Safety and Immunogenicity of SII-NVX-CoV2373 (COVID-19 Vaccine) In Adults in a Phase 2/3, Observer-Blind, Randomised, Controlled Study

Kulkarni, Prasad S.; Kadam, Abhijit; Godbole, Sheela; Bhatt, Vyomesh; Raut, Abhishek; Kohli, Sunil; Tripathi, Santanu Kumar; Kulkarni, Praveen; Ludam, Rakhi; Prabhu, Madhav; Bavdekar, Ashish; Gogtay, Nithya J; Meshram, Sushant; Kadhiravan, Tamilarasu; Kar, Sonali; Narayana, Ashwath; Samuel, Clarence; Kulkarni, Govind; Gaidhane, Abhay; Sathyapalan, Dipu T.; Raut, Sidram; Hadda, Vijay; Bhalla, Hira Lal; Bhamare, Chetanraj; Dharmadhikari, Abhijeet; Plested, Joyce S.; Cloney-Clarke, Shane; Zhu, Mingzhu; Pryor, Melinda; Thakar, Madhuri; Shete, Ashwini; Gautam, Manish; Gupta, Nivedita; Panda, Samiran; Shaligram, Umesh; Poonawalla, Cyrus S.; Bhargava, Balram; Gunale, Bhagwat; Kapse, Dhananjay; Group, for the COVOVAX Study

doi:10.2139/ssrn.4153455

Cited by 3 publications

(7 citation statements)

References 16 publications

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“…There was a substantial rise in the titres in the placebo groups compared to baseline likely due to SARS-CoV-2 infections. These results are on expected lines as seen with SII-NVX-CoV2373 in adults [14].…”

Section: Discussionsupporting

confidence: 77%

“…An age effect was clearly seen in the immune responses. Not only did both 12 to 17 years adolescents and 2 to 11 years children age groups show non-inferior immune responses to adults, but in fact, the titers in both the pediatric age groups were higher than in adults [14]. Moreover, the titers in the 2 to 11 years age group were also higher than in the 12 to 17 years age group.…”

Section: Discussionmentioning

confidence: 99%

“…Baseline serology and/or RT-PCR positivity for SARS-CoV-2 was around 10-13% in both the pediatric age groups. The corresponding value in the Phase 3 study in adults was around 33% [14]. This probably means that the first wave in 2020 as well as the second wave in 2021 and third wave in 2021-2022 in India did not affect children significantly.…”

Section: Discussionmentioning

confidence: 99%

“…Ltd. (SIIPL). This vaccine (SII-NVX-COV2373) has been tested in Indian adults and was found safe and immunogenic with more than 92% seroconversion with different antibody assays [14]. The vaccine has been granted emergency use authorization (EUA) for adults in India and received emergency use listing (EUL) by the World Health Organization in Dec 2021 [15,16].…”

Section: Introductionmentioning

confidence: 99%

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A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years

Gunale

Kapse

Kar

et al. 2023

Preprint

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Background: A recombinant, adjuvanted COVID-19 vaccine, SII-NVX-CoV2373 was manufactured in India and evaluated in Indian children and adolescents to assess safety and immunogenicity. Methods: This was a Phase 2/3 observer-blind, randomized, controlled study in children and adolescents aged 2 to 17 years. Participants were randomly assigned in 3:1 ratio to receive two doses of SII-NVX-CoV2373 or placebo on day 1 and day 22. Solicited adverse events (AEs) were collected for 7 days after each vaccination. Unsolicited AEs were collected for 35 days following first dose and serious AEs (SAEs) and adverse events of special interest (AESI) were collected throughout the study. Anti S IgG and neutralizing antibodies against the SARS-CoV-2 were measured at baseline, day 22, day 36 and day 180. Variant immune responses were assessed in a subset of participants at baseline, day 36 and day 180. Primary objectives were to demonstrate non-inferiority of SII-NVX-CoV2373 in each pediatric age group (12 to 17 years and 2 to 11 years, separately) to that in adults in terms of ratio of titers of both anti-S IgG and neutralizing antibodies 14 days after the second dose (day 36). Non-inferiority was to be concluded if the lower bound of 95% CI of the ratio was >0.67. Results: A total of 920 children and adolescents (460 in each age cohort; 12 to 17 years and 2 to 11 years) were randomized and vaccinated. The demographic and baseline characteristics between the two groups were comparable in both age groups. After the second dose, there were more than 100-fold rise in anti-S IgG GMEUs and more than 84-fold rise in neutralizing antibodies GMTs from baseline in the participants who received SII-NVX-CoV2373. The GMTs in both age groups were non-inferior to those observed in Indian adults. The seroconversion rate was ≥ 98% (anti-S IgG) and ≥ 97.9% (neutralizing antibodies) in both age groups, respectively. Similar findings were seen in the baseline seronegative participants. SII-NVX-CoV2373 also showed robust responses against various variants of concern. Injection site pain, tenderness, swelling, erythema and fever, headache, malaise, fatigue, myalgia, arthralgia, nausea and vomiting were the common solicited adverse events which were transient and resolved without any sequelae. Throughout the study, only two causally unrelated SAEs and no AESI were reported. Conclusion: SII-NVX-CoV2373 has been found safe and well tolerated in children and adolescents of 2 to 17 years. The vaccine was highly immunogenic and the immune response was non-inferior to that in adults.

