Phase 3
N=1,025
Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls
Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04508309 ↗Enrolled (actual)
1,025
Serious AEs
1.6%
Results posted
Jan 2025
Primary outcome: Primary: Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose — 1507.4; 2408.7; 3326.1; 1352.4 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cecolin® (Biological); Gardasil® (Biological)
- Age
- Pediatric · 9+ yrs
- Sex
- Female
- Sponsor
- PATH
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose |
1507.4; 2408.7; 3326.1; 1352.4; 2387.3 | — |
| PRIMARY Geometric Mean Concentration of Anti-HPV-18 Immunoglobulin G Antibodies One Month After the Second Dose |
382.7; 534.7; 535.2; 306.1; 379.0 | — |
| SECONDARY Geometric Mean Titer (GMT) of Anti-HPV-16 Neutralizing Antibodies |
104.0; 95.1; 125.7; 71.6; 125.4; 16790.9 | — |
| SECONDARY Geometric Mean Titer (GMT) of Anti-HPV-18 Neutralizing Antibodies |
65.9; 51.1; 77.9; 47.6; 55.8; 6081.5 | — |
| SECONDARY Seroconversion Rate For HPV-16 One Month After the Second Dose |
100; 100; 100; 100; 100 | — |
| SECONDARY Seroconversion Rate For HPV-18 One Month After the Second Dose |
100; 100; 100; 100; 100 | — |
| SECONDARY GMC of Anti-HPV-16 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen |
1352.4; 2387.3 | — |
| SECONDARY GMC of Anti-HPV-18 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen |
306.1; 379.0 | — |
| SECONDARY GMC of Anti-HPV-16 IgG Antibodies 18-Months After Second Dose |
138.5; 119.1 | — |
| SECONDARY GMC of Anti-HPV-18 IgG Antibodies 18-Months After Second Dose |
30.2; 23.2 | — |
| SECONDARY Number of Participants With Solicited Adverse Events |
4; 15; 2; 12; 5; 12 | — |
| SECONDARY Number of Participants With Unsolicited Adverse Events |
43; 41; 46; 52; 34 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
4; 0; 5; 4; 3 | — |
Summary
This randomized controlled trial will evaluate a bivalent HPV vaccine, Cecolin®, in alternate 2-dose regimens, compared to an established HPV vaccine. Gardasil® will be used as the comparator vaccine, as this vaccine is most widely used in low- and low-middle income countries.
Eligibility Criteria
Inclusion Criteria
- Healthy (determined by investigator's assessment following medical history and physical examination, laboratory evaluation could be performed at the investigator's discretion) female between the ages of 9 - 14 years (all inclusive) at time of enrollment
- Ability and willingness to provide parental consent and, if applicable based on local in-country regulations, participant assent
- Parent/Legally Acceptable Representative provides informed consent
- Anticipated ability and willingness to complete all study visits and evaluations
- Living within the catchment area of the study without plans to move during the conduct of the study
Exclusion Criteria
- Presence of fever or acute disease on the day of vaccination (oral or axillary temperature ≥ 38˚ C)
- If participants have childbearing potential, must not be breastfeeding or confirmed pregnant
- Receipt of an investigational product within 30 days prior to randomization
- Receipt of blood and/or blood products (including immunoglobulin) 3 months prior to any dose of vaccination or blood sampling
- Receipt of a live virus vaccine (varicella virus containing vaccine, any measles, mumps, or rubella virus containing vaccine such as Measles, Mumps, and Rubella (MMR), or yellow fever vaccine but not including live attenuated influenza virus vaccine) 4 weeks prior and after each dose of HPV vaccine
- History of any physical, mental, or developmental disorder that may hinder a participant's ability to comply with the study requirements
- Any malignancy or confirmed or suspected immunodeficient condition such as HIV infection, based on medical history and physical examination
- Receipt of or history of receipt of any medications or treatments that affect the immune system
- Allergies to any components of the vaccine
- Current or former participation in HPV vaccine related research.
- Prior receipt of an investigational or licensed HPV vaccine
- Any other condition(s) that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant unable to comply with the protocol
Data sourced from ClinicalTrials.gov (NCT04508309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.