Tags

Type your tag names separated by a space and hit enter

A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine.
Vaccine. 2021 05 12; 39(20):2791-2799.V

Abstract

BACKGROUND

Vaccines are urgently needed to prevent the global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We assessed the safety and immunogenicity of vaccine candidate mRNA-1273, encoding the prefusion-stabilized spike protein of SARS-CoV-2.

METHODS

This phase 2, randomized, observer-blind, placebo-controlled trial was conducted at 8 sites in the USA, in healthy adults aged ≥18 years with no known history or risk of SARS-CoV-2 infection, and had not previously received an investigational CoV vaccine or treatment. Participants were stratified into two age cohorts (≥18-<55 and ≥55) and were randomly assigned (1:1:1) to either 50 or 100 µg of mRNA-1273, or placebo administered as two intramuscular injections 28 days apart. The primary outcomes were safety, reactogenicity, and immunogenicity assessed by anti-SARS-CoV-2-spike binding antibody level (bAb). Secondary outcome was immunogenicity assessed by SARS-CoV-2 neutralizing antibody (nAb) response.

RESULTS

Between 29 May and 8 July 2020, 600 participants were randomized, 300 per age cohort. The most common solicited adverse reactions were pain at injection site, headache, and fatigue following each vaccination in both age cohorts. One serious adverse event deemed unrelated by the site investigator occurred 33 days post-vaccination one. mRNA-1273 induced bAb and nAb by 28 days post-vaccination one that were higher at the 100 µg dose relative to the 50 µg dose; this difference was less apparent post-vaccination two. Binding antibodies and nAb increased substantially by 14 days following the second vaccination (day 43) to levels exceeding those of convalescent sera and remained elevated through day 57.

CONCLUSIONS

Vaccination with mRNA-1273 resulted in significant immune responses to SARS-CoV-2 in participants 18 years and older, with an acceptable safety profile, confirming the safety and immunogenicity of 50 and 100 µg mRNA-1273 given as a 2 dose-regimen. ClinicalTrials.gov; NCT04405076.

Authors+Show Affiliations

Benchmark Research, 3100 Red River St #2, Austin, TX 78705, United States.Moderna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States.Moderna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States.Moderna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States.Moderna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States.Moderna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States.Moderna, Inc., 200 Technology Sq, Cambridge, MA 02139, United States. Electronic address: brett.leav@modernatx.com.No affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

33707061

Citation

Chu, Laurence, et al. "A Preliminary Report of a Randomized Controlled Phase 2 Trial of the Safety and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine." Vaccine, vol. 39, no. 20, 2021, pp. 2791-2799.
Chu L, McPhee R, Huang W, et al. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine. 2021;39(20):2791-2799.
Chu, L., McPhee, R., Huang, W., Bennett, H., Pajon, R., Nestorova, B., & Leav, B. (2021). A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine, 39(20), 2791-2799. https://doi.org/10.1016/j.vaccine.2021.02.007
Chu L, et al. A Preliminary Report of a Randomized Controlled Phase 2 Trial of the Safety and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine. Vaccine. 2021 05 12;39(20):2791-2799. PubMed PMID: 33707061.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. AU - Chu,Laurence, AU - McPhee,Roderick, AU - Huang,Wenmei, AU - Bennett,Hamilton, AU - Pajon,Rolando, AU - Nestorova,Biliana, AU - Leav,Brett, AU - ,, Y1 - 2021/02/09/ PY - 2021/01/08/received PY - 2021/02/03/revised PY - 2021/02/05/accepted PY - 2021/3/13/pubmed PY - 2021/5/7/medline PY - 2021/3/12/entrez KW - COVID-19 KW - Immunogenicity KW - Phase 2 KW - SARS-CoV-2 KW - Safety KW - Vaccine KW - mRNA-1273 SP - 2791 EP - 2799 JF - Vaccine JO - Vaccine VL - 39 IS - 20 N2 - BACKGROUND: Vaccines are urgently needed to prevent the global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We assessed the safety and immunogenicity of vaccine candidate mRNA-1273, encoding the prefusion-stabilized spike protein of SARS-CoV-2. METHODS: This phase 2, randomized, observer-blind, placebo-controlled trial was conducted at 8 sites in the USA, in healthy adults aged ≥18 years with no known history or risk of SARS-CoV-2 infection, and had not previously received an investigational CoV vaccine or treatment. Participants were stratified into two age cohorts (≥18-<55 and ≥55) and were randomly assigned (1:1:1) to either 50 or 100 µg of mRNA-1273, or placebo administered as two intramuscular injections 28 days apart. The primary outcomes were safety, reactogenicity, and immunogenicity assessed by anti-SARS-CoV-2-spike binding antibody level (bAb). Secondary outcome was immunogenicity assessed by SARS-CoV-2 neutralizing antibody (nAb) response. RESULTS: Between 29 May and 8 July 2020, 600 participants were randomized, 300 per age cohort. The most common solicited adverse reactions were pain at injection site, headache, and fatigue following each vaccination in both age cohorts. One serious adverse event deemed unrelated by the site investigator occurred 33 days post-vaccination one. mRNA-1273 induced bAb and nAb by 28 days post-vaccination one that were higher at the 100 µg dose relative to the 50 µg dose; this difference was less apparent post-vaccination two. Binding antibodies and nAb increased substantially by 14 days following the second vaccination (day 43) to levels exceeding those of convalescent sera and remained elevated through day 57. CONCLUSIONS: Vaccination with mRNA-1273 resulted in significant immune responses to SARS-CoV-2 in participants 18 years and older, with an acceptable safety profile, confirming the safety and immunogenicity of 50 and 100 µg mRNA-1273 given as a 2 dose-regimen. ClinicalTrials.gov; NCT04405076. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/33707061/A_preliminary_report_of_a_randomized_controlled_phase_2_trial_of_the_safety_and_immunogenicity_of_mRNA_1273_SARS_CoV_2_vaccine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(21)00153-5 DB - PRIME DP - Unbound Medicine ER -