tetano
Editor, Senior Moderator
Sci Rep
. 2023 Oct 3;13(1):16579.
doi: 10.1038/s41598-023-43578-w. A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Prasad S Kulkarni[SUP] 1 [/SUP], Bhagwat Gunale[SUP] 2 [/SUP], Sunil Kohli[SUP] 3 [/SUP], Sanjay Lalwani[SUP] 4 [/SUP], Srikanth Tripathy[SUP] 5 [/SUP], Sonali Kar[SUP] 6 [/SUP], Sidram Raut[SUP] 7 [/SUP], Praveen Kulkarni[SUP] 8 [/SUP], Aditi Apte[SUP] 9 [/SUP], Ashish Bavdekar[SUP] 9 [/SUP], Hira Lal Bhalla[SUP] 10 [/SUP], Joyce S Plested[SUP] 11 [/SUP], Shane Cloney-Clark[SUP] 11 [/SUP], MingZhu Zhu[SUP] 11 [/SUP], Raj Kalkeri[SUP] 11 [/SUP], Melinda Pryor[SUP] 12 [/SUP], Stephanie Hamilton[SUP] 12 [/SUP], Madhuri Thakar[SUP] 13 [/SUP], Ranga S Sannidhi[SUP] 14 [/SUP], Punjita Baranwal[SUP] 14 [/SUP], Chetanraj Bhamare[SUP] 2 [/SUP], Abhijeet Dharmadhikari[SUP] 2 [/SUP], Manish Gupta[SUP] 2 [/SUP], Cyrus S Poonawalla[SUP] 2 [/SUP], Umesh Shaligram[SUP] 2 [/SUP], Dhananjay Kapse[SUP] 2 [/SUP]; COVOVAX-Booster Study Group
Collaborators, Affiliations
Due to waning immunity following primary immunization with COVID-19 vaccines, booster doses may be required. The present study assessed a heterologous booster of SII-NVX-CoV2373 (spike protein vaccine) in adults primed with viral vector and inactivated vaccines. In this Phase 3, observer-blind, randomized, active controlled study, a total of 372 adults primed with two doses of ChAdOx1 nCoV-19 (n = 186) or BBV152 (n = 186) at least six months ago, were randomized to receive a booster of SII-NVX-CoV2373 or control vaccine (homologous booster of ChAdOx1 nCoV-19 or BBV152). Anti-S IgG and neutralizing antibodies (nAbs) were assessed at days 1, 29, and 181. Non-inferiority (NI) of SII-NVX-CoV2373 to the control vaccine was assessed based on the ratio of geometric mean ELISA units (GMEU) of anti-S IgG and geometric mean titers (GMT) of nAbs (NI margin > 0.67) as well as seroresponse (≥ 2 fold-rise in titers) (NI margin -10%) at day 29. Safety was assessed throughout the study period. In both the ChAdOx1 nCoV-19 prime and BBV152 prime cohorts, 186 participants each received the study vaccines. In the ChAdOx1 nCoV-19 prime cohort, the GMEU ratio was 2.05 (95% CI 1.73, 2.43) and the GMT ratio was 1.89 (95% CI 1.55, 2.32) whereas the difference in the proportion of seroresponse was 49.32% (95% CI 36.49, 60.45) for anti-S IgG and 15% (95% CI 5.65, 25.05) for nAbs on day 29. In the BBV152 prime cohort, the GMEU ratio was 5.12 (95% CI 4.20, 6.24) and the GMT ratio was 4.80 (95% CI 3.76, 6.12) whereas the difference in the proportion of seroresponse was 74.08% (95% CI 63.24, 82.17) for anti-S IgG and 24.71% (95% CI 16.26, 34.62) for nAbs on day 29. The non-inferiority of SII-NVX-CoV2373 booster to the control vaccine for each prime cohort was met. SII-NVX-CoV2373 booster showed significantly higher immune responses than BBV152 homologous booster. On day 181, seroresponse rates were ≥ 70% in all the groups for both nAbs and anti-S IgG. Solicited adverse events reported were transient and mostly mild in severity in all the groups. No causally related SAE was reported. SII-NVX-CoV2373 as a heterologous booster induced non-inferior immune responses as compared to homologous boosters in adults primed with ChAdOx1 nCoV-19 and BBV152. SII-NVX-CoV2373 showed a numerically higher boosting effect than homologous boosters. The vaccine was also safe and well tolerated.
