The purpose of this study was to evaluate efficacy and safety of a gadolinium (Gd) zeolite suspension as an oral MRI contrast agent. Serial dilutions of GADO-LITE Oral Suspension 1,2-300 micrograms of Gd(III)/mL) were prepared. MRI (T1 and T2 weighted) of standards and dogs (precontrast and postcontrast) were performed. Toxicity and Gd absorption were also assessed. Subsequently, 30 normal male adult volunteers were divided into six groups of five subjects each. Gd zeolite po suspension was administered before and after MRI in volumes and concentrations ranging from 250 to 1500 mL; 6 to 60 micrograms of Gd+3/mL. The images were rated (efficacy score) by a blinded reader. Vital signs, blood chemistries and urinalysis were recorded. Gadolite Oral Suspension produced excellent enhancement of the dog gastrointestinal (GI) tract. No toxicity or absorption of Gd was observed in dogs receiving doses up to 4 times the anticipated human dose daily for 14 consecutive days. In clinical trials, Gd zeolite significantly improved the efficacy scores for all groups and all pulsing sequences (all P values < .05). Efficacy scores and signal intensities generally increased with concentration and volume. No Gd was detected in blood or urine specimens. No significant adverse events were reported. Gd zeolite is a promising contrast medium for enhancement of the GI tract in MRI.

Administration, Oral↗

PubMedDate not supplied

The immunogenicity and safety of a new combined diphtheria, tetanus and poliomyelitis booster vaccine (Td-eIPV).

In view of the continuing risk of contracting tetanus, diphtheria and poliomyelitis, and the well-documented decline in immunity with time, the need for booster vaccinations is substantial. The immunogenicity and safety of a new combined booster vaccine against tetanus, diphtheria and poliomyelitis (REVAXIS) developed by Pasteur Mérieux Connaught (Lyon, France) were evaluated in four clinical studies. This vaccine (Td-eIPV) combines an adsorbed tetanus toxoid and low-dose diphtheria toxoid vaccine (Td) with an enhanced, inactivated polio vaccine against poliovirus types 1, 2 and 3 (eIPV). In 256 healthy young adults, a single dose of Td-eIPV was shown to be immunogenic, eliciting antibody levels considered protective against disease for each vaccine component in > or = 99.6% of the subjects. In 112 healthy older subjects (> 40 years of age), two doses of Td-eIPV elicited seroprotective levels of antibodies in 94% of the subjects for diphtheria, and in all subjects for tetanus and poliovirus types 1, 2 and 3. Safety data from all 368 subjects, as well as 31 phase I volunteers and 1,742 subjects included in a safety study, reveal that the vaccine is safe. Most reactions were predictable, temporary and mild. There was no evidence that the vaccine was associated with any clinically serious event or modification of clinical laboratory parameters. The data reviewed here show that Td-eIPV is immunogenic and safe when administered as a booster vaccination in healthy adults of all ages.

Adult↗

PubMedDate not supplied

Booster effect of a new chromatographically purified Vero-cell rabies vaccine (CPRV): immunogenicity and safety of a single or double injection.

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Adult↗

PubMedDate not supplied

Clinical indicators of envenoming and serum levels of venom antigens in patients bitten by Bothrops lanceolatus in Martinique. Research Group on Snake Bites in Martinique.

An enzyme-linked immunosorbent assay was developed to measure venom antigen levels in the serum of 40 patients bitten by Bothrops lanceolatus. The grading system used for the severity of envenomation (grades 1 to 4, minor to major) was predominantly based on the presence of local signs. Serum venom levels increased with the grade of severity (P < 0.001, by Spearman's rank correlation test); they were 6 +/- 6 ng/mL (mean +/- SD) in clinically non-envenomed patients (grade 1, n = 3), 7.6 +/- 11.7 (n = 17), 44.3 +/- 41.8 (n = 17), and 80.3 +/- 34.1 ng/mL (n = 3) in patients diagnosed as grade 2, 3 and 4 respectively. However, venom antigens could not be detected in the serum of 54% of patients who showed clinical signs of envenomation. Most patients diagnosed as grade 2, 3 or 4 were given 20, 40 and 60 mL of a monospecific F(ab')2 antivenom, respectively. Venom concentrations > or = 15 ng/mL were observed in all patients with progressive aggravation of swelling despite the use of early antivenom therapy. No venom was detectable in blood samples taken after completion of serotherapy. All patients recovered. These results confirm the efficacy of both the clinical severity scoring system used and the therapeutic regimen.

Adolescent↗

PubMedDate not supplied

Clinical safety of a polyvalent F(ab')2 equine antivenom in 223 African snake envenomations: a field trial in Cameroon. VAO (Venin Afrique de l'Ouest) Investigators.

