Trial Title:
Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years
NCT ID:
NCT06281119
Condition:
Human Papillomavirus Infection
Conditions: Official terms:
Papillomavirus Infections
Conditions: Keywords:
Cervavac
Quadrivalent
HPV
Vaccine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Cervavac as three dose regimen
Description:
Cervavac manufactured by Serum Institute of India Pvt Ltd administered as three doses at
day 0, 60 and 180.
Arm group label:
Cervavac administered as three doses
Intervention type:
Biological
Intervention name:
Cervavac as two dose regimen
Description:
Cervavac manufactured by Serum Institute of India Pvt Ltd administered as two doses at
day 0 and 180.
Arm group label:
Cervavac administered as two doses
Intervention type:
Biological
Intervention name:
Gardasil as three dose regimen
Description:
Gardasil manufactured by MSD administered as a three doses at day 0,60 and 180.
Arm group label:
Gardasil administered as three doses
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.
Detailed description:
A Phase-3b, partially double-blind, randomized, multi-country study to assess the
immunogenicity, safety, and reactogenicity of SIIPL qHPV vaccine in WLWH aged 15-25
years. A total of 450 subjects will be enrolled in the study such that 150 subjects in
each group receive either 3-doses of SIIPL qHPV vaccine, 2-doses of SIIPL qHPV vaccine or
3-doses of Gardasil®.
Subjects will be randomized in a 1:1:1 ratio to a 2-dose or 3-dose schedule of SIIPL qHPV
vaccine or 3-dose schedule of Gardasil®. This study is designed as a partially
double-blind, randomized study with a primary objective to compare the immunogenicity of
the 3-dose schedule of SIIPL qHPV vaccine versus a 3-dose schedule of Gardasil®. The
secondary objectives include comparison in the immune response between WLWH receiving
2-dose schedule of SIIPL qHPV vaccine and a 3-dose schedule of SIIPL qHPV. The
immunogenicity data will be collected up to Month 12 and data at 7-month will be
considered for analysis of primary immunogenicity endpoints.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
Women
Minimum age:
15 Years
Maximum age:
25 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre For Clinical Research, Kemri
Address:
City:
Nairobi
Zip:
54840-00200
Country:
Kenya
Contact:
Last name:
Nelly Mugo
Phone:
+254733629665
Email:
rwamba@uw.edu
Facility:
Name:
Partners in Health and Research Development (Phrd)
Address:
City:
Thika
Zip:
19865-00202
Country:
Kenya
Contact:
Last name:
Nelly Mugo
Phone:
+254733629665
Email:
rwamba@uw.edu
Facility:
Name:
Manhiça Health Research Center - Manhiça Foundation (CISM-FM)
Address:
City:
Manhiça
Zip:
1929
Country:
Mozambique
Contact:
Last name:
Tacilta Nhampossa
Phone:
+258 21 810 181
Email:
tacilta.nhampossa@manhica.net
Facility:
Name:
Clinical HIV Research Unit (CHRU), Helen Joseph Hospital
Address:
City:
Johannesburg
Zip:
2092
Country:
South Africa
Contact:
Last name:
Carla Chibwesha
Phone:
+27 072 744 7899
Email:
carla_chibwesha@med.unc.edu
Start date:
June 2024
Completion date:
May 2026
Lead sponsor:
Agency:
Serum Institute of India Pvt. Ltd.
Agency class:
Industry
Collaborator:
Agency:
Bill and Melinda Gates Foundation
Agency class:
Other
Source:
Serum Institute of India Pvt. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06281119
