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An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial
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An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial
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Journal Article
An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial
2024
Overview
Here we conducted a multicenter open-label, randomized phase 2 and 3 study to assess the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron-specific (BA.1/B.1.1.529), monovalent, thermostable, self-amplifying mRNA vaccine, GEMCOVAC-OM, when administered intradermally as a booster in healthy adults who had received two doses of BBV152 or ChAdOx1 nCoV-19. GEMCOVAC-OM was well tolerated with no related serious adverse events in both phase 2 and phase 3. In phase 2, the safety and immunogenicity of GEMCOVAC-OM was compared with our prototype mRNA vaccine GEMCOVAC-19 (D614G variant-specific) in 140 participants. At day 29 after vaccination, there was a significant rise in anti-spike (BA.1) IgG antibodies with GEMCOVAC-OM (
P
< 0.0001) and GEMCOVAC-19 (
P
< 0.0001). However, the IgG titers (primary endpoint) and seroconversion were higher with GEMCOVAC-OM (
P
< 0.0001). In phase 3, GEMCOVAC-OM was compared with ChAdOx1 nCoV-19 in 3,140 participants (safety cohort), which included an immunogenicity cohort of 420 participants. At day 29, neutralizing antibody titers against the BA.1 variant of SARS-CoV-2 were significantly higher than baseline in the GEMCOVAC-OM arm (
P
< 0.0001), but not in the ChAdOx1 nCoV-19 arm (
P
= 0.1490). GEMCOVAC-OM was noninferior (primary endpoint) and superior to ChAdOx1 nCoV-19 in terms of neutralizing antibody titers and seroconversion rate (lower bound 95% confidence interval of least square geometric mean ratio >1 and difference in seroconversion >0% for superiority). At day 29, anti-spike IgG antibodies and seroconversion (secondary endpoints) were significantly higher with GEMCOVAC-OM (
P
< 0.0001). These results demonstrate that GEMCOVAC-OM is safe and boosts immune responses against the B.1.1.529 variant. Clinical Trial Registry India identifier:
CTRI/2022/10/046475
.
A self-amplifying mRNA vaccine shows promise in this new modality by eliciting neutralizing antibodies against the SARS-CoV-2 Omicron (BA.1) variant in a phase 2/3 trial.
Publisher
Nature Publishing Group US,Nature Publishing Group
Subject
/ Adult
/ Antibodies, Neutralizing - blood
/ Antibodies, Neutralizing - immunology
/ Antibodies, Viral - immunology
/ Biomedical and Life Sciences
/ ChAdOx1 nCoV-19 - immunology
/ COVID-19
/ COVID-19 - prevention & control
/ COVID-19 Vaccines - administration & dosage
/ COVID-19 Vaccines - adverse effects
/ COVID-19 Vaccines - immunology
/ Female
/ Humans
/ Immunogenicity, Vaccine - immunology
/ Immunoglobulin G - immunology
/ Male
/ mRNA
/ Safety
/ Severe acute respiratory syndrome coronavirus 2
/ Spike Glycoprotein, Coronavirus - genetics
/ Spike Glycoprotein, Coronavirus - immunology
/ Vaccines
