A Single Dose of the DENV-1 Candidate Vaccine rDEN1Δ30 Is Strongly Immunogenic and Induces Resistance to a Second Dose in a Randomized Trial
PLoS Neglected Tropical Diseases·
- DOI
- 10.1371/journal.pntd.0001267
- PMID
- 21829748
- PMCID
- PMC3149013
- OpenAlex
- W1997329577
- Study type
- Randomised controlled trial
- Publisher
- Public Library of Science (PLoS)
- Article type
- journal-article
- Integrity
- current
Why this research matters now
Dengue has emerged as the most important arboviral infection globally. The safety and immunogenicity profile observed supports the inclusion of rDEN1Δ30 in a tetravalent dengue vaccine under Phase I evaluation.
Structured evidence summary
Research question
The trial evaluated whether a second dose of rDEN1Δ30 vaccine, given 4 or 6 months after initial vaccination, could boost humoral immune responses in healthy flavivirus-naive adults.
Study design
This was a randomized placebo-controlled trial enrolling 60 healthy flavivirus-naive adults. Participants received either two doses of rDEN1Δ30 vaccine (N=50) or placebo (N=10), with dosing intervals of 120 days (cohort 1) or 180 days (cohort 2).
Population and setting
The study enrolled 60 healthy adults with no prior flavivirus exposure.
Main findings
The first vaccine dose was well tolerated, infected 47 of 50 vaccinees, and induced seroconversion in 46 of 50 participants. The second dose was also well tolerated but did not produce detectable viremia or a fourfold or greater rise in neutralizing antibody titer, regardless of whether it was given at 4 or 6 months. Only five subjects showed an anamnestic antibody response by ELISA after the second dose, indicating that most vaccinees developed sterilizing humoral immunity lasting at least six months.
Public-health relevance
Dengue has emerged as the most important arboviral infection globally. The safety and immunogenicity profile observed supports the inclusion of rDEN1Δ30 in a tetravalent dengue vaccine under Phase I evaluation.
Important limitations
This summary relies on the supplied single-article abstract and metadata. Full assessment of study limitations, generalizability, and decision-grade interpretation requires review of the complete published article.
GIDS interpretation
The article was classified under dengue and malaria diseases, and linked to treatment, vaccination, and vaccine effectiveness topics. These links facilitate discoverability within surveillance and research databases but do not imply connection to active outbreak signals or clinical guidance.
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 11 auditable classifier relationships to diseases, places, topics, and study design.