ANRS0640s LKV-PAN-01 (PANCOV)
A phase I/IIa multicenter trial to evaluate the safety and immunogenicity of the CD40.Pan.CoV vaccine, adjuvanted or not, as a booster in adult participants.
Topic
COVID-19 vaccine in healthy volunteers
Sponsor
Inserm – ANRS MIE
Coordinating investigator
Jean-Daniel LELIEVRE MD, PhD – AP-HP
Short description
ANRS0640s LKV-PAN-01 (PANCOV) is a first-in-human phase I/IIa dose escalation trial of CD40.Pan.CoV vaccine adjuvanted with Poly-ICLC (Hiltonol®) or not, as a booster in adult volunteers. The objective of the trial is to evaluate the safety and the immunogenicity of different doses of a booster of a CD40.Pan.CoV vaccine.
Study design
Phase I/IIa, muliticenter, open-label, dose-escalating. 12 participants will be enrolled in each dose cohorts described below:
- Cohort 1: One subcutaneous (SC) injection of low dose CD40.Pan.CoV vaccine non adjuvanted
- Cohort 2: One SC injection of low dose CD40.Pan.CoV vaccine Hiltonol®-adjuvanted
- Cohort 3: One SC injection of high dose CD40.Pan.CoV vaccine non adjuvanted
- Cohort 4: One SC injection of high dose CD40.Pan.CoV vaccine Hiltonol®-adjuvanted
Primary objective
- To determine the safety and reactogenicity of different doses (0,25 mg and 1 mg) of a booster of a CD40.Pan.CoV vaccine, adjuvanted or not, in healthy volunteers between D0 and M1.
- To determine the humoral immune response (neutralizing antibody titers) induced by different doses (0,25 mg and 1 mg) of a booster of a CD40.Pan.CoV vaccine, adjuvanted or not, at M1 after administration.
Primary endpoint
- Proportion of participants without any grade 3 or 4 solicited local/systemic or unsolicited AEs between D0 and M1 after the vaccine administration and considered to be related or possibly related to IMP administration.
- Geometric mean titers of neutralizing antibodies against the original strain D614G and the relevant circulating variants measured at M1 after administration.
Study population
Healthy adult volunteers having received a primary series of vaccination and ≥ 1 booster(s) of COVID-19 mRNA vaccination(s) with the last boost at least 6 months prior to the IMP administration, age between 18 and 64 years
Intervention
Enrolment of a given cohort will open sequentially depending on the « go-criterion » based on the safety data of the previous cohort(s)
Number of subjects
48 healthy participants recruited into 4 dose cohorts
Participating country(ies) and sites
France, 7 sites
Study duration
16 months
Funding
VRI funding
UMS MART activities
Methodological aspects, trial coordination, monitoring, data management and statistical analysis