SepsisPhase 4VACIRiSSNCT03565159
Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors
A Phase 4 study testing Prevenar 13 and Sodium Chloride 0.9% in people with Sepsis, run by Guy's and St Thomas' NHS Foundation Trust at 12 sites in United Kingdom.
Trial summary
The VACIRiSS trial is a phase-IV, multi-centre placebo controlled randomised trial of conjugate pneumococcal vaccine in adult sepsis survivors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Prevenar 13 and Sodium Chloride 0.9%
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- 2 Aug 2018to 31 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Belfast Health and Social Care Trust
Belfast
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 2QQ
NHS Lothian
Edinburgh, EH16 4SA
Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Aneurin Bevan University Health Board
Newport, NP20 2EF
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
Portsmouth Hospitals NHS Trust
Portsmouth, PO6 3LY
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, SR4 7TP
About this study
The VACIRiSS trial is a phase-IV, multi-centre placebo controlled randomised trial of conjugate pneumococcal vaccine in adult sepsis survivors.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Prevenar 13, Sodium Chloride 0.9%
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar 13Biological
Pneumococcal polysaccharide conjugate vaccine
Sodium Chloride 0.9%Other
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Prevenar 13 | Active comparator | A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label. Receives: 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. Receives: Other: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary - Time to Event
Comparison of the time taken for infection related rehospitalisation or death between intervention and control arms.
Measured: Up to 365 days
Secondary outcomes (5)
Secondary - Precision Estimates
Outcome event data to inform future definitive trial, including:
- proportion of rehospitalisation
Measured: Up to 365 days
Secondary - Precision Estimates
- proportions of reinfections
Measured: Up to 365 days
Secondary - Precision Estimates
- proportions of reinfection related rehospitalisation
Measured: Up to 365 days
Secondary - Precision Estimates
- time to first all cause rehospitalisation and
Measured: Up to 365 days
Secondary - Precision Estimates
- time to first infection requiring antibiotic therapy
Measured: Up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start2 Aug 2018
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Manu Shankar-Hari, PhD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust and King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565159
- Sponsor's protocol ID
- 430321
- Other IDs
- 2017-002236-17, 2017
- Acronym
- VACIRiSS
- Status last verified
- Nov 2023
- First submitted
- 25 May 2018
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Shankar-Hari M, Smith P, Szakmany T, Summers C, McGuigan PJ, Brealey D, Hopkins P, Creagh Brown B, Pogson D, McKechnie S, Rostron A, Fish M, Jennings A, Hoekstra R, Rynne J, Ghnewa Y, Cape A, Rahman A, Palmer-Joyce J, Viola T, Ostermann M, Pearce E, Goldblatt D, Rubenfeld G, Rowan K, Walsh TS, Singer M, Spencer J, McAuley DF, Harrison DA. A randomized, placebo-controlled trial of 13-valent pneumococcal conjugate vaccination to accelerate immune recovery after sepsis. Sci Transl Med. 2026 Aug 12;18(862):eaeb4113. doi: 10.1126/scitranslmed.aeb4113. Epub 2026 Aug 12.
PubMed 42585292
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors
- ClinicalTrials.gov ID
- NCT03565159
- Acronym / sponsor ID
- VACIRiSS / 430321
- Conditions
- Sepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The VACIRiSS trial is a phase-IV, multi-centre placebo controlled randomised trial of conjugate pneumococcal vaccine in adult sepsis survivors.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomised 1:1 to receive one single 0.5ml dose of active or placebo Investigational Medicinal Product at baseline.
| Arm | Type | Receives |
|---|---|---|
| Prevenar 13 | Active comparator | Biological: Prevenar 13A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label. |
| Sodium chloride 0.9% | Placebo comparator | Other: Sodium Chloride 0.9%A volume of 0.5ml will be drawn up into a syringe and labelled with an Annex 13 label. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevenar 13Pneumococcal polysaccharide conjugate vaccine | Biological | Prevenar 13 |
| Sodium Chloride 0.9%Placebo | Other | Sodium chloride 0.9% |
Primary outcome
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.
5 secondary outcomes
Secondary - Precision Estimates
Time frame: Up to 365 days
Secondary - Precision Estimates
Time frame: Up to 365 days
Secondary - Precision Estimates
Time frame: Up to 365 days
Secondary - Precision Estimates
Time frame: Up to 365 days
Secondary - Precision Estimates
Time frame: Up to 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 42585292Shankar-Hari M, Smith P, Szakmany T, Summers C, McGuigan PJ, Brealey D, Hopkins P, Creagh Brown B, Pogson D, McKechnie S, Rostron A, Fish M, Jennings A, Hoekstra R, Rynne J, Ghnewa Y, Cape A, Rahman A, Palmer-Joyce J, Viola T, Ostermann M, Pearce E, Goldblatt D, Rubenfeld G, Rowan K, Walsh TS, Singer M, Spencer J, McAuley DF, Harrison DA. A randomized, placebo-controlled trial of 13-valent pneumococcal conjugate vaccination to accelerate immune recovery after sepsis. Sci Transl Med. 2026 Aug 12;18(862):eaeb4113. doi: 10.1126/scitranslmed.aeb4113. Epub 2026 Aug 12.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manu Shankar-Hari, PhD principal investigator
Guy's and St Thomas' NHS Foundation Trust and King's College London
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prevenar 13 and Sodium Chloride 0.9% in people with Sepsis, run by Guy's and St Thomas' NHS Foundation Trust at 12 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary - Time to Event (time frame: Up to 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03565159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.