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PubMed1997

[Recent progress in live influenza vaccine development].

As live influenza vaccine, cold-adapted influenza virus vaccines (ca vaccine) have been extensively investigated in both the U.S and Russia. In Russia it has been licensed since 1988 and it is going to be licensed in the U.S. within a year or two. In general, the ca vaccine is more effective in seronegative population than the inactivated vaccine. In seropositive adult population, both are equally effective. In the elderly, inactivated vaccine is better than the live vaccine. In Japan, clinical trials were also conducted with the American ca vaccines. Although the efficacy was confirmed in limited locations, the vaccine could not be evaluated from the point of license approval because big epidemic did not occur during the studies.

Adult↗

PubMed2006

Assembling a global vaccine development pipeline for infectious diseases in the developing world.

Commercial realities have drastically reduced private investment in the development of new public health tools, but increased awareness of this situation has resulted in the emergence of a variety of research-based, nonprofit organizations. We reviewed current vaccine developments and developed a framework for efficient research and development investments in this area. We have identified several key "push" and "pull" forces within the vaccine research and product development environment and have examined their impacts on the process. These forces affect the global vaccine pipeline, which is composed of all individual vaccine initiatives and global partnerships (i.e., stakeholders), All of these research and development stakeholders must work together to establish and promote a global, sustainable research and development pipeline that delivers optimal vaccines and immunization technologies.

Child↗

PubMed1996

Selected regulatory and scientific topics for candidate rotavirus vaccine development.

Various aspects of the development of rotavirus vaccine candidates are discussed. As is true with other vaccines, comprehensive testing must be done to detect the possible presence of adventitious agents in the vaccine and seed preparations. Consideration must also be given to other biologic materials that come in contact with the vaccine preparation during production to prevent the introduction of contaminants. The clinical testing of rotavirus vaccines from early safety and immunogenicity studies through final efficacy studies is also discussed. Issues surrounding coadministration of investigational rotavirus vaccines with US-licensed vaccines are ideally addressed before initiation of efficacy trials. Other subjects discussed are identification of correlates of protection, multivalent vaccines, foreign efficacy trials, safety data, and statistical considerations. Sponsors of investigational vaccines are urged to contact the Food and Drug Administration for guidance during the development process, especially before the investigational new drug application and pivotal efficacy trial stages.

Child, Preschool↗

PubMedDate not supplied

Perspectives on FIV vaccine development.

Feline immunodeficiency virus (FIV), discovered a decade ago, is the causative agent of feline immunodeficiency syndrome (FAIDS), a chronically degenerative, fatal disease in domestic cats. Our understanding of the immunopathogenesis of FIV has improved but the development of an effective therapy and prophylaxis has been slow, reflecting the remarkable adaptability of the virus to modern medical intervention. FIV vaccine development has had its successes and failures similar to those encountered in human immunodeficiency virus (HIV) vaccine research. This review summarizes the status of FIV vaccine research, including trials of conventional, recombinant subunit and recombinant vector-based vaccines, and potential mechanisms of vaccine protection. The lessons learned from the FIV model should provide new insights for the approaches toward the development of HIV vaccines.

Animals↗

PubMed1992

Recent observations regarding the pathogenesis of recurrent respiratory syncytial virus infections: implications for vaccine development.

Respiratory syncytial virus (RSV) and influenza virus are common pathogens for all age groups. Currently licensed influenza virus vaccines generally provide protection from clinically detectable disease caused by antigenically matched challenging viruses. In contrast, vaccine development for RSV has been hampered by the inability of candidate vaccines to induce protective immunity to naturally occurring infection. The precise mechanism(s) responsible for the RSV vaccine failures have not been determined. We raise the possibility that infection by RSV is associated with attenuation of both proliferative and non-proliferative RSV-specific responses by human mononuclear leucocytes that results in the suppression or delay of host anamnestic defences, allowing development of recurrent clinical illness despite pre-existing immunity.

Humans↗

PubMed2006

Strategies for developing vaccines against H5N1 influenza A viruses.

