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NCT03610581

Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix

Terminated Phase 1, PHASE2 Results posted Last updated 4 February 2025
What this trial tests

Phase 1, PHASE2 trial testing Ad26.HPV16 in Human Papillomavirus Infections in 9 participants. Terminated before completion.

Timeline
27 September 2018
Primary endpoint
15 October 2020
15 October 2020

Quick facts

Lead sponsorJanssen Vaccines & Prevention B.V.
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingtriple
Primary purposetreatment
Enrollment9
Start date27 September 2018
Primary completion15 October 2020
Estimated completion15 October 2020
Sites12 locations across Belgium, United States

Drugs / interventions tested

Conditions studied

Sponsor

Janssen Vaccines & Prevention B.V. — full company profile →

Who can join

Adults 18 to 60, female only, with Human Papillomavirus Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Solicited Local Adverse Events (AEs) Primary · Up to 7 days after each vaccination (Up to Day 64)

Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling.

Post- Dose 1
GroupValue95% CI
Regimen 12
Placebo0
Post- Dose 2
GroupValue95% CI
Regimen 11
Placebo0
Number of Participants With Solicited Systemic AEs Primary · Up to 7 days after each vaccination (Up to Day 64)

Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, chills, and fever.

Post-Dose 1
GroupValue95% CI
Regimen 14
Placebo0
Post-Dose 2
GroupValue95% CI
Regimen 11
Placebo0
Number of Participants With Unsolicited AEs Primary · 28 days after each vaccination (Up to Day 85)

Number of participants with unsolicited AEs were reported. Unsolicited AEs included all AEs for which the participant was not specifically questioned in the participant diary.

Post-Dose 1
GroupValue95% CI
Regimen 12
Placebo1
Post-Dose 2
GroupValue95% CI
Regimen 10
Placebo0
Number of Participants With Serious Adverse Events (SAEs) Primary · Up to 12 months after the first vaccination (target visit Day 366)

Number of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

GroupValue95% CI
Regimen 10
Placebo0
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Secondary · Day 57, Day 78, Day 239, and Day 366

Percentage of participants with HPV-Specific CD4+ T-cell responses for IFNg+ to peptide pools were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Day 57: E2
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E2
GroupValue95% CI
Regimen 133.30.8 – 90.6
Placebo00 – 70.8
Day 239: E2
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 366: E2
GroupValue95% CI
Regimen 100 – 84.2
Placebo00 – 70.8
Day 57: E6/E7
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E6/E7
GroupValue95% CI
Regimen 133.30.8 – 90.6
Placebo00 – 70.8
Day 239: E6/E7
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 366: E6/E7
GroupValue95% CI
Regimen 100 – 84.2
Placebo00 – 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Secondary · Day 57, Day 78, Day 239, and Day 366

Percentage of participants with HPV-Specific CD4+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Day 57: E2
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E2
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 239: E2
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 366: E2
GroupValue95% CI
Regimen 100 – 84.2
Placebo00 – 70.8
Day 57: E6/E7
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E6/E7
GroupValue95% CI
Regimen 133.30.8 – 90.6
Placebo00 – 70.8
Day 239: E6/E7
GroupValue95% CI
Regimen 133.30.8 – 90.6
Placebo00 – 70.8
Day 336: E6/E7
GroupValue95% CI
Regimen 100 – 84.2
Placebo00 – 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Secondary · Day 57, Day 78, Day 239, and Day 366

Percentage of participants with HPV-Specific CD4+ T-cell responses for TNF a+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Day 57: E2
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E2
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 239: E2
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 366: E2
GroupValue95% CI
Regimen 100 – 84.2
Placebo00 – 70.8
Day 57: E6/E7
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E6/E7
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 239: E6/E7
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 366: E6/E7
GroupValue95% CI
Regimen 100 – 84.2
Placebo00 – 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Secondary · Day 57, Day 78, Day 239, and Day 366

Percentage of participants with HPV-Specific CD8+ T-cell responses for IFNg+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Day 57: E2
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E2
GroupValue95% CI
Regimen 110029.2 – 100
Placebo00 – 70.8
Day 239: E2
GroupValue95% CI
Regimen 166.79.4 – 99.2
Placebo00 – 70.8
Day 366: E2
GroupValue95% CI
Regimen 1501.3 – 98.7
Placebo00 – 70.8
Day 57: E6/E7
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E6/E7
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 239: E6/E7
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 366: E6/E7
GroupValue95% CI
Regimen 100 – 84.2
Placebo00 – 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Secondary · Day 57, Day 78, Day 239, and Day 366

