NIH Begins Clinical Trial and Expands Supply of Intradermal Delivery of Monkeypox Vaccine – Global Biodefense

A clinical trial evaluating alternative strategies for administering the JYNNEOS monkeypox vaccine to increase the number of available doses has begun enrolling adult volunteers.

Adults between the ages of 18 and 50 who have never been vaccinated against smallpox or monkeypox are eligible to enroll in the NIAID trial. Investigators aim to include a demographically diverse group of volunteers representative of those affected by monkeypox.All trial participants will receive some form of her JYNNEOS vaccine. .

The trial, which will enroll more than 200 adults at eight research sites in the United States, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. JYNNEOS is manufactured by Copenhagen-based Bavarian Nordic.

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 injections (tissue under the skin) 28 days apart. However, the FDA recently approved the vaccine for intradermal (between layers of the skin) administration for adults. This alternative intradermal regimen uses one-fifth of the standard dose used for subcutaneous administration, allowing a healthcare provider to administer up to five times the vaccine dose per vial of his JYNNEOS vaccine. NIH-supported researchers Published in 2015 Intradermal administration of one-fifth the standard dose elicited an immune response in recipients comparable to subcutaneous administration.

“NIAID’s trial of JYNNEOS provides important information about the immunogenicity, safety, and tolerability of an alternative administration approach that expands the current supply of vaccines,” said Anthony S. Fauci, M.D., NIAID Director. said.

Since May 2022, the Centers for Disease Control and Prevention has reported 20,733 cases of monkeypox in the United States. The global pandemic is primarily affecting men who have sex with men. The virus usually causes painful skin lesions and flu-like symptoms. Serious complications that are rare in the United States include dehydration, bacterial infections, pneumonia, brain inflammation, sepsis, eye infections, and death. Historically, viruses have been known to be transmitted from person to person through direct contact with skin lesions, body fluids, respiratory droplets, and indirect contact with items such as contaminated clothing and bedding. I’m here. Preliminary analysis indicates that sexual transmission may play a role in the current outbreak.

Investigators should assess whether the peak immune response induced in recipients administered the vaccine intradermally is at least as great as that induced by the licensed subcutaneous regimen, and assess the relative to compare their overall safety and tolerability.

Volunteers will be asked to participate in eight research visits during the year. There, you will undergo a physical examination and be given a blood sample for laboratory evaluation. An independent Data and Safety Monitoring Board (DSMB) will monitor participant safety for the duration of the study.

This exam registers volunteers at:

• Saint Louis University of Missouri
• Baylor College of Medicine in Houston
• Brigham and Women’s Hospital in Boston
• NIH Clinical Center in Bethesda, Maryland
• George Washington University in Washington DC
• Vanderbilt University in Nashville, Tennessee
• Hope Clinic at Emory University in Decatur, Georgia
• University of California, San Diego

Investigators expect the trial to take 15 months to complete. However, the first results are likely for him to be available in early 2023.

A Trial to Evaluate the Immunogenicity of MVA-BN Monkeypox Vaccine Dose Reduction Strategy. ClinicalTrials.gov NCT05512949This study was a Phase 2, randomized, open-label, non-placebo-controlled, multi-site clinical trial to evaluate the efficacy of two intradermal modified vaccinia Ankara Bavarian Nordic (MVA-BN) vaccines compared to standard subcutaneous administration. (ID) To evaluate regimen (SC) regimen in healthy, vaccinia-naïve adults aged 18-50 years. At least 210 participants will be enrolled and randomly assigned to one of three study arms. Two dose-sparing strategies included 5-fold (2 x 10^7) and 1-fold (1 x 10^7) standard doses of MVA-BN administered ID on days 1 and 29. (arms 1 and 2 respectively). The comparison arm (arm 3) is a 2-dose standard (1 x 10^8) MVA-BN SC regimen.

The primary objectives were: 1) 2 x 10^7 50% tissue culture infectious dose (TCID50) peak humoral immune response following an ID regimen of MVA-BN to exceed the approved regimen of 1 x 10^8; to determine whether MVA-BN is not inferior to SC administration. 2) To determine whether the peak humoral immune response following an ID regimen of 1 x 10^7 TCID50 MVA-BN is not inferior to the approved SC dosing regimen of 1 x 10^8 MVA-BN. Secondary purposes are: 1) To determine whether peak individual humoral immune responses following each ID regimen are not inferior to approved regimens administered SC. 2) Assess the humoral immune response of each ID regimen (individually) compared to the licensed SC regimen on each study day. 3) To assess (separately) the kinetics of the humoral immune response of each ID regimen compared to SC regimens licensed up to day 365; 4) Systemic and local reactogenicity for 14 days after each vaccination; relative safety between study arms as assessed by sex, unsolicited adverse events during 28 days after each vaccination, and serious adverse events (SAEs) and medically-related events (MAAEs) from day 1. Up to day 57 for comparison and related SAEs/MAAEs up to day 181.