A large-scale clinical trials was conducted, according to World Health Organization Good Clinical Practice guidelines, in 7 centres in north Cameroon to determine the safety and efficacy of a polyvalent antivenom composed of purified F(ab')2. This study included 223 patients presenting clinically with obvious snake bite, predominantly due to Echis ocellatus (viper), the most abundant species in this savannah region. Clinical surveillance was maintained for 5 d in all patients and until the twenty-sixth day in 74% of cases. Two 10 mL ampoules of polyvalent F(ab')2 equine antivenom (Ipser Africa) were administered to each patient by intravenous infusion. If necessary, treatment was repeated 1 h after the end of the first infusion, and then with a frequency determined by the patient's clinical condition. Before initiation of antivenom treatment, the main clinical disorders observed on admission were oedema (93.7%) and haemorrhage (48.9%), with a clotting time longer than 30 min in 65.4% of patients. Clinical cure was obtained in 213 patients (96.8%). No amputation was necessary, and the case fatality rate was only 1.3%. On average, 4.6 (+/- 3.7) ampoules were administered per patient; 43% of subjects recovered after only a single infusion of 2 ampoules. Early adverse reactions, of varying degrees of severity, were observed in 6.3% of patients. A severe early reaction, anaphylactic shock, was observed in only one patient (0.4%). Serum sickness was observed in another patient. Polyvalent F(ab')2 equine antivenom given by repeated 20 mL intravenous infusions is a safe and effective treatment for envenomation caused by African vipers.

Adolescent↗

PubMedDate not supplied

Prognostic significance of clinical grading of patients envenomed by Bothrops lanceolatus in Martinique. Members of the Research Group on Snake Bite in Martinique.

The correlation between clinical grading of patients bitten by Bothrops lanceolatus and the subsequent development of their envenoming was examined. Severity of envenoming was graded using a 1-4 scale (minor to major). Patients were classified into 2 groups according to the time elapsed between bite and treatment with a specific purified equine F(ab')2 antivenom. The late/no treatment group (n = 33) was characterized by a systemic thrombotic complication rate of 14/33 (42.4%) leading to 4 deaths, which increased with the maximum severity assessed on the first day following the bite (P = 0.003). However, infarctions could develop in patients who presented initially with signs of moderate envenoming, normal blood clotting and low serum levels of venom antigens. No such complication of fatality occurred in the early (0.5-6 h) treatment group (n = 70). Multiple regression analysis showed that duration of stay in hospital in this group increased with the length of the snake (P = 0.017), venom antigenaemia (P = 0.016), initial grading (P < 0.001), and with the need for surgical debridement (n = 10/70, P < 0.001). Outcome was correlated with initial severity of envenoming. However, the only factor with a positive prognostic significance for the individual envenomed patient was the early infusion of specific antivenom, which led to 100% recovery in our series.

Analgesics↗

PubMedDate not supplied

Immunogenicity and safety of low-dose intradermal rabies vaccination given during an Expanded Programme on immunization session in Viet Nam: results of a comparative randomized trial.

The World Health Organization recently recommended a rabies vaccine pre-exposure schedule using 3 intradermal (i.d.) injections of one-fifth the standard intramuscular (i.m.) dose of current cell culture vaccines as a cost-reducing alternative for developing countries. As a strategy to improve further the acceptability of childhood rabies immunization, we assessed, in a controlled, randomized trial performed in 240 Vietnamese infants, the possibility of associating i.d. administration of a one-fifth dose of purified Vero-cell rabies vaccine (PVRV) with routine Expanded Programme on Immunization vaccines given at 2, 3 and 4 months of age (diphtheria, tetanus, whole-cell pertussis and inactivated poliomyelitis combined vaccine, DTP-IPV). Safety and immunogenicity results were compared with a group of infants given 2 i.m. doses of PVRV (2, 4 months) in association with DTP-IPV (2, 3, 4 months). After i.d. injection, more infants experienced local reactions, particularly redness, but these reactions were generally mild and transient. The rate of systemic reactions was the same in both groups. Although the rabies antibody titres (rapid fluorescent focus inhibition test) were higher 1 month after the third vaccine dose in the i.m. group (30.6 IU/mL vs 12.0 IU/mL in the i.d. group), all infants in both groups had achieved WHO-acceptable protective antibody titres (> or = 0.5 IU/mL) at this time. There was no evidence for any interference between DTP-IPV and rabies vaccine, supporting the interest of a low-dose i.d. PVRV pre-exposure regimen in infants living in rabies-endemic developing countries.

Antibodies, Viral↗