Motivation for participating in phase 1 vaccine trials: Comparison of an influenza and an Ebola randomized controlled trial

Introduction/Hypothesis

Recruitment of participants into phase 1 vaccine clinical trials can be challenging since these vaccines have not been used in humans and there is no perceived benefit to the participant. Occasionally, as was the case with a phase 1 clinical trial of an Ebola vaccine in Halifax, Canada, during the 2014–2016 West African Ebola virus outbreak, recruitment is less difficult. In this study, we explored the motivations of participants in two phase 1 vaccine trials that were concurrently enrolling at the same centre and compared the motivations of participants in a high-profile phase 1 Ebola vaccine trial to those in a less high-profile phase 1 adjuvanted seasonal influenza vaccine study.

Posterior chamber intraocular lenses in a series of 75 autopsy eyes. Part I: Loop location

Over a period of 27 months, November 1983 to February 1986, 75 eyes obtained postmortem with posterior chamber intraocular lenses (IOLs) were examined at the Center for Intraocular Lens Research, University of Utah Health Sciences Center. These IOLs were studied by histopathological techniques to determine the location of the loops. The most common combination, found in 47% of the specimens, was one loop in the lens capsular sac (bag) and one loop in the ciliary sulcus. In 32% of the specimens, both loops were in the capsular sac; in 17%, both loops were in the ciliary sulcus. Compared to results observed in other autopsy studies, in which capsular fixation was documented in less than 3% of cases, these findings reflect a trend toward capsular sac (in-the-bag) implantation of open-looped posterior chamber IOLs.     

Difficulties and bonuses of evaluation: evaluating New Zealand''s Children''s Nightclothes Act 1977

Difficulties and bonuses of evaluating injury prevention programmes are illustrated by reference to an evaluation of the New Zealand's Children's Nightclothes Act 1977. It is demonstrated that despite the difficulties encountered in that evaluation, and the equivocal results, there were significant bonuses which more than justified the resources devoted to the evaluation. The paper is presented in an attempt to encourage others to evaluate thermal injury countermeasures who may be hesitant to do so because of the difficulties they foresee.     

The effect of fulminant hepatic failure on protein C antigen and activity

In eighteen patients with fulminant hepatic failure (FHF), in grade III or IV coma, both protein C antigen and activity were significantly decreased (0.35 +/- 0.03 u/ml and 0.35 +/- 0.03 u/ml respectively). There was a significant correlation between protein C antigen and activity (r = 0.61, p less than 0.01). Protein C antigen levels were inversely correlated with prothrombin time (r = -0.57, p less than 0.05) as were protein C activity levels (r = -0.57, p less than 0.05). There was also significant correlations between fibrinogen and protein C antigen (r = 0.69, p less than 0.01) and protein C activity (r = 0.61, p less than 0.01). These results demonstrate that the naturally occurring inhibitor of coagulation, protein C, is present at low levels in FHF and this is probably due to the lack of synthesis of the protein in the damaged liver. The low levels of protein C may make these patients more susceptible to the disseminated intravascular coagulation which is known to occur in FHF and this in turn will lead to a further reduction in protein C levels.     

Doppler assessment of the uterine circulation and the clinical behaviour of gestational trophoblastic tumours requiring chemotherapy.

The haemodynamics of the uterine arteries and myometrium were assessed using Doppler ultrasound in forty consecutive patients requiring treatment for invasive mole and choriocarcinoma. The investigations were performed prior to the commencement of chemotherapy and the subjects followed prospectively. The Doppler waveforms from the uterine arteries were analysed using the pulsatility index. It was found that patients with a pulsatility index of 1.1 or less were significantly more likely to develop drug resistance than those with a higher value (P < 0.04). There was no significant association between the pulsatility index and metastatic disease or uterine bleeding. Five out of eight patients who developed drug resistance could have avoided initial inadequate treatment if the Doppler findings were included in the scoring system for selecting chemotherapy for these tumours. It can be concluded that assessment of the uterine arteries using the pulsatility index prior to the treatment of patients with invasive mole and choriocarcinoma is of help in predicting those who will develop drug resistance.