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

NCT06281119 | Not Yet Recruiting Phase 3

• 1 other identifier: SII-qHPV/MC-03
• Study Type: interventional
• Target: 450
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Human Papillomavirus Infection

Keywords

Cervavac; Quadrivalent; HPV; Vaccine

Outcome Measures

Primary Outcomes (1)

• Geometric mean titers of anti HPV 16 and 18 IgG antibodies

  GMTs of anti HPV 16 and 18 IgG antibodies in WLWH receiving 3 doses of SIIPL qHPV and 3 doses of Gardasil®

  at 1 month after the last dose

Secondary Outcomes (3)

• Immune response (Geometric mean titers) of anti HPV 6 and 11 IgG antibodies

  at 1 month after the last dose

• Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion

  at 1 month after the last dose

• Adverse Events

  solicited AEs up to 7 days following each vaccination, unsolicited AEs from Day 0 through Month 7 and Month12 and SAEs from Day 0 through Month 7 and Month 12.

Other Outcomes (3)

• Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion

  at Month 12

• Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage

  at Month 2 and 6

• CD4+ cell count, HIV viral load, and HIV clinical staging

  at Month 7 and Month 12

Study Arms (3)

Cervavac administered as three doses

EXPERIMENTAL

Recombinant Quadrivalent Human Papillomavirus (Types 6,11 16, 18) Vaccine manufactured by Serum Institute of India Pvt Ltd administered as three doses at day 0, 60 and 180.

Biological: Cervavac as three dose regimen

Cervavac administered as two doses

EXPERIMENTAL

Recombinant Quadrivalent Human Papillomavirus (Types 6,11 16, 18) Vaccine manufactured by Serum Institute of India Pvt Ltd administered as two doses at day 0 and 180.

Biological: Cervavac as two dose regimen

Gardasil administered as three doses

ACTIVE COMPARATOR

Recombinant Quadrivalent Human Papillomavirus (Types 6,11 16, 18) Vaccine manufactured by MSD administered as three doses at day 0, 60 and 180.

Biological: Gardasil as three dose regimen

Interventions

Cervavac as three dose regimen BIOLOGICAL

Cervavac manufactured by Serum Institute of India Pvt Ltd administered as three doses at day 0, 60 and 180.

Cervavac administered as three doses

Cervavac as two dose regimen BIOLOGICAL

Cervavac manufactured by Serum Institute of India Pvt Ltd administered as two doses at day 0 and 180.

Cervavac administered as two doses

Gardasil as three dose regimen BIOLOGICAL

Gardasil manufactured by MSD administered as a three doses at day 0,60 and 180.

Gardasil administered as three doses

Eligibility Criteria

• Age: 15 Years - 25 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.
• Subject must be asymptomatic (or only have persistent generalized lymphadenopathy) regardless of prior clinical stage.
• 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.

You may not qualify if:

• 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.
• Bleeding diathesis or uncontrolled condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection.
• History of major congenital defects or illness that requires medical therapy, as determined by medical history or clinical assessment.
• 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.
• History of receiving a blood transfusion or other blood products in three months prior to screening.
• 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.
• History of any cancer, organ transplant or any other immune system disease (other than HIV/AIDs).
• Subject or subject's parent, is or has an immediate family member who is study specific site staff directly involved with this trial.

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (4)

Centre For Clinical Research, Kemri

Nairobi, 54840-00200, Kenya

Location

Partners in Health and Research Development (Phrd)

Thika, 19865-00202, Kenya

Location

Manhiça Health Research Center - Manhiça Foundation (CISM-FM)

Manhiça, 1929, Mozambique

Location

Clinical HIV Research Unit (CHRU), Helen Joseph Hospital

Johannesburg, 2092, South Africa

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Clinical Protocols; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Carla Chibwesha

  Clinical HIV Research Unit, Helen Joseph Hospital, Johannesburg, South Africa

  PRINCIPAL INVESTIGATOR

• Nelly Mugo

  CCR, KEMRI, Nairobi-Kenya & PHRD, Thika-Kenya

  PRINCIPAL INVESTIGATOR

• Tacilta Nhampossa

  Manhiça Health Research Center - Manhiça Foundation,Manhiça

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hitt Sharma

CONTACT

+912026602451; drhjs@seruminstitute.com

Sameer Parekh

CONTACT

+912026602139; sameer.parekh@seruminstitute.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 Months after completion of the study
• Access Criteria: Researchers who provide a methodologically sound proposal may be provided the access after Sponsor permission and if signed data-access agreements are in place.

Locations

KE (2); ZA (1); MO (1)