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Safety and Immunogenicity of a DNA SARS-CoV-2 vaccine (ZyCoV-D): Results of an open-label, non-randomized phase I part of phase I/II clinical study by intradermal route in healthy subjects in India.
Momin, Taufik; Kansagra, Kevinkumar; Patel, Hardik; Sharma, Sunil; Sharma, Bhumika; Patel, Jatin; Mittal, Ravindra; Sanmukhani, Jayesh; Maithal, Kapil; Dey, Ayan; Chandra, Harish; Rajanathan, Chozhavel Tm; Pericherla, Hari Pr; Kumar, Pawan; Narkhede, Anjali; Parmar, Deven.
  • Momin T; Zydus Research Center, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat 382213, India.
  • Kansagra K; Zydus Research Center, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat 382213, India.
  • Patel H; Zydus Research Center, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat 382213, India.
  • Sharma S; Zydus Research Center, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat 382213, India.
  • Sharma B; Zydus Research Center, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat 382213, India.
  • Patel J; Zydus Research Center, Clinical R & D, Cadila Healthcare Limited, Sarkhej-Bavla N. H. No. 8 A, Moraiya, Ahmedabad, Gujarat 382213, India.
  • Mittal R; Zydus Corporate Park, Ahmedabad, India.
  • Sanmukhani J; Zydus Corporate Park, Ahmedabad, India.
  • Maithal K; Vaccine Technology Center, Cadila Healthcare Ltd, Ahmedabad, India.
  • Dey A; Vaccine Technology Center, Cadila Healthcare Ltd, Ahmedabad, India.
  • Chandra H; Vaccine Technology Center, Cadila Healthcare Ltd, Ahmedabad, India.
  • Rajanathan CT; Vaccine Technology Center, Cadila Healthcare Ltd, Ahmedabad, India.
  • Pericherla HP; Vaccine Technology Center, Cadila Healthcare Ltd, Ahmedabad, India.
  • Kumar P; Vaccine Technology Center, Cadila Healthcare Ltd, Ahmedabad, India.
  • Narkhede A; Quality Assurance and Regulatory Affairs, Cadila Healthcare Limited, Ahmedabad, India.
  • Parmar D; Zydus Discovery DMCC, Dubai, United Arab Emirates.
EClinicalMedicine ; 38: 101020, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1313060
ABSTRACT

BACKGROUND:

ZyCoV-D is a DNA vaccine candidate, which comprises a plasmid DNA carrying spike-S gene of SARS-CoV-2 virus along with gene coding for signal peptide. The spike(S) region includes the receptor-binding domain (RBD), which binds to the human angiotensin converting Enzyme (ACE)-2 receptor and mediates the entry of virus inside the cell.

METHODS:

We conducted a single-center, open-label, non-randomized, Phase 1 trial in India between July 2020 and October 2020. Healthy adults aged between 18 and 55 years were sequentially enrolled and allocated to one of four treatment arms in a dose escalation manner. Three doses of vaccine were administered 28 days apart and each subject was followed up for 28 days post third dose to evaluate safety and immunogenicity.

FINDINGS:

Out of 126 individuals screened for eligibility. Forty-eight subjects (mean age 34·9 years) were enrolled and vaccinated in the Phase 1 study Overall, 12/48 (25%) subjects reported at least one AE (i.e. combined solicited and unsolicited) during the study. There were no deaths or serious adverse events reported in Phase 1 of the study. The proportion of subjects who seroconverted based on IgG titers on day 84 was 4/11 (36·36%), 4/12 (33·33%), 10/10 (100·00%) and 8/10 (80·00%) in the treatment Arm 1 (1 mg Needle), Arm 2 (1 mg NFIS), Arm 3 (2 mg Needle) and Arm 4 (2 mg NFIS), respectively.

INTERPRETATION:

ZyCoV-D vaccine is found to be safe, well-tolerated and immunogenic in the Phase 1 trial. Our findings suggest that the DNA vaccine warrants further investigation.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: EClinicalMedicine Year: 2021 Document Type: Article Affiliation country: J.eclinm.2021.101020

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: EClinicalMedicine Year: 2021 Document Type: Article Affiliation country: J.eclinm.2021.101020