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Peer reviewedOpen accessEbola

Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial

The Lancet·

Hannah Kibuuka, Nina M Berkowitz, Monica Millard, Mary E Enama, Allan Tindikahwa, Arthur B Sekiziyivu, Pamela Costner, Sandra Sitar, Deline Glover, Zonghui Hu, Gyan Joshi, Daphne Stanley, Meghan Kunchai, Leigh Anne Eller, Robert T Bailer, Richard A Koup, Gary J Nabel, John R Mascola, Nancy J Sullivan, Barney S Graham, Mario Roederer, Nelson L Michael, Merlin L Robb, Julie E Ledgerwood

DOI
10.1016/s0140-6736(14)62385-0
PMID
25540891
PMCID
OpenAlex
W2147572243
Study type
Randomised controlled trial
Publisher
Elsevier BV
Article type
journal-article
Integrity
current

Why this research matters now

The paper is relevant to vaccine development for two high-fatality viral diseases and to early clinical evaluation of candidate vaccines in an African setting. It also provides context for later development work on Ebola vaccine antigens.

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Structured evidence summary

Research question

The study asked whether two investigational DNA vaccines for Ebola virus and Marburg virus glycoproteins were safe and immunogenic when given separately or together in healthy adults in Uganda.

Study design

This was a phase 1b, randomized, double-blind, placebo-controlled clinical trial. Participants were assigned to receive vaccine or placebo in separate active vaccine groups and were analyzed by intention to treat.

Population and setting

The study enrolled healthy adults aged 18-50 years in Kampala, Uganda. The abstract reports 108 enrolled participants and includes safety data for all 108.

Main findings

The injections were generally well tolerated, with no meaningful differences in local or systemic reactogenicity across groups. The vaccines produced glycoprotein-specific antibody and T-cell responses, and the abstract reports no difference between separate and combined administration.

Public-health relevance

The paper is relevant to vaccine development for two high-fatality viral diseases and to early clinical evaluation of candidate vaccines in an African setting. It also provides context for later development work on Ebola vaccine antigens.

Important limitations

The abstract provides only phase 1b trial results, so the evidence is early and limited to a small healthy-adult sample. This summary is also limited to the supplied single-article abstract and metadata; the original paper would be needed for decision-grade interpretation.

GIDS interpretation

From a discoverability and context standpoint, the article is a controlled early-phase vaccine study that sits within Ebola/Marburg vaccine development rather than outbreak field surveillance. The supplied metadata and classifier links support retrieval by disease, vaccination, and outbreak-related topic tags, but they do not establish a live surveillance signal.

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Related GIDS surveillance

Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.

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Evidence relationships

This article has 12 auditable classifier relationships to diseases, places, topics, and study design.

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