Cited by 424SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesImmune responses and vaccinations

The DOI matches its Crossref record; 44 of the 47 references it cites were found in a registry or an index.

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial

Open access

Ella, Raches, Vadrevu, Krishna Mohan, Jogdand, Harsh, Prasad, Sai, Reddy, Siddharth, Sarangi, Vamshi, Ganneru, Brunda, Sapkal, Gajanan, Yadav, Pragya, Abraham, Priya, Panda, Samiran, Gupta, Nivedita, Reddy, Prabhakar, Verma, Savita, Kumar Rai, Sanjay, Singh, Chandramani, Redkar, Sagar Vivek, Gillurkar, Chandra Sekhar, Kushwaha, Jitendra Singh, Mohapatra, Satyajit, Rao, Venkat, Guleria, Randeep, Ella, Krishna, Bhargava, Balram·2021·The Lancet Infectious Diseases

DOI 10.1016/s1473-3099(20)30942-7PMC PMC7825810

Published version of a preprint

Open this paper in CoChat — free account Open PDF

Abstract

Background To mitigate the effects of COVID-19, a vaccine is urgently needed. BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel).Methods We did a double-blind, multicentre, randomised, controlled phase 1 trial to assess the safety and immunogenicity of BBV152 at 11 hospitals across India. Healthy adults aged 18-55 years who were deemed healthy by the investigator were eligible. Individuals with positive SARS-CoV-2 nucleic acid and/or serology tests were excluded. Participants were randomly assigned to receive either one of three vaccine formulations (3 μg with Algel-IMDG, 6 μg with Algel-IMDG, or 6 μg with Algel) or an Algel only control vaccine group. Block randomisation was done with a web response platform. Participants and investigators were masked to treatment group allocation. Two intramuscular doses of vaccines were administered on day 0 (the day of randomisation) and day 14. Primary outcomes were solicited local and systemic reactogenicity events at 2 h and 7 days after vaccination and throughout the full study duration, including serious adverse events. Secondary outcome was seroconversion (at least four-fold increase from baseline) based on wild-type virus neutralisation. Cell-mediated responses were evaluated by intracellular staining and ELISpot. The trial is registered at ClinicalTrials.gov (NCT04471519).Findings Between July 13 and 30, 2020, 827 participants were screened, of whom 375 were enrolled. Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group (Algel only). After both doses, solicited local and systemic adverse reactions were reported by 17 (17%; 95% CI 10·5-26·1) participants in the 3 μg with Algel-IMDG group, 21 (21%; 13·8-30·5) in the 6 μg with Algel-IMDG group, 14 (14%; 8·1-22·7) in the 6 μg with Algel group, and ten (10%; 6·9-23·6) in the Algel-only group. The most common solicited adverse events were injection site pain (17 [5%] of 375 participants), headache (13 [3%]), fatigue (11 [3%]), fever (nine [2%]), and nausea or vomiting (seven [2%]). All solicited adverse events were mild (43 [69%] of 62) or moderate (19 [31%]) and were more frequent after the first dose. One serious adverse event of viral pneumonitis was reported in the 6 μg with Algel group, unrelated to the vaccine. Seroconversion rates (%) were 87·9, 91·9, and 82·8 in the 3 μg with Algel-IMDG, 6 μg with Algel-IMDG, and 6 μg with Algel groups, respectively. CD4+ and CD8+ T-cell responses were detected in a subset of 16 participants from both Algel-IMDG groups.Interpretation BBV152 led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted.Funding Bharat Biotech International.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

Integrity signals

Registry

Crossref · 10.1016/s1473-3099(20)30942-7

Cites

44 of 44 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

WHO Coronavirus Disease (COVID-19) Dashboard
e, C. R. D. I. (2020) · Bangladesh Physiotherapy Journal · doi:10.46945/bpj.10.1.03.01 · Cited by 5,465
Tracking Changes in SARS-CoV-2 Spike: Evidence that D614G Increases Infectivity of the COVID-19 Virus
Korber, B., Fischer, W. M., Gnanakaran, S., Yoon, H., Theiler, J., Abfalterer, W., Hengartner, N., Giorgi, E. E., Bhattacharya, T., Foley, B., et al. (2020) · Cell · doi:10.1016/j.cell.2020.06.043 · Cited by 4,281
Targets of T Cell Responses to SARS-CoV-2 Coronavirus in Humans with COVID-19 Disease and Unexposed Individuals
Grifoni, A., Weiskopf, D., Ramirez, S. I., Mateus, J., Dan, J. M., Moderbacher, C. R., Rawlings, S. A., Sutherland, A., Premkumar, L., Jadi, R. S., et al. (2020) · Cell · doi:10.1016/j.cell.2020.05.015 · Cited by 3,595
An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
Jackson, L. A., Anderson, E. J., Rouphael, N. G., Roberts, P. C., Makhene, M., Coler, R. N., McCullough, M. P., Chappell, J. D., Denison, M. R., Stevens, L. J., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2022483 · Cited by 3,237
RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study
Walsh, E. E., Frenck, R., Falsey, A. R., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Mulligan, M. J., Bailey, R., et al. (2020) · doi:10.1101/2020.08.17.20176651 · Cited by 2,615
Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial
Folegatti, P. M., Ewer, K. J., Aley, P. K., Angus, B., Becker, S., Belij-Rammerstorfer, S., Bellamy, D., Bibi, S., Bittaye, M., Clutterbuck, E. A., et al. (2020) · The Lancet · doi:10.1016/s0140-6736(20)31604-4 · Cited by 2,419
Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report
Mulligan, M. J., Lyke, K. E., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Raabe, V., Bailey, R., Swanson, K. A., et al. (2020) · doi:10.1101/2020.06.30.20142570 · Cited by 1,569
Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults
Anderson, E. J., Rouphael, N. G., Widge, A. T., Jackson, L. A., Roberts, P. C., Makhene, M., Chappell, J. D., Denison, M. R., Stevens, L. J., Pruijssers, A. J., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2028436 · Cited by 1,523
Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial
Zhang, Y., Zeng, G., Pan, H., Li, C., Hu, Y., Chu, K., Han, W., Chen, Z., Tang, R., Yin, W., et al. (2021) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(20)30843-4 · Cited by 1,504
Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial
Zhu, F.-C., Li, Y.-H., Guan, X.-H., Hou, L.-H., Wang, W.-J., Li, J.-X., Wu, S.-P., Wang, B.-S., Wang, Z., Wang, L., et al. (2020) · The Lancet · doi:10.1016/s0140-6736(20)31208-3 · Cited by 1,382

