A National Institute of Allergy and Infectious Diseases (NIAID) new Phase 1 clinical trial was launched recently to investigate the safety, reactogenicity and immunogenicity of Moderna’s mRNA-1273 vaccine against the South African SARS-CoV-2 variant known as B.1.351. Recently, a couple Seattle-area residents received the jab kicking off this important clinical trial conducted at Kaiser Permanente Washington Health Research Institute led by Dr. Lisa Jackson. As reported in the Seattle Times, a retired family physician named Suzanne Spencer, already vaccinated with the Moderna vaccine, now is rolling her sleeves up again to help test this new experimental booster designed to protect against the South African variant, one that she refers to a “…the virulent one, the nasty one.” Spencer and two other residents from the same area received jabs last Thursday as at least 17 cases of COVID-19 associated with this variant.
Booster or Possible New Vaccine
Vaccine makers are now modifying their formulations due to the emergence of what can be problematic variants. But of all of the variants emerging thus far, the South African variant appears to cause the most concern. It appears to be 50% more infectious, and the mutant is more adept at evading natural and vaccine-induced immunity.
Moderna has initiated this study along with support from NIAID as a potential way to develop a booster shot or as a stand-alone vaccine. This study is organized as a reaction to the imminent threat posed by variants, such as the one from South Africa. During this study, the sponsor will also look at different dose scenarios in addition to mixes of two different formulations.
While Dr. Antony Fauci was recently on record that the existing vaccines are still effective, “…out of an abundance of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine.”
This Phase 1 clinical trial (NCT04785144) includes two cohorts, including 1) that provides rapid information about the immunogenicity of the actual experimental booster called mRNA-1273.351 in a previously vaccinated group, and 2) one that evaluates different strategies for generation of cross protective immune responses in a naïve population (that is a group that hasn’t received the jab yet). While this particular cohort effort will take longer to produce results covering immunogenicity of the variant, it’s certainly important for public health strategies.
A total of 60 participants. will be involved with Cohort 1 while Cohort 2 will involve about 150 participants.
Seattle Trial Site
In Seattle, the study is co-led by Dr. Lisa Jackson, a prominent principal investigator at Kaiser Permanente Washington Health Research Institute. Dr. Jackson reports, “We’re investigating possible strategies for use of a vaccine like this.” This site as well as three others at Vanderbilt University, Pediatric Vanderbilt Vaccine Research Center, Nashville, Emory Vaccine Center, the Hope Clinic in Atlanta and Cincinnati Children’s Hospital Medical Center—Infectious Diseases will include a targeted 150 participants who haven’t yet been vaccinated.
Dr. Lisa Jackson has been profiled by TrialSite and is well known in the research community. She was a leader of Moderna’s first clinical trial in the Pacific Northwest, which was the first human trial of a COVID-19 vaccine, reports the Seattle Times’ Sandi Doughton.
The New Vaccine
Ms. Doughton reports that this new vaccine is nearly identical to mRNA-1273, Moderna’s existing one but does include the mRNA code for the variant’s spike protein: that is, the mechanism the pathogen uses to hook onto and thus penetrate cells.