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Section: Discussionsupporting

confidence: 77%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years

Gunale

Kapse

Kar

et al. 2023

Preprint

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“…During the phase II clinical trial in India, 40.7% of the vaccinated participants reported 96 adverse events. In contrast, 18% of the placebo group reported 11 adverse events [ 111 ], and most side effects were mild and resolved without intervention. Overall, the approved COVID-19 vaccines were well tolerated, with only mild to moderate adverse reactions.…”

Section: Adverse Effects Due To Sars-cov-2 Vaccinesmentioning

confidence: 99%

COVID-19 Vaccines, Effectiveness, and Immune Responses

Abufares

Alsoud

Alqudah

et al. 2022

IJMS

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The COVID-19 pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has captivated the globe’s attention since its emergence in 2019. This highly infectious, spreadable, and dangerous pathogen has caused health, social, and economic crises. Therefore, a worldwide collaborative effort was made to find an efficient strategy to overcome and develop vaccines. The new vaccines provide an effective immune response that safeguards the community from the virus’ severity. WHO has approved nine vaccines for emergency use based on safety and efficacy data collected from various conducted clinical trials. Herein, we review the safety and effectiveness of the WHO-approved COVID-19 vaccines and associated immune responses, and their impact on improving the public’s health. Several immunological studies have demonstrated that vaccination dramatically enhances the immune response and reduces the likelihood of future infections in previously infected individuals. However, the type of vaccination and individual health status can significantly affect immune responses. Exposure of healthy individuals to adenovirus vectors or mRNA vaccines causes the early production of antibodies from B and T cells. On the other hand, unhealthy individuals were more likely to experience harmful events due to relapses in their existing conditions. Taken together, aligning with the proper vaccination to a patient’s case can result in better outcomes.

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A randomized, controlled study to evaluate the safety and immunogenicity of a heterologous booster dose of an adjuvanted SARS CoV-2 recombinant spike protein vaccine in adults

Kulkarni

Gunale

Kohli

et al. 2023

Preprint

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Background 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. Methods In this Phase 3, observer-blind, randomized, active controlled study, a total of 372 adults primed with 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. The control group received homologous booster of ChAdOx1 nCoV-19 or BBV152 depending upon the prime cohort. Anti-S IgG and neutralizing antibodies were assessed at baseline (day 1), day 29, day 91 and day 181 for immunogenicity assessments. Solicited reactions were collected for one week after vaccination. Unsolicited adverse events (AEs) were collected for 28 days while serious adverse events (SAE) and adverse events of special interest (AESI) were reported throughout the six-month study duration. (Identifier: CTRI/2022/04/042017) Results In both the ChAdOx1 nCoV-19 primed group and BBV152 primed group, 186 participants each received the study vaccines. In the ChAdOx1 nCoV-19 Prime cohort, at 28 days after the booster dose, there was a 3.9- to 5.1-fold-rise and 1.9- to 2.8-fold-rise in anti-S IgG and neutralizing antibody titres from the baseline in the SII-NVX-CoV2373 group and the ChAdOx1 nCoV-19 group, respectively. The same responses for the BBV152 prime cohort was 7.4- to 10.4-fold-rise and 1.5- to 2.5-fold-rise in the SII-NVX-CoV2373 group and the BBV152 group, respectively. There was 86.96% (95% CI 78.32, 93.07) to 94.57% (95% CI 87.77, 98.21) and 37.63% (95% CI 27.79, 48.28) to 79.57% (95% CI 69.95, 87.23) anti-S IgG and neutralizing antibody seroresponse (2-fold-rise from baseline) in the SII-NVX-CoV2373 group and ChAdOx1 nCoV-19 group, respectively. The same was 94.51% (95% CI 87.64, 98.19) to 98.90% (95% CI 94.03, 99.97) and 20.43% (95% CI 12.77, 30.05) to 74.19% (95% CI 64.08, 82.71) in the SII-NVX-CoV2373 group and BBV152 group, respectively. No SAE or AESI was caused by the study vaccines. Conclusion SII-NVX-CoV2373 showed a numerically higher boosting effect than homologous boosters in adults primed with ChAdOx1 nCoV-19 and BBV152. The vaccine was also safe and well tolerated.

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Safety and Immunogenicity of SII-NVX-CoV2373 (COVID-19 Vaccine) In Adults in a Phase 2/3, Observer-Blind, Randomised, Controlled Study

Cited by 3 publications

References 16 publications

A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years

A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years

COVID-19 Vaccines, Effectiveness, and Immune Responses

A randomized, controlled study to evaluate the safety and immunogenicity of a heterologous booster dose of an adjuvanted SARS CoV-2 recombinant spike protein vaccine in adults

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