Strengthening HPV Immunization Through EPI Leveraged Delivery
A Randomized, Observer-Blind, Placebo-Controlled, Proof-of-Concept Study to Assess the Safety, Tolerability and Immunogenicity of a Bivalent Human Papillomavirus (HPV) Vaccine in 9 and 15 Month Old Infants and Toddlers, 2-5 Year Old Children and an Open Label Single Dose Study in Young Unmarried Females Aged 15-20 Years in Ghana
International Vaccine Institute
115 participants
Apr 30, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria10
- 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 condition or criteria, including acute or chronic clinically significant abnormality or infection that in the opinion of the investigator might compromise the wellbeing of the participant or interfere with the outcome of the study.
- Administration of immunoglobulins and/ or any blood products within the three months preceding the administration of the study vaccine.
- Known history of allergy or anaphylaxis to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse reaction.
- Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within 3 months prior to recruitment (topical steroids may be allowed).
- Any other finding that in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor-quality data.
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Interventions
0.5 mL HPV Vaccine Injection Intramuscular
0.5 mL Placebo injection intramuscular
Measles and rubella Vaccine according to EPI
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07377656