tetano
Editor, Senior Moderator
Nat Med
. 2024 Apr 18.
doi: 10.1038/s41591-024-02955-2. Online ahead of print. An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial
Amit Saraf[SUP] #[/SUP][SUP] 1 [/SUP], Rohan Gurjar[SUP] #[/SUP][SUP] 1 [/SUP], Swarnendu Kaviraj[SUP] 1 [/SUP], Aishwarya Kulkarni[SUP] 1 [/SUP], Durgesh Kumar[SUP] 1 [/SUP], Ruta Kulkarni[SUP] 2 [/SUP], Rashmi Virkar[SUP] 2 [/SUP], Jayashri Krishnan[SUP] 3 [/SUP], Anjali Yadav[SUP] 3 [/SUP], Ekta Baranwal[SUP] 3 4 [/SUP], Ajay Singh[SUP] 1 [/SUP], Arjun Raghuwanshi[SUP] 1 [/SUP], Praveen Agarwal[SUP] 1 [/SUP], Laxman Savergave[SUP] 1 [/SUP], Sanjay Singh[SUP] 5 [/SUP]; GEMCOVAC-OM Study Investigators
Collaborators, Affiliations
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 .
. 2024 Apr 18.
doi: 10.1038/s41591-024-02955-2. Online ahead of print. An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial
Amit Saraf[SUP] #[/SUP][SUP] 1 [/SUP], Rohan Gurjar[SUP] #[/SUP][SUP] 1 [/SUP], Swarnendu Kaviraj[SUP] 1 [/SUP], Aishwarya Kulkarni[SUP] 1 [/SUP], Durgesh Kumar[SUP] 1 [/SUP], Ruta Kulkarni[SUP] 2 [/SUP], Rashmi Virkar[SUP] 2 [/SUP], Jayashri Krishnan[SUP] 3 [/SUP], Anjali Yadav[SUP] 3 [/SUP], Ekta Baranwal[SUP] 3 4 [/SUP], Ajay Singh[SUP] 1 [/SUP], Arjun Raghuwanshi[SUP] 1 [/SUP], Praveen Agarwal[SUP] 1 [/SUP], Laxman Savergave[SUP] 1 [/SUP], Sanjay Singh[SUP] 5 [/SUP]; GEMCOVAC-OM Study Investigators
Collaborators, Affiliations
- PMID: 38637636
- DOI: 10.1038/s41591-024-02955-2
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 .