Four months after the Wistar Institute and Penn Medicine began testing its COVID-19 vaccine, all trial participants have demonstrated an overall immune response and experienced little to no side effects. Phases two and three of the study are expected to commence in September with more participants.
The phase one trial, taking place at Penn Medicine and Center for Pharmaceutical Research in Kansas City, has 40 participants between 18 and 50 years old. The trial began on April 3 to test the safety and initial immunogenicity of the vaccine. Immunogenicity is the vaccine’s ability to induce an immune response in the body.
The vaccine was the second of its kind to enter a phase one clinical study in the United States. Four U.S. vaccines have already reached at least phase two of clinical trials, according to The New York Times.
Phase two will test the vaccine’s safety and immunogenicity in a larger population, while phase three will simultaneously evaluate its efficacy and readiness for distribution. Penn Med professor and principal clinical investigator of the study Pablo Tebas will continue to oversee the next phases with greater numbers of participants at more universities nationwide, Weiner said.
The Wistar Institute’s Vaccine and Immunotherapy Center Director David Weiner said the universities and number of participants will be determined once the Wistar Institute receives approval from the Food and Drug Administration to enter the next phases, which he anticipates will be by September. He said he is certain the data from the phase one trial will be “well-received” by the FDA.
All 40 trial participants in the phase one trial demonstrated an overall immune response, with 95% of trial participants developing antibodies, according to an update from Inovio Pharmaceuticals on Aug. 10. COVID-19 antibody tests can help identify people who may have been infected with the virus or have recovered from the infection, according to the FDA.
The Wistar Institute announced its partnership with Inovio Pharmaceuticals on Jan. 23 to develop a COVID-19 vaccine. The collaboration is backed by $9 million from the Coalition for Epidemic Preparedness Innovations, a global organization based in Norway.
The vaccine was generally safe and well-tolerated in all participants, with only six vaccine-related grade one adverse events — mild, asymptomatic or mild symptoms, clinical or diagnostic observations — which do not require intervention, Weiner said. He added that the vaccine produced less adverse events than most of the other COVID-19 vaccines that have entered clinical trials.
A COVID-19 vaccine developed by Oxford University and the drug giant AstraZeneca elicited side effects such as fever, headaches, muscle aches, and injection site reactions in about 60% of patients, according to American health news website Stat. Some…