Recent outbreaks of highly pathogenic avian influenza A virus (H5N1 subtype) infections in poultry and humans (through direct contact with infected birds) have raised concerns that a new influenza pandemic might occur in the near future. Effective vaccines against H5N1 virus are, therefore, urgently needed. Reverse-genetics-based inactivated vaccines have been prepared according to World Health Organization (WHO) recommendations and are now undergoing clinical evaluation in several countries. Here, we review the current strategies for the development of H5N1 influenza vaccines, and future directions for vaccine development.

Animals↗

PubMed2004

Design of synthetic peptidic constructs for the vaccine development against viral infections.

The practical development of modern vaccines has been greatly advanced by the availability of synthetic antigens. The use of such synthetic antigens might be more acceptable for human therapy since synthetic peptides do not have any of the potential dangers associated with the induction of an infection by recombinant viruses. However, synthetic peptides alone are often not immunogenic enough, and a strong immunoadjuvant is usually employed for their elaboration. Unfortunately, only a few adjuvants used in experimental models are allowed for use in human beings. In this regard, different presentations of synthetic peptides such as incorporation into liposomes, modification of the lipophilic properties by means of a covalently coupled fatty acid moiety and the synthesis of larger constructs such as multiple antigenic peptides (MAP) have been demonstrated to yield efficient immunological reagents for the amplification in the analysis and induction of immune responses to a variety of infectious agents. This review outlines recent research on synthetic peptide immunology. The development of a MAP with a built-in adjuvant is highlighted as a robust method for vaccine design.

Adjuvants, Immunologic↗

PubMed2006

Pregnancy-associated malaria: parasite binding, natural immunity and vaccine development.

Humans living in areas of high malaria transmission gradually acquire, during the early years of life, protective clinical immunity to Plasmodium falciparum, limiting serious complications of malaria to young children. However, pregnant women become more susceptible to severe P. falciparum infections during their first pregnancy. Pregnancy associated malaria is coupled with massive accumulation of parasitised erythrocytes and monocytes in the placental intervillous blood spaces, contributing to disease and death in pregnant women and developing infants. Indirect evidence suggests that prevention may be possible by vaccinating women of childbearing age before their first pregnancy. This review aims to introduce the reader to the implications of malaria infection during pregnancy and to analyse recent findings towards the identification and characterisation of parasite encoded erythrocyte surface proteins expressed in malaria-infected pregnant women that are likely targets of protective immunity and have potential for vaccine development.

Animals↗

PubMed1993

Borrelia burgdorferi is clonal: implications for taxonomy and vaccine development.

The chromosomal genes fla and p93 and the ospA gene from a linear plasmid were sequenced from up to 15 isolates of Borrelia burgdorferi, which causes Lyme borreliosis in man. Comparison of the gene trees provides no evidence for genetic exchange between chromosomal genes, suggesting B. burgdorferi is strictly clonal. Comparison of the chromosomal gene trees with that of the plasmid-encoded ospA reveals that plasmid transfer between clones is rare. Evidence for intragenic recombination was found in only a single ospA allele. The analysis reveals three common clones and a number of rare clones that are so highly divergent that vaccines developed against one are unlikely to provide immunity to organisms from others. Consequently, an understanding of the geographic and genetic variability of B. burgdorferi will prove essential for the development of effective vaccines and programs for control. While the major clones might be regarded as different species, the clonal population structure, the geographic localization, and the widespread incidence of Lyme disease suggest that B. burgdorferi should remain the name for the entire array of organisms.

Bacterial Vaccines↗

PubMed1996

Controlled delivery of antigens and adjuvants in vaccine development.

Advances in the understanding of the pathogenesis of infectious diseases and cancer immunology have inspired many new approaches to vaccine development. Many subunit antigens and peptides that are effective for vaccination have been discovered. These subunit antigens in tum stimulate synthesis of effective adjuvants to enhance their immunogenicity. Controlled-release technology offers the potential of further improving the efficacy of conventional vaccine formulations by optimizing the temporal and spatial presentation of the-antigens and adjuvants to the immune system. The combination of sustained release and depot effect may also reduce the amount of antigens or adjuvants needed and eliminate the booster shots that are necessary for the success of many vaccinations. This review examines the contribution controlled release technology can make in various areas of vaccination, with an emphasis on tumor vaccines.

