Clinical Study to Evaluate SIIPL QHPV Vaccine (CERVAVAC®) in Women Living with HIV Aged 15-25 Years

Launched by SERUM INSTITUTE OF INDIA PVT. LTD. · Feb 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called CERVAVAC® to see how well it works and how safe it is for women aged 15-25 who are living with HIV. The vaccine aims to protect against Human Papillomavirus (HPV), which is a common virus that can lead to serious health issues like cervical cancer. The trial will compare two different schedules of vaccine doses to find out which one is more effective.

To participate in the study, women must be between the ages of 15 and 25 and living with HIV. They need to provide consent if they are over 18, or have a parent or guardian give consent if they are younger. Participants should be in good health, have a certain level of immune function, and must agree to use effective birth control if they can become pregnant. The trial is not yet recruiting participants, but once it starts, volunteers can expect to receive the vaccine and be monitored for their health and safety throughout the study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Women Living with HIV aged 15-25 years at the time of screening
• • 2. 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.
• • 3. Subject or parent willing to comply with all study requirements.
• • 4. Subjects who are determined by medical history, physical examination and clinical judgment of the Investigator to be eligible for inclusion in the study.
• 5. Women of childbearing potential (WOCBP) (sexually active/ ≥18 years of age) must meet all the following criteria:
• • Have practiced effective contraception (such as any one of the following: oral, transdermal, injectable or implanted contraceptive; condoms; occlusive cap \[diaphragm or cervical vault caps\]; spermicidal foam/gel/cream, etc.) or have abstained from all activities that could result in pregnancy from the time of screening up to first vaccine administration (Day 0).
• • Have a negative Urine Pregnancy Test (UPT) at screening and on the day of vaccination (Day 0).
• • Have agreed to continue effective contraception during the entire treatment period and for two months after completion of the vaccination series.
• • 6. Subject must be asymptomatic (or only have persistent generalized lymphadenopathy) regardless of prior clinical stage.
• • 7. 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.
• • 8. If the subjects are not on HAART, subjects should have a CD4+ cell count \> 350 cells/mm3 at study entry.
• Exclusion Criteria:
• • 1. Known history of prior vaccination with HPV vaccine.
• • 2. Concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens.
• • 3. Current diagnosis or prior history of genital warts or treatment of genital warts.
• • 4. Current diagnosis or history of treatment for cervical pre malignancies or malignancies.
• • 5. Pregnant females.
• • 6. History of any allergic diseases or severe allergic reaction to any agent.
• • 7. Presence of an acute illness and/or fever at the time of vaccination or during the 72 hours prior to the vaccination.
• • 8. Presence of active tuberculosis or currently on TB therapy.
• • 9. Bleeding diathesis or uncontrolled condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection.
• • 10. History of major congenital defects or illness that requires medical therapy, as determined by medical history or clinical assessment.
• • 11. History of chronic administration of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study.
• • 12. History of receiving a blood transfusion or other blood products in three months prior to screening.
• • 13. History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
• • 14. History of any cancer, organ transplant or any other immune system disease (other than HIV/AIDs).
• • 15. Subject or subject's parent, is or has an immediate family member who is study specific site staff directly involved with this trial.