Percentage of participants with HPV-Specific CD8+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Day 57: E2
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E2
GroupValue95% CI
Regimen 166.79.4 – 99.2
Placebo00 – 70.8
Day 239: E2
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 366: E2
GroupValue95% CI
Regimen 1501.3 – 98.7
Placebo00 – 70.8
Day 57: E6/E7
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E6/E7
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 239: E6/E7
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 366: E6/E7
GroupValue95% CI
Regimen 100 – 84.2
Placebo00 – 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Secondary · Day 57, Day 78, Day 239, and Day 366

Percentage of participants with HPV-Specific CD8+ T-cell responses for TNFa+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Day 57: E2
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E2
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 239: E2
GroupValue95% CI
Regimen 133.30.8 – 90.6
Placebo00 – 70.8
Day 366: E2
GroupValue95% CI
Regimen 100 – 84.2
Placebo00 – 70.8
Day 57: E6/E7
GroupValue95% CI
Regimen 100 – 60.2
Placebo00 – 60.2
Day 78: E6/E7
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 239: E6/E7
GroupValue95% CI
Regimen 100 – 70.8
Placebo00 – 70.8
Day 366: E6/E7
GroupValue95% CI
Regimen 100 – 84.2
Placebo00 – 70.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 12 months after the first vaccination (target visit Day 366). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Regimen 1
Serious: 0/5 (0%)
Deaths: 0/5
Placebo
Serious: 0/4 (0%)
Deaths: 0/4
Other adverse events (5 terms — click to expand)

ReactionSystemRegimen 1Placebo
Increased Tendency to BruiseBlood and lymphatic system disorders——
Upper Respiratory Tract InfectionInfections and infestations——
Urinary Tract InfectionInfections and infestations——
Vulvovaginal Mycotic InfectionInfections and infestations——
SyncopeNervous system disorders——

Data from ClinicalTrials.gov NCT03610581 adverse events section.

Sponsor's own description

The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Therapeutic Vaccines for HPV-Associated Malignancies.
    Smalley Rumfield C, Roller N, Pellom ST, Schlom J, et al · · 2020 · cited 87× · PMID 33117742 · DOI 10.2147/itt.s273327
  2. Current and future direction in treatment of HPV-related cervical disease.
    Khairkhah N, Bolhassani A, Najafipour R. · · 2022 · cited 44× · PMID 35478255 · DOI 10.1007/s00109-022-02199-y
  3. Review of the Standard and Advanced Screening, Staging Systems and Treatment Modalities for Cervical Cancer.
    Boon SS, Luk HY, Xiao C, Chen Z, et al · · 2022 · cited 34× · PMID 35740578 · DOI 10.3390/cancers14122913
  4. Vaccination Strategies for the Control and Treatment of HPV Infection and HPV-Associated Cancer.
    Farmer E, Cheng MA, Hung CF, Wu TC. · · 2021 · cited 28× · PMID 33200366 · DOI 10.1007/978-3-030-57362-1_8
  5. NF-κB as an Important Factor in Optimizing Poxvirus-Based Vaccines against Viral Infections.
    Struzik J, Szulc-Dąbrowska L. · · 2020 · cited 8× · PMID 33260450 · DOI 10.3390/pathogens9121001
  6. Viral vector-based therapeutic HPV vaccines.
    Ji T, Liu Y, Li Y, Li C, et al · · 2024 · cited 3× · PMID 39196444 · DOI 10.1007/s10238-024-01470-5
  7. Clinical research progress and challenges of vaccine for human papillomavirus-associated cancers.
    Xue L, Li X, Guo X, Xing H, et al · · 2026 · PMID 42179134 · DOI 10.1080/21645515.2026.2676391
  8. An Ad26‐MVA‐BN‐based therapeutic vaccine targeting HPV16 and HPV18 related disease is immunogenic in preclinical models and in women with persistent HPV infections
    Khan S, Boedhoe S, Baert M, Serroyen J, et al · · 2026

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing