Evidence map›Paper›PMID 36109788›Full record

ArticleTrials2022

Rapamycin and inulin for booster vaccine response stimulation (RIVASTIM)-rapamycin: study protocol for a randomised, controlled trial of immunosuppression modification with rapamycin to improve SARS-CoV-2 vaccine response in kidney transplant recipients.

Matthew Tunbridge, Griffith B Perkins, Julian Singer, Tania Salehi, Tracey Ying, Branka Grubor-Bauk, Simon Barry, Beatrice Sim, Pravin Hissaria, Steven J Chadban and 1 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. CD8Cell reports. Medicine · 2026
    Review
  2. CD56Clinical & translational immunology · 2026
    Article
  3. Article
  4. Review
  5. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

Matthew Tunbridge *Central and Northern Adelaide Renal and Transplantation Service (CNARTS), The Royal Adelaide Hospital, Adelaide, South Australia, Australia. Matthew.Tunbridge@sa.gov.au.ORCID http://orcid.org/0000-0001-8814-1008
Griffith B Perkins *School of Biological Sciences, The University of Adelaide, Adelaide, South Australia, Australia.
Julian Singer *Department of Renal Medicine, Kidney Centre, Royal Prince Alfred Hospital, Sydney, Australia.
Tania SalehiCentral and Northern Adelaide Renal and Transplantation Service (CNARTS), The Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Tracey YingDepartment of Renal Medicine, Kidney Centre, Royal Prince Alfred Hospital, Sydney, Australia.
Branka Grubor-BaukDiscipline of Medicine, Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.
Simon BarryDiscipline of Medicine, Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.
Beatrice SimCentral and Northern Adelaide Renal and Transplantation Service (CNARTS), The Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Pravin HissariaDepartment of Immunology, The Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Steven J Chadban *Department of Renal Medicine, Kidney Centre, Royal Prince Alfred Hospital, Sydney, Australia.
P Toby Coates *Central and Northern Adelaide Renal and Transplantation Service (CNARTS), The Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Royal Adelaide Hospital · AUThe University of Sydney · AUBasil Hetzel Institute · AUSouth Australia Pathology · AUWomen's and Children's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Kidney transplant recipients are at an increased risk of severe COVID-19-associated hospitalisation and death. Vaccination has been a key public health strategy to reduce disease severity and infectivity, but the effectiveness of COVID vaccines is markedly reduced in kidney transplant recipients. Urgent strategies to enhance vaccine efficacy are needed.

methodsRIVASTIM-rapamycin is a multicentre, randomised, controlled trial examining the effect of immunosuppression modification prior to a third dose of COVID-19 vaccine in kidney transplant recipients who have failed to develop protective immunity to a 2-dose COVID-19 vaccine schedule. Participants will be randomised 1:1 to either remain on standard of care immunosuppression with tacrolimus, mycophenolate, and prednisolone (control) or cease mycophenolate and commence sirolimus (intervention) for 4 weeks prior to and following vaccination. The primary outcome is the proportion of participants in each trial arm who develop protective serological neutralisation of live SARS-CoV-2 virus at 4-6 weeks following a third COVID-19 vaccination. Secondary outcomes include SARS-CoV-receptor binding domain IgG, vaccine-specific immune cell populations and responses, and the safety and tolerability of sirolimus switch. DISCUSSION: Immunosuppression modification strategies may improve immunological vaccine response. We hypothesise that substituting the mTOR inhibitor sirolimus for mycophenolate in a triple drug regimen will enhance humoral and cell-mediated responses to COVID vaccination for kidney transplant recipients.

trial registrationAustralia New Zealand Clinical Trials Registry ACTRN12621001412820. Registered on 20 October 2021; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382891&isReview=true.

Indexed as

COVID-19COVID-19 VaccinesImmunosuppressive AgentsKidney TransplantationHumansImmunoglobulin GImmunosuppression TherapyInulinMulticenter Studies as TopicPrednisoloneRandomized Controlled Trials as TopicSARS-CoV-2SirolimusTacrolimusTOR Serine-Threonine KinasesCOVID-19 VaccinesImmunoglobulin GImmunosuppressive AgentsInulinPrednisoloneSirolimusTacrolimusTOR Serine-Threonine KinasesCOVID-19ImmunosuppressionKidney transplantationRandomised controlled trialSARS-CoV-2SirolimusVaccination

Identifiers

PMID36109788
PMCPMC9477178
OpenAlexW4295929530

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.