Tetanus Antitoxin / Serum Institute of India - LARVOL DELTA

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

The effect of BCG revaccination on the response to unrelated vaccines in urban Ugandan adolescents (POPVAC C): an open-label, randomised controlled trial. (PubMed, Lancet Glob Health) - "We found no evidence that BCG revaccination is an effective strategy to improve immunogenicity of other vaccines in this low-income, urban setting."

Clinical • Journal • Allergy • Fibrosis • Human Immunodeficiency Virus • Immunology • Infectious Disease • Oncology • Psychiatry • Tetanus

The effect of intermittent preventive treatment for malaria with dihydroartemisinin-piperaquine on vaccine-specific responses among schoolchildren in rural Uganda (POPVAC B): a double-blind, randomised controlled trial. (PubMed, Lancet Glob Health) - "IPT for malaria with dihydroartemisinin-piperaquine did not improve peak vaccine responses, despite reducing malaria prevalence. Possible longer-term effects on response waning should be further explored."

Clinical • Journal • Infectious Disease • Malaria • Oncology • Tetanus • IFNG

The effect of intensive praziquantel administration on vaccine-specific responses among schoolchildren in Ugandan schistosomiasis-endemic islands (POPVAC A): an open-label, randomised controlled trial. (PubMed, Lancet Glob Health) - "We show evidence suggesting that praziquantel administration improves the BCG-specific cellular response, but not humoral responses to other vaccines. Despite observational evidence that helminths impair vaccine response, these results show minimal immediate benefits of reducing helminth burden. The effect of longer-term helminth control should be investigated."

Clinical • Journal • Infectious Disease • Oncology • Tetanus • IFNG

A randomized, active-controlled, multi-centric, phase-II clinical study to assess safety and immunogenicity of a fully liquid DTwP-HepB-IPV-Hib hexavalent vaccine (HEXASIIL®) in Indian toddlers. (PubMed, Vaccine) - "HEXASIIL® vaccine was found to be safe and immunogenic in toddlers and supported its further clinical development in infants. Clinical Trial Registration - CTRI/2019/11/022052."

Journal • P2 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Respiratory Diseases • Tetanus

Human health implications of emerging diseases and the current situation in India's vaccine industry. (PubMed, Sci One Health) - "With heavy privatesector investments, Indian pharmacology now provides core Expanded Programme on Immunization vaccines to United Nations International Children's Emergency Fund, producing previously unattainable vaccines for diseases like meningitis, hepatitis B, pneumococcal conjugate, rotavirus, influenza A (H1N1), and COVID-19...The Serum Institute has developed several vaccines, including Nasovac, MenAfriVac, Pentavac, and an inactivated polio vaccine...Despite its booming economy and technical advances, India's disproportionate share of the world's child mortality rate remains unchanged. However, the growing production and distribution of vaccinations in developing nations has initiated a new era, leading to a worldwide decline in childhood death and disease."

Journal • Review • CNS Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Measles • Novel Coronavirus Disease • Pertussis • Pneumococcal Infections • Respiratory Diseases • Rotavirus Infections • Tetanus

Safety and immunogenicity of SIIPL Tdap, a new tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, in healthy subjects 4-65 years of age: A Phase II/III randomized, observer-blinded, active controlled, multicenter clinical study in Germany. (PubMed, Vaccine) - "Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to the immunogenicity of the vaccine components and was equally well tolerated. EudraCT number: 2019-002706-46."

Journal • P2/3 data • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

A Phase I study to evaluate safety and tolerability of DTaP-IPV + Hib vaccine in healthy adult volunteers in India. (PubMed, Vaccine X) - "SIIPL DTaP-IPV + Hib vaccine was well tolerated and safe in study subjects. Further clinical development will be conducted to assess safety and immunogenicity in young children, the target population.Clinical Trial Registration: CTRI/2017/07/009034."

Journal • P1 data • Infectious Disease • Influenza • Pertussis • Respiratory Diseases • Tetanus

Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India. (PubMed, Expert Rev Vaccines) - "In this Phase II/III, multicenter, randomized, active-controlled, open-label study, 1500 healthy individuals, aged 4 - 65 years, were randomized to receive a single dose of SIIPL Tdap or comparator Tdap vaccine (Boostrix®; GlaxoSmithKlines, India). Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to immunogenicity against tetanus, diphtheria, and pertussis and was well tolerated. - Trial is registered at Clinical Trials Registry-India (CTRI/2018/06/014617)."

Journal • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16-24 months. (PubMed, Hum Vaccin Immunother) - "was found to be safe, well tolerated and showed a robust immune response in toddlers. It was concluded that this vaccine should be assessed in the next phases of clinical development in the target population.Clinical Trial Registration - CTRI/2018/10/015875."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

Immunogenicity and Safety of Three WHO Prequalified (DTwP -HB-Hib) Pentavalent Combination Vaccines Administered As Per Iranian National Immunization Plan in Iranian Infants: A Randomized, Phase III Study. (PubMed, Indian Pediatr) - "Pentavac and Shan 5 had similar immunogenicity, the former having better immunogenicity against pertussis than Pentabio. Pentavac and Pentabio had a comparable safety profile."

Clinical • Journal • P3 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pertussis • Respiratory Diseases • Tetanus

Evaluation of Critical Quality Attributes of a Pentavalent (A, C, Y, W, X) Meningococcal Conjugate Vaccine for Global Use. (PubMed, Pathogens) - "Lot-to-lot manufacturing consistency was also demonstrated in preclinical studies for polysaccharide-specific IgG and complement-dependent serum bactericidal activity for each serogroup. This study demonstrates the high quality and stability of NmCV-5, which is now undergoing Phase 3 clinical trials in Africa and India."

Clinical • Journal • CNS Disorders • Infectious Disease • Meningococcal Infections • Tetanus

Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization (clinicaltrials.gov) - P3; N=1500; Recruiting; Sponsor: Serum Institute of India Limited; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar

Challenges and Opportunities While Developing a Group A Meningococcal Conjugate Vaccine Within a Product Development Partnership: A Manufacturer's Perspective From the Serum Institute of India. (PubMed) - Clin Infect Dis - "The project proved to be a sound investment for SIIL and is a concrete example of the potential for PDPs to provide needed products for resource-poor countries."

Journal • Biosimilar • Immunology • Inflammation