Several years have elapsed since the publication by Johnson et al. (1989) of the cloning of a recombinant antigen from the cestode parasite Taenia ovis which stimulated high levels of protective immunity in sheep. A great deal of subsequent research and development was necessary to bring the fledgling vaccine to the point of being a registered commercial product. The results of these subsequent studies are dealt with briefly in this paper, including the results of field trials. The T. ovis vaccine was registered by the New Zealand Animal Remedies Board in February 1994. Where then is the commercial product ? This paper gives a background to market problems which have emerged through the politics (and realities) of the NZ T. ovis control campaign. It serves as notice that the best science dedicated to producing vaccines or products for parasitic, or other, diseases often faces significant hurdles in the real world of commerce and politics.

This paper describes the development of the first commercial vaccine for toxoplasmosis. The vaccine comprises live tachyzoites of the S48 ‘incomplete’ strain of Toxoplasma gondii and is deployed to control toxoplasma abortion in sheep. A discussion of protective immune mechanisms and recent studies on host responses to the vaccine is also included.

Genetically defined, live attenuated Salmonella vaccines are proving useful both as oral vaccines against salmonellosis and for the development of multivalent vaccines based on the expression of heterologous antigens in such strains. Several candidate attenuated S. typhi strains are at present being evaluated as new single dose oral typhoid vaccines in human volunteers. The emergence of such a vaccine will facilitate the development of multivalent vaccines for humans. Many antigens from different infectious organisms have been expressed in attenuated Salmonella. A focus of this work has been on developing vaccines against parasitic diseases. This review will summarize the efforts that have been made in this area.

Several years ago the Walter Reed Army Institute of Research (WRAIR) initiated an independent analysis of the candidate malaria blood stage vaccine SPf66. WRAIR contracted for the synthesis and formulation of SPf66 in United States Food and Drug Administration (FDA) inspected laboratories within the U.S., and in 1992, filed an Investigational New Drug (IND) application with the FDA. Preclinical studies indicated that the vaccine could be synthesized to meet its release specifications, and when adjuvanted with alum, was essentially equivalent to Colombian produced SPf66 in regards to immunogenicity in preclinical studies of rodents and primates, and in human volunteers in Phase I studies. The goal of these efforts was ultimately to conduct a Phase IIb field trial to determine the safety and efficacy of SPf66 produced under current Good Manufacturing Practices (cGMP). Such a trial is currently underway in a malaria endemic refugee camp along the Thai–Burmese border. Here we briefly describe the study and present the formal analytic plan that was submitted to regulatory authorities in the United States for analysis of the study results. We believe such independent confirmatory studies are an essential part of the vaccine development process and are required to provide important data regarding the safety and efficacy of candidate vaccines in diverse geographical regions, and as a means to assess their role in the context of broader malaria control programmes.

To improve both safety and stability of the vaccines used in the field to vaccinate foxes against rabies by the oral route, a recombinant vaccinia virus, expressing the glycoprotein of rabies virus (VVTGgRAB) has been developed. VVTGgRAB innocuity was verified in target species and in domestic animals as well as in numerous wild animal species that could compete with the red fox in consuming vaccine baits in Europe. Oral immunization of foxes, by distributing VVTGgRAB vaccine-baits, was undertaken for the whole infected area in Belgium (10000 km2). Five campaigns of fox vaccination, were carried out from autumn 1989 until 1991. Each time, 150000 vaccine-baits were dropped by air at a mean density of 15 per km2. These campaigns induced a drastic decrease in the incidence of rabies and the elimination of the disease from 80% of the initially infected area. Regarding the geographical evolution of rabies in Belgium and in adjacent regions in neighbouring countries, new spatial strategies for bait dispersal were planned for 1992, 1993 and 1994: successive confined campaigns were carried out along political borders only. These campaigns induced a new decrease of incidence; no rabid fox could be detected in 1993 in spite of an improved epidemiological surveillance. In 1994, rabies was again confirmed in 13 foxes collected in an area close to the French border. These cases demonstrate the persistence of a border rabies focus and justify further restricted vaccination campaigns.

Increasingly, there is need for methods to control cattle tick (Boophilus microplus) infestations by the use of non-chemical technology. This need is brought about by a mixture of market forces and the failure or inadequacy of existing technology. A recombinant vaccine has now been developed against the tick. This vaccine relies on the uptake with the blood meal of antibody directed against a critical protein in the tick gut. The isolation of the vaccine antigen, Bm86, and its production as a recombinant protein is briefly described. The vaccine has been tested in the field, has been taken through the full registration process and is now in commercial use in Australia. A related development has occurred in Cuba. The potential for improvement of the current vaccine and for the development of similar vaccines against other haematophagous parasites is discussed.

The development of a successful vaccine depends not only on the production of the vaccine itself, but also on the design of the vaccination programme. This involves a better understanding of the epidemiology of the disease to be controlled, the delivery system to be used and the costs involved. This review focuses on current understanding of parasite population dynamics and epidemiology, and on the logistic experience gained from immunization programmes using existing viral and bacterial vaccines. The feasibility and sustainability of any new vaccine would greatly benefit from research into epidemiology and health systems which are conducted in parallel, rather than sequential to, vaccine development.