Trial CTRI/2020/08/027170
Publication Kulkarni P, EClinicalMedicine, 2021
Dates: 2020-08-25 to 2020-10-31
Funding: Mixed (Serum Institute of India Pvt Ltd, Indian Council of Medical Research, AstraZeneca)
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / India
Follow-up duration (months): 6
SII-ChAdOx1 (Covishield) (N = 301
ChAdOx1 / AZD1222 (Vaxzevria) (n = 100)
Inclusion criteria
  • Adults aged 18 years and older
  • individuals with controlled comorbid conditions, including diabetes and hypertension, and controlled cardiovascular, respiratory, hepatic, renal and neurological conditions were eligible
  • female participants were required to have a negative pregnancy test prior to enrolment and were required to use adequate contraception from 28 days before the first dose through 28 days after the second dose of vaccine
Exclusion criteria
  • Acute illness
  • known prior SARS-CoV-2 infection
  • an immunosuppressive condition or receipt of immunosuppressive therapy
Interventions
Intervention
2 IM doses of 5x10^10 vp, 28 days apart
Control
2 IM doses of 5x10^10 vp, 28 days apart
Participants
Randomized
401 participants
Characteristics of participants
Type of participants: Adults
N=401
308 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 19-83
Description of participants
Adults (seronegative and seropositive) without a history of COVID and not immunocompromised at 14 centers in India
Primary outcome
In the register
Ratio of GMTs of anti-S IgG antibodies, 28 days after the second vaccination
In the report
Ratio of geometric mean titre (GMT) of IgG antibodies against SARS-CoV-2 S protein (anti-S IgG) at 1 month after the second dose of vaccine
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: No
Data accessibility: corresponding author: Dr Prasad S Kulkarni, email: drpsk@seruminstitute.com
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Low
General comment In addition to the published article, the protocol, statistical plan and prospective study registry were used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. The target sample size specified in the registry was achieved. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. The article reported on a study with two cohorts, this part of the study relates to the immunogenicity cohort. This trials was updated on Mars 1st, 2022 after publication of study report.