Strengthening HPV Immunization Through EPI Leveraged Delivery
Ghana115 participantsStarted 2026-04-30
Plain-language summary
This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.
Who can participate
Age range
9 Months – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male and female individuals aged 9 months, 15 months, 2-5 years and unmarried females aged 15-20 years at the time of vaccination
* Participants aged 9 months, 15 months and 2-5 years who are up to date with their EPI vaccinations.
* Residing within the area of the study and planning to stay for the study duration.
* Participants that are HIV negative at screening (for the 9-15-month-olds a documented negative maternal ANC HIV screening).
* Unmarried females with a negative pregnancy test at screening practicing/willing to practice continuous effective contraception as recommended by the Ghana Health Services guidance in Ghana
* Able and willing to comply with all study requirements.
* Willingness to provide written informed consent before any trial procedure. Assent will be required for young female participants aged 15-17 years at vaccination in addition to their parent's/LAR's consent.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the study vaccine dose
* Previous vaccination against HPV (Only for the 15-20-year-old efficacy cohort)
* Presence of malnutrition (weight-for-length z-score ≤-2SD median, per WHO published child growth standards)
* Planning to migrate out of the study areas before the end of the study follow-up
* Any underlying known conditi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Reactogenicity of HPV Vaccination
Timeframe: 9 months post vaccination
2
HPV16/18 VLP ELISA Antibody Titers
Timeframe: At 1, 7, 12, and 24 months post-HPV vaccination
3
Geometric Mean Concentration of HPV16/18 Antibodies
Timeframe: At 1, 7, 12, and 24 months post-HPV vaccination