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- | Spikevax (elasomeran) / Moderna
Journal: Profiling antibody epitopes induced by mRNA-1273 vaccination and boosters. (Pubmed Central) - Apr 6, 2024
Notably, the strength of antibody responses after booster vaccination differed by the exact vaccine formulation, with variant-updated mRNA-1273.211 and mRNA-1273.617.2 booster formulations inducing significantly stronger S-specific signals than a mRNA-1273 booster. Overall, these results identify key S-specific epitopes targeted by antibodies induced by mRNA-1273 primary and variant-updated booster vaccination.
- | Biomarker, Journal: Temporal changes in biomarkers of neutrophil extracellular traps and NET-promoting autoantibodies following adenovirus-vectored, mRNA, and recombinant protein COVID-19 vaccination. (Pubmed Central) - Mar 25, 2024
The increased levels of citH3/MPO-DNA accompanied by NET-promoting autoantibodies suggest a potential connection between mRNA-1273/ChAdOx1-S vaccines and cardiovascular complications. These findings provide insights for risk assessments of future vaccines.
- ||||||| Trial completion: A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (clinicaltrials.gov) - Dec 21, 2023
P2/3, N=5404, Completed, Sponsor: ModernaTX, Inc.
These findings provide insights for risk assessments of future vaccines. Active, not recruiting --> Completed
- | Trial completion, Trial completion date, Trial primary completion date: Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (clinicaltrials.gov) - Sep 5, 2023
P1/2, N=867, Completed, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Jun 2023 | Trial primary completion date: Jun 2024 --> Jun 2023
- |||| Trial completion date, Trial primary completion date: A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (clinicaltrials.gov) - May 24, 2023
P2/3, N=5404, Active, not recruiting, Sponsor: ModernaTX, Inc.
Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Jun 2023 | Trial primary completion date: Jun 2024 --> Jun 2023 Trial completion date: Apr 2023 --> Nov 2023 | Trial primary completion date: Apr 2023 --> Nov 2023
- | Enrollment closed: Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (clinicaltrials.gov) - Apr 21, 2023
P1/2, N=867, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Trial completion date: Apr 2023 --> Nov 2023 | Trial primary completion date: Apr 2023 --> Nov 2023 Recruiting --> Active, not recruiting
- | Trial completion date, Trial primary completion date: Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (clinicaltrials.gov) - Feb 13, 2023
P1/2, N=1130, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting --> Active, not recruiting Trial completion date: Dec 2023 --> Jul 2024 | Trial primary completion date: Dec 2023 --> Jul 2024
- | Trial completion date, Trial primary completion date: Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (clinicaltrials.gov) - Dec 9, 2022
P1/2, N=1130, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Trial completion date: Dec 2023 --> Jul 2024 | Trial primary completion date: Dec 2023 --> Jul 2024 Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- ||| mRNA-1273.211 / Moderna, Spikevax (elasomeran) / Moderna
P2/3 data, Clinical Trial,Phase III, Journal: Safety, immunogenicity and antibody persistence of a bivalent Beta-containing booster vaccine against COVID-19: a phase 2/3 trial. (Pubmed Central) - Nov 22, 2022
P2/3, P2a,
Immunization with the primary series does not set a ceiling to the neutralizing antibody response, and a booster dose of the bivalent vaccine elicits a robust response with titers that are likely to be protective against COVID-19. These results indicate that bivalent booster vaccines can induce potent, durable and broad antibody responses against multiple variants, providing a new tool in response to emerging variants.
- || Review, Journal: Do We Really Need Omicron Spike-Based Updated COVID-19 Vaccines? Evidence and Pipeline. (Pubmed Central) - Nov 15, 2022
An accelerated rate of immune escape to vaccine-elicited immunity has been associated with Spike protein antigenic shifts, as seen in the Omicron variant of concern and its sublineages, demanding the development of Omicron Spike-based vaccines. Herein, we review the evidence in animal models and topline results from ongoing clinical trials with such updated vaccines, discussing the pros and cons for their deployment.