Show all 47 references

Research works printed but not linked: 2

Mulligan, 2020, Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults, Nature, 586, 589, 10.1038/s41586-020-2639-4 · DOI · Paper page
Walsh, 2020, Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates, N Engl J Med, 10.1056/NEJMoa2027906 · DOI · Paper page

Sorted by citations

Items 101–200 of 422

Asian-Origin Approved COVID-19 Vaccines and Current Status of COVID-19 Vaccination Program in Asia: A Critical Analysis
Chakraborty, C., Sharma, A. R., Bhattacharya, M., Agoramoorthy, G., & Lee, S. (2021) · Vaccines · doi:10.3390/vaccines9060600 · Cited by 30
RBD-homodimer, a COVID-19 subunit vaccine candidate, elicits immunogenicity and protection in rodents and nonhuman primates
Pan, X., Shi, J. R., Hu, X., Wu, Y. L., Zeng, L., Yao, Y., Shang, W., Liu, K., Gao, G., Guo, W., et al. (2021) · Cell Discovery · doi:10.1038/s41421-021-00320-y · Cited by 30
CD8+ T Cells in SARS-CoV-2 Induced Disease and Cancer—Clinical Perspectives
Mortezaee, K., & Majidpoor, J. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.864298 · Cited by 34
An overview of current drugs and prophylactic vaccines for coronavirus disease 2019 (COVID-19)
Bahrami, A. A., Azargoonjahromi, A., Sadraei, S., Aarabi, A., Payandeh, Z., & Rajabibazl, M. (2022) · Cellular & Molecular Biology Letters · doi:10.1186/s11658-022-00339-3 · Cited by 33
Inactivated vaccine Covaxin/BBV152: A systematic review
Ahmed, T. I., Rishi, S., Irshad, S., Aggarwal, J., Happa, K., & Mansoor, S. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.863162 · Cited by 31
SARS-CoV-2 Vaccination in IBD: Past Lessons, Current Evidence, and Future Challenges
Wellens, J., Colombel, J., Satsangi, J. J., & Wong, S.-Y. (2021) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjab046 · Cited by 30
Publications and retracted articles of COVID-19 pharmacotherapy-related research: A systematic review
El-Menyar, A. A., Mekkodathil, A. A., Asim, M., Consunji, R. J., Rizoli, S. B., Bahey, A. A., & Al-Thani, H. A. S. (2021) · Science Progress · doi:10.1177/00368504211016936 · Cited by 33
Antibody response elicited by a third boost dose of inactivated SARS-CoV-2 vaccine can neutralize SARS-CoV-2 variants of concern
Yue, L., Zhou, J., Zhou, Y., Yang, X., Xie, T., Yang, M., Zhao, H., Zhao, Y., Yang, T., Li, H., et al. (2021) · Emerging Microbes & Infections · doi:10.1080/22221751.2021.1996210 · Cited by 30
Cell-culture process optimization via model-based predictions of metabolism and protein glycosylation
Reddy, J. V., Raudenbush, K., Papoutsakis, E. T., & Ierapetritou, M. (2023) · Biotechnology Advances · doi:10.1016/j.biotechadv.2023.108179 · Cited by 32
COVID-19 vaccines: progress and understanding on quality control and evaluation
Mao, Q., Xu, M., He, Q., Li, C., Meng, S., Wang, Y., Cui, B., Liang, Z., & Wang, J. (2021) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-021-00621-4 · Cited by 29
A quest for universal anti-SARS-CoV-2 T cell assay: systematic review, meta-analysis, and experimental validation
Binayke, A., Zaheer, A., Vishwakarma, S., Singh, S., Sharma, P., Chandwaskar, R., Gosain, M., Raghavan, S., Murugesan, D. R., Kshetrapal, P., et al. (2024) · npj Vaccines · doi:10.1038/s41541-023-00794-9 · Cited by 28
COVID-19 Research: Lessons from Non-Human Primate Models
Albrecht, L., Bishop, E., Jay, B., Lafoux, B., Minoves, M., & Passaes, C. (2021) · Vaccines · doi:10.3390/vaccines9080886 · Cited by 30
COVID-19 Vaccine Platforms: Challenges and Safety Contemplations
Al-Jighefee, H. T., Najjar, H., Ahmed, M. N., Qush, A., Awwad, S., & Kamareddine, L. (2021) · Vaccines · doi:10.3390/vaccines9101196 · Cited by 29
Facile and rapid detection of SARS-CoV-2 antibody based on a noncompetitive fluorescence polarization immunoassay in human serum samples
Nishiyama, K., Takahashi, K., Fukuyama, M., Kasuya, M., Imai, A., Usukura, T., Maishi, N., Maeki, M., Ishida, A., Tani, H., et al. (2021) · Biosensors and Bioelectronics · doi:10.1016/j.bios.2021.113414 · Cited by 27
Key Considerations for the Development of Safe and Effective SARS‐CoV‐2 Subunit Vaccine: A Peptide‐Based Vaccine Alternative
Shalash, A. O., Hussein, W. M., Skwarczyński, M., & Tóth, I. (2021) · Advanced Science · doi:10.1002/advs.202100985 · Cited by 25
SARS-CoV-2 Production in a Scalable High Cell Density Bioreactor
Offersgaard, A., Hernandez, C. R. D., Pihl, A. F., Costa, R., Venkatesan, N., Lin, X., Pham, L. V., Feng, S., Fahnøe, U., Scheel, T. K. H., et al. (2021) · Vaccines · doi:10.3390/vaccines9070706 · Cited by 26
