dMAbs for COVID-19 Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of two new treatments, dMAb AZD5396 and dMAb AZD8076, designed to help prevent COVID-19. It examines how well these treatments are tolerated and how they behave in the body at different doses. The study involves healthy adults who haven't received recent vaccines or had COVID-19 and are free of serious health issues like uncontrolled diabetes or heart disease. Participants must be comfortable with injections and adhere closely to study procedures.
As a Phase 1 trial, participants will be among the first to receive these new treatments, aiding researchers in understanding how they work in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot take certain medications like blood thinners or immunosuppressive therapies. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both dMAb AZD5396 and dMAb AZD8076 were generally well-tolerated in earlier studies. Most participants experienced only mild side effects, localized to the treatment area. Importantly, about 1,000 blood samples revealed no anti-drug antibodies, suggesting a low risk of adverse reactions to the treatment.
Additionally, these DNA-encoded monoclonal antibodies (DMAbs) appeared in the bloodstream of all participants tested in past trials, with no major safety concerns reported. This is encouraging for those considering joining a trial, as the treatment demonstrated a good safety profile in previous research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about dMAbs AZD5396 and AZD8076 for COVID-19 prevention because they represent a novel approach using DNA-based antibodies. Unlike traditional vaccines or antiviral drugs, which stimulate the immune system or directly attack the virus, these dMAbs introduce DNA sequences that instruct the body to produce antibodies against the virus, providing a potentially faster and more adaptable response. Additionally, the use of electroporation — a technique that enhances the uptake of DNA into cells — could improve the efficiency and effectiveness of antibody production. This innovative delivery method sets these treatments apart, potentially offering a more rapid protective effect than existing options.
What evidence suggests that this trial's treatments could be effective for COVID-19 prevention?
Research has shown that dMAb AZD5396 and dMAb AZD8076, both under study in this trial, are designed to help the body produce antibodies against COVID-19. In earlier studies, these treatments maintained stable antibody levels in participants for up to 72 weeks, suggesting long-lasting antibodies that might offer extended protection against the virus. These treatments are based on successful monoclonal antibodies but use a DNA method to instruct the body to produce them. Initial results appear promising, but further information is needed to fully confirm their effectiveness.16789
Who Is on the Research Team?
Pablo Tebas, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
Healthy adults aged 18-60 with a BMI of 20-30, normal ECG and lab results, willing to use contraception if fertile. Excludes those with SARS-CoV-2 infection, recent antibody treatments or vaccines, pregnancy, certain infections like hepatitis B/C, immunosuppressive conditions or medications, major surgery within the last 6 months, metal implants at EP site.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dMAb AZD5396 and dMAb AZD8076 with Hylenex® delivered intramuscularly followed by electroporation in a 2-dose or 4-dose regimen
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- dMAb AZD5396
- dMAb AZD8076
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pablo Tebas
Lead Sponsor
The Wistar Institute
Collaborator
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Inovio Pharmaceuticals
Industry Sponsor