Safety, tolerability and immunogenicity of Biological E’s CORBEVAX™ vaccine in children and adolescents: A prospective, randomised, double-blind, placebo controlled, phase-2/3 study

Thuluva, Subhash; Paradkar, Vikram; Gunneri, SubbaReddy; Yerroju, Vijay; Mogulla, Rammohan; Suneetha, Pothakamuri Venkata; Turaga, Kishore; Kyasani, Mahesh; Manoharan, Senthil Kumar; Adabala, Srikanth; Javvadi, Aditya Sri; Medigeshi, Guruprasad R; Singh, Janmejay; Shaman, Heena; Binayke, Akshay; Zaheer, Aymaan; Awasthi, Amit; Narang, Manish; Nanjappa, Pradeep; Mahantshetti, Niranjana; Garg, B S; Pandey, Anil

doi:10.1016/j.vaccine.2022.10.045

Cited by 22 publications

(13 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…To our knowledge, there are only a few published phase 2-3 studies of authorized COVID-19 vaccines in the pediatric population for primary immunization—2 mRNA vaccines, a subunit vaccine, NVX-CoV2373 (adolescents only), and a nonrandomized study of an inactivated vaccine . Our study is the first, to our knowledge, publishing data for the spike protein vaccine among children and adds to the existing evidence that COVID-19 vaccines work well in the pediatric population.…”

Section: Discussionmentioning

confidence: 86%

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

View full text Add to dashboard Cite

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

show abstract

Section: Discussionmentioning

confidence: 86%

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

View full text Add to dashboard Cite

show abstract

“…Hotez noted that there was not enough consideration on leveraging pre‐existing infrastructure in developing countries that had been producing billions of doses of recombinant hepatitis B vaccines. Hotez and colleagues had developed adjuvanted yeast‐expressed recombinant protein SARS and COVID‐19 vaccines designed for low‐ to middle‐income countries that are easy to produce and cost‐effective 157–160 . In collaboration with the Indian vaccine producer Biological E Ltd, the COVID‐19 vaccine marketed under the brand name Corbevax TM in India demonstrated immunogenic superiority over ChAdOxInCoV‐19 in a phase 2/3 trial 158 .…”

Section: Vaccine Diplomacy and Distributionmentioning

confidence: 99%

“…Hotez and colleagues had developed adjuvanted yeast-expressed recombinant protein SARS and COVID-19 vaccines designed for low-to middle-income countries that are easy to produce and cost-effective. [157][158][159][160] In collaboration with the Indian vaccine producer Biological E Ltd, the COVID-19 vaccine marketed under the brand name Corbevax TM in India demonstrated immunogenic superiority over ChAdOxInCoV-19 in a phase 2/3 trial. 158 The technology has been transferred for local production in India, Indonesia, Bangladesh, South Africa, and Botswana.…”

Section: Vaccine Diplomacy and Distributionmentioning

confidence: 99%

Progress in vaccine development for infectious diseases—a Keystone Symposia report

Cable¹,

Graham

Koup

et al. 2023

Annals of the New York Academy of Sciences

View full text Add to dashboard Cite

The COVID‐19 pandemic has taught us many things, among the most important of which is that vaccines are one of the cornerstones of public health that help make modern longevity possible. While several different vaccines have been successful at stemming the morbidity and mortality associated with various infectious diseases, many pathogens/diseases remain recalcitrant to the development of effective vaccination. Recent advances in vaccine technology, immunology, structural biology, and other fields may yet yield insight that will address these diseases; they may also help improve societies’ preparedness for future pandemics. On June 1–4, 2022, experts in vaccinology from academia, industry, and government convened for the Keystone symposium “Progress in Vaccine Development for Infectious Diseases” to discuss state‐of‐the‐art technologies, recent advancements in understanding vaccine‐mediated immunity, and new aspects of antigen design to aid vaccine effectiveness.

show abstract

“…Regarding the latter, this did eventually happen through a partnership between the Texas Children’s Hospital Center for Vaccine Development and several developing country vaccine manufacturers. In India, this led to the production of CORBEVAX that was released for emergency use authorisation in adults and children,9 21 while in Indonesia it led to the release of INDOVAC, with almost 100 million doses of both vaccines administered so far. However, this approach could potentially have been accelerated and applied more widely with additional G7 support.…”

Section: Accelerating Vaccine Production and Regulatory Science In Lmicsmentioning

confidence: 99%

COVID-19 vaccines and the pandemic: lessons learnt for other neglected diseases and future threats

et al. 2023

View full text Add to dashboard Cite

Through the experiences gained by accelerating new vaccines for both Ebola virus infection and COVID-19 in a public health emergency, vaccine development has benefited from a ‘multiple shots on goal’ approach to new vaccine targets. This approach embraces simultaneous development of candidates with differing technologies, including, when feasible, vesicular stomatitis virus or adenovirus vectors, messenger RNA (mRNA), whole inactivated virus, nanoparticle and recombinant protein technologies, which led to multiple effective COVID-19 vaccines. The challenge of COVID-19 vaccine inequity, as COVID-19 spread globally, created a situation where cutting-edge mRNA technologies were preferentially supplied by multinational pharmaceutical companies to high-income countries while low and middle-income countries (LMICs) were pushed to the back of the queue and relied more heavily on adenoviral vector, inactivated virus and recombinant protein vaccines. To prevent this from occurring in future pandemics, it is essential to expand the scale-up capacity for both traditional and new vaccine technologies at individual or simultaneous hubs in LMICs. In parallel, a process of tech transfer of new technologies to LMIC producers needs to be facilitated and funded, while building LMIC national regulatory capacity, with the aim of several reaching ‘stringent regulator’ status. Access to doses is an essential start but is not sufficient, as healthcare infrastructure for vaccination and combating dangerous antivaccine programmes both require support. Finally, there is urgency to establish an international framework through a United Nations Pandemic Treaty to promote, support and harmonise a more robust, coordinated and effective global response.

show abstract

Safety, tolerability and immunogenicity of Biological E’s CORBEVAX™ vaccine in children and adolescents: A prospective, randomised, double-blind, placebo controlled, phase-2/3 study

Cited by 22 publications

References 20 publications

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

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

Progress in vaccine development for infectious diseases—a Keystone Symposia report

COVID-19 vaccines and the pandemic: lessons learnt for other neglected diseases and future threats

Contact Info

Product

Resources

About