Highly Neutralizing COVID-19 Convalescent Plasmas Potently Block SARS-CoV-2 Replication and Pneumonia in Syrian Hamsters
Takamatsu, Y., Imai, M., Maeda, K., Nakajima, N., Higashi‐Kuwata, N., Iwatsuki‐Horimoto, K., Ito, M., Kiso, M., Maemura, T., Takeda, Y., et al. (2021) · Journal of Virology · doi:10.1128/jvi.01551-21 · Cited by 25
Development of COVID-19 vaccines utilizing gene therapy technology
Nakagami, H. (2021) · International Immunology · doi:10.1093/intimm/dxab013 · Cited by 25
Counting on COVID-19 Vaccine: Insights into the Current Strategies, Progress and Future Challenges
Kandimalla, R. J. L., Chakraborty, P., Vallamkondu, J., Chaudhary, A., Samanta, S., Reddy, P. H., Feo, V. D., & Dewanjee, S. (2021) · Biomedicines · doi:10.3390/biomedicines9111740 · Cited by 25
Self-citation
Adjuvants: Engineering Protective Immune Responses in Human and Veterinary Vaccines
Akache, B., Stark, F. C., Agbayani, G., Renner, T. M., & McCluskie, M. J. (2021) · Methods in molecular biology · doi:10.1007/978-1-0716-1892-9_9 · Cited by 26
Adverse Events following Immunization with COVID‐19 Vaccines: A Narrative Review
Bhandari, B., Rayamajhi, G., Lamichhane, P., & Shenoy, A. K. (2022) · BioMed Research International · doi:10.1155/2022/2911333 · Cited by 28
Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: Interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials
Özdarendeli, A., Sezer, Z., Pavel, S. T. I., İnal, A., Yetişkin, H., Kaplan, B. S., Uygut, M. A., Bayram, A., Mazıcıoğlu, M. M., Ünüvar, G. K., et al. (2022) · Vaccine · doi:10.1016/j.vaccine.2022.10.093 · Cited by 25
Mice Immunized with the Vaccine Candidate HexaPro Spike Produce Neutralizing Antibodies against SARS-CoV-2
Seephetdee, C., Buasri, N., Bhukhai, K., Srisanga, K., Manopwisedjaroen, S., Lertjintanakit, S., Phueakphud, N., Pakiranay, C., Kangwanrangsan, N., Srichatrapimuk, S., et al. (2021) · Vaccines · doi:10.3390/vaccines9050498 · Cited by 22
The Current Status and Challenges in the Development of Vaccines and Drugs against Severe Acute Respiratory Syndrome‐Corona Virus‐2 (SARS‐CoV‐2)
Beeraka, N. M., Tulimilli, S. V., Karnik, M., Sadhu, S. P., Pragada, R. R., Aliev, G., & Madhunapantula, S. V. (2021) · BioMed Research International · doi:10.1155/2021/8160860 · Cited by 25
Safety and Seroconversion of Immunotherapies against SARS-CoV-2 Infection: A Systematic Review and Meta-Analysis of Clinical Trials
Sheng‐Kai, K., Lee, C., Liu, K., Wei, J. C., Lee, Y., & Wang, L. (2021) · Pathogens · doi:10.3390/pathogens10121537 · Cited by 24
Development of variant‐proof severe acute respiratory syndrome coronavirus 2, pan‐sarbecovirus, and pan‐β‐coronavirus vaccines
Zhou, J., Liu, Z., Zhang, G., Xu, W., Xing, L., Lu, L., Wang, Q., & Jiang, S. (2022) · Journal of Medical Virology · doi:10.1002/jmv.28172 · Cited by 24
Clearance of persistent SARS-CoV-2 associates with increased neutralizing antibodies in advanced HIV disease post-ART initiation
Karim, F., Riou, C., Bernstein, M. P., Jule, Z., Lustig, G., van Graan, S., Keeton, R., Upton, J., Ganga, Y., Khan, K., et al. (2024) · Nature Communications · doi:10.1038/s41467-024-46673-2 · Cited by 26
COVID-19 vaccine decisions: considering the choices and opportunities
Hotez, P. J., Nuzhath, T., Callaghan, T., & Colwell, B. (2021) · Microbes and Infection · doi:10.1016/j.micinf.2021.104811 · Cited by 25
Correction to: Ethnic and minority group differences in engagement with COVID-19 vaccination programmes – at Pandemic Pace; when vaccine confidence in mass rollout meets local vaccine hesitancy
Reid, J. A., & Mabhala, M. A. (2021) · Israel Journal of Health Policy Research · doi:10.1186/s13584-021-00470-0 · Cited by 24
Potential for Developing Plant-Derived Candidate Vaccines and Biologics against Emerging Coronavirus Infections
Shanmugaraj, B., Siriwattananon, K., Malla, A., & Phoolcharoen, W. (2021) · Pathogens · doi:10.3390/pathogens10081051 · Cited by 23
Immune Evasive Effects of SARS-CoV-2 Variants to COVID-19 Emergency Used Vaccines
Zhang, Y., Ndzouboukou, J. B., Gan, M., Lin, X., & Fan, X. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.771242 · Cited by 21
End Group Dye‐Labeled Polycarbonate Block Copolymers for Micellar (Immuno‐)Drug Delivery
Czysch, C., Medina‐Montano, C., Dal, N. K., Dinh, T., Fröder, Y., Winterwerber, P., Maxeiner, K., Räder, H. J., Schuppan, D., Schild, H., et al. (2022) · Macromolecular Rapid Communications · doi:10.1002/marc.202200095 · Cited by 24
Will Host Genetics Affect the Response to SARS-CoV-2 Vaccines? Historical Precedents
Smatti, M. K., Al-Khatib, H. A., Thani, A. A. A., & Yassine, H. M. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2022.802312 · Cited by 23
Development of antibody resistance in emerging mutant strains of SARS CoV‐2: Impediment for COVID‐19 vaccines
Beeraka, N. M., Sukocheva, O. A., Lukina, E., Liu, J., & Fan, R. (2022) · Reviews in Medical Virology · doi:10.1002/rmv.2346 · Cited by 23
An Update on the Status of Vaccine Development for SARS-CoV-2 Including Variants. Practical Considerations for COVID-19 Special Populations
Kantarcıoğlu, B., Iqbal, O., Lewis, J., Carter, C. A., Singh, M., Lievano, F. A., Ligocki, M. A., Jeske, W. P., Adıgüzel, C., Gerotziafas, G., et al. (2022) · Clinical and Applied Thrombosis/Hemostasis · doi:10.1177/10760296211056648 · Cited by 25
Influence of COVID-19 vaccines on endocrine system
Zhao, Y. H., & Wu, X. (2022) · Endocrine · doi:10.1007/s12020-022-03119-3 · Cited by 22
COVID-19 therapy and vaccination: a clinical narrative review
Chinta, S. R., Guerra, M. A. R., Shaban, M., Pandey, N., Jaquez-Duran, M., & Vittorio, T. J. (2023) · Drugs in Context · doi:10.7573/dic.2022-7-2 · Cited by 25
Comparing COVID-19 vaccines for their characteristics, efficacy and effectiveness against SARS-CoV-2 and variants of concernPreprint
Fiolet, T., Kherabi, Y., MacDonald, C. J., Ghosn, J., & Peiffer‐Smadja, N. (2021) · OSF Preprints (OSF Preprints) · doi:10.31219/osf.io/z4x7t · Cited by 22
The importance of genomic analysis in cracking the coronavirus pandemic
Zella, D., Giovanetti, M., Cella, E., Borsetti, A., Ciotti, M., Ceccarelli, G., d’Ettorre, G., Pezzuto, A., Tambone, V., Campanozzi, L. L., et al. (2021) · Expert Review of Molecular Diagnostics · doi:10.1080/14737159.2021.1917998 · Cited by 23
COVID-19 Vaccines in Patients With Chronic Liver Disease
Sharma, A., Patnaik, I., Kumar, A. S., & Gupta, R. K. (2021) · Journal of Clinical and Experimental Hepatology · doi:10.1016/j.jceh.2021.06.013 · Cited by 21
Prime-Boost Vaccination With Covaxin/BBV152 Induces Heightened Systemic Cytokine and Chemokine Responses
Kumar, N. P., Banurekha, V. V., Purushothaman, G. K. C., Nancy, A., Padmapriyadarsini, C., Mary, A., Devi, K., Murhekar, M. V., & Babu, S. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.752397 · Cited by 21
Molecular variants of SARS-CoV-2: antigenic properties and current vaccine efficacy
Damavandi, A. R., Dowran, R., Sharif, S. A., Kashanchi, F., & Jafari, R. (2022) · Medical Microbiology and Immunology · doi:10.1007/s00430-022-00729-6 · Cited by 21
Application of Traditional Vaccine Development Strategies to SARS-CoV-2
Rando, H. M., Lordan, R., Lee, A. J., Naik, A. S., Wellhausen, N., Sell, E., Kolla, L., Gitter, A., Greene, C. S., Bansal, V., et al. (2023) · mSystems · doi:10.1128/msystems.00927-22 · Cited by 22
Influenza Virus and SARS-CoV-2 Vaccines
Sandor, A., Sturdivant, M. S., & Ting, J. P. ‐. (2021) · The Journal of Immunology · doi:10.4049/jimmunol.2001287 · Cited by 23
SARS-CoV-2: Current trends in emerging variants, pathogenesis, immune responses, potential therapeutic, and vaccine development strategies
Jeda, A. S., Abbassi, S., Mousavizadeh, A., Esghaie, M., Bokharaei‐Salim, F., Jeddi, F., Shafaati, M., & Abdoli, A. (2021) · International Immunopharmacology · doi:10.1016/j.intimp.2021.108232 · Cited by 22
Clinical and Molecular Relationships between COVID-19 and Feline Infectious Peritonitis (FIP)
Sweet, A., André, N. M., Stout, A. E., Licitra, B. N., & Whittaker, G. R. (2022) · Viruses · doi:10.3390/v14030481 · Cited by 20
Kikuchi–Fujimoto disease following vaccination against COVID-19
Guan, Y., Xia, X., & Lu, H. (2022) · Journal of Hematopathology · doi:10.1007/s12308-021-00477-1 · Cited by 20
Safety and Adverse Events Related to Inactivated COVID-19 Vaccines and Novavax;a Systematic Review.
Dadras, O., Mehraeen, E., Karimi, A., Tantuoyir, M. M., Afzalian, A., Nazarian, N., Mojdeganlou, H., Mirzapour, P., Shamsabadi, A., Dashti, M., et al. (2022) · Archives of Academic Emergency Medicine · doi:10.22037/aaem.v10i1.1585 · Cited by 19
Recombinant Bacillus Calmette–Guérin Expressing SARS-CoV-2 Chimeric Protein Protects K18-hACE2 Mice against Viral Challenge
Mambelli, F., Marinho, F. V., Andrade, J. M., de Araujo, A. C. V. S. C., Abuna, R. P. F., Fabri, V. M. R., Santos, B. D. P. O., da Silva, J. S., de Magalhães, M. T. Q., Homan, E. J., et al. (2023) · The Journal of Immunology · doi:10.4049/jimmunol.2200731 · Cited by 20
COVID‐19: vaccine’s progress
Brüssow, H. (2021) · Microbial Biotechnology · doi:10.1111/1751-7915.13818 · Cited by 18
Classical and Next-Generation Vaccine Platforms to SARS-CoV-2: Biotechnological Strategies and Genomic Variants
Simões, R. S. D. Q., & Rodrı́guez-Làzaro, D. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph19042392 · Cited by 22
Immunogenicity of two COVID-19 vaccines used in India: An observational cohort study in health care workers from a tertiary care hospital
Arankalle, V. A., Kulkarni, A. G., Kulkarni, R., Palkar, S. H., Patil, R., Oswal, J., Lalwani, S. K., & Mishra, A. C. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.928501 · Cited by 18
Discovery and development of COVID ‐19 vaccine from laboratory to clinic
Saravanan, V., Chagaleti, B. K., Narayanan, P. L., Anandan, V. B., Manoharan, H., Anjana, G. V., Peraman, R., Namasivayam, S. K. R., Kavisri, M., Arockiaraj, J., et al. (2023) · Chemical Biology & Drug Design · doi:10.1111/cbdd.14383 · Cited by 19
Adjuvantation helps to optimise COVID-19 vaccine candidate
Li, J., & Zhu, F. (2021) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(21)00094-3 · Cited by 18
Coronavirus disease 2019 vaccination in transplant recipients
Eberhardt, C. S., Balletto, E., Cornberg, M., & Mikulska, M. (2021) · Current Opinion in Infectious Diseases · doi:10.1097/qco.0000000000000739 · Cited by 18
Inactivated COVID-19 vaccines: durability of Covaxin/BBV152 induced immunity against variants of concern
Kumar, N. P., Banurekha, V. V., Kumar, C. P. G., Nancy, A., Padmapriyadarshini, C., Shankar, S., Hanna, L. E., Murhekar, M. V., Devi, K., & Babu, S. (2022) · Journal of Travel Medicine · doi:10.1093/jtm/taac088 · Cited by 19
A Comprehensive Review on the Current Vaccines and Their Efficacies to Combat SARS-CoV-2 Variants
Rabaan, A. A., Mutair, A. S. A., Hajissa, K., Alfaraj, A. H., Al-Jishi, J. M., Alhajri, M. M., Alwarthan, S. M., Alsuliman, S. A., Al-Najjar, A. H., Al-Zaydani, I. A., et al. (2022) · Vaccines · doi:10.3390/vaccines10101655 · Cited by 18
COVID-19 Vaccines: Where Did We Stand at the End of 2023?
Lundstrom, K. H. (2024) · Viruses · doi:10.3390/v16020203 · Cited by 22
Design and Synthesis of Polyphenolic Imidazo[4,5-c]quinoline Derivatives to Modulate Toll Like Receptor-7 Agonistic Activity and Adjuvanticity
Kumar, K., Sihag, B., Patil, M. T., Singh, R. P., Sakala, I. G., Honda‐Okubo, Y., Singh, K. N., Petrovsky, N., & Salunke, D. B. (2024) · ACS Pharmacology & Translational Science · doi:10.1021/acsptsci.4c00163 · Cited by 18
Current Update on Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine Development with a Special Emphasis on Gene Therapy Viral Vector Design and Construction for Vaccination
Bişgin, A., Şanlioğlu, A. D., Ekşi, Y. E., Griffith, T. S., & Şanlıoğlu, S. (2021) · Human Gene Therapy · doi:10.1089/hum.2021.052 · Cited by 18
Reporting and data sharing level for COVID-19 vaccine trials: A cross-sectional study
Duan, Y., Luo, J., Zhao, L., Zhang, X., Miao, J., Moher, D., & Bian, Z. (2022) · EBioMedicine · doi:10.1016/j.ebiom.2022.103962 · Cited by 18
Development of COVID 19 vaccine: A summarized review on global trials, efficacy, and effectiveness on variants
Prakash, S. (2022) · Diabetes & Metabolic Syndrome Clinical Research & Reviews · doi:10.1016/j.dsx.2022.102482 · Cited by 17
Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial
Feng, Y., Chen, J., Yao, T., Chang, Y., Li, X., Xing, R., Li, H., Xie, R., Zhang, X., Wei, Z., et al. (2021) · Infectious Diseases of Poverty · doi:10.1186/s40249-021-00924-2 · Cited by 17
A Large Cluster of New Onset Autoimmune Myositis in the Yorkshire Region Following SARS-CoV-2 Vaccination
Marco, G. D., Giryes, S., Williams, K., Alcorn, N., Slade, M., Fitton, J. M., Nizam, S., Smithson, G., Iqbal, K., Tran, G. T., et al. (2022) · Vaccines · doi:10.3390/vaccines10081184 · Cited by 16
Comparison and Analysis of Neutralizing Antibody Levels in Serum after Inoculating with SARS-CoV-2, MERS-CoV, or SARS-CoV Vaccines in Humans
Yu, S., Chen, K., Fang, L., Mao, H., Lou, X., Li, C., & Zhang, Y. (2021) · Vaccines · doi:10.3390/vaccines9060588 · Cited by 17
Immunogenicity and safety of a heterologous prime-boost COVID-19 vaccine schedule: ChAdOx1 vaccine Covishield followed by BBV152 Covaxin
Kant, R., Dwivedi, G. R., Zaman, K., Sahay, R. R., Sapkal, G. N., Kaushal, H., Nyayanit, D. A., Yadav, P. D., Deshpande, G. R., Singh, R., et al. (2021) · Journal of Travel Medicine · doi:10.1093/jtm/taab166 · Cited by 16
Self-citation
Vaccines Against COVID-19: A Review
Torres-Estrella, C. U., Reyes-Montes, M. D. R., Duarte-Escalante, E., Sierra-Martínez, M., León, M. G. F.-D., & Acosta‐Altamirano, G. (2022) · Vaccines · doi:10.3390/vaccines10030414 · Cited by 18
