Immunogenicity of third dose COVID-19 vaccine strategies in patients who are immunocompromised with suboptimal immunity following two doses (OCTAVE-DUO): an open-label, multicentre, randomised, controlled, phase 3 trial
Authors' conclusion
A third vaccine dose improved the serological and T-cell response in the majority of patients who are immunocompromised.
Study context
- Population
- Immunocompromised patients aged ≥18 years with sub-optimal responses to two doses of SARS-CoV-2 vaccine, nine disease cohorts, 11 UK hospitals
- Participants
- 804 patients9 disease cohorts
- Comparison
- Third COVID-19 vaccine dose with BNT162b2 vs mRNA-1273
- BNT162b2n = 377
- mRNA-1273n = 374
- NVX-CoV2373n = 53
- Primary endpoint
- Vaccine-specific immunity: anti-SARS-CoV-2 spike antibodies and T-cell responses before and 21 days after the third dose
- Follow-up
- 21 days after the third dose
Methodological detailsphase 3, open-label, multicentre, prospective, stratified by disease, previous vaccination type and anti-spike antibody response, Individuals with lived experience of immune susceptibility were involved in study design and implementation
- Phase 3
- Open-label
- Multicentre
- Prospective
- Stratified by disease, previous vaccination type and anti-spike antibody response
- Individuals with lived experience of immune susceptibility were involved in study design and implementation
Primary result
As reported in the abstract
Anti-SARS-CoV-2 spike antibodies, 21 days after third dose vs pre-third dose baseline (all participants)
- Post-third dose anti-spike antibodies, median (IQR 4.3-7990.0)
- 1384 AU/mL
- Baseline pre-third dose anti-spike antibodies, median (IQR 0.4-63.1)
- 11.5 AU/mL
- Post-third dose vs baseline
- p<0.001
- Detectable T-cell responses after third dose
- 494 (80%) of 616
Further findings
Baseline low responders increasing antibody concentrations to >400 AU/mL
- Low responders with >400 AU/mL
- 380 (90%) of 423
Baseline non-responders with no response after third dose
- Non-responders with no response
- 166 (54%) of 308
Deaths
- Deaths during the trial, none vaccine-related
- 7 (1%)
Safety
Serious adverse events (24 in total; two [8%] vaccine-related)
- Serious adverse events (24 in total; two [8%] vaccine-related): percentages are of the 24 serious adverse events
Original publication
Immunogenicity of third dose COVID-19 vaccine strategies in patients who are immunocompromised with suboptimal immunity following two doses (OCTAVE-DUO): an open-label, multicentre, randomised, controlled, phase 3 trial. Lancet Rheumatol. Published 8 May 2024. doi:10.
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