This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Article
Balram Bhargava
Indian Council of Medical Research
Corresponding Author
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This work is licensed under a CC BY 4.0 License. Read Full License
The COVID-19 pandemic is a global health crisis that has severely affected mankind and posed a great challenge to the public health system of affected countries. The availability of a safe and effective vaccine is the need of the hour to overcome this crisis. Here, we have developed and assessed the protective efficacy and immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in rhesus macaques (Macaca mulata). Twenty macaques were divided into four groups of five animals each. One group was administered a placebo while three groups were immunized with three different vaccine candidates at 0 and 14 days. All the macaques were challenged with SARS-CoV-2 fourteen days after the second dose. The protective response was observed with increasing SARS-CoV-2 specific IgG and neutralizing antibody titers from 3rd-week post-immunization. Viral clearance was observed from bronchoalveolar lavage fluid, nasal swab, throat swab, and lung tissues at 7 days post-infection in the vaccinated groups. No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group which showed features of interstitial pneumonia and localization of viral antigen in the alveolar epithelium and macrophages by immunohistochemistry. Data from this study substantiate the immunogenicity of the vaccine candidates and BBV152 is being evaluated in Phase I clinical trials in India (NCT04471519).
Keywords
SARS-CoV-2, vaccine, BBV152, immunogenicity
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Figure 4
There is NO Competing Interest.
This is a list of supplementary files associated with this preprint. Click to download.
- Supplementarytable123.docx
Dataset 1, Dataset 2, Dataset 3. Supplementary Table 1: Clinical scoring sheet Supplementary Table 2: Histopathological scoring of lungs Supplementary Table 3: Daily observation parameters
- ExtendedDataFigure1and2.pdf
Extended Data 1, Extended Data 2. Extended Data Figure. 1| Anteroposterior (AP) chest radiographs obtained from different animals. (A) Normal chest X-ray. (B) Infiltrate in left upper lobe (black arrowhead), bronchopneumonia in lower lobes of both the lungs (black circles). (C) Infiltrate in left upper lobe (white arrowhead) and lobar consolidation in left lower lobe (white arrow) (D) Lobar consolidation in left upper lobe (black arrow) with bilateral lower lobe bronchopneumonia (white circles) where ‘R’ represents the position indicator for the right side of the animal. Extended Data Figure. 2| Lymphocyte profile in animals of each group at 0,1,3,5 and 7 DPI. (A) Lymphocyte percentage. (B) Percentage of CD3+ T cells/lymphocytes. (C) Percentage of CD8+ T cells/ CD3+ T cells, (D) Percentage of CD4+ T cells/ CD3+ T cells. (E) Percentage of CD20+ T cells/ CD45+ cells.
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This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Article
Balram Bhargava
Indian Council of Medical Research
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 10 Sep, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
The COVID-19 pandemic is a global health crisis that has severely affected mankind and posed a great challenge to the public health system of affected countries. The availability of a safe and effective vaccine is the need of the hour to overcome this crisis. Here, we have developed and assessed the protective efficacy and immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in rhesus macaques (Macaca mulata). Twenty macaques were divided into four groups of five animals each. One group was administered a placebo while three groups were immunized with three different vaccine candidates at 0 and 14 days. All the macaques were challenged with SARS-CoV-2 fourteen days after the second dose. The protective response was observed with increasing SARS-CoV-2 specific IgG and neutralizing antibody titers from 3rd-week post-immunization. Viral clearance was observed from bronchoalveolar lavage fluid, nasal swab, throat swab, and lung tissues at 7 days post-infection in the vaccinated groups. No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group which showed features of interstitial pneumonia and localization of viral antigen in the alveolar epithelium and macrophages by immunohistochemistry. Data from this study substantiate the immunogenicity of the vaccine candidates and BBV152 is being evaluated in Phase I clinical trials in India (NCT04471519).
Figure 1
Figure 2
Figure 3
Figure 4
There is NO Competing Interest.
This is a list of supplementary files associated with this preprint. Click to download.
- Supplementarytable123.docx
Dataset 1, Dataset 2, Dataset 3. Supplementary Table 1: Clinical scoring sheet Supplementary Table 2: Histopathological scoring of lungs Supplementary Table 3: Daily observation parameters
- ExtendedDataFigure1and2.pdf
Extended Data 1, Extended Data 2. Extended Data Figure. 1| Anteroposterior (AP) chest radiographs obtained from different animals. (A) Normal chest X-ray. (B) Infiltrate in left upper lobe (black arrowhead), bronchopneumonia in lower lobes of both the lungs (black circles). (C) Infiltrate in left upper lobe (white arrowhead) and lobar consolidation in left lower lobe (white arrow) (D) Lobar consolidation in left upper lobe (black arrow) with bilateral lower lobe bronchopneumonia (white circles) where ‘R’ represents the position indicator for the right side of the animal. Extended Data Figure. 2| Lymphocyte profile in animals of each group at 0,1,3,5 and 7 DPI. (A) Lymphocyte percentage. (B) Percentage of CD3+ T cells/lymphocytes. (C) Percentage of CD8+ T cells/ CD3+ T cells, (D) Percentage of CD4+ T cells/ CD3+ T cells. (E) Percentage of CD20+ T cells/ CD45+ cells.
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