NCT03565159

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for phase_4 sepsis

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_4 sepsis

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 2, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

5.1 years

First QC Date

May 25, 2018

Last Update Submit

November 22, 2023

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Primary - Time to Event

    Comparison of the time taken for infection related rehospitalisation or death between intervention and control arms.

    Up to 365 days

Secondary Outcomes (5)

  • Secondary - Precision Estimates

    Up to 365 days

  • Secondary - Precision Estimates

    Up to 365 days

  • Secondary - Precision Estimates

    Up to 365 days

  • Secondary - Precision Estimates

    Up to 365 days

  • Secondary - Precision Estimates

    Up to 365 days

Other Outcomes (2)

  • Exploratory - Immune recovery patterns

    Day 0 (baseline) to Day 90

  • Exploratory - Immune recovery patterns

    Day 0 (baseline) to Day 90

Study Arms (2)

Prevenar 13

ACTIVE COMPARATOR

A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label.

Biological: Prevenar 13

Sodium chloride 0.9%

PLACEBO COMPARATOR

A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label.

Other: Sodium Chloride 0.9%

Interventions

Prevenar 13BIOLOGICAL

Pneumococcal polysaccharide conjugate vaccine

Prevenar 13
Sodium Chloride 0.9%OTHER

Placebo

Sodium chloride 0.9%

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)
  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Belfast Health and Social Care Trust

Belfast, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 2QQ, United Kingdom

Location

NHS Lothian

Edinburgh, EH16 4SA, United Kingdom

Location

Royal Surrey County Hospital NHS Foundation Trust

Guildford, GU2 7XX, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Aneurin Bevan University Health Board

Newport, NP20 2EF, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

South Tyneside and Sunderland NHS Foundation Trust

Sunderland, SR4 7TP, United Kingdom

Location

MeSH Terms

Conditions

Sepsis

Interventions

13-valent pneumococcal vaccineSodium Chloride

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Manu Shankar-Hari, PhD

    Guy's and St Thomas' NHS Foundation Trust and King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomised 1:1 to receive one single 0.5ml dose of active or placebo Investigational Medicinal Product at baseline.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2018

First Posted

June 21, 2018

Study Start

August 2, 2018

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
Undecided
Access Criteria
Undecided

Locations

GB(12)