A Phase IV Open-Label, Non-Randomized, Multi-Cohort, Multicenter Study in Previously Unvaccinated Immunocompromised Adults to Determine the Immunogenicity and Safety of AZD1222 Vaccine for the Prevention of COVID-19. (VICTORIA)

Study type

• Study type:
  Clinical trial
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  The aim of this study is to assess the immunogenicity and safety of AZD1222 for prevention of COVID-19 in immunocompromised adults.

Clinical trials

• Clinical trial phase:
  Therapeutic use (Phase IV)
• Clinical trial randomisation:
  Non-randomised clinical trial

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX03) covid-19 vaccines

  covid-19 vaccines
• Medical condition to be studied:
  COVID-19 immunisation

  COVID-19

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  34

Study design details

• Main study objective:
  The purpose of this study is to demonstrate the immunogenicity and safety of AZD1222, AstraZeneca’s approved ChAdOx1 vector vaccine against SARS-CoV-2, in SARS-CoV-2 seronegative immunocompromised individuals who are unvaccinated.
• Outcomes:
  1. SARS-CoV-2 specific titres in SARS-CoV-2 naïve immunocompromised adults and immunocompetent adults ≥ 18 years Time Frame: 28 days after dosing 2. Seroresponse of SARS-CoV-2 specific titres (≥ 4-fold rise in titres from baseline) in SARS-CoV-2 naïve immunocompromised adults and immunocompetent adults ≥ 18 years Time Frame: 28 days after dosing , 1) Reactogenicity: Incidence of local and systemic solicited AEs for 7 days after each dose of AZD1222 by eDiary. 2) Incidence of unsolicited AEs for 28 days post dose after each vaccination. 3) Incidence of SAEs, MAAEs and AESIs from Day 1 post treatment to Day 365. 4) Absolute and change from baseline for safety lab measures.
• Data analysis plan:
  There was no formal statistical hypothesis testing planned for this study. All analyses – safety and immunogenicity – were descriptive. As the study was terminated prematurely due to recruitment challenges, analyses were streamlined, and no summaries were produced by individual immunocompromised cohort. No comparisons were done between the immunocompromised and immunocompetent cohorts. Antibody titers (pseudoneutralizing and anti-spike) were summarized as geometric mean titers with 95% confidence intervals based on the lognormal distribution. Seroresponse (4-fold increase in titers compared to baseline) was reported as percentage and 95% exact Clopper-Pearson confidence intervals. The primary analysis timepoint was 28 days post dose 2, a secondary analysis timepoint summarized post dose 3 antibody titers. Exploratory endpoints of nucleocapsid antibodies and anti-vector antibodies were performed similarly to primary and secondary immunogenicity analyses.