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A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as Booster Vaccine for COVID-19 in Healthy Adults Who Have Received 2 Doses of BNT162b2
To evaluate the safety and immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as booster vaccine for COVID-19 in healthy adults who have received 2 doses of BNT162b2
Details
| Lead sponsor | The University of Hong Kong |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 150 |
| Start date | 2022-02-08 |
| Completion | 2024-02 |
Conditions
- Covid19
Interventions
- DelNS1-2019-nCoV-RBD-OPT1
- Matching placebo
Primary outcomes
- Reactogenicity — Day 1 to 15 and Day 22 to 36
Occurrence of solicited local events (nasal irritation, sneezing, nasal congestion, cough, sore throat, change in smell, change in taste, change in vision and eye pain) and solicited systemic events (fever, headache, malaise, myalgia, joint pain, nausea, vomiting, diarrhea, abdominal pain, chills and sweating) for a 14-day period after each vaccination - Adverse Events — Day 1 to Day 202(±7)
Occurrence of unsolicited AEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) - Neutralizing Antibodies in Serum against Live SARS-CoV-2 Measured by Neutralization Assay — Day 1(pre-dose), 22(pre-dose), 36(+2) and 50(±3)
Measurement of neutralizing antibody levels by microneutralization (MN) assay in serum samples - Binding Antibodies in Serum against SARS-CoV-2 RBD Measured by CMIA — Day 1(pre-dose), 22(pre-dose), 36(+2) and 50(±3)
Measurement of binding antibody responses by chemiluminescent microparticle immunoassay (CMIA) in serum samples
Countries
Hong Kong