Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
BACKGROUND: Immune responses to alphavirus vaccines might be impaired when heterologous alphavirus vaccines are administered sequentially. We aimed to compare immunogenicity and safety of a chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of heterologous alphavirus vaccines with alphavirus-naive controls in the USA. METHODS: -transformed titre as the dependent variable, and study arm, age, and sex as predictors. Least squares means, difference, and 95% CIs were back-transformed and reported as geometric mean titres (GMTs). This trial is registered with ClinicalTrials.gov, NCT03992872. FINDINGS: Between Nov 20, 2019, and Jan 19, 2021, 60 participants (20 [33%] female and 40 [67%] male; 40 (67%) White; median age 47·0 years [IQR 13·5]), 30 previous alphavirus vaccine recipients and 30 alphavirus vaccine-naive controls, were enrolled, vaccinated with CHIKV VLP, and completed the trial. The anti-CHIKV neutralising antibody seroconversion rate at day 22 was 100% (95% CI 88·6-100) in both groups. GMTs peaked in previous alphavirus vaccine recipients and alphavirus vaccine-naive controls at day 22 (2032·5 [95% CI 1413·0-2923·6] and 2299·2 [1598·1-3307·8], respectively) and were similar between the groups on day 22 and all subsequent visits. A higher proportion of previous alphavirus vaccine recipients (93·3% [95% CI 78·7-98·2]) had a four-fold neutralising antibody increase at day 8 than did alphavirus vaccine-naive controls (66·7% [48·8-80·8]; p=0·021). There was no statistically significant difference in the incidence of solicited adverse events between the previous alphavirus vaccine recipients and alphavirus vaccine-naive controls (53·3% vs 40·0%, respectively), although the relatively small sample size of the trial limited the power to detect a significant difference, and there were no reported vaccine-related serious adverse events. INTERPRETATION: CHIKV VLP vaccine was well tolerated and similarly immunogenic in both alphavirus vaccine-naive participants and previous recipients of a heterologous alphavirus vaccine. There were no significant differences in adverse events between the groups. The results of this study support the use of CHIKV VLP vaccine in individuals with previous alphavirus vaccine exposure. FUNDING: Defense Health Program, Emergent Travel Health, and Bavarian Nordic A/S.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it