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

Innovations in HPV vaccination and their role in global cervical cancer control: a review. (PubMed, Ther Adv Vaccines Immunother) - "To address persistent global health disparities, regionally produced, cost-effective alternatives such as Cecolin and Cervavac have been introduced to enhance accessibility within low- and middle-income countries. However, achieving the WHO's 2030 cervical cancer elimination targets remains contingent upon overcoming infrastructural, cultural, and informational barriers that hinder vaccine uptake. This review synthesizes the molecular composition and immunological mechanisms of current and emerging HPV vaccines, evaluating their clinical efficacy and the systemic strategies required to ensure equitable global access."

Journal • Review • Cervical Cancer • CNS Disorders • Gynecologic Cancers • 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 | Active, not recruiting | Sponsor: Serum Institute of India Pvt. Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Human Papillomavirus Infection • Infectious Disease • Oncology • CD4

Human Papillomavirus Vaccination in India: Paving the Way to Cervical Cancer Prevention. (PubMed, Ann Afr Med) - "Recent developments, including the introduction of the indigenous quadrivalent HPV vaccine Cervavac and its proposed inclusion in the Universal Immunization Programme (UIP) for girls aged 9-14 years, represent a significant milestone. However, challenges such as vaccine hesitancy, logistical barriers, and limited awareness must be addressed. A comprehensive approach integrating vaccination, screening, and public education is essential for achieving the World Health Organization's cervical cancer elimination targets."

Journal • Cervical Cancer • Infectious Disease • Oncology • Solid Tumor

New HPV Vaccines on the Market and Future Trends: A State-of-the-Art Review. (PubMed, Vaccines (Basel)) - "This review aggregates current clinical, immunological, and programme-related evidence on newly licensed vaccines, including the World Health Organization (WHO)-prequalified bivalent formulations (Cecolin® and Walrinvax®), the quadrivalent Cervavac®, and the Escherichia coli-derived nonavalent Cecolin 9®, which received national licensure in 2025. Economic evaluations demonstrating favorable cost-effectiveness emphasize the essential role of next-generation vaccines in improving access and reducing inequity. Overall, innovations in valency, technology, and delivery strategies have the potential to significantly expand global HPV prevention coverage and accelerate progress toward cervical cancer elimination."

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

Cervical cancer elimination in India: Repurposing diagnostics, vaccination, and accelerating policy for the 2030 target. (PubMed, Cancer) - "The introduction of the indigenous quadrivalent vaccine Cervavac in 2023 has provided renewed momentum; however, limitations in infrastructure, public awareness, and stratic barrier to implementation continue to hinder progress toward achieving the World Health Organization's 2030 elimination targets. This opinion article highlights the epidemiological landscape, diagnostic and programmatic barriers, and emphasis to repurpose India's vast coronavirus disease-era reverse transcriptase-polymerase chain reaction network for HPV molecular testing. Integrating HPV vaccination into the Universal Immunization Program and incorporating the HPV Nucleic Acid Amplification Test (NAAT) into the National Essential Diagnostics List (NEDL) are critical steps for accelerating India's pathway to cervical cancer elimination by 2030."

Journal • Review • Cervical Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor

CervALONE: A Randomized, Active Controlled, Assessors-blind Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls/Women Aged 15 to 20 Years in Zambia (clinicaltrials.gov) - P4 | N=1266 | Not yet recruiting | Sponsor: International Agency for Research on Cancer

Head-to-Head • New P4 trial

Effect of educational intervention on knowledge of HPV and HPV vaccine and vaccine acceptability among teachers: A pilot investigation. (PubMed, Indian J Cancer) - "This study highlights the importance of HPV knowledge and awareness in improving vaccine acceptability, suggesting a tailored approach that engages the target population in vaccination decisions to augment uptake."

Journal • Cervical Cancer • Oncology

HUMAN PAPILLOMAVIRUS VACCINE LANDSCAPE (IPVC 2025) - " Since 2006, WHO has approved five HPV vaccines: three bivalent vaccines (Cervarix, Cecolin, and Walrinvax); one quadrivalent vaccine (Gardasil); and one nonavalent vaccine (Gardasil 9). Two domestically licensed vaccines are available in Bangladesh (HPvax) and India (Cervavac)... Global vaccine introduction has made good progress in recent years. Countries that have introduced the vaccine subnationally—such as China, Russia, and India—have large populations and wide geographical areas. The vaccine landscape in China is changing rapidly with more low-cost vaccines becoming available, that will likely further influence global vaccine availability."

Cervical Cancer • Genito-urinary Cancer • Penile Cancer • Solid Tumor

SCALING UP HPV VACCINATION COVERAGE IN INDIA: KARKINOS'S MULTI-MODEL APPROACH TO EQUITY AND ACCESS (IPVC 2025) - "Vaccines used included Gardasil-4, Gardasil-9, and Cervavac. This multi-pronged strategy demonstrates the feasibility and effectiveness of scaling HPV vaccination through context-adaptable models supported by public–private collaboration and digital infrastructure. Building trust, improving affordability, and enhancing community engagement are critical to achieving equitable vaccine coverage. These early outcomes offer a replicable model for national scale-up in India and valuable insights for other low- and middle-income countries aiming to meet the WHO cervical cancer elimination targets."

Cervical Cancer • Solid Tumor

Redefining the Global HPV Infection and Disease Landscape with CERVAVAC® (IPVC 2025) - No abstract available

Clinical • Human Papillomavirus Infection • Infectious Disease

PRODUCT THEATER 03 (NOT INCLUDED IN THE MAIN EVENT CME/CPD CREDIT) (IPVC 2025) - "It supports widespread regulatory approvals and worldwide use of the CERVAVAC. This sustainable, high quality, cost effective vaccine manufactured at the world-class facilities of SIIPL will change the landscape of HPV immunization across the globe."

CME • Cervical Cancer • Hepatitis B • Hepatology • Human Papillomavirus Infection • Infectious Disease • Influenza • Malaria • Meningococcal Infections • Pertussis • Pneumococcal Infections • Respiratory Diseases • Solid Tumor • Tetanus

From hesitancy to hope: charting India's path to widespread HPV immunisation. (PubMed, Eur J Contracept Reprod Health Care) - "The introduction of Cervavac, an indigenously developed quadrivalent HPV vaccine, marks a pivotal shift in India's immunisation landscape. To achieve the WHO's cervical cancer elimination targets, India must pursue a dual approach: gender-neutral HPV vaccination alongside accessible, structured cervical screening programmes. A coordinated, evidence-based strategy is essential for equitable and sustained public health impact."

Journal • Cervical Cancer • Gynecologic Cancers • Infectious Disease • Novel Coronavirus 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. | 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 ) - "(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