ISRCTN15354495已完成3 期
A Phase III, multicentre, randomised trial comparing SARS-CoV-2 re-boost vaccine strategies in immunocompromised patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 804
研究概览
简要总结
2024 Results article in https://doi.org/10.1016/S2665-9913(24)00065-1 (added 20/08/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =18 years
- •2. Have an inadequate response to two doses of SARS-CoV-2 vaccine measured at least 14 days after receipt of the second vaccine, defined by SARS-CoV-2 spike antibody response. An inadequate response is defined as:
- •2.1. Antibody non-response: SARS-CoV-2 anti-spike antibodies below the level of detection using the PHE Roche platform [or equivalent] =8 AU/ml, or
- •2.2. Antibody low-response: SARS-CoV-2 anti-spike antibodies >8 and <400 AU/mL using the Roche platform [or equivalent])
- •2.3. There is no agreed international/WHO cut off for titres of AU following vaccination and serologic assessment. As such, the low responder status for OCTAVE-DUO eligibility is by definition arbitrary. We have examined the serology levels obtained in the OCTAVE study, compared with PITCH (health care workers without vulnerable conditions) and elected to choose a titre that equates to approximately 30% of the OCTAVE population – this equates to approx. 400 AU hence this selection for this part of the eligibility criteria. Since in practice all vulnerable groups will receive a re-boost in due course, by choosing the lowest tertile for evaluation of enhancement of response, we are maximising the pragmatic value of the study in terms of policy advice, and determination of the magnitude of the immune response, representing our primary outcome. Moreover, we are thereby ensuring rapid and representative recruitment from the variety of vulnerable patient groups in the study protocol.
- •3. Anticipated life expectancy of 6 months or greater.
- •4. Fall into one (or more) of the following patient cohorts who will meet disease-relevant classification, disease state, and staging according to established international standards:
- •4.1. Diagnosed with any of the following solid cancers:
- •4.1.1. Breast
- •4.1.2. Lung
- •4.2. Diagnosed with any of the following lymphoid malignancy categories:
- •4.2.1. Aggressive B-NHL
- •4.2.2 Chronic lymphocytic leukemia (CLL)
- •4.2.3. Hodgkin Lymphoma
- •4.2.4. Indolent B NHL (except CLL and small lymphocytic lymphoma [SLL])
- •4.2.5. Myeloma
- •4.3.Diagnosed with the following rheumatic/inflammatory conditions:
- •4.3.1. Rheumatoid arthritis
- •4.3.2. Psoriatic arthritis
- •4.3.3. Seronegative arthritis
- •4.3.4. Spondyloarthritis
- •4.3.5. ANCA-associated vasculitis
- •4.3.6. Systemic lupus erythematosus (SLE)
- •4.3.7. Psoriasis
- •4.3.8. Crohn’s disease/ulcerative colitis
- •4.3.9. Autoimmune hepatitis
- •4.4. Diagnosed with the following chronic renal conditions:
- •4.4.1. End-stage kidney disease secondary to any cause
- •4.4.2. Renal transplant following end-stage kidney disease
- •4.5. Diagnosed with the following chronic liver conditions:
- •4.5.1. Liver cirrhosis
- •4.5.2. Liver transplantation
- •4.6. Chronic liver disease (of any stage) on immune suppressive therapy
- •4.6.1. Diagnosed with gastrointestinal disease and on immune suppressive therapy
- •4.7. Diagnosed with primary antibody deficiency: defined as any patient who is on immunoglobulin replacement therapy or any patient with an IgG <4g/l and on prophylactic antibiotics.
- •4.8. Haematopoietic stem cell transplant:
- •4.8.1. Previously treated with autologous or allogenic haematopoietic stem cell transplant for any indication and with any conditioning regimens and intensities
- •4.8.2. Previously treated with CAR-T cell therapies
- •5. Participant is willing and able to comply with trial requirements.
- •6. For the randomised sub-study only, female participants of childbearing potential* must be willing to ensure that they or their par
排除标准
- •1. Receipt of any vaccine within 30 days before trial entry, with the exception of a SARS-CoV2 vaccine which is allowed =14 days prior, or a flu vaccination which is allowed =7 days prior
- •2. For aggressive B-NHL or Hodgkin lymphoma only, participants on active systemic treatment or within 4 weeks of completion of systemic treatment
- •3. Any known contraindications as specified in the applicable product information (see Section 7.1) including but not limited to:
- •3.1. Known allergy or hypersensitivity to any of the trial IMPs or any of the trial drug excipients
- •3.2. History of anaphylaxis
- •4. In the judgement of the Investigator the patient is unsuitable to participate in the trial or is unlikely to comply with trial procedures
- •5. For the randomised sub-study only, patients who are pregnant at trial entry or planning to become pregnant within 3 months after re-vaccination
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