Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls

A Phase 3 study testing Cecolin® and Gardasil® in people with Cervical Cancer, run by PATH at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 9 to 14 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Cancer
What is being tested?: Cecolin® and Gardasil®
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,025 participants
Where: 2 sitesin 2 countries
Study dates: 15 Mar 2021to 14 Dec 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 14 years
Women only
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Bangladesh1 site

International Centre for Diarrhoeal Disease Research
Dhaka

Other trials in Bangladesh

Ghana1 site

Malaria Research Centre, Agogo Presbyterian Hospital
Agogo

Other trials in Ghana

About this study

Official title: Phase 3 Randomized, Active-Comparator Controlled, Open-Label Trial to Evaluate the Immunogenicity & Safety of Alternate 2-Dose Regimens of Cecolin® Compared to Gardasil® in 9-14 Year-Old Girls in Low and Low-Middle Income Countries

Read the detailed description

This randomized, active-comparator controlled, open-label study will enroll total of approximately 1025 girls aged 9 to 14 years, in one country in Africa (Ghana) and one country in South/Southeast Asia (Bangladesh). Participants will be randomized 1:1:1:1:1 to receive Cecolin® at 0 and 6 months, 0 and 12 months, or 0 and 24 months, Gardasil® at 0 and 6 months, or Gardasil® at 0 months and Cecolin® at 24 months. For each arm, blood will be collected for immunologic testing at baseline and one month following second dose. Additional blood collections will occur immediately prior to the administration of the second dose, as well as at additional later time points, for immunobridging to other published and ongoing trials. The study also aims to evaluate the performance of a mixed arm (group 5) of Gardasil® followed by Cecolin® and collect data on effects of interchangeability.

Girls of target age will be identified, and their parents contacted to attend an informational session for individual discussion, informed consent, assent and randomization.

The study will be conducted by the research groups in International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) in Bangladesh and the Malaria Research Center (MRC) in Ghana.

Conditions: Cervical Cancer
Being tested: Cecolin®, Gardasil®
Medical subject headings: Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cecolin®Biological
Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine
Gardasil®Biological
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine

Study groups in NCT04508309
Study group	Role	What they receive
Cecolin® at 0 and 6 months	Experimental	Two doses of Cecolin® given at 0 and 6 months with blood draw at baseline, prior to second dose, one-month post second dose and 24 months after first dose Receives: Biological: Cecolin®
Cecolin® at 0 and 12 months	Experimental	Two doses of Cecolin® given at 0 and 12 months with blood draw at baseline, prior to second dose and one-month post second dose Receives: Biological: Cecolin®
Cecolin® at 0 and 24 months	Experimental	Two doses of Cecolin® given at 0 and 24 months with blood draw at baseline, prior to second dose and one-month post second dose Receives: Biological: Cecolin®
Gardasil® at 0 and 6 months	Active comparator	Two doses of Gardasil® given at 0 and 6 months with blood draw at baseline, prior to second dose, one-month post second dose and 24 months after first dose Receives: Biological: Gardasil®
Gardasil® at 0 and Cecolin® at 24 months	Other	One dose of Gardasil® at 0 months and one dose of Cecolin® at 24 months with blood draw at baseline, prior to second dose and one-month post second dose. Receives: Biological: Cecolin®; Biological: Gardasil®

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose
Anti-HPV-16 IgG antibodies were measured using HPV-16 virus-like particle (VLP) enzyme-linked immunosorbent assay (ELISA) one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 assay was 1.41 international units (IU)/mL.
Measured: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Geometric Mean Concentration of Anti-HPV-18 Immunoglobulin G Antibodies One Month After the Second Dose
Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 assay was 1.05 IU/mL.
Measured: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).

Secondary outcomes (11)

