A researcher and physician from a trial site organization known as El Paso Medical Research Institute is working on the final stages of a COVID-19 vaccine trial that he is confident will offer powerful immunity against SARS-CoV-2 for up to one year. Dr. J.D. Burgos has been intimately involved with a COVID-19 vaccine-like investigational product to be tested in the “Borderland” region (El Paso and Ciudad Juarez). Known as the “Provent” study, the local press actually mistakenly referred to the investigational product with the name of the study. The Provent clinical trial team evaluates an investigational product developed by AstraZeneca called AZD7442. The candidate, a combination monoclonal antibody, is easily transportable and it doesn’t necessitate storage at minus 100 degrees like at least some of the vaccine candidates, hence precluding limiting factors associated with storage. The Provent trial just secured Institutional Review Board approval recently in the El Paso area, and now Dr. Burgos has the thumbs up to move forward with human testing. Consequently, El Paso Medical Research Institute is recruiting participants for the clinical trial. Participants will receive the experimental treatment against COVID-19 free and receive payment for participation in the study. The stakes for this study are large: should the results be positive, the first approved pre-exposure prophylaxis for SARS-CoV-2, the virus behind COVID-19, could be within reach.
TrialSite offers a brief background of the players here.
El Paso Research Institute Background
El Paso Medical Research Institute is a clinical trial center dedicated to improve the health and quality of life of patients through new and innovative therapies. Within this organization a group of physicians came together to form MedResearch Inc., to support the process of developing new cutting edge therapies to improve patient lives. With over 20 years of extensive clinical, teaching and research experience, the team emphasizes research inn the El Paso Texas, Las Cruces, New Mexico and Ciudad Juarez Mexico regions.
The Provent trial (NCT04625725) is sponsored by AstraZeneca in collaboration with global CRO IQVIA. This global study will investigate the efficacy and safety of a single dose of AZD7442 via two IM injections as compared to placebo for the prevention of COVID-19. In this way this study tests a candidate that acts like a vaccine. Up to 5,000 participants will be involved in this study.
Formally titled “A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19,” the stakes for this study are large: should the results be positive the first approved pre-exposure prophylaxis for SARS-CoV-2, the virus behind COVID-19, could be within reach.
The Investigational Product
Used as a form of PrEP, an important need TrialSite has identified to fight COVID-19 with effective interventions to prevent the spread of the disease. Thus far clinical management either before infection or upon onset for mild to moderate cases is limited to supportive care, consequently overwhelming resources of healthcare systems around the world.
In response to the pandemic, AstraZeneca has developed monoclonal antibodies to the SARS-CoV-2 protein. As this pathogen includes the virus RBD (receptor-binding domain), which enables the virus to bind to receptors on human cells, the investigational candidate targets this region of SARS-CoV-2’s spike protein. The product was designed so that the antibodies can block the pathogen’s attachment to the human cells and hence and hopefully, block human infection.
AstraZeneca scientists introduced amino acid substitutions into the antibodies to both extend their half-lives, which should prolong their potential prophylactic benefit, as well as lower Fc effector function in a bid to decrease the potential risk of antibody-dependent enhancement of disease.
The investigational product, known as AZD7442, is actually made up of two monoclonal antibodies known as AZD8895 and AZD1061. AstraZeneca is now evaluating this combined product for administration to prevent and/or treat COVID-19.