A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for an inactivated viral vaccine against Chikungunya virus
Vaccine·
- DOI
- 10.1016/j.vaccine.2022.06.006
- PMID
- 35715351
- PMCID
- PMC9197579
- OpenAlex
- W4282913684
- Study type
- Journal article
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Why this research matters now
Inactivated viral vaccine technology has been applied to diseases of global health threat, and this chikungunya vaccine candidate offers an effective, flexible system for high-yield manufacturing with favorable stability for distribution.
Structured evidence summary
Research question
This paper applies a standardized Brighton Collaboration template to review benefit and risk considerations for an inactivated whole chikungunya virus vaccine that has undergone preclinical and clinical evaluation.
Study design
The work is a structured review using the BRAVATO inactivated virus vaccine template. It draws on safety data from completed phase I trials (60 subjects), ongoing phase II studies outside India (850 participants from parts A and B), and an ongoing phase II study in India (600 participants), with immunogenicity evaluation also reported.
Population and setting
As of April 2022, a total of 1410 participants had been vaccinated across the clinical studies, including populations in India and outside India.
Main findings
The inactivated whole CHIKV vaccine, produced on Vero cells and inactivated with β-propiolactone, was well tolerated with no significant safety issues identified. It demonstrated strong and durable humoral immune responses and favorable thermostability profiles compatible with vaccine supply chains.
Public-health relevance
Inactivated viral vaccine technology has been applied to diseases of global health threat, and this chikungunya vaccine candidate offers an effective, flexible system for high-yield manufacturing with favorable stability for distribution.
Important limitations
This summary relies on the supplied single-article abstract and metadata. Comprehensive assessment of study limitations, detailed safety profiles, comparator data, and long-term follow-up require access to the original full-text paper.
GIDS interpretation
The article was classified under chikungunya, COVID-19, SARS, poliomyelitis, and influenza due to its discussion of inactivated vaccine technology across these diseases. It was tagged for India based on one of the phase II trial settings, and linked to treatment, vaccination, and vaccine safety topics reflecting the benefit-risk assessment scope.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 12 auditable classifier relationships to diseases, places, topics, and study design.