Cervavac (recombinant human papillomavirus recombinant quadrivalent vaccine, human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine) / Serum Institute of India - LARVOL DELTA

Clinical Study to Evaluate SIIPL QHPV Vaccine (CERVAVAC®) in Women Living with HIV Aged 15-25 Years (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Serum Institute of India Pvt. Ltd. | Trial completion date: May 2026 ➔ Dec 2026 | Initiation date: Jun 2024 ➔ Mar 2025 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Trial initiation date • Trial primary completion date • Human Immunodeficiency Virus • Human Papillomavirus Infection • Infectious Disease • Oncology • CD4

PRECLINIC IMMUNOGENICITY STUDY OF A RECOMBINANT HUMAN PAPILLOMAVIRUS NONAVALENT VIRUS-LIKE PARTICLE VACCINE (IPVC 2024) - "Currently, six prophylactic HPV vaccines are available on the market: Cervarix, Gardasil and Gardasil 9, Cervavac and Cecolin and Walrinvax. These immunogenicity data in different animal species demonstrated that the HPV-9 candidate vaccine might provide a comparable protection against HPV infection to those of Gardasil 9, which support further investigation of the efficacy of the vaccine in clinical trials."

Cervical Cancer • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor

Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Serum Institute of India Pvt. Ltd.

New P3 trial • Human Immunodeficiency Virus • Human Papillomavirus Infection • Infectious Disease • Oncology • CD4

Immunogenicity and safety of a new quadrivalent HPV vaccine in girls and boys aged 9-14 years versus an established quadrivalent HPV vaccine in women aged 15-26 years in India: a randomised, active-controlled, multicentre, phase 2/3 trial. (PubMed, Lancet Oncol) - "We observed a non-inferior immune response with the SIIPL quadrivalent HPV vaccine in girls and boys aged 9-14 years and an acceptable safety profile compared with the comparator vaccine. These findings support extrapolation of efficacy from the comparator vaccine to the SIIPL quadrivalent HPV vaccine in the younger population. The availability of the SIIPL quadrivalent HPV vaccine could help meet the global demand for HPV vaccines, and boost coverage for both girls and boys globally."

Journal • P2/3 data • P3 data • Cervical Cancer • Dengue Fever • Oncology • Solid Tumor

Human papilloma virus vaccines: A comprehensive narrative review. (PubMed, Cancer Treat Res Commun) - "Vaccination is a cost-effective strategy to reduce the incidence of cervical cancer and mortality compared to no vaccination based on the cost of cancer treatment. Well-coordinated vaccination strategy with focus on adolescent girls and if possible, boys can lead to dramatic impact on disease reduction around the world."

Journal • Review • Cervical Cancer • Gynecology • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor

A phase-I, open label clinical trial to assess the safety & tolerability of qHPV vaccine manufactured by Serum Institute of India Pvt. Ltd. in adults. (PubMed, Vaccine X) - "(SIIPL) quadrivalent HPV (qHPV) vaccine. A total of 48 healthy male and female (24 each) adult volunteers were administered a 0.5 ml single dose of SIIPL qHPV vaccine intramuscularly, and were followed for one month for safety outcomes viz., immediate, solicited, unsolicited and serious adverse events...qHPV vaccine manufactured by SIIPL was found to be safe and well tolerable in adults. Further clinical development should continue to assess safety and immunogenicity, in the target population following recommended 2 and 3-dose schedule.Clinical Trial Registration - CTRI/2017/02/007785."

Journal • Pain

SEXUALLY TRANSMITTED INFECTIONS AND HPV CO-INFECTION AMONG FEMALE SEX WORKERS FROM MUMBAI, INDIA: A COMPARATIVE STUDY OF 2009 AND 2019 COHORTS (IPVC 2023) - "Cervical cancer screening must be launched and bundled with STI screening given the high HPV infection prevalence among these women. The indigenously crafted Indian HPV vaccine Cervavac may protect this high-risk population from future cervical disease and may also reduce transmission risk."

Cervical Cancer • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Oncology • Solid Tumor • Women's Health