Safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in China: preliminary report of a randomised, double-blind, placebo-controlled, phase 1 trial
The Lancet·
- DOI
- 10.1016/s0140-6736(15)60553-0
- PMID
- 25817373
- PMCID
- —
- OpenAlex
- W2084667813
- Study type
- Randomised controlled trial
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Why this research matters now
This is an early clinical evaluation of an Ebola vaccine candidate, so it is relevant to vaccine development and preparedness work. The study addresses a vaccine targeting the 2014 epidemic strain rather than providing outbreak surveillance evidence.
Structured evidence summary
Research question
To assess the safety and immunogenicity of a recombinant adenovirus type-5 vector Ebola vaccine expressing the 2014 epidemic strain glycoprotein in healthy adults in China.
Study design
A randomized, double-blind, placebo-controlled phase 1 trial conducted at one site in Taizhou County, Jiangsu Province, China. Participants were analyzed by intention to treat.
Population and setting
Healthy adults aged 18 to 60 years were sequentially enrolled in China between late December 2014 and early January 2015. The trial enrolled 120 participants across placebo, low-dose, and high-dose groups.
Main findings
The abstract reports more solicited adverse reactions in the vaccine groups than in placebo, with the highest frequency in the high-dose group; injection-site pain was the most common reaction. It also states that the high-dose vaccine was safe and robustly immunogenic, with glycoprotein-specific humoral and T-cell responses by day 14.
Public-health relevance
This is an early clinical evaluation of an Ebola vaccine candidate, so it is relevant to vaccine development and preparedness work. The study addresses a vaccine targeting the 2014 epidemic strain rather than providing outbreak surveillance evidence.
Important limitations
The study was phase 1, single-site, and limited to healthy adults with 28 days of follow-up. This summary is also limited to the supplied single-article abstract and metadata; the original paper is needed for decision-grade interpretation.
GIDS interpretation
The article is discoverable as a randomized phase 1 Ebola vaccine trial in humans and is indexed with Ebola, China, and vaccination-related classifiers. That supports topical relevance, but it does not by itself establish any live surveillance signal.
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.