A Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls/Women Aged 15 to 20 Years in Zambia (CervALONE)

March 23, 2026 updated by: Ravivarman Lakshmanasamy, International Agency for Research on Cancer

A Randomized, Active Controlled, Assessors-blind Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls/Women Aged 15 to 20 Years in Zambia

The goal of this study is to compare the immune response of the single dose of the CERVAVAC vaccine with the single dose of Gardasil vaccine in girls/women aged 9 to 20 and boys aged 9 to 14 at 6 months, 12 months and 24 months post vaccination. The vaccine will be given randomly to the boys and girls/women in these age group and they will be followed up to check the immune status developed in them after vaccination. The status of immune response developed by the two differnet vaccines will be compared in these group of participants of the study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1266

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Girl/woman between 9 and 20 years of age and boy between the age of 9 and 14 years at the time of recruitment.
  2. Participant willing to sign a written informed consent (for participants 18 years of age and above).
  3. Parent (s) willing to provide written informed consent and participant is willing to sign written assent form for participation (for participants below 18 years of age at the time of eligibility assessment).
  4. Participant or parent (s) willing to comply with all study requirements.
  5. Participants who are determined by Medical History (MH), Physical Examination (PE) and clinical judgment of the Investigator to be eligible for inclusion in the study.

Exclusion Criteria:

  1. Participants who are sexually active and missed their last menstrual period will have a urine pregnancy test and will be excluded if found pregnant.
  2. Participant has a known history of prior vaccination with any HPV vaccine.
  3. Participant known to be HIV positive (no routine HIV testing will be performed unless clinically indicated)
  4. Participant currently enrolled in any other clinical studies of investigational products.
  5. Participant with a current diagnosis or prior history of genital warts or treatment of genital warts.
  6. Participant with a current diagnosis or prior history of cervical intraepithelial neoplasia (CIN) or cervical cancer.
  7. Participant has a history of any allergic diseases or severe allergic reaction to any agent/vaccine product (e.g., swelling of the mouth and throat, difficulty in breathing, hypotension, or shock).
  8. Participant has had an acute illness (moderate or severe) and/or fever (body temperature ≥ 38°C or ≥ 100.4 °F) at the time of vaccination or during the 72 hours prior to the vaccination.
  9. Bleeding diathesis or uncontrolled condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate IM injection.
  10. Participant has history of major congenital defects or illness that requires medical therapy, as determined by MH or clinical assessment.
  11. Participant has had chronic administration (defined as more than 14 days) of high doses of corticosteroids (prednisone or equivalent at a dose of >0.5 mg/kg/day), cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study.
  12. Participant has history of receiving a blood transfusion or other blood products in three months prior to screening.
  13. Planned administration of a vaccine not foreseen by the study protocol within 14 days before and 14 days after any dose of study vaccine except TT given for emergency use and any vaccine mandated by government program.
  14. Participant has history of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the Investigator might interfere with the evaluation of the study objectives.
  15. Participant has history of any cancer, organ transplant or any other immune system disease.
  16. Individuals who, in the opinion of the investigator, are unlikely to be compliant to all study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Girls/women and boys vaccinated with single dose CERVAVAC-4 vaccine
CERVAVAC-4 single dose vaccine will be administered - off label in one arm
Biological: quadrivalent HPV vaccine
CERVAVAC-4 single dose vaccine
Other Names:
  • CERVAVAC single dose
Biological: quadrivalent HPV vaccine
Gardasil-4 single dose
Other Names:
  • Gardasil-4 vaccine
Active Comparator: Girls/women and boys vaccinated with single dose Gardasil-4 vaccine
Gardasil-4 single dose vaccine will be administered in one arm
Biological: quadrivalent HPV vaccine
CERVAVAC-4 single dose vaccine
Other Names:
  • CERVAVAC single dose
Biological: quadrivalent HPV vaccine
Gardasil-4 single dose
Other Names:
  • Gardasil-4 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Geometric mean Titre (GMT) of IgG antibodies against HPV 16 and 18 assessed from blood samples collected at 24 months and measured by M9ELISA on Meso-scale Discovery (MSD®) platform
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Agency for Research on Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

January 15, 2029

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CervALONE Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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