News Statement
A Trial at the NIH is Evaluating Intradermal Delivery to Increase Vaccine Supply.
For additional information about the experiment, including a list of venues, participants can visit clinicaltrials.gov and search for the identifier NCT05512949. Please do not contact the NIAID News and Science Writing Branch with enrollment-related questions.
Adult participants have begun to be enrolled in a clinical trial testing alternate techniques for administering the JYNNEOS monkeypox vaccine to expand the number of accessible doses. The National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health, is sponsoring the experiment, which will enroll more than 200 adults across eight U.S. research locations. JYNNEOS is produced by Bavarian Nordic, a Copenhagen-based company. It is sanctioned by the United States. Food and Drug Administration for the prevention of smallpox and monkeypox disease in people 18 years and older who are found to be at a high risk of contracting smallpox or monkeypox.
JYNNEOS contains modified vaccinia Ankara (MVA), an attenuated orthopoxvirus that does not multiply in human cells. It is approved for administration by two subcutaneous (beneath the skin) injections 28 days apart; however, the FDA has recently authorized intradermal (between layers of skin) administration of the vaccine for adults, expanding the number of people who can be vaccinated with the current limited supply. This alternate intradermal dosing regimen utilizes one-fifth of the usual dose used for subcutaneous injection, allowing healthcare professionals to provide up to five times as many doses per vial of JYNNEOS vaccine. In a 2015 paper, researchers backed by the NIH revealed that intradermal delivery at one-fifth the normal dose generated an immunological response comparable to subcutaneous administration.
Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), stated that in order to stop the global spread of monkeypox and protect individuals at risk of infection, there must be a sufficient supply of monkeypox vaccine. The trial of JYNNEOS by the NIAID will give crucial information regarding the immunogenicity, safety, and tolerance of alternate dosage techniques that might increase the current vaccine supply.
Since May 2022, the Centers for Disease Control and Prevention have documented 20,733 cases of monkeypox in the United States. The global outbreak predominantly affects guys who have sexual relations with other men. Typically, the virus causes painful skin sores and influenza-like symptoms. Infrequent in the United States, serious effects can include dehydration, bacterial infections, pneumonia, brain inflammation, sepsis, ocular infections, and death. Historically, the virus has been known to spread from person to person by direct contact with skin lesions, bodily fluids, and respiratory droplets, as well as through indirect contact with contaminated clothing or bedding. Initial findings suggest that sexual transmission may have contributed to the current outbreak.
Adults between the ages of 18 and 50 who have never been vaccinated against smallpox or monkeypox are eligible to participate in the NIAID trial. The researchers intend to include a demographically varied group of volunteers that is representative of monkeypox sufferers. All trial participants will receive some form of the JYNNEOS vaccine. Random assignment will allocate participants to one of three study arms:
One arm will be subcutaneously injected with 1 x 108 infectious virus particles as per the normal protocol.
A second arm will receive 2 x 107 infectious virus particles (one-fifth of the normal regimen) injected intradermally, a recently FDA-approved regimen.
A third arm will receive intradermal administration of one-tenth (1×107 infectious virus particles) of the normal dose of JYNNEOS.
The investigators will compare the relative safety and tolerability of the licensed subcutaneous and intradermal vaccine regimens and determine whether the peak immune responses induced in recipients receiving the vaccine intradermally are at least as good as those induced by the licensed subcutaneous vaccine regimen.
Over the course of one year, volunteers will be required to attend eight research visits where they will receive physical examinations and provide blood samples for laboratory analysis. Throughout the life of the trial, an independent Data and Safety Monitoring Board (DSMB) will monitor participant safety.
Volunteers will be recruited at the following locations:
University of Saint Louis in Missouri
Houston’s Baylor College of Medicine
Boston’s Brigham and Women’s Hospital
The National Institutes of Health Clinical Center in Bethesda, Maryland
In Washington, D.C., George Washington University is located.
Vanderbilt University in Nashville, Tennessee
The Emory University Hope Clinic in Decatur, Georgia
San Diego’s University of California
Researchers expect that the trial will take 15 months to complete; however, preliminary data may be available by the beginning of 2023. Please visit clinicaltrials.gov and search for identification number NCT05512949.
NIAID conducts and funds research at NIH, throughout the United States, and internationally to investigate the causes of infectious and immune-mediated disorders and to create better methods for preventing, detecting, and treating them. On the NIAID website, you can find press releases, fact sheets, and other relevant information.
About the National Institutes of Health (NIH): The NIH is the nation’s medical research organization and consists of 27 Institutes and Centers. The Health and Human Services Department The NIH is the principal government organization that conducts and supports basic, clinical, and translational medical research and investigates the causes, treatments, and cures for both common and rare diseases. Visit www.nih.gov for more information on the NIH and its initiatives.
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