Minassian et al. report that the RH5.1/AS01 B vaccine against blood-stage Plasmodium falciparum malaria is safe and immunogenic in a phase I/IIa clinical trial. They demonstrate a significantly reduced blood-stage parasite growth rate in vaccinees following controlled human malaria infection and identify that in vitro antibody-mediated growth inhibition activity is associated with challenge outcome.

Alpha and beta carotene, provitamin A activity, dehydroascorbic acid, L-ascorbic acid and total ascorbic acid content of ' 'jalapeho," 'bell," long green/red "chile," " serrano" and "yellow wax" peppers (Cupsicutn unnuum L.) at green and red stages of maturity were determined by HPLC. Effects of thermal processing on vitamin A and C retention in "jalapeno" peppers was also determined. Provitamin A activity ranged from 27.3 to 501.9 Retinol Equivalents (RE/loOg). Ascorbic acid concentration ranged from 76.1 to 243.1 (mg/lOOg). Provitamin A activity and ascorbic acid content increased with maturity in all cultivars. Thermal processing of "jalapeho" cultivars resulted in a 25% decrease of total provitamin A activity and a 75% decrease in total ascrobic acid.

Plasmodium falciparum reticulocyte-binding protein homolog 5 (PfRH5) is a leading asexual blood-stage vaccine candidate for malaria. In preparation for clinical trials, a full-length PfRH5 protein vaccine called “RH5.1” was produced as a soluble product under cGMP using the ExpreS2 platform (based on a Drosophila melanogaster S2 stable cell line system). Following development of a high-producing monoclonal S2 cell line, a master cell bank was produced prior to the cGMP campaign. Culture supernatants were processed using C-tag affinity chromatography followed by size exclusion chromatography and virus-reduction filtration. The overall process yielded >400 mg highly pure RH5.1 protein. QC testing showed the MCB and the RH5.1 product met all specified acceptance criteria including those for sterility, purity, and identity. The RH5.1 vaccine product was stored at −80 °C and is stable for over 18 months. Characterization of the protein following formulation in the adjuvant system AS01B showed that RH5.1 is stable in the timeframe needed for clinical vaccine administration, and that there was no discernible impact on the liposomal formulation of AS01B following addition of RH5.1. Subsequent immunization of mice confirmed the RH5.1/AS01B vaccine was immunogenic and could induce functional growth inhibitory antibodies against blood-stage P. falciparum in vitro. The RH5.1/AS01B was judged suitable for use in humans and has since progressed to phase I/IIa clinical trial. Our data support the future use of the Drosophila S2 cell and C-tag platform technologies to enable cGMP-compliant biomanufacture of other novel and “difficult-to-express” recombinant protein-based vaccines.

Objectives To determine lower genital tract carriage rates of C. trachomatis, A! gonorrhoeae and bacterial vaginosis among women seeking termination of pregnancy. To compare two clinical management strategies for minimising the risks of infective morbidity after induced abortion.Design Prevalence of infections was assessed by screening women undergoing abortion. Clinical management strategies were compared by a randomised trial.Setting The gynaecology departments of four hospitals in Scotland.Participants 1672 women undergoing induced abortion.Interventions Women randomised to prophylaxis received metronidazole 1 g rectally before abortion plus doxycycline 100 mg twice daily for seven days. Women randomised to screen-andtreat received appropriate antibiotics only if screening proved positive for one or more infection.Main outcome measures Prevalences of infections; morbidity in the eight weeks following abortion as assessed by reported symptoms, general practitioner consultation and prescription rates and hospital re-attendances; costs to the NHS of alternative managements. ResultsPrevalence rates: C. trachomatis 5.6%; A! gonorrhoeae 0.19%; bacterial vaginosis 17.5%.Overall, women allocated to receive prophylaxis had lower rates of measures of short term infective morbidity than those allocated to screen-and-treat. These differences only reached statistical significance for women who were reported negative on screening. The direct costs to the NHS of prophylaxis and screen-and-treat were calculated to be E8.17 and f18.34 per woman, respectively.Conclusions Prevalences of lower genital tract infections which have been implicated in increased rates of infective morbidity after abortion are similar to those reported elsewhere. Universal antibiotic prophylaxis is at least as effective as a policy of screen-and-treat in minimising the risk of short term infective morbidity and is far more cost efficient.

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