Trial NCT04962906; NCT05027672
Publication Macchia A, Lancet Reg Health Am, 2022
Dates: 2021-07-06 to 2021-08-03
Funding: Public/non profit (the Buenos Aires City Government)
Conflict of interest: no COI

Methods
RCT
Location : Single center / Argentina
Follow-up duration (months): 1
rAd26/rAd5 (n = 150)
rAd26/ChAdOx1 (n = 150)
rAd26/BBIBP-CorV (n = 65)
rAd26/rAd26 (n = 87)
rAd26/mRNA-1273 (n = 88)
Inclusion criteria
  • Both sexes aged ≥ 21 and ≤ 65 years
  • had received a dose of the first component of Sputnik V (rAd26) vaccine at least 30 days before randomization and were awaiting a second dose
Exclusion criteria
  • Known history of COVID in the last 6 months
  • being pregnant or breastfeeding
  • use of systemic corticosteroids in the last 30 days
  • known history of allergy to any vaccine
  • history of anaphylaxis
  • known history of autoimmune disease
  • cancer treatment in the last 6 months
  • having any medical procedure scheduled that could jeopardize the 14th and 28th post-randomisation visits
  • any disease or condition that, in the investigator's opinion, could jeopardize participation in the study
Interventions
Intervention
1 IM dose rAd26 (1st component of Sputnik V) + 1 IM dose ChAdOx1, at least 30 days apart
2 IM doses rAd26 (= 2 x 1st component of Sputnik V regimen), at least 30 days apart
1 IM dose rAd26 (1st component of Sputnik V) + 1 IM dose m-RNA-1273, at least 30 days apart
1 IM dose rAd26 (1st component of Sputnik V) + 1 IM dose BBIBP-CorV, at least 30 days apart
Control
1 IM dose rAd26 + 1 IM dose rAd5 (standard Sputnik V regimen), at least 30 days apart
Participants
Randomized
540 participants
Characteristics of participants
Type of participants: Adults
N=540
297 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Adults who had received the first dose (rAd26) of the Sputnik V vaccine at least 30 days earlier and no history of SARS-CoV-2 at a single centre in Argentina
Primary outcome
In the register
1. ELISA assessment of IgG anti Spike (UI/ml) [ Time Frame: 28 days ]; 2. Serious adverse events of special interest [ Time Frame: 28 days ]
In the report
Geometric mean concentration ratio (SARS-CoV-2 anti-spike IgG) at 28 days
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Yes
Data accessibility: Corresponding author: Alejandro Macchia, amacchia@buenosaires.gob.ar
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
Some concerns
General comment In addition to the published article, the study registry (dated a few days after recruitment started) and protocol were used in data extraction and risk of bias assessment. The paper reported on two similar trials in a combined analysis. The target sample size specified in the registry was achieved. There is no change from the trial registration in the intervention and control treatments. The primary immunogenicity outcome in the registry and protocol corresponded to the primary outcome in the report. The registry also reports safety outcomes as primary, but not the article.