Evidence map›Paper›PMID 30699178›Full record

Trial reportPloS one2019

Re-boost immunizations with the peptide-based therapeutic HIV vaccine, Vacc-4x, restores geometric mean viral load set-point during treatment interruption.

Jürgen K Rockstroh, David Asmuth, Giuseppe Pantaleo, Bonaventura Clotet, Daniel Podzamczer, Jan van Lunzen, Keikawus Arastéh, Ronald Mitsuyasu, Barry Peters, Nozza Silvia and 4 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 34% 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

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Peptides for Vaccine Development.ACS applied bio materials · 2022
    Review
  5. Review
  6. Review
  7. Article
  8. Conserved multiepitope vaccine constructs: A potent HIV-1 therapeutic vaccine in clinical trials.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    Review
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

14 authors at 12 institutions in 7 countries.

Jürgen K RockstrohBonn University Hospital, HIV Outpatient Clinic, Bonn, Germany.
David AsmuthUniversity of California Davis Medical Center, Division of Infectious Diseases, Sacramento, California, United States of America.
Giuseppe PantaleoLausanne University Hospital, Division of Immunology and Allergy, Lausanne, Switzerland.
Bonaventura ClotetHospital Universitari Germans Trias i Pujol, Department of Infectious Diseases, Badalona, Spain.
Daniel PodzamczerUniversity de Bellvitge, The HIV Unit, Barcelona, Spain.
Jan van LunzenUniversity Medical Center Hamburg-Eppendorf, Department of Medicine, Hamburg, Germany.
Keikawus ArastéhEPIMED c/o Vivantes Auguste-Viktoria Hospital, Berlin, Germany.
Ronald MitsuyasuUCLA CARE Center, Department of Medicine, Los Angeles, California, United States of America.
Barry PetersGuys and St. Thomas' Hospital Trust, Guys Hospital, Harrison Wing, London, United Kingdom.
Nozza SilviaSan Raffaele Hospital, Department of Infectious Diseases, Milan, Italy.
Darren JolliffeS-Cubed Biometrics Ltd. Oxfordshire, United Kingdom.
Mats ÖkvistBionor Immuno AS, Oslo, Norway.
Kim KrogsgaardKLIFO, Glostrup, Denmark.
Maja A SommerfeltBionor Immuno AS, Oslo, Norway.ORCID 0000-0003-4934-4042
Bionor (Norway) · NOAuguste-Viktoria-Klinik · DEBellvitge University Hospital · ESGlostrup Hospital · DKGuy's Hospital · GBHospital Universitari Germans Trias i Pujol · ESUCLA Health · USUniversität Hamburg · DEUniversity Hospital Bonn · DEUniversity of California Davis Medical Center · USUniversity of Lausanne · CHZimmer Biomet (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVacc-4x, a therapeutic HIV vaccine candidate has previously induced a significant reduction in viral load (VL) set-point compared to placebo upon interruption of combination anti-retroviral therapy (ART) (2007/1 study). This study, (2012/1), explored the potential to maintain Vacc-4x effect by re-boosting eligible 2007/1 study participants.

methodsParticipant inclusion required 2007/1 participants to have completed all Vacc-4x immunizations and interrupted ART for up to 26 weeks. At weeks (wk)0 and 2, participants received intradermal (i.d.) Vacc-4x booster immunizations (1.2mg) on ART with GM-CSF (60μg) i.d. as a local adjuvant. ART was interrupted for up to 16 weeks (wk12-wk28). Participants were then followed on ART until wk36. VL set-point, total proviral DNA (pvDNA) and immunogenicity assessed by IFN-γ ELISPOT, T-cell proliferation and delayed type hypersensitivity (DTH) reactions were compared to participants' values in the 2007/1 study where available.

resultsThis open, multicenter, clinical study enrolled 33 participants from 9 clinical trial sites in the US and Europe. In the per-protocol (PP) population, the VL set-point geometric mean (GM) 18162 copies/mL was not significantly changed compared to the 2007/1 study (GM VL 22035 copies/mL), (p = 0.453, n = 18). For participants with available preART VL values, the VL set-point (GM 26279 copies/mL) remained significantly lower than the preART VL set-point (GM 74048 copies/mL, p = 0.021, n = 13). A statistically significant reduction in pvDNA (49%) from baseline to wk4 was observed (p = 0.03, n = 26). DTH responses (wk4) increased significantly from baseline (p = 0.006, n = 30) and compared to the 2007/1 study (p = 0.022, n = 29) whilst the proportion of participants with ELISPOT and T-cell proliferation responses was similar between the two studies.

conclusionsVacc-4x booster immunizations safely maintained the mean VL set-point at that established following primary Vacc-4x therapeutic immunization. The reduction in pvDNA during ART supports the potential for Vacc-4x immunization to reduce HIV reservoirs and thereby contribute to combination HIV cure strategies.

Indexed as

Viral LoadAdultAIDS VaccinesAnti-HIV AgentsCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesDrug Administration ScheduleFemaleFollow-Up StudiesHIV InfectionsHumansHypersensitivity, DelayedImmunization ScheduleImmunization, SecondaryLymphocyte ActivationLymphocyte CountAIDS VaccinesAnti-HIV AgentsVacc-4x

Identifiers

PMID30699178
PMCPMC6353572
OpenAlexW2912770391

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.