COVID-19 Booster Dose Coverage and Hesitancy among Older Adults in an Urban Slum and Resettlement Colony in Delhi, India
Sharma, N., Basu, S., Lalwani, H., Rao, S., Malik, M., Garg, S., Shrivastava, R., & Singh, M. M. (2023) · Vaccines · doi:10.3390/vaccines11071177 · Cited by 17
India’s Fight against the COVID-19 Pandemic: Lessons and the Way Forward
Sharma, S. D. (2022) · India Quarterly A Journal of International Affairs · doi:10.1177/09749284211068470 · Cited by 15
The Kinetics of COVID-19 Vaccine Response in a Community-Vaccinated Population
Tu, M. K., Chiang, S. H., Bender, R. A., Wong, D. T., & Strom, C. M. (2022) · The Journal of Immunology · doi:10.4049/jimmunol.2100919 · Cited by 14
An Analysis of the COVID-19 Situation in India in Terms of Testing, Treatment, Vaccine Acceptance and National Economic Performance
Patel, R. B., & Patel, B. B. (2022) · International Journal of Public Health · doi:10.3389/ijph.2022.1604975 · Cited by 15
Carbohydrates-based diagnosis, prophylaxis and treatment of infectious diseases: Special emphasis on COVID-19
Kumbhar, P., Pandya, A., Manjappa, A. S., Disouza, J., & Patravale, V. B. (2021) · Carbohydrate Polymer Technologies and Applications · doi:10.1016/j.carpta.2021.100052 · Cited by 15
Comprehensive narrative review of real-world COVID-19 vaccines: viewpoints and opportunities
Liu, S., Kang, M., Zhao, N., Zhuang, Y., Li, S., & Song, T. (2022) · Medical Review · doi:10.1515/mr-2021-0021 · Cited by 15
The scientific journey of a novel adjuvant (AS37) from bench to bedside
D’Oro, U., & O’Hagan, D. T. (2024) · npj Vaccines · doi:10.1038/s41541-024-00810-6 · Cited by 14
From Detection to Protection: Antibodies and Their Crucial Role in Diagnosing and Combatting SARS-CoV-2
Kumar, A., Tripathi, P., Kumar, P., Shekhar, R., & Pathak, R. (2024) · Vaccines · doi:10.3390/vaccines12050459 · Cited by 17
Regulatory approval of COVID-19 vaccine for restricted use in clinical trial mode
Mohapatra, P. R., & Mishra, B. (2021) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(21)00045-1 · Cited by 14
Recent updates on immunological, pharmacological, and alternative approaches to combat COVID-19
Saleem, A., Akhtar, M. F., Haris, M., & Abdel‐Daim, M. M. (2021) · Inflammopharmacology · doi:10.1007/s10787-021-00850-7 · Cited by 14
Antibody responses to the BBV152 vaccine in individuals previously infected with SARS-CoV-2
Chandrasekaran, P., Kumar, N., Devi, K. U., Banurekha, V. V., Nancy, A., Kumar, C. P. G., Murhekar, M. V., Gupta, N., Panda, S., Babu, S., et al. (2021) · The Indian Journal of Medical Research · doi:10.4103/ijmr.ijmr_2066_21 · Cited by 13
Self-citation
Safety and immunogenicity of an inactivated virus particle vaccine for SARS-CoV-2, BIV1-CovIran: findings from double-blind, randomised, placebo-controlled, phase I and II clinical trials among healthy adults
Mohraz, M., Salehi, M., Tabarsi, P., Abbasi‐Kangevari, M., Ghamari, S., Ghasemi, E., Pouya, M. A., Rezaei, N., Ahmadi, N., Heidari, K., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-056872 · Cited by 14
Prevalence, severity, and risk factor of breakthrough infection after vaccination with either the Covaxin or the Covishield among healthcare workers: A nationwide cross-sectional study
Krishna, B., Gupta, A., Meena, K., Gaba, A., Krishna, S., Jyoti, R., Aeron, N., Prashanth, S., Samriti, & Ganapathy, U. (2022) · Journal of Anaesthesiology Clinical Pharmacology · doi:10.4103/joacp.joacp_436_21 · Cited by 14
Immunogenicity, efficacy, and safety of SARS-CoV-2 vaccine dose fractionation: a systematic review and meta-analysis
Yang, B., Huang, X., Gao, H., Leung, N., Tsang, T. K., & Cowling, B. J. (2022) · BMC Medicine · doi:10.1186/s12916-022-02600-0 · Cited by 14
A self-assembled graphene oxide adjuvant induces both enhanced humoral and cellular immune responses in influenza vaccine
Huang, S., Li, Y., Zhang, S., Chen, Y.-M., Su, W., Sanchez, D. J., John, D. H., Zhi, X., Chen, H., & Ding, X. (2023) · Journal of Controlled Release · doi:10.1016/j.jconrel.2023.11.047 · Cited by 13
Efficacy and limitations of repurposed drugs and vaccines for COVID-19
Murmu, N., Sarkar, M., Dey, S., Manna, R., Roy, S., Mondal, T., Halder, S., Bhattacharjee, N., Dash, S. K., & Giri, B. (2023) · Journal of Medicine Surgery and Public Health · doi:10.1016/j.glmedi.2023.100041 · Cited by 13
Autoimmune response after SARS-CoV-2 infection and SARS-CoV-2 vaccines
Hromić‐Jahjefendić, A., Lundstrom, K. H., Adilović, M., Aljabali, A. A. A., Tambuwala, M. M., Serrano‐Aroca, Á., & Uversky, V. N. (2023) · Autoimmunity Reviews · doi:10.1016/j.autrev.2023.103508 · Cited by 14