Geometric Mean Titer (GMT) of Anti-HPV-16 Neutralizing Antibodies
Anti-HPV 16 serum neutralizing antibodies were measured in a subset of participants by pseudovirion-based neutralization assay (PBNA) at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 PBNA was a titer of < 21.
Samples were collected prior to the second dose and 1 month after the second dose for all treatment groups, and 18 months after the second dose for participants in Groups 1 and 4.
Measured: Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 only
Geometric Mean Titer (GMT) of Anti-HPV-18 Neutralizing Antibodies
Anti-HPV 18 serum neutralizing antibodies were measured in a subset of participants by pseudovirion-based neutralization assay (PBNA) at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 PBNA was a titer of < 16.
Samples were collected prior to the second dose and 1 month after the second dose for all treatment groups, and 18 months after the second dose for participants in Groups 1 and 4.
Measured: Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 only
Seroconversion Rate For HPV-16 One Month After the Second Dose
Seroconversion rate is defined as the percentage of participants with a 4-fold rise in anti-HPV 16 IgG antibodies as measured by ELISA from baseline one month following the second dose.
Measured: Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Seroconversion Rate For HPV-18 One Month After the Second Dose
Seroconversion rate is defined as the percentage of participants with a 4-fold rise from baseline in anti HPV-18 IgG antibodies as measured by ELISA one month following the second dose.
Measured: Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
GMC of Anti-HPV-16 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen
Anti-HPV-16 IgG antibodies were measured using HPV-16 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 assay was 1.41 IU/mL.
Anti-HPV-16 IgG GMCs measured 1 month after the second dose were compared between the Gardasil at Month 0 and Cecolin at 24 months two-dose regimen (Group 5) and the Gardasil at Month 0 and 6 two-dose regimen (Group 4).
Measured: One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).
GMC of Anti-HPV-18 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen
Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 assay was 1.405 IU/mL.
Anti-HPV-18 IgG GMCs measured 1 month after the second dose were compared between the Gardasil at Month 0 and Cecolin at 24 Months two-dose regimen (Group 5) and the Gardasil at Month 0 and 6 two-dose regimen (Group 4).
Measured: One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).
GMC of Anti-HPV-16 IgG Antibodies 18-Months After Second Dose
Anti-HPV-16 IgG antibodies were measured using HPV-16 VLP ELISA 18 months after the second dose for participants who received a 6-month dosing regimen (Groups 1 and 4) only.
Measured: 18 months after the second dose (Month 24)
GMC of Anti-HPV-18 IgG Antibodies 18-Months After Second Dose
Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA 18 months after the second dose for participants who received a 6-month dosing regimen (Groups 1 and 4) only.
Measured: 18 months after the second dose (Month 24)
Number of Participants With Solicited Adverse Events
Solicited adverse events (AEs) were assessed by study staff 30 minutes after each vaccination and then daily for seven days after each vaccination by the participants using a memory aid.
The following specific solicited AEs were monitored for this trial:
- Local Reactions:
- Pain, erythema/redness, swelling, induration, pruritus, abscess.
- General/Systemic Reactions:
- Fever (oral or axillary temperature ≥ 38.0°C), headache, vomiting, nausea, fatigue, chills, muscle pain, cough, diarrhea, dizziness, allergic dermatitis, rash, syncope, and anorexia.
Measured: For 30 minutes after each vaccination and for up to 7 days after each vaccination
Number of Participants With Unsolicited Adverse Events
Unsolicited AEs were any AEs reported spontaneously by the participant, identified during interview at study visits, observed by the study personnel during study visits or those identified during review of medical records or source documents. Unsolicited AEs were events occurring from the time of each study injection through approximately 30 days after each vaccination. Solicited AEs with onset after the solicitation period and through Day 30 post-vaccination were captured as unsolicited AEs.
Measured: For 30 days after each dose (Month 0 (all groups), Month 6 (Groups 1 and 4), Month 12 (Group 2), and Month 24 (Groups 3 and 5)
Number of Participants With Serious Adverse Events (SAEs)
An SAE was any AE that resulted in any of the following outcomes:
1. Death
2. Was life-threatening
3. Required inpatient hospitalization or prolongation of existing hospitalization.
4. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
5. Congenital abnormality or birth defect.
6. Important medical event that may not have resulted in one of the above outcomes but may have jeopardized the health of the study participant or (and) required medical or surgical intervention to prevent one of the outcomes listed in the above definition of SAEs.
SAEs were collected from the time of first vaccination through the end of the study for each participant.
Measured: From first dose through the end of study (up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202114 Dec 2023

First posted11 Aug 2020
Study start15 Mar 2021
Primary completion14 Dec 2023
Study completion14 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,025 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04508309
Sponsor's protocol ID: CVIA-087
Status last verified: Dec 2024
First submitted: 4 Aug 2020
Last updated: 30 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zaman K, Schuind AE, Adjei S, Antony K, Aponte JJ, Buabeng PB, Qadri F, Kemp TJ, Hossain L, Pinto LA, Sukraw K, Bhat N, Agbenyega T. Safety and immunogenicity of Innovax bivalent human papillomavirus vaccine in girls 9-14 years of age: Interim analysis from a phase 3 clinical trial. Vaccine. 2024 Apr 2;42(9):2290-2298. doi: 10.1016/j.vaccine.2024.02.077. Epub 2024 Mar 1.
PubMed 38431444
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PubMed 41276263
Agbenyega T, Schuind AE, Adjei S, Antony K, Aponte JJ, Buabeng PBY, Clemens JD, Hossain L, Kemp TJ, Mercer LD, Pinto LA, Qadri F, Sukraw K, Bhat N, Zaman K. Immunogenicity and safety of an Escherichia coli-produced bivalent human papillomavirus vaccine (Cecolin) in girls aged 9-14 years in Ghana and Bangladesh: a randomised, controlled, open-label, non-inferiority, phase 3 trial. Lancet Infect Dis. 2025 Aug;25(8):861-872. doi: 10.1016/S1473-3099(25)00031-3. Epub 2025 Mar 19.
PubMed 40120597

