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V116
V116 is a monoclonal antibody that targets group B Streptococcus (GBS) to enhance immune recognition and clearance of the pathogen.
V116 is a monoclonal antibody that targets group B Streptococcus (GBS) to enhance immune recognition and clearance of the pathogen. Used for Prevention of group B Streptococcus (GBS) disease in pregnant women and neonates.
At a glance
| Generic name | V116 |
|---|---|
| Also known as | Polyvalent pneumococcal conjugate vaccine (pPCV), Pneumococcal 21-valent Conjugate Vaccine |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Monoclonal antibody vaccine |
| Target | Group B Streptococcus surface antigens |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
V116 binds to conserved epitopes on the surface of group B Streptococcus, promoting opsonophagocytosis and complement-mediated killing. By enhancing the immune system's ability to recognize and eliminate GBS, the vaccine aims to prevent invasive GBS disease, particularly in pregnant women and neonates.
Approved indications
- Prevention of group B Streptococcus (GBS) disease in pregnant women and neonates
Common side effects
- Injection site reactions
- Fever
- Myalgia
Key clinical trials
- A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013) (PHASE3)
- Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008) (PHASE3)
- Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10) (PHASE3)
- Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7) (PHASE3)
- A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5) (PHASE3)
- Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3) (PHASE3)
- A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6) (PHASE3)
- Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |