A Small Research Site in Rural NorCal Selected by Moderna & Pfizer/BioNTech for Phase 3 COVID-19 Vaccine Trials

Jul 11, 2020 | BNT162, California, COVID-19, Leading Sites, mRNA-1273, News, Site Success, Site Watch, Vaccine

A Small Research Site in Rural NorCal Selected by Moderna & PfizerBioNTech for Phase 3 COVID-19 Vaccine Trials

Paradigm Clinical Research Centers Inc. (Paradigm Research) in Redding, California, was selected to participate in both the Moderna mRNA-1273 and the Pfizer/BioNTech forthcoming Phase 3 BNT162 clinical trials. Paradigm Research is both a medical clinic and research site. Its founder and CEO, Dr. Jamshid Saleh who practiced neurosurgery for 22 years, stands clear about the importance of these vaccine trials. Forget politics and partisanship and whether one wears a mask or not; step up and prioritize community and patriotic duty above all else. Get out of the house, down to the clinic and volunteer to test these critical vaccine candidates. Introducing Redding, CA’s Paradigm Research and two forthcoming COVID-19 vaccine trials, involving Moderna’s mRNA-1273 and Pfizer’s BNT162.

COVID-19 Cases Quadrupled in Shasta County

Redding is far removed from most of the rate race of urban California, like San Francisco. A beautiful and heavily rural region far to the North (about 120 miles south of Oregon border), one would think they would be safe from pandemic hotspots. But that isn’t the case at all as COVID-19 cases have quadrupled in just the last month with 176 total cases and six deaths reported thus far. There is no avoiding the SARS-CoV-2 pathogen. Recently, the Record Searchlight, part of the USA Today Network, carried David Brenda’s introduction to a small investigational site taking on two major vaccine trials, with worldwide implications, up in the far north of California.

Redding CA & Shasta County

This clinical investigational site isn’t located in a major urban center adjacent to a major academic medical center but rather in the heavily rural, and for many desirable, part of Northern California. At the northern end of California’s great Central Valley, Redding is the Shasta County government seat and “big city” of 92,000 for these parts.

An incredibly desirable place for those that like high quality, slow pace living with access to absolutely gorgeous outdoor surroundings, Redding is nestled below one of the highest and most spectacular mountains in the lower 48 states: the active volcano Mount Shasta. Adjacent to the Sacramento River and near Shasta Lake, to the town’s west rise the northern California coastal mountains, covered in towering redwood groves and to the east the rugged northern end of the Sierra Nevada.

A hub of the fly fishing industry, the town is known as the “Trails Capital of California.” Many have flocked from the crowded, rat race of the Bay Area and even Sacramento to buy land and properties in Redding, but the homeless have followed; and it’s becoming a problem as large settlements congregate along riversides and in other areas, creating concern.

The Research Site: Paradigm Clinical Research

Founded by Dr. Jamshid Saleh, who practiced neurosurgery with Dignity Health for 22 years, runs Northern California Neurological & Spinal Surgery while also launching Paradigm Research, which operates three investigational sites including the one in Redding, another one in Southern California in La Mesa, CA (near San Diego), and a center in Wheat Ridge, Colorado (near Denver).

With over 12 investigators in different specialties spanning neurology, ENT, internal medicine, pulmonology, infectious disease and dermatology, the center’s website touts extensive experience in vaccine clinical trials. This claim should be taken seriously; otherwise how did a small site operation in such a rural isolated area secure access to not one but two major COVID-19 vaccine clinical trials? According to Saleh, he has been collaborating with major pharmaceutical companies for nearly a decade; he is clearly connected.

Every good research site has not only star principal investigators but importantly, dedicated, highly skilled and well trained clinical research coordinators; and Paradigm Research advertises this as a benefit of the center.

Paradigm also runs health clinics, truly offering clinical research as a care option. They use the electronic medical resource for source documentation and report a fast turnaround time for CTA  and budgets. Importantly, they claim a high subject retention rate (90% average among all studies, which is high for industry). Recent FDA inspections show no problems

Dr. Saleh emphasized his research organization’s experience, commitment and expertise in conducting high quality clinical trials. Highlighting the severity of this pandemic, he reminds all that it will take a community to turn this thing around: “I think we all have the responsibility to at least participate in this trial to get a vaccine out to prevent this pandemic from continuing.” 

The Study

Paradigm Clinical Research is participating in two major Phase 3 COVID-19 focused vaccine trials, including one sponsored by Moderna (mRNA-1273) and one sponsored by Pfizer and BioNTech (BNT162). As the Phase 3 Moderna study is in delay, Saleh notes that the study may start later in the month. But he shared the date could be delayed further.

The study invites those 18 to 50, especially healthcare workers and first-responders are ideal. But other healthy individuals over the age of 50 can participate as well.

Study participants will be paid about $70 to $120 per visit; Dr. Saleh reminds readers that Paradigm doesn’t determine compensation. Rather, the institutional review board decides on the payment that is only for time and travel.  Dr. Saleh reminds all that money should by no means be the reason for participation.  

Participants won’t know if they are participating in the Moderna or Pfizer (BioNTech) trials but both are advanced investigational mRNA-based vaccine candidates. A two-year commitment for the participants, they will also receive a smart phone that will have electronic diary/patient outcome features for tracking during the study.

Paradigm reports that possible side effects of either mRNA-1273 and BNT162 could be pain, redness, swelling and itchiness at the injection site. Participant’s may also experience a low grade fever, muscle aches, a headache or nausea, reports the local news Record Searchlight. As far as safety of these trials, Dr. Saleh commented that the FDA has approved of this next phase 3 trial meaning the safety risks have been clearly identified from the first two trial phases.

Lead Research/investigator

Dr. Jamshid Saleh

Call to Action: If you live up in Shasta County or somewhere in adjacent areas in Northern California, think about what Dr. Saleh has to stay about patriotic obligation and check out Paradigm’s website for more information.

1 Comment

  1. John Hainaut

    Selection of a trial site seems odd. It is counter intuitive that a relatively isolated population is a good venue for a clinical trial on the efficacy of a vaccine.

    You may get little to no information on the efficacy of either. A “bake off” between Pfizer and Moderna is not likely to produce a compelling winner.

    I’m puzzled.