Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    VACIRISS
Previous Study | Return to List | Next Study

Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors (VACIRiSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03565159
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:
The VACIRiSS trial is a phase-IV, multi-centre placebo controlled randomised trial of conjugate pneumococcal vaccine in adult sepsis survivors.

Condition or disease Intervention/treatment Phase
Sepsis Biological: Prevenar 13 Other: Sodium Chloride 0.9% Phase 4

Detailed Description:
The aim of VACIRiSS trial is to evaluate the immunogenicity and heterologous effects of single dose 13-valent conjugate pneumococcal vaccine (PCV-13) in preventing infection related rehospitalisation in sepsis survivors and to collect outcome event data with necessary precision to inform future definitive trial design.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomised 1:1 to receive one single 0.5ml dose of active or placebo Investigational Medicinal Product at baseline.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Active Comparator: Prevenar 13
A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label.
Biological: Prevenar 13
Pneumococcal polysaccharide conjugate vaccine

Placebo Comparator: Sodium chloride 0.9%
A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label.
Other: Sodium Chloride 0.9%
Placebo




Primary Outcome Measures :
  1. Primary - Time to Event [ Time Frame: Up to 365 days ]
    Comparison of the time taken for infection related rehospitalisation or death between intervention and control arms.


Secondary Outcome Measures :
  1. Secondary - Precision Estimates [ Time Frame: Up to 365 days ]

    Outcome event data to inform future definitive trial, including:

    - proportion of rehospitalisation


  2. Secondary - Precision Estimates [ Time Frame: Up to 365 days ]
    - proportions of reinfections

  3. Secondary - Precision Estimates [ Time Frame: Up to 365 days ]
    - proportions of reinfection related rehospitalisation

  4. Secondary - Precision Estimates [ Time Frame: Up to 365 days ]
    - time to first all cause rehospitalisation and

  5. Secondary - Precision Estimates [ Time Frame: Up to 365 days ]
    - time to first infection requiring antibiotic therapy


Other Outcome Measures:
  1. Exploratory - Immune recovery patterns [ Time Frame: Day 0 (baseline) to Day 90 ]

    Differences between the intervention and control arms of the following:

    anti-pneumococcal antibody


  2. Exploratory - Immune recovery patterns [ Time Frame: Day 0 (baseline) to Day 90 ]

    Differences between the intervention and control arms of the following:

    B cell subsets, T cell subsets and monocyte HLA-DR and PD-1 expression), function and leukocyte transcriptome




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who meet all the following inclusion criteria are eligible to participate in the trial.

  • Male or female adult patients aged 18 years or older on the date of screening for the trial
  • Registered with a General Practitioner
  • Reason for admission to intensive care unit or high dependence unit (HDU) was sepsis
  • Clinical condition has improved and the patient is ready for step down to HDU or ward based care in the next 24 - 48 hours
  • Provision of written informed consent by the patient OR by patient's Legal Representative OR Professional Consultee.

Exclusion Criteria:

Patients who meet one or more of the following will be excluded from the trial.

  • Core temperature ≥38.0°C within the past 24 hours prior to study IMP administration. As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
  • Hypersensitivity reaction (e.g., anaphylaxis) to any component of Prevenar 13 or any diphtheria toxoid-containing vaccine.
  • Recent vaccination defined as any vaccination administered to subjects within 7 days of enrolment.
  • Pregnant and lactating women.
  • Limitations of care set including not for resuscitation, not for readmission to critical care.
  • Residence in a nursing home, long-term care facility, or other institution, or requirement of semiskilled nursing care. (An ambulatory subject who was a resident of a retirement home or village is eligible for the trial.)
  • As the IMP is administered intra muscularly, coagulopathy defined as platelet count less than 50 x 109/L and/or International Normalized Ratio (INR) greater than 1.3. For this exclusion criteria bloods taken within 72 hours of screening are valid. If these standard of care blood results are not available, then these should form part of the screening bloods for assessing eligibility.
  • Splenectomy (previous or in the current admission)
  • Diagnosis of pneumococcal sepsis in the current admission
  • APACHE II score defined Immune deficiency or suppression, defined as presence of 1 or more of the following conditions:
  • Documented human immunodeficiency virus (HIV) infection at any time-point pre-trial. If previous results are not available and/or current admission is not due to HIV infection, these patients do not need new testing and are considered eligible for the trial.
  • leukaemia (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
  • lymphoma (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years) Hodgkin disease (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
  • multiple myeloma (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
  • malignancy (defined as presence of any malignancy that had been treated by or had been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
  • chronic renal failure (defined as receipt of renal dialysis or transplant) or nephrotic syndrome
  • receipt of immunosuppressive therapy, including steroids, within 3 months of study vaccine administration (For corticosteroids, prednisone or equivalent 0.5 mg/kg/day for 14 days or longer. Inhaled, intra- articular, and topical steroids are not considered immunosuppressive).
  • Receipt of an organ or bone marrow transplant with ongoing immunosuppressive medications. Failed previous transplant patients not currently on immunosuppression are eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565159


Contacts
Layout table for location contacts
Contact: Noelia Pitrelli, MPhil 02071887188 ext 53378 noelia.pitrelli@gstt.nhs.uk
Contact: Joanne Palmer, MSc 02071887188 ext 53378 Joanne.PalmerJoyce@gstt.nhs.uk

Locations
Layout table for location information
United Kingdom
Belfast Health and Social Care Trust Recruiting
Belfast, United Kingdom
Principal Investigator: Prof Danny McAuley         
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB2 2QQ
Principal Investigator: Dr Charlotte Summers         
NHS Lothian Recruiting
Edinburgh, United Kingdom, EH16 4SA
Principal Investigator: Dr Timothy Walsh         
Royal Surrey County Hospital NHS Foundation Trust Recruiting
Guildford, United Kingdom, GU2 7XX
Principal Investigator: Dr Ben Creagh-Brown         
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1 2BU
Principal Investigator: Dr David Brealey         
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Manu Shankar Hari, MD, PhD, FFICM       manu.shankar-hari@kcl.ac.uk   
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Principal Investigator: Dr Phil Hopkins         
Manchester University NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M13 9WL
Principal Investigator: Dr Tim Felton         
Aneurin Bevan University Health Board Recruiting
Newport, United Kingdom, NP20 2EF
Principal Investigator: Dr Tamas Szakmany         
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, United Kingdom, OX3 9DU
Principal Investigator: Dr Matthew Rowland         
Portsmouth Hospitals NHS Trust Recruiting
Portsmouth, United Kingdom, PO6 3LY
Principal Investigator: Dr David Pogson         
South Tyneside and Sunderland NHS Foundation Trust Not yet recruiting
Sunderland, United Kingdom, SR4 7TP
Principal Investigator: Dr Anthony Rostron         
Taunton and Somerset NHS Foundation Trust Recruiting
Taunton, United Kingdom, TA1 5DA
Principal Investigator: Dr Richard Innes         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
Layout table for investigator information
Principal Investigator: Manu Shankar-Hari, PhD Guy's and St Thomas' NHS Foundation Trust and King's College London
Layout table for additonal information
Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03565159    
Other Study ID Numbers: 430321
2017-002236-17 ( EudraCT Number )
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs