Monkeypox spread could be monitored with wastewater, study suggests
Monkeypox, a virus that causes painful rashes and flu-like symptoms, is spreading rapidly throughout many parts of the world, including the U.S. To get a fast understanding of how the virus is moving through communities, researchers reporting in ACS’ Environmental Science & Technology Letters suggest turning to wastewater epidemiology. They show how the method — widely applied to monitor SARS-CoV-2 transmission — could be optimized for monkeypox, potentially detecting as few as seven infections per 100,000 people.
Like SARS-CoV-2, the monkeypox virus can shed from infected people through their feces, urine and saliva. Recently, researchers have detected its DNA in wastewater using polymerase chain reaction (PCR) assays. However, monitoring current monkeypox outbreaks in the U.S. with wastewater-based epidemiology has been limited, despite its success in tracking community-level SARS-CoV-2 prevalence. So, Kyle Bibby and William Chen wanted to evaluate the feasibility of this technique for detecting monkeypox viral DNA in different wastewater scenarios.
The researchers collected information from previous scientific studies about the shedding of monkeypox viral DNA from saliva, stool and urine into wastewater streams. They analyzed that data in combination with people’s daily water usage, concluding that infected people can shed from 13,000 to 208 billion genome copies daily into sewers, with most of that amount coming from stool. These results indicated that a single PCR assay conducted at the lowest level of sensitivity, or 10 genome copies per liter of wastewater, could theoretically detect seven cases out of 100,000 people at the average U.S. wastewater treatment plant. In addition, replicate assays could likely identify even lower infection rates.
Next, the team developed a computer-based strategy to determine the number of PCR assays that would need to be run for wastewater samples collected in the U.S. and other countries, depending on the expected case rates of monkeypox and the desired level of sensitivity. For the U.S., at the average case rate as of July 15, 2022, each sample would need eight replicate assays using a moderately high level of sensitivity to correctly detect monkeypox in the sewage, whereas at a suspected maximum case rate (0.0012%) only four replicates at a lower level of sensitivity would be needed. Since mid-July, case rates have likely increased, so the researchers predict that a lower number of replicates could be implemented now in the U.S. Although there is a lack of information about monkeypox DNA shedding from humans and its persistence wastewater, the researchers say that their computer model can still be a useful framework for developing robust community monitoring programs.
The authors acknowledge funding from a University of Notre Dame Dean’s Fellowship.
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JOURNAL
Environmental Science & Technology Letters
ARTICLE TITLE
Model-Based Theoretical Evaluation of the Feasibility of Using Wastewater-Based Epidemiology to Monitor Monkeypox
Clinical trial evaluating monkeypox vaccine begins
NIH trial is evaluating intradermal delivery to expand the vaccine supply
Business AnnouncementIMAGE: COLORIZED TRANSMISSION ELECTRON MICROGRAPH OF MONKEYPOX PARTICLES (GREEN) FOUND WITHIN AN INFECTED CELL (PINK AND PURPLE), CULTURED IN THE LABORATORY. IMAGE CAPTURED AT THE NIAID INTEGRATED RESEARCH FACILITY (IRF) IN FORT DETRICK, MARYLAND. view more
CREDIT: NIAID
A clinical trial evaluating alternative strategies for administering the JYNNEOS monkeypox vaccine to increase the number of available doses has begun enrolling adult volunteers. The trial, which will enroll more than 200 adults across eight U.S. research sites, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. JYNNEOS is manufactured by Bavarian Nordic, based in Copenhagen. It is approved by the U.S. Food and Drug Administration for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
JYNNEOS contains an attenuated orthopoxvirus called modified vaccinia Ankara (MVA), which does not replicate in human cells. It is approved for administration by two subcutaneous (in the tissue beneath the skin) injections 28 days apart; however, the FDA recently authorized intradermal (between layers of the skin) administration of the vaccine for adults, which expands the number of people who can be vaccinated with the currently limited supply. This alternative intradermal dosing regimen uses one-fifth of the standard dose used for subcutaneous administration, allowing health care providers to administer up to five times the number of vaccine doses per vial of JYNNEOS vaccine. NIH-supported researchers demonstrated in a 2015 publication that intradermal administration at one-fifth of the standard dose induced an immune response in recipients that was comparable to the subcutaneous method of administration.
“To halt the global outbreak of monkeypox and to help protect those at risk of infection, we need to ensure we have an adequate supply of monkeypox vaccine,” said NIAID Director Anthony S. Fauci, M.D. “NIAID’s trial of JYNNEOS will provide important information on the immunogenicity, safety, and tolerability of alternative dosing approaches that would expand the current supply of vaccine.”
The Centers for Disease Control and Prevention has reported 20,733 cases of monkeypox in the United States since May 2022. The global outbreak is primarily affecting men who have sex with men. The virus usually causes painful skin lesions and flu-like symptoms. Serious complications—which have been rare in the United States—can include dehydration, bacterial infections, pneumonia, brain inflammation, sepsis, eye infections and death. Historically, the virus is known to be transmitted from person to person through direct contact with skin lesions, body fluids, and respiratory droplets and by indirect contact with items such as contaminated clothing or bedding. Preliminary analyses indicate that sexual transmission may be playing a role in the current outbreak.
Adults ages 18 to 50 years who have not been vaccinated against smallpox or monkeypox previously are eligible to enroll in the NIAID trial. Investigators aim to include a demographically diverse group of volunteers that represents those affected by monkeypox. All trial participants will receive the JYNNEOS vaccine in some form. Participants will be assigned at random to one of three study arms:
- One arm will receive the standard, licensed regimen of 1x108 infectious virus particles administered subcutaneously.
- Another arm will receive 2x107 infectious virus particles (one-fifth of the standard regimen) administered intradermally, the regimen recently authorized by the FDA.
- A third arm will receive one-tenth (1x107 infectious virus particles) of the standard regimen of JYNNEOS administered intradermally.
Investigators will assess whether the peak immune responses induced in recipients receiving the vaccine intradermally are at least as good as those induced by the licensed subcutaneous regimen and will compare the relative safety and tolerability of the different regimens.
Volunteers will be asked to participate in eight study visits over the course of a year where they will undergo physical examinations and provide blood samples for laboratory evaluations. An independent Data and Safety Monitoring Board (DSMB) will monitor participant safety throughout the duration of the study.
The trial will enroll volunteers at the following sites:
- Saint Louis University in Missouri
- Baylor College of Medicine in Houston
- Brigham and Women’s Hospital in Boston
- The NIH Clinical Center in Bethesda, Maryland
- George Washington University in Washington, D.C.
- Vanderbilt University in Nashville, Tennessee
- The Hope Clinic at Emory University in Decatur, Georgia
- The University of California, San Diego
Investigators anticipate the trial will take 15 months to complete; however, initial results could be available in early 2023. For more information, please visit clincialtrials.gov and search identifier NCT05512949.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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