Trial NCT04900467; EudraCT: 2021-002174-52
Publication Janssen C, EClinicalMedicine, 2022
Dates: 2021-05-28 to 2021-07-02
Funding: Public/non profit (French Ministries of Solidarity and Health and Research; French Ministry of Solidarity and Health)
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / France
Follow-up duration (months): 1
BNT162b2/BNT162b2 (n=101)
BNT162b2/mRNA-1273 (n=102)
mRNA-1273/mRNA-1273 (n=105)
mRNA-1273/BNT162b2 (n=106)
Inclusion criteria
  • Adults
  • received a first dose of a mRNA SARS-CoV-2 vaccine (mRNA-1273 or BNT162b2)
  • scheduled for receiving a second dose 28 to 49 days after later.
Exclusion criteria
  • Pregnancy or breastfeeding
  • history of SARS-CoV-2 infection
  • acute febrile infection within the previous 72 h
  • symptoms suggestive of COVID-19 or contact with a case within the last 14 days prior to the inclusion visit
  • use of immunosuppressive medications or any immunosuppression condition that may reduce the immune response
  • history of severe post-vaccination adverse events or severe allergic manifestations
  • having received another vaccine within four weeks prior to the first injection or scheduled to receive a licensed vaccine within the next four weeks.
Interventions
Intervention
1 IM dose 30 mcg + 1 dose 0.1 mg, 28-49 days apart
1 IM dose 0.1 mg + 1 dose 30 mcg, 28-49 days apart
Control
2 IM doses 30 mcg, 28-49 days apart2 IM doses 0.1 mg, 28-49 days apart
Participants
Randomized
414 participants
Characteristics of participants
Type of participants: Adults
N=414
227 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 19-64
Description of participants
Adults with no known or suspected history of SARS-CoV-2 infection at 17 centers in France.
Primary outcome
In the register
Anti-Spike IgG titer measured by ELISA and neutralising antibodies to European SARS-CoV-2 and SARS-CoV-2 variants 28 days after the second injection.
In the report
Immune response (anti-spike IgG antibodies titer) 28 days after the second injection
Documents
available

Protocol

NR

Statistical plan

Yes

Data-sharing stated: Yes, After publication and finalisation of the complete clinical study report, for at least 6 months.
Data accessibility: Correspondence: Odile Launay, MD, PhD. e-mail: Odile.launay@aphp.fr
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 registry was 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. The primary outcome in the article reflects that in the registry. There is no change from the trial registration in intervention and control treatments.
This trial was updated on June 22nd, 2022 after publication of the study report.