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 N.; Godbole, Sheela; Bhatt, Varsha; 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, Doddabele Hanumanthaiah 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; Hamilton, Stephanie; Thakar, Madhuri; Shete, Ashwini; Gautam, Manish; Gupta, Nivedita; Panda, Samiran; Shaligram, Umesh; Poonawalla, Cyrus S.; Bhargava, Balram; Gunale, Bhagwat; Kapse, Dhananjay; Kanitkar, Shubhangi A.; Kakrani, Arjun Lal; Tripathy, Srikanth; Tilak, Abhijit V.; Dhamne, Akshay A.; Mirza, Shahzad; Athavale, Prachi V.; Bhowmik, Mandakini; Ratnakar, Parag J.; Gupta, Subodh; Deotale, Vijayshri; Jain, Jyoti; Kalantri, Ashwini; Jain, Vineet; Goyal, Nidhi; Arya, Alok; Rongsen-Chandola, Temsunaro; Dasgupta, Shreyasi; Periera, Pratibha; Vanmathi, A; Kawade, Anand; Gondhali, Arunkumar; Kudyar, Palvi; Singh, Rajesh; Yadav, Ravi; Alexander, Alina; Gunasekaran, Venugopalan; Dineshbabu, Sekar; Ravish, H.S.; Kamra, Deepshikha; Gaidhane, Shilpa; Zahiruddin, Quazi Syed; Moni, Merlin; Kumar, Anil; Dravid, Ameet; Suri, Tejas M; Patel, Tejas; Kishore, Surekha; Choche, Rahul; Ghatage, Deepak; Salvi, Sugam

doi:10.1016/j.lansea.2022.100139

Cited by 9 publications

(23 citation statements)

References 23 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: 81%

“…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].…”

Section: Discussionmentioning

confidence: 95%

“…NVX-CoV2373 has shown around 90% efficacy in adults [12,13]. The immune responses by SII-NVX-CoV2373 in children were much higher than that seen in adults [14]. Higher levels of all immune markers are known to correlate with a reduced risk of symptomatic infection [39].…”

Section: Discussionmentioning

confidence: 99%

“…[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.…”

mentioning

confidence: 94%

“…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: 81%

Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

“…[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.…”

mentioning

confidence: 94%

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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Safety and Immunogenicity of SARS-CoV-2 Recombinant Spike Protein Vaccine in Children and Adolescents in India

Gunale,

Kapse,

Kar

et al. 2023

JAMA Pediatr

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ImportanceThe recombinant COVID-19 vaccine NVX-CoV2373 has demonstrated efficacy of approximately 90% in adults; however, its safety and efficacy in children is unknown.ObjectiveTo assess the noninferiority of SII-NVX-CoV2373 in children and adolescents compared to adults and to evaluate its safety in comparison with placebo.Design, Setting, and ParticipantsThis phase 2-3 observer-blind randomized clinical trial was conducted in 2 cohorts, children (aged 2 to 11 years) and adolescents (aged 12 to 17 years) between August 2021 and August 2022. Participants were randomized 3:1 to SII-NVX-CoV2373 or placebo and monitored for 179 days. The participants, study team, and laboratory staff were blinded. This was a multicenter study conducted across 10 tertiary care hospitals in India. Exclusion criteria included previous COVID-19 infection or vaccination, immunocompromised condition, and immunosuppressive medications.InterventionsTwo doses of 0.5-mL SII-NVX-CoV2373 or placebo were administered intramuscularly on days 1 and 22.Main Outcomes and MeasuresPrimary outcomes were geometric mean titer ratio of both anti-spike (anti-S) IgG and neutralizing antibodies (NAbs) between both pediatric age groups to that of adults on day 36. Noninferiority was concluded if the lower bound of 95% CI of this ratio was greater than 0.67 for each age group. Both the antibodies were assessed for the index strain and for selected variants at various time points. Solicited adverse events (AEs) were recorded for 7 days after each vaccination, unsolicited AEs were recorded for 35 days, and serious AEs and AEs of special interest were recorded for 179 days.ResultsA total of 460 children in each age cohort were randomized to receive vaccine or placebo. The mean (SD) age was 6.7 (2.7) years in the child cohort and 14.3 (1.6) years in the adolescent cohort; 231 participants (50.2%) in the child cohort and 218 in the adolescent cohort (47.4%) were female. Both anti-S IgG and NAb titers were markedly higher in the SII-NVX-CoV2373 group than in the placebo group on both day 36 and day 180. The geometric mean titer ratios compared to those in adults were 1.20 (95% CI, 1.08-1.34) and 1.52 (95% CI, 1.38-1.67) for anti-S IgG in adolescents and children, respectively; while for NAbs, they were 1.33 (95% CI, 1.17-1.50) and 1.93 (95% CI, 1.70-2.18) in adolescents and children, respectively, indicating noninferiority. SII-NVX-CoV2373 also showed immune responses against variants studied. Injection site reactions, fever, headache, malaise, and fatigue were common solicited AEs. There were no AEs of special interest and no causally related serious AEs.Conclusions and RelevanceSII-NVX-CoV2373 was safe and well tolerated in children and adolescents in this study. The vaccine was highly immunogenic and may be used in pediatric vaccination against COVID-19.Trial RegistrationClinical Trials Registry of India Identifier: CTRI/2021/02/031554

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Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial

Nurdin,

Movieta Nency,

Maddeppungeng

et al. 2024

Vaccine

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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 9 publications

References 23 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

Safety and Immunogenicity of SARS-CoV-2 Recombinant Spike Protein Vaccine in Children and Adolescents in India

Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial

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