6th Canadian Immunization Conference: <i>Immunization in Canada</i>
Bibliographic record
Abstract
Introduction: P. aeruginosa (PA) is a leading cause of nosocomial infections, affecting approximately 1 in 5 patients in intensive care units.Patients with cystic fibrosis, cancer, solid organ transplant or burns are at high risk for serious PA infection.An effective prophylactic vaccine could reduce morbidity and mortality in these groups.Methods: We conducted a Phase I dose-escalation trial of Cytovaxine, a synthetic consensus sequence pilin peptide conjugated to tetanus toxoid (TT) plus alum, in 35 healthy adult volunteers.Subjects were screened for good general health and had saliva, blood, and nasal washes collected for baseline antibody titres.Three vaccine doses were evaluated: 15 µg conjugate vaccine (CV)-2.5 Lf TT, 30 µg CV-5 Lt TT, and 60 µg CV-10 Lf TT.Dose escalation was permitted after review of the 6-week safety data following each dose level.Subjects were randomized within each dose level to receive either CV or TT plus alum control, and intramuscular injections were given on days 0, 42, and 140 with clinical and laboratory follow-up for safety and anti-consensus sequence peptide antibody titres.Results: Study injections were well tolerated and no safety concerns were raised.No serious adverse events (AEs) occurred.Mild tenderness at the injection site and mild pain with arm movement were the most commonly reported AEs; these events were similar between the study vaccine and the control.A mild systemic AE was reported by 40%-80% of subjects after one or more doses.Mild muscle aches were commonly reported (0%-40%) but were more common in the control arms; headaches were common in all groups but more common following the third 30 µg vaccine dose.Fever was not reported by any subject and no pattern of abnormal results was noted in clinical chemistry, hematology, or urinalysis.An IgG anti-consensus sequence antibody response was seen at all dose levels; there was no apparent dose-response effect.Forty to 50% of subjects in the three consensus sequence immunized group had a 2-fold rise in antibody titre and 30%-50% had a 4-fold rise.Little IgA or IgM response was demonstrated and there were no increases in salivary or nasal wash anticonsensus sequence antibody in any group.Conclusions: The PA study vaccine was safe and well tolerated in this Phase 1 trial.Immunogenicity was modest and further study is warranted.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.003 | 0.001 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.006 | 0.003 |
| Insufficient payload (model declined to judge) | 0.080 | 0.018 |
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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".