SARS-CoV-2 Vaccines: The Advantage of Mucosal Vaccine Delivery and Local Immunity
Tobias, J., Steinberger, P., Wilkinson, J., Klais, G., Kundi, M., & Wiedermann, U. (2024) · Vaccines · doi:10.3390/vaccines12070795 · Cited by 15
SARS-CoV-2 vaccines — the biggest medical research project of the 21st century
Kurup, D., & Schnell, M. J. (2021) · Current Opinion in Virology · doi:10.1016/j.coviro.2021.04.008 · Cited by 13
The Immunopathobiology of SARS-CoV-2 Infection
Patel, M., Shahjin, F., Cohen, J. D., Hasan, M., Machhi, J., Chugh, H., Singh, S., Das, S., Kulkarni, T. A., Herskovitz, J., et al. (2021) · FEMS Microbiology Reviews · doi:10.1093/femsre/fuab035 · Cited by 15
Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study
Kulkarni, P. S., Kadam, A., Godbole, S., Bhatt, V. R., Raut, A. V., Kohli, S., Tripathi, S. K., Kulkarni, P., Ludam, R., Prabhu, M., et al. (2023) · The Lancet Regional Health - Southeast Asia · doi:10.1016/j.lansea.2022.100139 · Cited by 13
Self-citation
Heterologous boost with mRNA vaccines against SARS-CoV-2 Delta/Omicron variants following an inactivated whole-virus vaccine
Lu, C., Zhang, Y., Liu, X., Hou, F., Cai, R., Yu, Z., Liu, F., Yang, G., Ding, J., Xu, J., et al. (2023) · Antiviral Research · doi:10.1016/j.antiviral.2023.105556 · Cited by 12
Ginseng Polysaccharide Enhances the Humoral and Cellular Immune Responses to SARS-CoV-2 RBD Protein Subunit Vaccines
Zhang, J., Feng, J., Huang, Y., Zhou, B., Li, B., & Zhang, R. (2023) · Vaccines · doi:10.3390/vaccines11121833 · Cited by 13
Incidence, Pattern and Severity of Adverse Events Following Immunization (AEFIs) Associated With Chadox1 nCOV-19 Corona Virus Vaccine (Recombinant) Among the Healthcare Workers of a Tertiary Care Institute of Eastern Uttar Pradesh, India
Kamble, B. D., Bashar, M. A., & Mishra, C. P. (2022) · Cureus · doi:10.7759/cureus.21848 · Cited by 13
Dynamic observation of SARS‐CoV‐2 IgM, IgG, and neutralizing antibodies in the development of population immunity through COVID‐19 vaccination
Jiang, R., Dou, X., Li, M., Wang, E., Hu, J., Xiong, D., & Zhang, X. (2022) · Journal of Clinical Laboratory Analysis · doi:10.1002/jcla.24325 · Cited by 11
Seroconversion Rate After SARS-CoV-2 Infection and Two Doses of Either ChAdOx1-nCOV COVISHIELD™ or BBV-152 COVAXIN™ Vaccination in Renal Allograft Recipients: An Experience of Two Public and Private Tertiary Care Center
Prasad, N., Bansal, S. B., Yadav, B., Manhas, N., Yadav, D., Gautam, S., Kushwaha, R. S., Singh, A., BHADAURIA, D. S., Yachha, M., et al. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.911738 · Cited by 12
A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis
Kaur, U., Anju, K. L., Chauhan, M., Joshi, A. U., Das, A., Kansal, S., Jaisawal, V., Patwardhan, K., & Chakrabarti, S. S. (2022) · Drug Safety · doi:10.1007/s40264-022-01226-8 · Cited by 10
Vaccines for the Prevention of Coronavirus Disease 2019 in Older Adults
Oyebanji, O. A., Mylonakis, E. E., & Canaday, D. H. (2022) · Infectious Disease Clinics of North America · doi:10.1016/j.idc.2022.11.002 · Cited by 13
Serendipitous COVID-19 Vaccine-Mix in Uttar Pradesh, India: Safety and Immunogenicity Assessment of a Heterologous RegimePreprint
Kant, R., Dwivedi, G. R., Zaman, K., Sahay, R. R., Sapkal, G. N., Kaushal, H., Nyayanit, D. A., Yadav, P. D., Deshpande, G. R., Singh, R., et al. (2021) · medRxiv · doi:10.1101/2021.08.06.21261716 · Cited by 12
Self-citation
Measuring the impact of a single dose of ChAdOx1 nCoV-19 (recombinant) coronavirus vaccine on hospital stay, ICU requirement, and mortality outcome in a tertiary care centre
Desai, A. K., Desai, P., Mehta, J., Sachora, W., Bharti, N., Patel, T. C., Sukhwani, K., Jain, A., Sorathiya, D., Nanda, V., et al. (2021) · International Journal of Infectious Diseases · doi:10.1016/j.ijid.2021.10.032 · Cited by 11
Incidence and severity of COVID-19 infection post-vaccination: a survey among Indian doctors
Parameswaran, A., Apsingi, S., Eachempati, K. K., Dannana, C. S., Jagathkar, G. M., Iyer, M., & Aribandi, H. (2022) · Infection · doi:10.1007/s15010-022-01758-2 · Cited by 13
A comparative analysis on the safety and efficacy of Covaxin versus other vaccines against COVID-19: a review
Talukder, A., Kalita, C., Neog, N., Goswami, C., Sarma, M. K., & Hazarika, I. (2022) · Zeitschrift für Naturforschung C · doi:10.1515/znc-2021-0301 · Cited by 11
The prevalence of inverse health consequences of COVID-19 vaccines: A post-vaccination study
Shrestha, Y., & Venkataraman, R. (2022) · Vacunas · doi:10.1016/j.vacun.2022.03.002 · Cited by 10

