Safety and Tolerability of COVID-19 Vaccine (ABNCoV2)
Condition: Covid19; Severe Acute Respiratory Syndrome; SARS-CoV-2 Infection
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase 1 trial aims to assess the safety and tolerability of two doses of ABNCoV2,
      formulated with and without the adjuvant MF59, in healthy adult volunteers and to identify
      the dosage and formulation that optimizes the immunogenicity-tolerability ratio 14 days
      following first vaccination with ABNCoV2.
    

Detailed description: 
      This first-in-human phase 1 trial of ABNCoV2 is a single center, sequential dose-escalation,
      open labelled trial to establish the safety and tolerability of two doses of ABNCoV2,
      formulated with and without MF59 in healthy, adult, severe acute respiratory syndrome
      coronavirus 2 (SARS-CoV-2)-naïve volunteers. The immunological objective of this trial is to
      identify a dosage that optimizes the immunogenicity-tolerability ratio 14 days following
      first vaccination with ABNCoV2. The trial will be carried out by the Radboud University
      Medical Center (Radboudumc).

      The trial involves first-in-human administration, dose escalation of ABNCoV2 and adjuvant
      selection. Volunteers will be screened for eligibility and receive two vaccinations by
      intramuscular injection. While we cannot predict with certainty the safety in human subjects,
      we have adopted a safety-orientated staggered trial design with ascending doses of ABNCoV2.
      Seven groups of volunteers (n=6) will receive a given dose of ABNCoV2, either with or without
      MF59, followed by a booster with the same dose and formulation four weeks after the first
      vaccination. All vaccinations will be given as intramuscular injection. The pre-defined
      escalation schedule will start with 6 μg ABNCoV2, with a maximum dose of 70 μg.
      Dose-escalation will proceed only in absence of protocol-defined safety signals.
      MF59-adjuvanted and non-adjuvanted formulations will be tested in parallel at the first three
      escalation steps (Group 1-3) to detect superiority or futility of the MF59-adjuvanted against
      the non-adjuvanted formulation. Up to forty-two (n=42) subjects will be enrolled, as well as
      one reserve subject per group.

      Safety follow-up will be done at following timepoints: baseline, day 1, day 2, day 7, day 14,
      day 25, day 29, day 30, day 35, day 42, day 70, day 119 and day 196 after first ABNCoV2
      administration.
    

Intervention name(s): ABNCoV2 Vaccine
Intervention type(s): Biological
Intervention description(s): SARS-CoV-2 vaccine
Other intervention name(s): cVLP-RBD; RBDn-CLP; ABNCoV2
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: ABNCoV2 is a virus-like particle vaccine. It will be administered as two intramuscular injections in groups of up to 9 volunteers. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. The pre-defined escalation schedule will start with 6 μg ABNCoV2, followed by 12, 25 and 50 μg with a maximum dose of 70 μg. MF59-adjuvanted and non-adjuvanted formulations will be tested in parallel to detect superiority or futility of the MF59-adjuvanted against the non-adjuvanted formulation at the 6, 12 and 25 μg dosage. Approval for further dose escalation and choice of adjuvant use will be provided by a safety monitoring committee (SMC), supported by pre-defined analyses of safety, tolerability and immunogenicity data at day 14 post-first-vaccination. Recruitment for the two best (safe, tolerable and most immunogenic) regimens will continue until 12 volunteers per regimen have been immunized.
Masking: None (Open Label)
Primary purpose: Prevention