. 2023 Oct 3;13(1):16579.
doi: 10.1038/s41598-023-43578-w. A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Prasad S Kulkarni[SUP] 1 [/SUP], Bhagwat Gunale[SUP] 2 [/SUP], Sunil Kohli[SUP] 3 [/SUP], Sanjay Lalwani[SUP] 4 [/SUP], Srikanth Tripathy[SUP] 5 [/SUP], Sonali Kar[SUP] 6 [/SUP], Sidram Raut[SUP] 7 [/SUP], Praveen Kulkarni[SUP] 8 [/SUP], Aditi Apte[SUP] 9 [/SUP], Ashish Bavdekar[SUP] 9 [/SUP], Hira Lal Bhalla[SUP] 10 [/SUP], Joyce S Plested[SUP] 11 [/SUP], Shane Cloney-Clark[SUP] 11 [/SUP], MingZhu Zhu[SUP] 11 [/SUP], Raj Kalkeri[SUP] 11 [/SUP], Melinda Pryor[SUP] 12 [/SUP], Stephanie Hamilton[SUP] 12 [/SUP], Madhuri Thakar[SUP] 13 [/SUP], Ranga S Sannidhi[SUP] 14 [/SUP], Punjita Baranwal[SUP] 14 [/SUP], Chetanraj Bhamare[SUP] 2 [/SUP], Abhijeet Dharmadhikari[SUP] 2 [/SUP], Manish Gupta[SUP] 2 [/SUP], Cyrus S Poonawalla[SUP] 2 [/SUP], Umesh Shaligram[SUP] 2 [/SUP], Dhananjay Kapse[SUP] 2 [/SUP]; COVOVAX-Booster Study Group
Collaborators, Affiliations
- PMID: 37789040
- PMCID: PMC10547846
- DOI: 10.1038/s41598-023-43578-w
Due to waning immunity following primary immunization with COVID-19 vaccines, booster doses may be required. The present study assessed a heterologous booster of SII-NVX-CoV2373 (spike protein vaccine) in adults primed with viral vector and inactivated vaccines. In this Phase 3, observer-blind, randomized, active controlled study, a total of 372 adults primed with two doses of ChAdOx1 nCoV-19 (n = 186) or BBV152 (n = 186) at least six months ago, were randomized to receive a booster of SII-NVX-CoV2373 or control vaccine (homologous booster of ChAdOx1 nCoV-19 or BBV152). Anti-S IgG and neutralizing antibodies (nAbs) were assessed at days 1, 29, and 181. Non-inferiority (NI) of SII-NVX-CoV2373 to the control vaccine was assessed based on the ratio of geometric mean ELISA units (GMEU) of anti-S IgG and geometric mean titers (GMT) of nAbs (NI margin > 0.67) as well as seroresponse (≥ 2 fold-rise in titers) (NI margin -10%) at day 29. Safety was assessed throughout the study period. In both the ChAdOx1 nCoV-19 prime and BBV152 prime cohorts, 186 participants each received the study vaccines. In the ChAdOx1 nCoV-19 prime cohort, the GMEU ratio was 2.05 (95% CI 1.73, 2.43) and the GMT ratio was 1.89 (95% CI 1.55, 2.32) whereas the difference in the proportion of seroresponse was 49.32% (95% CI 36.49, 60.45) for anti-S IgG and 15% (95% CI 5.65, 25.05) for nAbs on day 29. In the BBV152 prime cohort, the GMEU ratio was 5.12 (95% CI 4.20, 6.24) and the GMT ratio was 4.80 (95% CI 3.76, 6.12) whereas the difference in the proportion of seroresponse was 74.08% (95% CI 63.24, 82.17) for anti-S IgG and 24.71% (95% CI 16.26, 34.62) for nAbs on day 29. The non-inferiority of SII-NVX-CoV2373 booster to the control vaccine for each prime cohort was met. SII-NVX-CoV2373 booster showed significantly higher immune responses than BBV152 homologous booster. On day 181, seroresponse rates were ≥ 70% in all the groups for both nAbs and anti-S IgG. Solicited adverse events reported were transient and mostly mild in severity in all the groups. No causally related SAE was reported. SII-NVX-CoV2373 as a heterologous booster induced non-inferior immune responses as compared to homologous boosters in adults primed with ChAdOx1 nCoV-19 and BBV152. SII-NVX-CoV2373 showed a numerically higher boosting effect than homologous boosters. The vaccine was also safe and well tolerated.