Evidence map›Paper›PMID 33488576›Full record

ArticleFrontiers in immunology2020

Photochemical Internalization Enhanced Vaccination Is Safe, and Gives Promising Cellular Immune Responses to an HPV Peptide-Based Vaccine in a Phase I Clinical Study in Healthy Volunteers.

Tone Otterhaug, Sylvia Janetzki, Marij J P Welters, Monika Håkerud, Anne Grete Nedberg, Victoria Tudor Edwards, Sanne Boekestijn, Nikki M Loof, Pål Kristian Selbo, Hans Olivecrona and 2 more

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

Article in Frontiers in immunology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 17% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Enhancing antitumour immunity with photodynamic therapy.Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology · 2025
    Article
  5. Review
  6. Article
  7. Tailoring biomaterials for vaccine delivery.Journal of nanobiotechnology · 2024
    Review
  8. Review
  9. Vaccine adjuvants: mechanisms and platforms.Signal transduction and targeted therapy · 2023
    Review
  10. Emerging adjuvants for intradermal vaccination.International journal of pharmaceutics · 2023
    Review
  11. Review
  12. Review
  13. Review
  14. Article
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

12 authors at 3 institutions in 2 countries.

Tone OtterhaugPCI Biotech AS, Oslo, Norway.
Sylvia JanetzkiZellNet Consulting, Inc., Fort Lee, NJ, United States.
Marij J P WeltersDepartment of Medical Oncology, Oncode Institute, Leiden University Medical Center, Leiden, Netherlands.
Monika HåkerudPCI Biotech AS, Oslo, Norway.
Anne Grete NedbergPCI Biotech AS, Oslo, Norway.
Victoria Tudor EdwardsPCI Biotech AS, Oslo, Norway.
Sanne BoekestijnDepartment of Medical Oncology, Oncode Institute, Leiden University Medical Center, Leiden, Netherlands.
Nikki M LoofDepartment of Medical Oncology, Oncode Institute, Leiden University Medical Center, Leiden, Netherlands.
Pål Kristian SelboDepartment of Radiation Biology, Institute for Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
Hans OlivecronaPCI Biotech AS, Oslo, Norway.
Sjoerd H van der BurgDepartment of Medical Oncology, Oncode Institute, Leiden University Medical Center, Leiden, Netherlands.
Anders HøgsetPCI Biotech AS, Oslo, Norway.
Leiden University Medical Center · NLOslo University Hospital · NOPCI Biotech (Norway) · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and Aims: Photochemical internalization (PCI) is a technology for inducing release of endocytosed antigens into the cell cytosol Methods: The primary objective of the study was to assess the safety and local tolerance of PCI mediated vaccination, and to identify a safe fimaporfin dose for later clinical studies. A secondary objective was to analyze the immunological responses to the vaccination. Each subject received 3 doses of HPV16 E7 peptide antigens and two doses of Keyhole Limpet Hemocyanin (KLH) protein. A control group received Hiltonol and vaccine antigens only, whereas the PCI groups in addition received fimaporfin + light. Local and systemic adverse effects were assessed by standard criteria, and cellular and humoral immune responses were analyzed by ELISpot, flow cytometry, and ELISA assays. Results: 96 healthy volunteers were vaccinated with fimaporfin doses of 0.75-50 µg. Doses below 17.5 µg were safe and tolerable, higher doses exhibited local tolerability issues in some study subjects, mainly erythema, and pain during illumination. There were few, and only mild and expected systemic adverse events. The employment of PCI increased the number of subjects exhibiting a T-cell response to the HPV peptide vaccine about 10-fold over what was achieved with the antigen/Hiltonol combination without PCI. Moreover, the use of PCI seemed to result in a more consistent and multifunctional CD8+ T-cell response. An enhancement of the humoral immune response to KLH vaccination was also observed. Conclusions: Using PCI in combination with Hiltonol for intradermal vaccination is safe at fimaporfin doses below 17.5 µg, and gives encouraging immune responses to peptide and protein based vaccination.

Indexed as

AdultCells, CulturedFemaleHealthy VolunteersHuman papillomavirus 16HumansImmunity, CellularLightingMaleMiddle AgedPapillomavirus E7 ProteinsPapillomavirus InfectionsPapillomavirus VaccinesPeptidesPhotochemical ProcessesPhotosensitizing Agentsoncogene protein E7, human papilloma virus type 45Papillomavirus E7 ProteinsPapillomavirus VaccinesPeptidesPhotosensitizing AgentsVaccines, Subunitimmunologic adjuvantmultifunctional T-cells, phase I study photochemical enhancement of T-cell responsespeptide vaccinesphotochemical internalizationvaccine delivery

Identifiers

PMID33488576
PMCPMC7819858
OpenAlexW3118897378

What OpenQuestion holds

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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 OpenQuestion graph.