Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years (NCT06281119) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years
Kenya, Mozambique, South Africa450 participantsStarted 2025-10-03
Plain-language summary
Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Since cervical screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. People with HIV infection, even when effectively treated with antiretroviral therapy (ARV),are at higher risk of acquiring infection with multiple HPV types and are also known to be predisposed to a higher risk of HPV infection and subsequent CIN lesions. Vaccination of this high-risk group with HPV vaccine is highly beneficial. SIIPL's qHPV vaccine CERVAVAC®, India's first indigenous qHPV vaccine has received marketing authorization in India. The current study is a Phase 3b study to evaluate the immunogenicity and safety of two- and three-dose schedules of SIIPL qHPV vaccine in women living with HIV (WLWH) aged 15-25years.
Who can participate
Age range
15 Years – 25 Years
Sex
FEMALE
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
. Women Living with HIV aged 15-25 years at the time of screening
. Subjects with age 18 years and above, should be willing and able to provide written informed consent while for subjects \<18\*years of age, parents willing to provide written informed consent and subject is willing to sign written assent form for participation prior to initiating any study related procedure.
. Subject or parent willing to comply with all study requirements.
. Subjects who are determined by medical history, physical examination and clinical judgment of the Investigator to be eligible for inclusion in the study.
. Women of childbearing potential (WOCBP) (sexually active/ ≥18 years of age) must meet all the following criteria:
. Subject must be asymptomatic (or only have persistent generalized lymphadenopathy) regardless of prior clinical stage.
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
Geometric mean titers of anti HPV 16 and 18 IgG antibodies
. If the subjects were currently taking antiretroviral (ARV) therapy, subjects were to be on highly active antiretroviral therapy (HAART), have undetectable viral load reported at least six months prior, and have a CD4+ cell count \>350 cells/mm3 at study entry.
. If the subjects are not on HAART, subjects should have a CD4+ cell count \> 350 cells/mm3 at study entry.
Exclusion criteria
. Known history of prior vaccination with HPV vaccine.
. Concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens.
. Current diagnosis or prior history of genital warts or treatment of genital warts.
. Current diagnosis or history of treatment for cervical pre malignancies or malignancies.
. Pregnant females.
. History of any allergic diseases or severe allergic reaction to any agent.
. Presence of an acute illness and/or fever at the time of vaccination or during the 72 hours prior to the vaccination.
. Presence of active tuberculosis or currently on TB therapy.