Authors: Ella, R., Vadrevu, K. M., Jogdand, H., Prasad, S., Reddy, S., Sarangi, V., Ganneru, B., Sapkal, G., Yadav, P., Abraham, P., Panda, S., Gupta, N., Reddy, P., Verma, S., Kumar Rai, S., Singh, C., Redkar, S. V., Gillurkar, C. S., Kushwaha, J. S., Mohapatra, S., Rao, V., Guleria, R., Ella, K., & Bhargava, B.
Affiliations: Bharat Biotech (India) (IN)
ICMR-National Institute of Virology (IN)
Indian Council of Medical Research (IN)
Nizam's Institute of Medical Sciences (IN)
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (IN)
All India Institute of Medical Sciences, Patna (IN)
SRM Medical College Hospital and Research Centre (IN)
Institute of Medical Sciences and Sum Hospital (IN)
All India Institute of Medical Sciences (IN)
Corresponding author: Vadrevu, Krishna Mohan
ORCID: Ella, Raches
Vadrevu, Krishna Mohan
Prasad, Sai
Sapkal, Gajanan
Yadav, Pragya
Abraham, Priya
Panda, Samiran
Gupta, Nivedita
Verma, Savita
Singh, Chandramani
Redkar, Sagar Vivek
Mohapatra, Satyajit
Rao, Venkat
Guleria, Randeep
Ella, Krishna
Bhargava, Balram
Venue: The Lancet Infectious Diseases
Publisher: Elsevier BV
Published: 2021-05
Volume: 21
Issue: 5
Pages: 637-646
ISSN: 1473-3099 (ISSN-L)
DOI: 10.1016/s1473-3099(20)30942-7
PMC: PMC7825810
OpenAlex: W3121691244
Cited by: 424
References: 47
Citations by year: 2026: 12 · 2025: 14 · 2024: 32 · 2023: 64 · 2022: 135 · 2021: 164
FWCI: 31.25
Type: journal article
Language: en
Update notices: erratum (2023-03-01)
erratum (2021-04-01)
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
doi.org/10.15223/policy-017 (stm-asf)
doi.org/10.15223/policy-037 (stm-asf)
doi.org/10.15223/policy-012 (stm-asf)
doi.org/10.15223/policy-029 (stm-asf)
doi.org/10.15223/policy-004 (stm-asf)
Locations: The Lancet Infectious Diseases (publishedVersion)
medRxiv (acceptedVersion, cc-by-nd)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
Life Sciences › Immunology and Microbiology › Immunology › Immune responses and vaccinations
Keywords: BBV152, inactivated SARS-CoV-2 vaccine, COVID-19 vaccines, vaccine safety, vaccine immunogenicity, alum adjuvant, Toll-like receptor 7/8 agonist, reactogenicity, seroconversion, neutralizing antibodies, cell-mediated immunity, dose comparison, healthy adults, India
MeSH terms: COVID-19, SARS-CoV-2, COVID-19 Vaccines, Adolescent, Adult, Antibodies, Viral, Double-Blind Method, Female, Humans, Immunoglobulin G, Male, Middle Aged, Vaccination, Vaccines, Inactivated, Toll-Like Receptor 7, Toll-Like Receptor 8, Young Adult, Antibodies, Neutralizing

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial

Abstract

Overview

Integrity signals

Verification

Claims the paper makes

Claims other papers make about this one

Self-check

Citations

Cites

Cited by

Related

Metadata

Record

About these checks