HPV infection caused by type 6,11,16 and 18
Conditions
Interventions
CERVAVAC
Gardasil
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women Living with HIV aged 15-25 years (both inclusive) at the time of screening (as evidenced by ongoing ARV and /or assessment of viral load). 2. Subjects with age 18 years and above, should be willing and able to provide written informed consent while for subjects 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
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 (moderate or severe) and/or fever at the time of vaccination or during the 72 hours prior to the vaccination. 8. Presence of active tuberculosis (TB) 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 (defined as more than 14 days) of high doses of corticosteroids , cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants or other immune-modifying drugs (except for ART in WLWH women) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titers of anti HPV 16 and 18 IgG antibodies in WLWH receiving 3 doses of SIIPL qHPV vaccine or Gardasil vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titers of anti HPV 6 and 11 IgG antibodies in WLWH receiving 3 doses of SIIPL qHPV or Gardasil;Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion in WLWH receiving 2 doses or 3 doses of SIIPL qHPV ;Percentage of seroconverted WLWH following 3 doses of SIIPL qHPV vaccine or 3 doses of Gardasil ;Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and percentage seroconversion in WLWH receiving 2 doses of SIIPL qHPV and 3 doses of Gardasil ;Incidence, severity, and relationship of local and systemic solicited AEs up to 7 days following each vaccination. Incidence, severity, and relationship of unsolicited AEs from Day 0 through Month 7 and Month 12. Incidence, severity, and relationship of SAEs from Day 0 through Month 7 and Month 12. | — |
Countries
Kenya, Mozambique, South Africa
Contacts
Public ContactHitt Sharma
Additional Medical Director
Outcome results
None listed