lancet-header

Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.

Immunogenicity of Two COVID-19 Vaccines Currently Used in India: Experience in Health Care Workers From a Tertiary Care Hospital

16 Pages Posted: 22 Sep 2021

See all articles by Vidya A. Arankalle

Vidya A. Arankalle

Bharati Vidyapeeth (Deemed to be University) - Department of Communicable Diseases

Archana Kulkarni-Munje

Bharati Vidyapeeth (Deemed to be University)

Ruta Kulkarni

Bharati Vidyapeeth (Deemed to be University)

Sonali Palkar

Bharati Vidyapeeth (Deemed to be University) - Department of Community Medicine

Jitendra Oswal

Bharati Vidyapeeth (Deemed to be University)

Sanjay Lalwani

Bharati Vidyapeeth (Deemed to be University) - Department of Pediatrics

Akhilesh Chandra Mishra

Bharati Vidyapeeth (Deemed to be University) - Department of Communicable Diseases

More...

Abstract

Background: Being a long-term preventive measure, COVID-19 vaccines are used in global populations. In India, country-wide immunization drive was initiated in January 2021.

Methods: To assess immune response of health-care-workers to COVISHIELD(n=187) and COVAXIN(n=21), blood samples collected pre-vaccination and 1month-post-1/post-2 dose, administered 28days apart, were tested for IgG-anti-SARS-CoV-2 (ELISA) and neutralizing (Nab, PRNT50) antibodies. Spike protein-specific T cells were quantitated by IFN-γ ELISPOT and Flow-cytometry-based Intra-cellular-secretion (ICS) for IFN-γ/IL2.

Findings: Among pre-vaccination-antibody negative (pre-negatives, n=120) and positive (pre-positives, n=67) COVISHIELD recipients, %Nab seroconversion and median (IQR) Nab titers were 55.1%/95.6% and 16(IQR 2.5-36.3)/(64.5, IQR 34.5-154.2, p<0.000) and independent of age/gender. In pre-positives, Nab titers increased from 75 (IQR 29-129) before vaccination to 3050 (1282-3998, p< 0.001, n=42) post-1st dose, but declined to 1740(911-3116, p<0.05) post-2nd dose. Though the number of COVAXIN recipients was small, post-2nd dose humoral response was lower than COVISHIELD (50% seroconversion and median titer 6.75, IQR 2.5-24.75, p<0.0001). Despite higher age, COVAXIN recipients elicited superior IFN-γ-T cell response than COVISHIELD, as measured by ELISPOT (100% bsp;1226 bsp;522-3628 spot forming units, SFU/million PBMCs v/s 57.8%; 21.7, 0-2149; p<0.001) and ICS (56.9%, 24.8-78.6 v/s 30%, 8.1-90.4, p<0.05). During immunization, COVID-19 cases were detected among COVISHIELD (n=4) and COVAXIN (n=2) recipients.

Interpretation: This first-time, systematic, real-world assessment revealed stronger humoral (COVISHIELD) and cellular (COVAXIN) immune responses respectively. Relation of dose interval and post-2nd decline in Nab titers in pre-positives (COVISHIELD) needs evaluation. Immunogenicity/efficacy of vaccines will change with the progression of the pandemic and needs to be assessed in field-setting.

Funding Information: Biotechnology Industry Research Assistance Council (BIRAC), Grant/Award Number: BIRAC/BT/NBM0095/02/18.

Declaration of Interests: Authors declare no any commercial or financial conflict of interest.

Ethics Approval Statement: The study was approved by the “Human Ethics Committee” of BVDUMCH. Written informed consent was obtained from all the participants.

Keywords: SARS CoV-2, COVISHIELD, COVAXIN, Immunogenicity, T cell response

Suggested Citation

Arankalle, Vidya A. and Kulkarni-Munje, Archana and Kulkarni, Ruta and Palkar, Sonali and Oswal, Jitendra and Lalwani, Sanjay and Mishra, Akhilesh Chandra, Immunogenicity of Two COVID-19 Vaccines Currently Used in India: Experience in Health Care Workers From a Tertiary Care Hospital. Available at SSRN: https://ssrn.com/abstract=3928513 or http://dx.doi.org/10.2139/ssrn.3928513

Vidya A. Arankalle (Contact Author)

Bharati Vidyapeeth (Deemed to be University) - Department of Communicable Diseases ( email )

Katraj-Dhankawadi
Pune, 411043
India
+91 020- 24366920 (Phone)

Archana Kulkarni-Munje

Bharati Vidyapeeth (Deemed to be University) ( email )

Katraj-Dhankawadi
Pune, MA 411043
India

Ruta Kulkarni

Bharati Vidyapeeth (Deemed to be University) ( email )

Katraj-Dhankawadi
Pune, MA 411043
India

Sonali Palkar

Bharati Vidyapeeth (Deemed to be University) - Department of Community Medicine

Katraj-Dhankawadi
Pune, MA 411043
India

Jitendra Oswal

Bharati Vidyapeeth (Deemed to be University) ( email )

Katraj-Dhankawadi
Pune, MA 411043
India

Sanjay Lalwani

Bharati Vidyapeeth (Deemed to be University) - Department of Pediatrics

Katraj-Dhankawadi
Pune, MA 411043
India

Akhilesh Chandra Mishra

Bharati Vidyapeeth (Deemed to be University) - Department of Communicable Diseases

Katraj-Dhankawadi
Pune, 411043
India

Click here to go to TheLancet.com

Paper statistics

Abstract Views
247
Downloads
47
PlumX Metrics