NCT07377656 Strengthening HPV Immunization Through EPI Leveraged Delivery
| NCT ID | NCT07377656 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | International Vaccine Institute |
| Condition | HPV Vaccine |
| Study Type | INTERVENTIONAL |
| Enrollment | 115 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2028-02-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 115 participants in total. It began in 2026-04-30 with a primary completion date of 2028-02-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 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.
Contact & Investigator
Julia Lynch, MD
STUDY DIRECTOR
International Vaccine Institute
Frequently Asked Questions
Who can join the NCT07377656 clinical trial?
This trial is open to participants of all sexes, aged 9 Months or older, up to 20 Years, studying HPV Vaccine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07377656 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07377656 currently recruiting?
Yes, NCT07377656 is actively recruiting participants. Contact the research team at Derick.Kimathi@ivi.int for enrollment information.
Where is the NCT07377656 trial being conducted?
This trial is being conducted at Accra, Ghana.
Who is sponsoring the NCT07377656 clinical trial?
NCT07377656 is sponsored by International Vaccine Institute. The principal investigator is Julia Lynch, MD at International Vaccine Institute. The trial plans to enroll 115 participants.