Trial NCT04864561
Publication Lazarus R, Lancet Infect Dis, 2022
Dates: 2021-04-28 to 2021-06-03
Funding: Mixed (Department of Health and Social Care, UK ; Valneva Austria GmbH)
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / UK
Follow-up duration (months): 5.6
VLA2001 (n = 1978)
ADZ1222 (n = 997)
Inclusion criteria
  • Medically stable
  • adults aged ≥30 years
Exclusion criteria
  • Acute illness
  • pregnancy
  • known prior SARS-CoV-2 infection
  • any immunosuppressive condition or receipt of immunosuppressive therapy.
Interventions
Intervention
2 IM doses of 33 AU VLA2001, 28 days apart
Control
2 IM doses of ChAdOx1, 28 days apart
Participants
Randomized
2975 participants
Characteristics of participants
Type of participants: Adults
N=2975
1702 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 30-68
Description of participants
Medically stable adults, 30 years and older, at 26 centers in the UK.
Primary outcome
In the register
1) Immune response measured after completion of a 2-dose immunization schedule, as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies [ Time Frame: Day 43 ]; 2) Immune response measured after completion of a 2-dose immunization schedule, as determined by Seroconversion (definded as 4-fold increase from baseline) of SARS-CoV-2-specific neutralizing antibodies [ Time Frame: Day 43 ]; 3) Frequency and severity of any Adverse Events (AE) [ Time Frame: Up to Day 43 post-vaccination ]
In the report
1) Geometric mean titre (GMT) ratio and seroconversion of SARS-CoV-2-specific nAbs on day 43 ; 2) Frequency and severity of any adverse events up to day 43 after baseline in all participants.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Yes, All data will be made available for a minimum of 5 years from the end of the trial.
Data accessibility: Anonymized individual participant data will be made available when the study is complete, on reasonable requests made to the corresponding author. Proposals will be reviewed and approved by the sponsor, investigator, and collaborators based on scientific merit. After approval of a proposal, data can be shared through a secure online platform. Correspondence to: Christian Taucher, PhD. Email: christian.taucher@valneva.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
Some concerns
General comment In addition to the pre-print article, the prospective trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. This was a non-inferiority trial comparing VLA2001 with the already authorized ADZ1222. The primary outcomes in the article reflect those in the registry. The trial achieved its target sample size. This trial was updated on October 27th, 2022 after publication of the study report.