NIH Trial Seeks Answers for Monkeypox Vaccine Delivery, Antivirals

September 21, 2022

4 minute read

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This month, the NIH began enrolling participants in a clinical trial investigating the efficacy of split-dose monkeypox vaccine and another trial evaluating the antiviral drug tecovirimato in adults and children with monkeypox.

“Experience from previous studies and the thousands of doses given in the last few months in response to the outbreak show that the vaccine has a good safety profile and neutralizes the monkeypox virus to prevent infection. It shows that they produce antibodies.” David Diemert, MDHe is a professor of medicine and microbiology, immunology, and tropical medicine at George Washington University, where he leads one of eight NIH-sponsored sites of vaccine trials.

IDN0922Monkeypox_Trials_Graphic_01_WEB

Source: Anthony S. Fauci/NIAID

“Antibody responses to vaccines are often ‘maximum’, so higher doses do not produce higher antibody responses. That is, it reaches a plateau. Therefore, if the dose is still in the plateau portion of the dose-response curve, giving a lower dose may not actually lead to a lower antibody response.

According to the director of the National Institute of Allergy and Infectious Diseases, the trial Anthony S. Fauci, MD, to test three methods of inoculation. Intradermal regimen using one-fifth the standard dose. Intradermal regimen using one-tenth the standard dose. A fifth-sized dosing regimen was approved by the FDA in August, and thousands of vaccinations have been distributed since then.

“We intend to determine whether the peak response induced intradermally in the recipient is at least as good as the response induced with respect to the approved subcutaneous regimen,” he said. In addition to collecting data on safety, Fauci said. During a briefing by the White House National Monkeypox Response Team last week.

The split-dose concept is based on data from a 2015 clinical study evaluating the vaccine when delivered intradermally rather than subcutaneously. The study participant who received the intradermal vaccination received a dose that was one-fifth her dose of the participant who received the subcutaneous vaccination.

According to the FDA, data from that study showed additional side effects (redness, hardness, itching, swelling) at the injection site in intradermal recipients, but similar immune responses were seen in both participants. I got

“Broadly speaking, we do not yet have strong real-world efficacy data on how well the Jynneos vaccine works, so other measures, such as developing rapid tests and understanding spillovers to non-vaccine is required.[men who have sex with men] Until we know how long the vaccine response will last, the community will matter. ” Abraham Curran, M.D., MPHDTM&H, The infectious disease fellow and postdoctoral researcher at Stanford University’s Division of Infectious Diseases told Helio in an email.

As of September 14, the CDC had reported a total of 24,203 monkeypox cases and 1 death in the United States and 63,117 cases worldwide.

Robert FentonThe White House National Monkeypox Response Coordinator reported a 50% drop in new cases from its peak in August. . The program provides up to 50,000 meals for large LGBTQ events, leading to the announcement of a smaller event version of the program last week.

Preprint studies uploaded to medRXiv of September 1 suggested that fractionated doses may not provide sufficient protection for the effort. However, that study was not peer-reviewed and used data from several studies. We developed it, but “this can be difficult,” says Diemart.

“For this reason, our current studies show that the more accepted response to cowpox-like vaccinia, which has been used for decades to measure the immune response to the smallpox vaccine as a primary antibody endpoint, We use a neutralizing antibody test,” Diemert said.

The NIH said the trial will take 15 months to complete, but the first data are expected to be available early next year.

The NIH has also begun enrolling adults and children with monkeypox in a phase 3 clinical trial evaluating the antiviral drug tecovalimat, led by the AIDS Clinical Trials Group. Both vaccines and antiviral trials are sponsored by her NIAID.

According to the NIH, a trial of tecovalimat, which is approved for smallpox in the United States and used under extended access for monkeypox, collected data to determine if participants in the treatment arm were on placebo. to determine whether it heals faster compared to and what affects antiviral medications. Along with its safety are pain scores, rates of progression to critical disease, and monkeypox virus clearance. It will also provide data on optimal dosage and safety in children and pregnant women, according to the NIH.

In a briefing last week, Fauci said that, in addition to collecting efficacy data, data from the NIH study on the vaccine and tecovirimaton will be used to develop other avenues for future research.

References:

  • CDC. Monkeypox: 2022 outbreak cases and data. https://www.cdc.gov/poxvirus/monkeypox/response/2022/index.html. Accessed 21 September 2022.
  • Clinical trial of monkeypox vaccine started. https://www.nih.gov/news-events/news-releases/clinical-trial-evaluating-monkeypox-vaccine-begins. Published September 8, 2022. Accessed 21 September 2022.
  • Fact Sheet: U.S. Department of Health and Human Services Response to Monkeypox Outbreak. https://www.hhs.gov/about/news/2022/07/21/fact-sheet-us-department-of-health-and-human-services-response-to-the-monkeypox-outbreak.html. Published July 21, 2022. Accessed 21 September 2022.
  • Monkeypox Update: FDA Allows Emergency Use of Jynneos Vaccine to Increase Vaccine Supply. https://www.fda.gov/news-events/press-announcements/monkeypox-update-fda-authorizes-emergency-use-jynneos-vaccine-increase-vaccine-supply. Accessed 21 September 2022.
  • A US clinical trial is initiated to evaluate its antiviral activity against monkeypox. https://www.nih.gov/news-events/news-releases/us-clinical-trial-evaluating-antiviral-monkeypox-begins. Published September 9, 2022. Accessed 21 September 2022.
  • Zaek LM and others medRXiv. 2022;doi:10.1101/2022.08.31.22279414
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