A Phase Ia, Dose-finding Study to Assess the Safety and Immunogenicity of an Orf Virus-based COVID-19 Vaccine Booster (Prime-2-CoV_Beta) in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- Prime-2-CoV_Beta
- Conditions
- Not specified
- Sponsor
- Universitaetsklinikum Tuebingen AöR
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Proportion of participants with unsolicited treatment-emergent adverse events throughout the study
- Status
- Suspended
- Last Updated
- 10 months ago
Overview
Brief Summary
This is an open-label, first-in-human, dose-finding study to evaluate the safety and immunogenicity of a booster vaccination of Prime-2-CoV_Beta in healthy participants who had received the full course of vaccination, including booster vaccination (i.e., having received 3 doses) with the Pfizer/BioNTech-BNT162b2 vaccine (Comirnaty).
Detailed Description
Eligible participants will undergo baseline assessments and will receive 1 injection of Prime-2-CoV_Beta at Day 1. Participants will be followed up through 6 months post-booster vaccination. Follow-up visits will be performed at Days 4, 8, 15, 29, and Months 3 and 6, to assess the safety, tolerability, and immunogenicity of Prime-2-CoV_Beta. Additional safety and tolerability data will be assessed 1 day and 2 days after booster vaccination (Days 2 and 3) by telephone. A total of 60 participants is planned to be vaccinated in 5 cohorts of 12 participants each. Dose ranging of Prime-2-CoV_Beta will be done by dose escalation with doses ranging from 3x10000 plaque forming units (PFUs) up to 3x10 000 000 PFUs
Investigators
Sponsor Clinical Trial Contact
Scientific
Universitaetsklinikum Tuebingen AöR
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1
Prime-2-CoV_Beta, dose: 30 000 PFUs
Intervention: Prime-2-CoV_Beta
Cohort 2
Prime-2-CoV_Beta, dose: 300 000 PFUs
Intervention: Prime-2-CoV_Beta
Cohort 3
Prime-2-CoV_Beta, dose: 3 000 000 PFUs
Intervention: Prime-2-CoV_Beta
Cohort 4
Prime-2-CoV_Beta, dose: 150 000 000 PFUs
Intervention: Prime-2-CoV_Beta
Cohort 5
Prime-2-CoV_Beta, dose: 30 000 000 PFUs
Intervention: Prime-2-CoV_Beta
Outcomes
Primary Outcomes
Proportion of participants with unsolicited treatment-emergent adverse events throughout the study
Time Frame: Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)
All unsolicited adverse events which occur after the first administration of investigational product are defined as treatment-emergent adverse events. Treatment-emergent adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events) and presented by system organ class and preferred term, as well as by severity.
Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study
Time Frame: Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)
All safety data will be summarized descriptively overall and by cohort. TEAEs will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events) and presented by system organ class and preferred term, as well as by severity.
Proportion of participants with solicited local adverse events (first 7 days after Prime-2-CoV_Beta booster vaccination): pain at injection site, redness, induration, and swelling.
Time Frame: Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)
Solicited local adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events).
Proportion of participants with solicited systemic adverse events (first 7 days after Prime-2-CoV_Beta booster vaccination): fever, fatigue, headache, chills, vomiting, nausea, diarrhea, new or worsened muscle pain, new or worsened joint pain.
Time Frame: Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)
Solicited systemic adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events).
Secondary Outcomes
- Geometric mean titers (GMT) of receptor-binding protein-specific IgG antibodies(Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days))
- Proportion of participants with adverse events of special interest throughout the study(Day 1 (vaccination day) to day 8 (Visit 3; ±1 day))
- Level of neutralizing antibody titers versus SARS CoV-2 (Wuhan wild type) at each post-booster vaccination assessment(Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days))
- Geometric mean fold rise (GMFR) of neutralizing antibodies (versus Wuhan wild type) from Baseline to each post-booster vaccination assessment(Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days))
- IgG antibody titer versus SARS-CoV-2 receptor-binding protein(Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days))
- Geometric mean fold rise of receptor-binding protein-specific IgG antibodies from Baseline(Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days))