ANRS0407s – LKV.Cov40
A phase 1/2 multicenter, randomized study of the safety and immunogenicity of a sub-unit protein CD40.RBDv bivalent COVID-19 vaccine, adjuvanted or not, as a booster in volunteers.
Topic
COVID-19 vaccine
Sponsor
Inserm – ANRS MIE
Coordinating investigator
Pr Yves LEVY – Institut de recherche vaccinale (VRI)
Short description
This clinical trial is evaluating the safety and immunogenicity of the bivalent CD40.RBDv protein vaccine. This vaccine is a monoclonal antibody fused to two new versions of the RBD (receptor binding domain) protein of the SARS-CoV-2 virus: that of the Wuhan strain an another containing mutations present in several variants, including omicron.
Study design
Primary objective
- To determine the safety and reactogenicity of vaccine strategies during the 3 first months after each dose.
- Co-primary objective: To determine the humoral immune response (neutralizing antibody titers) induced by vaccine strategies at one month, after each dose.
Primary endpoint
- Primary endpoint: Proportion of participants without any grade 3 or 4 solicited local/systemic or unsolicited AEs between D1 and Month 3 after each IMP/vaccine administration and considered to be related or possibly related to IMP administration.
- Co-primary immunogenicity endpoint: Neutralization antibodies titers (anti-RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1 after each dose.
Study population
Healthy volunteers were enrolled. It is recommended to include a minimal number of 25% of volunteers above 65 years old.
Intervention
The bivalent CD40.RBDv COVID-19 vaccine will be tested at low (LD) and high (HD) dose, subcutaneously, each dose adjuvanted or not with a TLR3 agonist adjuvant Hiltonol® (poly-ICLC, 1mg/injection).
- Low Dose: 0.25 mg/injection
- High Dose: 1 mg/injection
Number of subjects
190 participants have been enrolled.
Participating country(ies) and sites
12 sites in France and 1 in Switzerland.
Study duration
Study starting date (1st consent signed): Q2 2024
- Effective enrollment duration: 20 months
- Participant screening duration: 28 days
- Participant duration from randomization (V3) to last visit (V15): 15 months
- Last participant’s last visit: Q1 2027
Study completion date (inclusive of centralized immunogenicity assessments): Q1 2028
Funding
UPEC VRI / Inserm – ANRS MIE / BPI
UMS MART activities
Study coordination, monitoring, methodological and statistical activities (management of these activities taken over during the trial, following the transition of activities with the CRO ICTA)