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Randomized, Active-Comparator Controlled, Open-Label Trial to Evaluate the Immunogenicity & Safety of Alternate 2-Dose Regimens of Cecolin® Compared to Gardasil® in 9-14 Year-Old Girls in Low and Low-Middle Income Countries
ClinicalTrials.gov ID: NCT04508309
Acronym / sponsor ID: CVIA-087
Conditions: Cervical Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,025 participants (actual)
Lead sponsor: PATHUniversity, hospital or other
Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh, Malaria Research Centre, Agogo Presbyterian Hospital, Ghana, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., USA, The Emmes Company, LLC, Xiamen Innovax Biotech Co., Ltd
Study start: 15 Mar 2021 (actual)
Primary completion: 14 Dec 2023 (actual)
Study completion: 14 Dec 2023 (actual)
First posted: 11 Aug 2020 (actual)
Results: Posted 30 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Girls of target age will be identified, and their parents contacted to attend an informational session for individual discussion, informed consent, assent and randomization.

The study will be conducted by the research groups in International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) in Bangladesh and the Malaria Research Center (MRC) in Ghana.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Cecolin® at 0 and 6 months	Experimental	Biological: Cecolin®Two doses of Cecolin® given at 0 and 6 months with blood draw at baseline, prior to second dose, one-month post second dose and 24 months after first dose
Cecolin® at 0 and 12 months	Experimental	Biological: Cecolin®Two doses of Cecolin® given at 0 and 12 months with blood draw at baseline, prior to second dose and one-month post second dose
Cecolin® at 0 and 24 months	Experimental	Biological: Cecolin®Two doses of Cecolin® given at 0 and 24 months with blood draw at baseline, prior to second dose and one-month post second dose
Gardasil® at 0 and 6 months	Active comparator	Biological: Gardasil®Two doses of Gardasil® given at 0 and 6 months with blood draw at baseline, prior to second dose, one-month post second dose and 24 months after first dose
Gardasil® at 0 and Cecolin® at 24 months	Other	Biological: Cecolin®, Biological: Gardasil®One dose of Gardasil® at 0 months and one dose of Cecolin® at 24 months with blood draw at baseline, prior to second dose and one-month post second dose.

Who may qualify

Ages: 9 to 14 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cecolin®Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine	Biological	Cecolin® at 0 and 12 months, Cecolin® at 0 and 24 months, Cecolin® at 0 and 6 months, Gardasil® at 0 and Cecolin® at 24 months
Gardasil®Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine	Biological	Gardasil® at 0 and 6 months, Gardasil® at 0 and Cecolin® at 24 months

Primary outcome

Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose
Time frame: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Anti-HPV-16 IgG antibodies were measured using HPV-16 virus-like particle (VLP) enzyme-linked immunosorbent assay (ELISA) one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 assay was 1.41 international units (IU)/mL.
Geometric Mean Concentration of Anti-HPV-18 Immunoglobulin G Antibodies One Month After the Second Dose
Time frame: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 assay was 1.05 IU/mL.

11 secondary outcomes

Geometric Mean Titer (GMT) of Anti-HPV-16 Neutralizing Antibodies
Time frame: Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 only
Geometric Mean Titer (GMT) of Anti-HPV-18 Neutralizing Antibodies
Time frame: Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 only
Seroconversion Rate For HPV-16 One Month After the Second Dose
Time frame: Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Seroconversion Rate For HPV-18 One Month After the Second Dose
Time frame: Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
GMC of Anti-HPV-16 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen
Time frame: One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).
GMC of Anti-HPV-18 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen
Time frame: One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).
GMC of Anti-HPV-16 IgG Antibodies 18-Months After Second Dose
Time frame: 18 months after the second dose (Month 24)
GMC of Anti-HPV-18 IgG Antibodies 18-Months After Second Dose
Time frame: 18 months after the second dose (Month 24)
Number of Participants With Solicited Adverse Events
Time frame: For 30 minutes after each vaccination and for up to 7 days after each vaccination
Number of Participants With Unsolicited Adverse Events
Time frame: For 30 days after each dose (Month 0 (all groups), Month 6 (Groups 1 and 4), Month 12 (Group 2), and Month 24 (Groups 3 and 5)
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From first dose through the end of study (up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5)

Results and safety

Results posted to the registry on 30 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1. Cecolin at Month 0 and 6	205	205
2. Cecolin at Month 0 and 12	206	206
3. Cecolin at Month 0 and 24	204	203
4. Gardasil at Month 0 and 6	205	204
5. Gardasil at Month 0 and Cecolin at Month 24	205	203

