HPV Immunization in Ghana to See if Vaccine Works in Babies and Teens

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 randomized, observer-blind, placebo-controlled proof-of-concept study conducted in Ghana. It evaluates the safety, tolerability, and immunogenicity of the bivalent Cecolin HPV vaccine given to 9- and 15-month-olds, and 2- to 5-year-olds, with a parallel open-label comparison in 15–20-year-old unmarried females. The trial includes an HPV vaccine arm, a placebo arm, and a measles-rubella vaccine arm as a control. Primary outcomes focus on short-term safety and antibody responses, with a goal of determining whether pediatric vaccination elicits immune responses comparable to those observed in older females where efficacy has been demonstrated. The study is conducted at the Dodowa Health Research Centre and involves collaboration among IVI, Karolinska Institutet, Noguchi Memorial Institute for Medical Research, and the Dodowa site.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dodowa Health Research Center
  Accra, Ghana Recruiting

Study contacts

• Principal investigator: George Armah, Prof. PhD — Noguchi Memorial Institute for Medical Research
• Study coordinator: Derick Kimathi, MBChB, PhD
• Email: Derick.Kimathi@ivi.int
• Phone: +254 727161778

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.