Immunogenicity and safety of an investigational quadrivalent measles, mumps, rubella, and varicella vaccine in children aged 4-6 years: A phase II, randomized, multi-country trial.
The investigational MMRV vaccine showed comparable immune responses and safety to the licensed vaccine, supporting its further clinical development.
Where it sits
this study against the rest of the kisspeptin (kp-10) corpusSummary and findings
This study evaluated the immunogenicity and safety of an investigational quadrivalent measles, mumps, rubella, and varicella vaccine (MMRVNS) in children aged 4-6 years. A total of 801 participants were enrolled, with 796 vaccinated and 765 completing the study. The findings indicated comparable immune responses and safety profiles between MMRVNS and a licensed MMRV vaccine.
Abstract
Two-dose childhood vaccination against measles, mumps, rubella, and varicella is widely recommended. Quadrivalent (MMRV) vaccines can be used for one or both immunizations against these diseases. In some countries, e.g. the United States, only one MMRV vaccine is licensed. Availability of another MMRV vaccine could strengthen supply resilience, optimal vaccine coverage, and disease control. In this phase II, single-blind, multi-country study, healthy children aged 4-6 y, previously primed with a first dose of any combination of measles/mumps/rubella/varicella-containing vaccine(s) in their second year of life, were randomized 2:2:2:1:1 to receive one dose of a GSK investigational MMRV (MMRVNS; three formulations) or a licensed MMRV vaccine (two lots). Immunogenicity was assessed at Day 43 post-vaccination. Adverse events (AEs) were recorded up to Day 4 (solicited administration-site and systemic AEs), Day 43 (solicited systemic and unsolicited AEs), and Day 181 (serious AEs [SAEs]) post-vaccination. Of 801 participants enrolled, 796 were vaccinated and 765 completed the study. Antigen-specific antibody geometric mean concentrations and seroresponse rates were generally comparable between MMRVNS (regardless of formulation) and MMRV recipients. Administration-site pain (29.0%-39.0% of participants) and systemic drowsiness (9.0%-15.9%) were the most common solicited AEs. Unsolicited AEs (mostly upper respiratory tract infections) were reported in 18.5%-27.2% of participants. At least one SAE (none considered vaccine-related) occurred in each group. Except for one reported fatality, all SAEs resolved. Compared to the licensed standard-of-care MMRV vaccine, the investigational MMRVNS formulations generated comparable immune responses and had a similarly acceptable safety profile, when administered as second dose. These results support further clinical development of MMRVNS.
Background
This paper addresses the need for additional measles, mumps, rubella, and varicella (MMRV) vaccines to enhance supply resilience and vaccination coverage. Prior research has established the importance of childhood vaccination against these diseases. The investigation of a new quadrivalent vaccine formulation could provide insights into its immunogenicity and safety compared to existing licensed options.
Methods
This phase II, single-blind, multi-country study involved healthy children aged 4-6 years who had previously received a first dose of any combination of MMRV vaccines. Participants were randomized in a 2:2:2:1:1 ratio to receive one dose of the investigational MMRVNS or a licensed MMRV vaccine. Immunogenicity was assessed at Day 43 post-vaccination, while adverse events were recorded up to Day 181.
Results
The study reported that antigen-specific antibody geometric mean concentrations and seroresponse rates were generally comparable between MMRVNS and licensed MMRV recipients. Solicited administration-site pain occurred in 29.0%-39.0% of participants, while systemic drowsiness was reported in 9.0%-15.9%. Unsolicited adverse events, primarily upper respiratory tract infections, were reported in 18.5%-27.2% of participants.
Interpretation
The findings suggest that the investigational MMRVNS vaccine generates comparable immune responses to the licensed MMRV vaccine, although specific statistical significance was not detailed. The reported adverse events are consistent with typical vaccine responses, but the clinical significance of the immune response comparability remains unclear. Limitations such as the single-blind design and lack of detailed statistical analysis may affect the robustness of the conclusions.
Key findings
- 29.0%-39.0% of participants reported administration-site pain.
- 9.0%-15.9% of participants experienced systemic drowsiness.
- Unsolicited adverse events were reported in 18.5%-27.2% of participants.
- At least one serious adverse event occurred in each group, with none considered vaccine-related.
- One reported fatality occurred, but all other serious adverse events resolved.
Limitations
- Single-blind study design.
- No detailed statistical analyses reported for immunogenicity.
- Small sample size may limit generalizability.
- Follow-up duration may not capture long-term safety.