A tiny Long Island biotechnology startup in a global race to develop a COVID-19 vaccine has rolled out plans for a human trial.
The Phase 1 trial using about 50 paid young adult volunteers will evaluate the safety of the Codagenix Inc. vaccine and will be conducted in London by a unit of Dublin-based Open Orphan plc.
Codagenix Inc.'s vaccine is made from a live, but attenuated — or weakened — version of the whole virus that is re-engineered to slow its ability to make copies of itself.
That differs from nearly every other vaccine candidate of the 169 cataloged by the World Health Organization.
Other than Codagenix and two other developers, according to WHO, all use dead virus, some of the virus' genetic material or a section of the virus such as the spike protein.
Executives at the 11-person Codagenix, which is partnering with the vaccine-manufacturing giant Serum Institute of India, are betting that their strategy will produce a stronger immune response to COVID-19.
White House coronavirus adviser Dr. Anthony Fauci has warned that vaccines under development are unlikely to provide total protection, and the Food and Drug Administration has said it would approve vaccines that were safe and more than 50% effective.
The coronavirus has infected more than 20 million people worldwide and killed more than 700,000, according to the Johns Hopkins University dashboard.
Steffen Mueller, president and chief scientific officer at Codagenix, based at the Broad Hollow Bioscience Park in Farmingdale, said a pilot study that infected vaccinated hamsters was encouraging.
"They were all fine," he said. "There was protection. It's very promising."
If the Phase 1 trial goes as planned, the company expects to conduct a traditional Phase 2-3 trial in India where some volunteers would be vaccinated and others would be given a placebo.
Should national drug regulators give the green light, "we might be interested" in a human-challenge trial, Mueller said.
In typical human-challenge trials, healthy volunteers are inoculated, given time to develop an immune response, and then infected with a pathogen, in this case COVID-19.
Adrian Wildfire, director of scientific and business strategy at Open Orphan, which specializes in human-challenge tests of vaccines and anti-viral medications, said a human-challenge study would reduce the time and number of volunteers required to establish the vaccine's effectiveness.
Human-challenge trials have been used in developing new therapies for malaria, smallpox and other diseases for which there already exists an effective treatment. No known treatment can stop COVID-19 in its tracks, making such trials controversial.
"There's a huge interest in human challenges," said Emily Largent, who teaches medical ethics and health policy at the University of Pennsylvania's Perelman School of Medicine.
She said that decisions on using human-challenge trials should be considered in the context of the value of speeding a vaccine candidate to market during a deadly pandemic.
"You likely can't eliminate all the risk," she said.
Bettie Steinberg, a vaccine expert and provost at Northwell Health's Feinstein Institutes for Medical Research, said that live-virus vaccines such as the one under development by Codagenix often work better than those using dead viruses.
"If you have a weakened virus that grows a little in the person, you get a better immune response," she said.
She pointed to the first polio vaccine, a dead version of the virus developed by Jonas Salk, which was later largely supplanted by Albert Sabin's live attenuated virus often delivered on a sugar cube.
Steinberg said Phase 1 trials are focused on calibrating the proper dosage of a drug or vaccine, while Phase 2 trials, traditionally involving hundreds of volunteers, consider safety over a longer term while harvesting some data on effectiveness. Phase 3 studies typically use thousands of people, some getting the vaccine and some a placebo, to gain insight on long-term effectiveness and safety, including rare reactions.
As of Aug. 10, the World Health Organization cataloged 28 COVID-19 vaccine candidates in clinical trials. Those included vaccines from pharmaceutical giants like AstraZeneca and partner University of Oxford and Pfizer and its partner BioNTech as well as several from China.
The WHO also listed 139 vaccine candidates in preclinical evaluation, including the one from Codagenix and its partner, Serum Institute of India.
Another Long Island company on the WHO's preclinical trial list, Stony Brook-based Applied DNA Sciences Inc., is providing DNA technology as part of the effort by Rome-based Takis Biotech.
The Serum Institute of India is spreading its bets in the global vaccine race.
Owned by the billionaire Poonawalla family, the Serum Institute already has begun manufacturing a vaccine candidate developed by AstraZeneca and the University of Oxford, gambling that it will be found safe and effective in ongoing trials and win regulatory approval.
News of Codagenix's planned Phase 1 trial comes as reports from Russia and China suggest that vaccine candidates from those countries are nearing release.
Last month Gao Fu, the director of China's Center for Disease Control and Prevention, said that he was injected with an experimental vaccine, while Russian President Vladimir Putin on Tuesday said a vaccine made by Moscow's Gamaleya Institute was the world's first to receive regulatory approval.
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