NIH-sponsored trial of nasal COVID-19 vaccine begins enrollment
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Key takeaways:
- An NIH-sponsored phase 1 trial will test the safety of an experimental nasal COVID-19 vaccine.
- This is the first NIAID clinical trial to be conducted as part of HHS Project NextGen.
A first-in-human trial of a nasal COVID-19 vaccine candidate began enrolling adults aged 18 to 64 years who have received at least three prior doses of a COVID-19 messenger RNA vaccine, according to the NIH.
The investigational vaccine, MPV/S-2P, may expand protection against emerging variants of SARS-CoV-2, the NIH said in a press release. The vaccine uses murine pneumonia virus (MPV) as a vector to deliver a stabilized version of the SARS-CoV-2 spike protein, according to the release.
MPV is “closely related to human respiratory syncytial virus,” John Beigel, MD, Associate Director for Clinical Research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, told Healio.
“We are starting a whole series of trials with the goal of developing next-generation COVID-19 vaccines, which we are viewing as those that might be able to stop transmission, those that have broader protection so we don’t have to chase variants or those that last longer. Ideally a vaccine will achieve all three goals, but that’s a pretty high bar,” Beigel said. “The goal for this particular vaccine is to generate enough of an immune response in the area where the virus is coming in and where the first infection occurs to stop not only illness in that person, but to actually stop transmission.”
Although first-generation COVID-19 vaccines remain effective at preventing severe illness, hospitalizations and death, they are less successful at preventing infection and milder forms of disease, NIAID Director Jeanne M. Marrazzo, MD, MPH, said in the release. Marrazzo also emphasized the need to develop next-generation COVID-19 vaccines as new virus variants continue to emerge.
“It’s not that we don’t think our current vaccines are good,” Beigel said. “Our current vaccines do a remarkable job of keeping people alive, out of the hospital and from having serious disease. We aren’t developing next generation vaccines because we have no confidence in our current vaccines; instead, we are asking, ‘Can we do this better? Is there a way to block transmission? Now that we’ve kept people out of the hospital and from getting severe disease, what are the next goals?’ That’s why we’re doing this.”
MPV/S-2P appeared safe and well tolerated in preclinical, nonhuman primate studies conducted by scientists from NIAID Laboratory of Infectious Diseases. The trial now underway is the first to evaluate the nasal vaccine in humans who, like primates, are not susceptible to MPV. Researchers will enroll healthy volunteers into one of three cohorts that will receive progressively higher doses of the vaccine.
“We hope this phase 1 trial will show it is safe and well tolerated, as well as that the vaccine is generating a good local immune response in the nose,” Beigel said. “Ideally it will also generate a systemic response, a good antibody response in the blood in addition to the nose. The best-case scenario would be if we got both of those with this one virus.”
This is the first NIAID clinical trial to be conducted as part of HHS Project NextGen, a coordinated effort between the federal government and the private sector to broaden the pipeline of new, innovative vaccines and therapeutics, according to the release.
As part of this initiative, researchers will compare MPV/S-2P and any other vaccines that make it into phase 2 trials with already available mRNA vaccines to see whether protection against COVID-19 improves, Beigel said.
“It is the goal for this product or any of the intranasal vaccines that we’re evaluating as a part of the NextGen program to better block transmission than the current mRNA vaccines,” he said. “If you’re blocking transmission, we have less virus circulating, protecting not only yourself but also people who are immunocompromised and don’t generate a good immune response. Ultimately, if we can find vaccines that block transmissions, then the amount of COVID circulating in the community would ideally come down.”
As Healio previously reported, the advantages of an intranasal COVID-19 vaccine might include needle-free delivery, the potential for self-administration or administration by someone who is not trained to perform intramuscular injections, and administration of the vaccine to the site most likely to be exposed to infection.
“There are a lot of people who don’t like intramuscular vaccination because it causes pain, fevers and redness in the arm,” Beigel said. “There might be groups that are hesitant to take the intramuscular vaccine, but would take a nasal vaccine. Will this increase COVID-19 vaccine uptake? That’s where I think it is challenging and only time would tell.”
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For more information:
John Beigel, MD, can be reached at jbeigel@niaid.nih.gov.
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