Trial NCT04671017; ISRCTN 82411169
Publication Lazarus R, J Infect, 2022
Dates: 2020-12-16 to 2021-06-03
Funding: Public/non profit (the Department of Health and Social Care, UK)
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / UK
Follow-up duration (months): 3.47
VLA2001 3 AU (n=51)

VLA2001 7 AU (n=51)
VLA2001 35 AU (n=51)
Inclusion criteria
  • Healthy adult volunteers aged 18-55 years
Exclusion criteria
  • Acute illness
  • pregnancy
  • known prior SARS-CoV-2 infection
  • and any immunosuppressive condition or receipt of immunosuppressive therapy
Interventions
Intervention
2 IM doses of 3 AU, 21 days apart
2 IM doses of 7 AU, 21 days apart
Control
2 IM doses of 35 AU, 21 days apart
Participants
Randomized
153 participants
Characteristics of participants
Type of participants: Healthy adults
N=153
83 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 21-53
Description of participants
Healthy adult volunteers aged 18-55 at 4 centers in the UK
Primary outcome
In the register
1. Frequency and severity of solicited AEs (local and systemic reactions) within 7 days after any vaccination [ Time Frame: until Day 29 ]; 2. Geometric mean titre (GMT) for neutralizing antibodies against SARS-CoV-2 [ Time Frame: Day 36 ]
In the report
1. Frequency and severity of solicited adverse events (AE) within 7 days of first or second vaccination; 2. Geometric mean titres (GMT) for SARS-CoV-2 neutralising antibodies at day 36
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes, Data available on request
Data accessibility: corresponding author: Christian Taucher, 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 study registries were used in data extraction and assessment of risk of bias. The protocol and supplementary materials (mentioned in the pre-print) were not avaialble. The first 15 participants were not blinded and were given low, medium or high doses sequentially in an open-label dose escalation phase to assess dose safety. Thereafter, participants were assigned randomly in a double-blinded manner. The primary outcomes in the article reflect those in the registry. Only safety outcomes were extracted for this Phase 1-2 study. The article presented results from the first 36 days of follow up, including two weeks after a second dose of vaccine, in an ongoing safety and dose-finding immunogenicity trial. This trial was updated on June 17th, 2022 after the publication of results on the trial registry website. This trials was updated on July 25th 2022, after publication of the study report.