of TPOXX in this population.

  • Trial Name: STOMP (Study of Tecovirimat for treatment of human Monkeypox)
  • Full Title: A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Persons Age 16 or Older with Human Monkeypox Virus Disease
  • Study Number:  A5418
  • Chair:  Tim Wilkin, of Weill Cornell Medicine University
  • Enrollment:  Approximately 500-600 US participants
  • Study Website: https://www.stomptpoxx.org/main

NIAID is making viral isolates available for distribution to the global research and surveillance community free-of-charge via the NIAID-funded BEI Resources repository.  Distribution of these resources will facilitate additional Office of Science and Technology Policy (OSTP)-identified priority research, particularly in the area of diagnostic tools and surveillance.

Mpox & HIV

Mpox and HIV FAQ

The CDC answers frequently asked questions for people with HIV, their likelihood of acquiring Mpox, and recommended treatment, vaccines, and preventive actions to take.

Clinical Considerations for People with HIV

This information is intended for healthcare professionals providing care for people with HIV and provides considerations for prevention and treatment of Mpox virus infection.

Multimedia Resources

Print, graphic, and video resources to support MPX communication with partners and community members. 

Partners can help by providing Mpox information to different communities and various channels. Be careful to avoid marginalizing groups who may be at increased risk for Mpox. Keep messages fact-based to help prevent stigmatizing populations most affected. Reference the CDC's guidelines for Reducing Stigma in Monkeypox Communication and Community Engagement

Mpox outbreak: Resource toolkit for event organisers Source: ECDC
This toolkit, jointly created by the World Health Organization (WHO) Regional Office for Europe and the European Centre for Disease Prevention and Control (ECDC), provides event organisers with customisable tools on Mpox for mass gatherings.

Training Resources