Please ensure Javascript is enabled for purposes of website accessibility
Final Phase of COVID Vaccine Trials is Here. CA Volunteers Needed.
TLBBHMAP3-U010ALB5ANM-348f959abae2-512-300x300-1
By Jim Jakobs, Digital Producer
Published 5 years ago on
July 15, 2020

Share

Moderna is targeting July 27 to begin phase 3 testing of their COVID-19 vaccine. The company is looking for thousands of volunteers to participate.

The Cambridge, Massachusetts-based biotech company is the first to announce an estimated start date for phase 3 trials in the United States.

Newly released data from earlier human trials showed their vaccine candidate appears to be safe and provide some immunity. The most commonly reported systemic adverse events following second vaccination at the 100 microgram dose were fatigue (80%), chills (80%), headache (60%), and myalgia (53%), all of which were moderate in severity. The most common local adverse event at the 100 microgram dose was pain at the injection site (100%), which was also transient and mild or moderate in severity.

(Moderna Facebook)

New data from early trials shows Moderna’s COVID-19 vaccine candidate appears to be safe and provide some immunity.

Guidance for Vaccine Volunteers

Information about the trial, including guidance for vaccine volunteers, was posted on clinicaltrials.gov on Tuesday.

A brief summary posted on the site says, “The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.”

Moderna describes mRNA as like software for the cell; mRNA medicines are sets of instructions. And these instructions direct cells in the body to make proteins to prevent or fight disease.

Below is a video Moderna posted to its Facebook page describing the use of mRNA therapeutics.

https://www.facebook.com/modernatx/videos/725992207466392/

For inclusion in the study, volunteers must meet several criteria including the following:

  • Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.
  • Understands and agrees to comply with the study procedures and provides written informed consent.
  • Able to comply with study procedures based on the assessment of the Investigator.
  • Female participants of non-childbearing potential may be enrolled in the study.
  • Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
    • Has a negative pregnancy test at Screening and on the day of the first dose (Day 1).
    • Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).
    • Has agreed to continue adequate contraception through three months following the second dose on Day 29.
    • Is not breastfeeding.
  • Male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from the time of the first dose and through three months after the second dose.
  • Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the three months before enrollment.

Moderna tweeted information and a link about the study Tuesday.

California Study Locations

Several locations throughout California will be utilized and volunteers will be needed for each.

  • Advanced Clinical Research, Rancho Paseo in Banning
  • University of California San Diego in La Jolla
  • eStudySite in La Mesa
  • UCLA Vine Street Clinic CRS  in Los Angeles
  • Paradigm Clinical Research Institute Inc. in Redding
  • Benchmark Research in Sacramento
  • Medical Center For Clinical Research, M3 Wake Research in San Diego

If you are interested, contact Moderna Clinical Trials at (855) 663-6762 or email clinicaltrials@modernatx.com

The randomized, placebo-controlled trial is expected to include approximately 30,000 participants at the 100 microgram dose level in the U.S.

Early Results Encouraging

Moderna’s experimental vaccine against the coronavirus showed encouraging results in early testing.

COVID-19 antibodies were found in all 45 participants, the biotech company announced in a May news release.

Neal Browning of Bothell, Washington, spoke to GV Wire via Zoom shortly after the early testing results were made public.

“I’m the second person to receive the vaccine in a small dose so that means I’ve got the antibodies,” Browning said. “One of the first people to reach out to me was Jennifer Haller, the lady who was the first to receive the vaccine. She was super excited, too. We chatted a little bit on text about that.”

Neal Browning becomes the second volunteer to receive the investigational COVID-19 vaccine in the NIH-supported clinical trial in Seattle. (AP File)

Moderna said the early vaccine data indicated that it provided full protection against viral replication in the lungs in a mouse challenge model.

An interim analysis just published in The New England Journal of Medicine shows mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2.

In a press release, Moderna says, “After two vaccinations, mRNA-1273 elicited robust neutralizing antibody titers. At Day 43, neutralizing activity against SARS-CoV-2 was seen in all evaluated participants.”

Moderna has posted a video of a conference call on Wednesday providing more information to investors.

500 Million Doses a Year

Moderna is working closely with Operation Warp Speed and the NIH, including NIAID’s COVID-19 Prevention Trials Network to conduct the Phase 3 study.

With the Phase 3 dose being finalized at 100 micrograms, the company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the company’s internal U.S. manufacturing site and strategic collaboration with Lonza.

In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. On July 9, Moderna announced a collaboration with ROVI for large-scale, commercial fill-finish manufacturing of mRNA-1273 intended in principle to supply markets outside of the U.S. starting in early 2021 at ROVI’s facility in Madrid, Spain.

