Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults
Nature Communications·
- DOI
- 10.1038/s41467-023-36789-2
- PMID
- 36878897
- PMCID
- PMC9988862
- OpenAlex
- W4323318833
- Study type
- Randomised controlled trial
- Publisher
- Springer Science and Business Media LLC
- Article type
- journal-article
- Integrity
- current
Why this research matters now
A thermostable tuberculosis vaccine candidate that does not require refrigerated storage could improve vaccine access and deployment in resource-limited settings where cold-chain infrastructure is inadequate.
Structured evidence summary
Research question
The trial evaluated whether a thermostable lyophilized single-vial presentation of the ID93 + GLA-SE tuberculosis vaccine candidate is safe, tolerable, and immunogenic compared to the non-thermostable two-vial presentation in healthy adults.
Study design
This was a randomized, double-blinded Phase 1 clinical trial (NCT03722472) in which participants received two intramuscular vaccine doses 56 days apart and were monitored for safety, tolerability, and immunogenicity endpoints.
Population and setting
The study enrolled healthy adults.
Main findings
Both vaccine presentations were safe and well tolerated and elicited robust antigen-specific serum antibody and Th1-type cellular immune responses. The thermostable formulation generated significantly greater serum antibody responses and more antibody-secreting cells compared to the non-thermostable presentation.
Public-health relevance
A thermostable tuberculosis vaccine candidate that does not require refrigerated storage could improve vaccine access and deployment in resource-limited settings where cold-chain infrastructure is inadequate.
Important limitations
This summary is limited to the supplied single-article abstract and metadata. The full paper is required for decision-grade interpretation, including details on sample size, demographic characteristics, follow-up duration, and efficacy against tuberculosis disease.
GIDS interpretation
This Phase 1 trial contributes evidence on vaccine safety and immunogenicity for tuberculosis prevention. The thermostable formulation addresses logistical barriers in vaccine distribution. The article was classified under tuberculosis, vaccination, treatment, and climate/environment topics.
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 8 auditable classifier relationships to diseases, places, topics, and study design.