Primary outcome: Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose

Time frame: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).. Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	1. Cecolin at Month 0 and 6 n = 198	2. Cecolin at Month 0 and 12 n = 189	3. Cecolin at Month 0 and 24 n = 190	4. Gardasil at Month 0 and 6 n = 194	5. Gardasil at Month 0 and Cecolin at Month 24 n = 193
Value	1507.4 (1329.0 to 1709.7)	2408.7 (2116.0 to 2741.8)	3326.1 (2960.6 to 3736.7)	1352.4 (1199.1 to 1525.3)	2387.3 (2091.4 to 2725.1)

1. Cecolin at Month 0 and 6 vs 4. Gardasil at Month 0 and 6: GMC Ratio: 1.09 (98.3% CI 0.891 to 1.327)
2. Cecolin at Month 0 and 12 vs 4. Gardasil at Month 0 and 6: GMC Ratio: 1.78 (98.3% CI 1.455 to 2.176)
3. Cecolin at Month 0 and 24 vs 4. Gardasil at Month 0 and 6: GMC Ratio: 2.37 (98.3% CI 1.942 to 2.903)

Population analysed: The Per Protocol Population includes participants who had no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine, were HPV-16 antibody negative at baseline, and had a valid serology result one month after second dose.

Primary outcome: Geometric Mean Concentration of Anti-HPV-18 Immunoglobulin G Antibodies One Month After the Second Dose

Time frame: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).. Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	1. Cecolin at Month 0 and 6 n = 200	2. Cecolin at Month 0 and 12 n = 198	3. Cecolin at Month 0 and 24 n = 191	4. Gardasil at Month 0 and 6 n = 197	5. Gardasil at Month 0 and Cecolin at Month 24 n = 192
Value	382.7 (337.8 to 433.6)	534.7 (469.4 to 609.1)	535.2 (474.9 to 603.3)	306.1 (269.3 to 347.9)	379.0 (327.7 to 438.3)

1. Cecolin at Month 0 and 6 vs 4. Gardasil at Month 0 and 6: GMC Ratio: 1.25 (98.3% CI 1.022 to 1.539)
2. Cecolin at Month 0 and 12 vs 4. Gardasil at Month 0 and 6: GMC Ratio: 1.68 (98.3% CI 1.372 to 2.069)
3. Cecolin at Month 0 and 24 vs 4. Gardasil at Month 0 and 6: GMC Ratio: 1.71 (98.3% CI 1.389 to 2.102)

Population analysed: The Per Protocol Population includes participants who had no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine, were HPV-18 antibody negative at baseline, and had a valid serology result one month after second dose.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1. Cecolin at Month 0 and 6	4 of 205 (2%)	155 of 205 (75.6%)	0 of 205
2. Cecolin at Month 0 and 12	0 of 206 (0%)	145 of 206 (70.4%)	0 of 206
3. Cecolin at Month 0 and 24	5 of 204 (2.5%)	130 of 204 (63.7%)	0 of 204
4. Gardasil at Month 0 and 6	4 of 205 (2%)	165 of 205 (80.5%)	0 of 205
5. Gardasil at Month 0 and Cecolin at Month 24	3 of 205 (1.5%)	145 of 205 (70.7%)	1 of 205

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 38431444Zaman K, Schuind AE, Adjei S, Antony K, Aponte JJ, Buabeng PB, Qadri F, Kemp TJ, Hossain L, Pinto LA, Sukraw K, Bhat N, Agbenyega T. Safety and immunogenicity of Innovax bivalent human papillomavirus vaccine in girls 9-14 years of age: Interim analysis from a phase 3 clinical trial. Vaccine. 2024 Apr 2;42(9):2290-2298. doi: 10.1016/j.vaccine.2024.02.077. Epub 2024 Mar 1.
Derived from this study: PubMed 41276263Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
Derived from this study: PubMed 40120597Agbenyega T, Schuind AE, Adjei S, Antony K, Aponte JJ, Buabeng PBY, Clemens JD, Hossain L, Kemp TJ, Mercer LD, Pinto LA, Qadri F, Sukraw K, Bhat N, Zaman K. Immunogenicity and safety of an Escherichia coli-produced bivalent human papillomavirus vaccine (Cecolin) in girls aged 9-14 years in Ghana and Bangladesh: a randomised, controlled, open-label, non-inferiority, phase 3 trial. Lancet Infect Dis. 2025 Aug;25(8):861-872. doi: 10.1016/S1473-3099(25)00031-3. Epub 2025 Mar 19.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cecolin® and Gardasil® in people with Cervical Cancer, run by PATH at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Bangladesh, Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose (time frame: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04508309, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.