Experience with Vi typhoid capsular polysaccharide vaccine in the U.K.

Adult volunteers were immunised with a single dose of typhoid Vi capsular polysaccharide vaccine. After immunisation, 96% of the 103 subjects seroconverted and 94% had antibody levels above the protective threshold. Systemic reactions were uncommon, local reactions were mild and transient.

An evaluation of diphtheria--tetanus (adult) vaccine in unselected human volunteers.

One hundred unselected adult volunteers received an adult diphtheria (less than 2 Lf)-tetanus (greater than or equal to 40 IU) adsorbed vaccine without prior Schick testing. No volunteer had a moderate or severe reaction although 39% complained of a transient sore arm. Only 10% reported local erythema. Of the study group, 37/43 (86%) patients who were initially seronegative for diphtheria attained levels normally considered as seropositive. The results confirm the safety and efficacy of adult diphtheria-tetanus vaccine and allow its recommendation for use in 'at risk' individuals without the need for prior Schick testing.

Triglyceride lowering effect of MaxEPA fish lipid concentrate: a multicentre placebo controlled double blind study.

A multicentre, double blind, randomised between-group study comparing the triglyceride lowering effect of MaxEPA, a natural marine oil, and a placebo control is described. Eighty-six patients with hypertriglyceridaemia (fasting serum triglyceride greater than or equal to 2 mmol/l) were studied for three months. There were no significant differences between the groups (48 active, 38 control) in respect of age, sex, height or weight, smoking habits or alcohol consumption. After one month triglyceride levels were reduced significantly from baseline in the treatment group and there was also a highly significant difference between the groups in favour of the marine oil. There was no significant change in serum total cholesterol in either group but there were fluctuations in high density lipoprotein (HDL) in both groups. Minor gastrointestinal side effects were reported by patients in both groups. Standard haematological and biochemical tests were done and there were no significant changes from baseline.

Influenza vaccine: the effects of the 1986/1987 viral strains.

One hundred and twenty healthy volunteers were recruited for a study to evaluate the reactogenicity and serological response of differing doses of the 1986/87 World Health Organization-recommended influenza viral strains. Each vaccine was prepared by Institut Merieux and contained A/Mississippi/1/85, A/Chile/1/83 and B/Ann Arbor/1/86. One vaccine was formulated as a 10/10/10 micrograms HA and the other as a 15/10/15 micrograms HA. No significant advantage could be found with the 15/10/15 micrograms HA combination and it was recommended, therefore, that a 10/10/10 micrograms HA formulation was to be preferred. This vaccine demonstrated a minimal cross-sensitivity to the A/Singapore/6/86 influenza strain. In view of the prevalence of the A/Singapore strain, a second study was subsequently undertaken with a monovalent A/Singapore/6/86-like vaccine in a further 62 volunteers. This demonstrated an overall sero-conversion rate of 90%. Local side-effects with both vaccines were lower than in a similar study in 1984 and this may reflect a reduction in endotoxin levels achieved by a minor modification in the manufacturing technique. These studies confirmed the efficacy of a trivalent A/Mississippi, A/Chile, B/Ann Arbor influenza vaccine and the efficacy of, and necessity for, an additional A/Singapore vaccine.

Rubella vaccination: a study in adult male volunteers.

One hundred adult male volunteers were randomized to receive either Merieux or Wellcome RA27/3 rubella vaccine. Prior to vaccination, 10% of the subjects were seronegative and all of these seroconverted. No significant boosting effect was found in those with a high pre-vaccine titre but some boost was shown in those with a low level. Side-effects reported were mild and self-limiting. No clinically or statistically significant difference could be found between the two vaccines. It is suggested that in view of the finding of 10% seronegative adult males it would be worthwhile considering routine screening of all medical staff who have contact with women in the early months of pregnancy.

A comparative bioavailability study of Molipaxin capsules and a trazodone liquid formulation in normal volunteers.

The pharmacokinetic parameters of Molipaxin capsules and a trazodone liquid formulation have been compared in healthy volunteers. The mean area under the plasma concentration/time curve was 10.07 micrograms h ml-1 and 10.44 micrograms h ml-1, for Molipaxin capsules and trazodone liquid, respectively. The difference was not statistically significant. There was considerable individual variation between the observed maximum plasma concentration of Molipaxin capsules and trazodone liquid but the mean values of 1.61 micrograms/ml and 1.66 micrograms/ml, respectively, were very similar. The time to observed maximum plasma concentrations varied from 15 min to 4 h, but there was no statistical difference between the two formulations. The terminal phase half-life was 7.16 h for Molipaxin capsules and 6.73 h for trazodone liquid. The difference was not statistically significant. Molipaxin capsules and trazodone liquid have similar kinetic profiles and they are considered to have comparable bioavailability. Tolerance to the two formulations was similar.

The monitored release of buprenorphine: results in the young.

Temgesic Injection (buprenorphine), a potent analgesic agent, was given to 240 patients under 18 years of age during a year of monitored release. All but four had the product for the management of moderate or severe pain in the immediate post-operative period. Analgesia was reported as adequate or good in 90% of these young patients when it was assessed 2 and 4 hours after infection. There were no reports of side-effects commonly associated with strong analgesics and particularly antagonist-analgesics such as confusion, hallucination, blurred vision, dry mouth and lightheadedness. There were no serious respiratory or cardiovascular effects. The incidences of other events did not differ from those recorded in the much larger adult population of almost 8,000 patients. Buprenorphine is an effective analgesic suitable for use in the young post-operative patient.

Methodology of monitored release of a new preparation: buprenorphine.

The analgesic agent Temgesic (buprenorphine) was made available under monitored release regulations for one year, which yielded data from 1736 doctors on 9123 patients. An analysis of 17 120 administrations of the drug confirmed the results of the pre-licensing clinical studies encompassing data from nine British hospitals on 483 patients. No important new adverse effects attributable to the product were observed, and apart from giving reassurance, the usefulness of monitored release is questioned in the light of the relatively small amount of additional information arising from it.