DON'T MISS

Measles Spreads to Central Texas; 5 States Have Active Outbreaks

DON'T MISS

Trump Tariff Fears Erase $2 Trillion From US Stocks

DON'T MISS

Startup Offers Controversial Microplastic Blood Cleansing Treatment

DON'T MISS

Senate Confirms Mehmet Oz to Take Lead of Medicare and Medicaid Agency

DON'T MISS

First California EV Mandates Hit Automakers This Year. Most Are Not Even Close

DON'T MISS

Pence Will Receive the Profile in Courage Award From the JFK Library for His Actions on Jan. 6

DON'T MISS

Politics Turns Ugly for a Conservative Running for Fresno State Student Body President

DON'T MISS

Pentagon’s Watchdog to Review Hegseth’s Use of Signal App to Convey Plans for Houthi Strike

DON'T MISS

President Trump’s Tariffs Could Be the Political Tipping Point

DON'T MISS

Order That Kept Water in the Kern River Reversed by 5th District Court of Appeal

UP NEXT

Startup Offers Controversial Microplastic Blood Cleansing Treatment

UP NEXT

Pence Will Receive the Profile in Courage Award From the JFK Library for His Actions on Jan. 6

UP NEXT

No More Calling ‘Shotgun?’ CA Could Ban Teens From Riding in Front Seat

UP NEXT

Protests Planned All Over the World Aimed at Donald Trump and Elon Musk

UP NEXT

Diehard Baseball Fans in Sacramento Welcome Athletics and Hope They Stay Awhile

UP NEXT

Flores Homers, Matos and Wade Also Go Deep to Help Giants Cap Sweep of Astros

UP NEXT

Israeli Strikes on Gaza Overnight Leaves More Than 50 Palestinians Dead

UP NEXT

Hungary to Exit ICC as Netanyahu Visits Amid Arrest Warrant Dispute

UP NEXT

Rubio Visits NATO Amid European Alarm Over Trump’s Agenda

UP NEXT

California’s Schools Chief Has a $200,000 Salary and a Side Gig

Senate Confirms Mehmet Oz to Take Lead of Medicare and Medicaid Agency

2 hours ago

First California EV Mandates Hit Automakers This Year. Most Are Not Even Close

3 hours ago

Pence Will Receive the Profile in Courage Award From the JFK Library for His Actions on Jan. 6

4 hours ago

Politics Turns Ugly for a Conservative Running for Fresno State Student Body President

4 hours ago

Pentagon’s Watchdog to Review Hegseth’s Use of Signal App to Convey Plans for Houthi Strike

4 hours ago

President Trump’s Tariffs Could Be the Political Tipping Point

5 hours ago

Order That Kept Water in the Kern River Reversed by 5th District Court of Appeal

5 hours ago

As Dem Candidates for Governor Increase, They Wait for Harris to Decide

5 hours ago

No More Calling ‘Shotgun?’ CA Could Ban Teens From Riding in Front Seat

5 hours ago

Protests Planned All Over the World Aimed at Donald Trump and Elon Musk

5 hours ago

Measles Spreads to Central Texas; 5 States Have Active Outbreaks

Texas, Oklahoma and New Mexico reported new measles cases this week, with the outbreak expanding for the first time into central Texas. Alre...

20 minutes ago

20 minutes ago

Measles Spreads to Central Texas; 5 States Have Active Outbreaks

27 minutes ago

Trump Tariff Fears Erase $2 Trillion From US Stocks

31 minutes ago

Startup Offers Controversial Microplastic Blood Cleansing Treatment

Dr. Mehmet Oz, President Donald Trump's pick to lead the Centers for Medicare and Medicaid Services, seated right, gives a thumbs-up alongside his wife Lisa Oz, seated left, with friends and family after he testified at his confirmation hearing before the Senate Finance Committee, on Capitol Hill in Washington, Friday, March 14, 2025. (AP/Ben Curtis)
2 hours ago

Senate Confirms Mehmet Oz to Take Lead of Medicare and Medicaid Agency

3 hours ago

First California EV Mandates Hit Automakers This Year. Most Are Not Even Close

Vice President Mike Pence hands the electoral certificate from the state of Arizona to Sen. Amy Klobuchar, D-Minn., as he presides over a joint session of Congress as it convenes to count the Electoral College votes cast in November's election, at the Capitol in Washington, Jan. 6, 2021. (AP File)
4 hours ago

Pence Will Receive the Profile in Courage Award From the JFK Library for His Actions on Jan. 6

4 hours ago

Politics Turns Ugly for a Conservative Running for Fresno State Student Body President

U.S. Secretary of Defense Pete Hegseth attends a joint news conference with Japan's Defense Minister Gen Nakatani at the Ministry of Defense in Tokyo Sunday, March 30, 2025. (Kiyoshi Ota/Pool Photo via AP)
4 hours ago

Pentagon’s Watchdog to Review Hegseth’s Use of Signal App to Convey Plans for Houthi Strike

Help continue the work that gets you the news that matters most.

Search

Send this to a friend