Therapy Areas: Autoimmune
First Participants Dosed in Phase 2/3 Study of COVID-19 Vaccine Candidate in Adolescents
10 December 2020 - - The first adolescent participants have been dosed in the Phase 2/3 study of mRNA-1273, US-based biotechnology company Moderna Inc's (NASDAQ: MRNA) vaccine candidate against COVID-19, in adolescents ages 12 to less than 18, the company said.

The study is being conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant secretary for Preparedness and Response at the US Department of Health and Human Services.

This randomized, controlled Phase 2/3 study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The company intends to enroll 3,000 adolescent participants in the US ages 12 to less than 18 years.

Each participant will be assigned to receive a placebo or a 100 μg dose at both vaccinations.

Participants will be followed through 12 months after the second vaccination. Vaccine effectiveness will either be inferred through achieving a correlate of protection (if established) or through immunobridging to the adult population.

Evaluation of vaccine safety and reactogenicity is also a primary endpoint of the study. The ClinicalTrials.gov identifier is NCT04649151.

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID's Vaccine Research Center.

The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 42 days from sequence selection.

The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation.

On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrollment.

Results from the second interim analysis of the NIH-led Phase 1 study of mRNA-1273 in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine.

On July 28, results from a non-human primate preclinical viral challenge study evaluating mRNA-1273 were published in The New England Journal of Medicine. 

On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of mRNA-1273 was published in The New England Journal of Medicine. mRNA-1273 currently is not approved for use by any regulatory body.

BARDA is supporting the continued research and development of mRNA-1273 with USD955 m in federal funding under Contract no. 75A50120C00034.

BARDA is reimbursing Moderna for 100 % of the allowable costs incurred by the company for conducting the program described in the BARDA contract.

The US government has agreed to provide up to USD 1.525bn to purchase supply of mRNA-1273 under US Department of Defense Contract No. W911QY-20-C-0100.

Moderna is advancing messenger RNA science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases.

The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates.

Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
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