- || mRNA-1273.211 / Moderna, Spikevax (elasomeran) / Moderna
That is not correct. The mRNA-1273.211 is bivalent with the BETA variant, not the OMICRON variant BA.1. From https://t.co/F8E7sUMy4p "... mRNA-1273.211, which includes mutations found in the Beta variant of concern ..." (Twitter) - Oct 13, 2022
- || mRNA-1273.211 / Moderna, Spikevax (elasomeran) / Moderna, Takeda
“There was a 2.20-fold (95% CI: 1.74, 2.79) and 2.15-fold (95% CI: 1.66, 2.78) increase in the neutralizing antibody titers against Omicron with the mRNA-1273.211 booster dose compared to the mRNA-1273 booster dose at 1 month and 6 months, respectively” (Twitter) - May 17, 2022
- ||||| Enrollment closed: A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (clinicaltrials.gov) - May 2, 2022
P2/3, N=4658, Active, not recruiting, Sponsor: ModernaTX, Inc.
Herein, we review the evidence in animal models and topline results from ongoing clinical trials with such updated vaccines, discussing the pros and cons for their deployment. Recruiting --> Active, not recruiting
- ||||| Enrollment change, Trial completion date, Trial primary completion date: A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (clinicaltrials.gov) - Mar 2, 2022
P2/3, N=4720, Recruiting, Sponsor: ModernaTX, Inc.
Recruiting --> Active, not recruiting N=3620 --> 4720 | Trial completion date: Nov 2022 --> Mar 2023 | Trial primary completion date: Jun 2022 --> Mar 2023
- mRNA-1273.211 / Moderna
Antibody responses to SARS-CoV-2 elicited by the multivalent, variant-matched booster mRNA-1273.211 vaccine among adults (Hall N) - Jan 31, 2022 - Abstract #ECCMID2022ECCMID_1157;
- | mRNA-1273.211 / Moderna, Spikevax (elasomeran) / Moderna, Takeda
Preclinical, Journal: Variant SARS-CoV-2 mRNA vaccines confer broad neutralization as primary or booster series in mice. (Pubmed Central) - Dec 25, 2021
A third (booster) dose of mRNA-1273.351 significantly increased both wild-type and B.1.351-specific neutralization titers. Both mRNA-1273.351 and mRNA-1273.211 are being evaluated in pre-clinical challenge and clinical studies.
- || mRNA-1273.211 / Moderna, Spikevax (elasomeran) / Moderna, Takeda
Clinical, Journal: Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis. (Pubmed Central) - Dec 16, 2021
P2a
and B.1.617.2, that were statistically equivalent to peak titers measured after the primary vaccine series against wild-type D614G virus, with superior titers against some VOIs. This trial is ongoing.
- |||||| Enrollment open, Enrollment change: A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (clinicaltrials.gov) - Oct 31, 2021
P2/3, N=3620, Recruiting, Sponsor: ModernaTX, Inc.
This trial is ongoing. Active, not recruiting --> Recruiting | N=1768 --> 3620
- | Trial completion date, Trial primary completion date: Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (clinicaltrials.gov) - Oct 7, 2021
P1/2, N=950, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Recruiting | N=1768 --> 3620 Trial completion date: May 2025 --> Dec 2022 | Trial primary completion date: May 2023 --> Dec 2022
- ||||| Enrollment change: A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (clinicaltrials.gov) - Aug 30, 2021
P2/3, N=1768, Active, not recruiting, Sponsor: ModernaTX, Inc.
Trial completion date: May 2025 --> Dec 2022 | Trial primary completion date: May 2023 --> Dec 2022 N=896 --> 1768
- ||||| Enrollment change: A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (clinicaltrials.gov) - Aug 18, 2021
P2/3, N=896, Active, not recruiting, Sponsor: ModernaTX, Inc.
N=896 --> 1768 N=300 --> 896
- | Enrollment change: Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (clinicaltrials.gov) - Aug 18, 2021
P1/2, N=800, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
N=300 --> 896 N=550 --> 800
- | Enrollment change: Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (clinicaltrials.gov) - Jul 14, 2021
P1/2, N=550, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
N=550 --> 800 N=400 --> 550
- |||||||||| New P2/3 trial: A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (clinicaltrials.gov) - Jun 15, 2021
P2/3, N=300, Active, not recruiting, Sponsor: ModernaTX, Inc.
- | Enrollment open: Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (clinicaltrials.gov) - Jun 3, 2021
P1/2, N=400, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
N=400 --> 550 Not yet recruiting --> Recruiting
- | New P1/2 trial: Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (clinicaltrials.gov) - May 17, 2021
P1/2, N=400, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)