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
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
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 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.
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.
IDSA Mpox fact sheet (English) Source: IDSA
IDSA Mpox fact sheet (Spanish) Source: IDSA
Mpox and safer sex Source: CDC
Mpox information for teens and young adults Source: CDC
Testing patients for Mpox Source: CDC
What to do if you suspect Mpox Source: CDC
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.
Mpox update "The message is the same for everyone", June 7, 2022 Source: HIV.gov
Mpox in the U.S.: an update for clinicians and the LGBTQ community, June 13, 2022 Source: IDSA
Mpox outbreak update, July 18, 2022 Source: HIV.gov
Mpox community listening session, August 2, 2022 Source: AIDS United
Duke experts talk Mpox, August 5, 2022 Source: Duke Health
Mpox: An overview, August 26, 2022 Source: Duke University School of Medicine and HANC