Clinical trial · Interventional
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
A Randomized, Double-blind, Placebo-controlled, First-in-Human, Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women With HPV16 or 18 Infection of the Cervix
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrolment and increasing COVID restrictions, following an earlier enrolment pause in April made it clear that completion of the study would not be feasible
Summary
Brief summary (as posted)
The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ad26.HPV16 | Biological | — | UNRESOLVED |
| Ad26.HPV18 | Biological | — | UNRESOLVED |
| MVA.HPV16/18 | Biological | — | UNRESOLVED |
| Placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18
- description
- Participants will receive a dose of adenovirus serotype 26 (Ad26)-human papillomavirus (HPV)16 or HPV18 (Ad26.HPV16 or Ad26.HPV18) as prime immunization and a dose of Modified Vaccinia Ankara (MVA)-HPV16/18 (MVA.HPV16/18) as boost immunization.
- interventionNames
- Biological: Ad26.HPV16
- Biological: Ad26.HPV18
- Biological: MVA.HPV16/18
- type
- EXPERIMENTAL
- label
- Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18
- description
- Participants will receive a double dose of Ad26.HPV16 or Ad26.HPV18 as prime immunization and a dose of MVA.HPV16/18 as boost immunization.
- interventionNames
- Biological: Ad26.HPV16
- Biological: Ad26.HPV18
- Biological: MVA.HPV16/18
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to adhere to the prohibitions and restrictions specified in this protocol * Must have an human papillomavirus (HPV) type 16 or 18 infection of the cervix as determined by a qualitative PCR test within 8 weeks prior to screening or at the time of screening. Available history of high-risk (HR)-HPV positivity and HPV16 or HPV18 positivity positivity will be recorded * Must have a recent colposcopy result (with a maximum of 12 months old at screening); in case a colposcopy has not been performed before, it will be done as screening procedure * Contraceptive (birth control) use by participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies * Agrees not to donate blood until 3 months after receiving the last dose of study vaccine Exclusion Criteria: * In case cytology results are available, participant has current or history of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma in situ (AIS) or any high-grade vulvar, vaginal or anal intraepithelial neoplasia * Current or history of cervical intraepithelial neoplasia (CIN)2+ or cervical cancer * Confirmed co-infection with both HPV16 and HPV18 * History of an underlying clinically significant acute or chronic medical condition, other than infection with HPV, or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * Tests positive for human immunodeficiency virus (HIV) at screening * Chronic active hepatitis B or hepatitis C infection, verified at screening by hepatitis B surface antigen or anti-hepatitis C virus antibody, respectively * Vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators * Exposed to at least 1 dose of an HPV prophylactic vaccine or participant has participated in the past in another preventive or therapeutic HPV vaccine study * Clinically significant gynecological abnormalities that could, in the judgment of the investigator, interfere with study evaluation (for example \[e.g.\], prolapse, myoma, fibroid, hysterectomy) * Symptomatic vaginal or genital infection (including genital herpes) as confirmed by physician or investigator
References
Publications (0)
Data not yet available