ArticleCancer immunology, immunotherapy : CII2021
A phase 1, single centre, open label, escalating dose study to assess the safety, tolerability and immunogenicity of a therapeutic human papillomavirus (HPV) DNA vaccine (AMV002) for HPV-associated head and neck cancer (HNC).
Article in Cancer immunology, immunotherapy : CII, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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Who cites it
24 citing papers in PubMed, 32 citations in OpenAlex.
- Toward next-generation therapeutic HPV vaccines: A review on expanding the antigen repertoire and an integrated bioinformatics selection framework.Human vaccines & immunotherapeutics · 2026Review
- Trends in immunotherapy for oral squamous cell carcinoma.Cellular oncology (Dordrecht, Netherlands) · 2025Review
- Review
- Unraveling the immunomodulatory role of TIM-3 in head and neck squamous cell carcinoma: implications for targeted therapy.Discover oncology · 2025Review
- Update: Immunotherapeutic Strategies in HPV-Associated Head and Neck Squamous Cell Carcinoma.Viruses · 2025Review
- Roles of human papillomavirus in cancers: oncogenic mechanisms and clinical use.Signal transduction and targeted therapy · 2025Review
- Therapeutic vaccines targeting HPV epitopes in human papillomavirus - positive oropharyngeal cancer: a critical review.Frontiers in immunology · 2025Review
- A phase Ib study to assess the safety of the human papillomavirus DNA vaccine (AMV002) in combination with durvalumab for HPV-associated oropharyngeal squamous cell carcinoma.Frontiers in oncology · 2024Article
- Current status and future directions for the development of human papillomavirus vaccines.Frontiers in immunology · 2024Review
- Article
- Vaccinating against cancer: getting to prime time.Journal for immunotherapy of cancer · 2023Review
- Review
- Review
- Review
- Treatment Options in Early Stage (Stage I and II) of Oropharyngeal Cancer: A Narrative Review.Medicina (Kaunas, Lithuania) · 2022Review
- Therapeutic DNA Vaccines against HPV-Related Malignancies: Promising Leads from Clinical Trials.Viruses · 2022Review
- Current status and perspective of tumor immunotherapy for head and neck squamous cell carcinoma.Frontiers in cell and developmental biology · 2022Review
- Prevention and treatment of human papillomavirus in men benefits both men and women.Frontiers in cellular and infection microbiology · 2022Review
- Prophylactic and Therapeutic HPV Vaccines: Current Scenario and Perspectives.Frontiers in cellular and infection microbiology · 2022Review
- An Update on the Immunotherapy for Oropharyngeal Squamous Cell Carcinoma.Frontiers in oncology · 2022Review
Corrections and comments
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Authors and funding
12 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe conducted a phase 1 dose escalation study (ACTRN12618000140257 registered on 30/01/2018) to evaluate the safety, tolerability and immunogenicity of a therapeutic human papillomavirus (HPV) DNA vaccine (AMV002) in subjects previously treated for HPV-associated oropharyngeal squamous cell carcinoma (OPSCC).
methodsEligible subjects had to have no evidence of recurrent and/or metastatic disease at least 12 weeks following the completion of treatment. Three dosing cohorts each consisted of four subjects: group 1: 0.25 mg/dose, group 2: 1 mg/dose, group 3: 4 mg/dose. AMV002 was delivered intradermally on days 0, 28 and 56. Incidence and severity of treatment-emergent adverse events (TEAE) including local reaction at the injection site, and vaccination compliance were recorded. T cell and antibody responses to HPV16 E6 and E7 were measured by interferon gamma (IFN-γ) enzyme-linked immunosorbent spot (ELISpot) assay and enzyme-linked immunosorbent assay (ELISA).
resultsAll subjects completed the vaccination programme and experienced mild discomfort at the injection site(s). Pre-immunisation, cell-mediated responses to HPV16 E6 and E7 were evident in all subjects, and E7-specific antibodies were detected in 11 (91.7%), reflecting previous exposure to HPV. Post-vaccination, 10 of 12 (83.3%) subjects responded to one or more of the E6 and/or E7 peptide pools, while 2 (16.7%) did not show additional vaccine-induced cell-mediated responses. Vaccination resulted in a ≥ 4-fold increase in anti-HPV16 E7 antibody titre in one subject in group 3.
conclusionsAMV002 was well tolerated at all dose levels and resulted in enhanced specific immunity to virus-derived tumour-associated antigens in subjects previously treated for HPV-associated OPSCC.
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