Adjuvants, Immunologic↗

PubMed2001

Recombinant Semliki Forest virus vector exhibits potential for avian virus vaccine development.

The Semliki Forest virus (SFV) expression system was evaluated as a basis for avian vaccine development. Initial studies indicated that 1-day-old specific pathogen-free (SPF) chicks were susceptible to infection with an infectious strain of SFV, producing SFV-specific antibodies but no clinical disease. One-day-old SPF chicks immunised intramuscularly with recombinant replication-defective SFV (rSFV) particles expressing the Escherichia coli (E. coli) lacZ reporter gene developed high titres of beta-gal- specific antibodies at 4 weeks p.i. after two inoculations. In contrast, significantly lower antibody levels were elicited in chicks immunised with a recombinant SFV-based DNA construct or a conventional CMV promoter-based DNA plasmid. rSFV particles encoding the protective VP2 protein or the VP2/VP4/VP3 polyprotein of infectious bursal disease virus (IBDV) were produced and the expressed antigens were characterised in cell culture. Proteins of the correct size were generated and found to react against a range of IBDV-specific monoclonal antibodies. Immunisation of 1-day-old SPF chicks with rSFV particles encoding the IBDV proteins resulted in specific antibodies being elicited in all birds, neutralising antibodies being induced in some but not all birds.

Animals↗

PubMed1999

Protective immune mechanisms against Theileria parva: evolution of vaccine development strategies.

Theileria parva is an intracellular sporozoan parasite that infects and transforms bovine lymphocytes, causing a severe lymphoproliferative disease known as East Coast fever in eastern, central and southern Africa. In this article, Declan McKeever and colleagues summarize the current understanding of immune mechanisms provoked by the parasite with regard to their role in both pathogenesis and protection. In particular, the influence of genomic polymorphism in parasite and host on the development of immunity is discussed, along with the evolution of current vaccine development strategies as a result of immunological research on the disease.

Animals↗

PubMed2005

Vaccine development for non-typeable Haemophilus influenzae and Moraxella catarrhalis: progress and challenges.

An urgent need exists for vaccines to prevent infections caused by nontypeable Haemophilus influenzae and Moraxella catarrhalis. These bacteria cause otitis media in children, a clinical problem associated with enormous morbidity and cost. H. influenzae and M. catarrhalis also cause lower respiratory tract infections in adults with chronic lung disease. Infections in this clinical setting are associated with disability and death. Recent progress in identifying potential vaccine antigens in both bacteria raises great promise in developing effective vaccines. This paper reviews the key issues in vaccine development for H. influenzae and M. catarrhalis, including areas where progress has been stalled, and proposes areas that deserve investigation in the next 5 years.

Animals↗

PubMed1996

Novel approaches to vaccine development against HBV.

This review summarizes studies from my laboratory based on two novel approaches towards vaccine development against hepatitis B surface antigen. The first approach deals with the ability of a monoclonal anti-idiotypic antibody to functionally mimic the a determinant of HBsAg. The second approach exploits the strategy of genetically engineering plants so that they can be used as inexpensive alternatives to fermentation systems for the production of candidate vaccine antigens.

Amino Acid Sequence↗

PubMed2002

Influence of genomics on cancer vaccine development from guess to prediction.

After more than 100 years since the first adjuvant for a cancer vaccine was described and more than a decade since the first tumor antigen has been molecularly cloned, it seems possible that cancer vaccines might be integrated into the standard care of cancer patients. Exciting new technologies concerning tumor antigen discovery, vaccine delivery and formulation define the basis for enormous efforts in academia as well as in the pharmaceutical and biotech industry. With the unveiling of the human genome additional targets will emerge that could further enhance vaccine efficacy, specificity and clinical applicability. Most likely therefore, tumor antigen targets which are widely expressed in cancer will be of advantage over patient-oriented approaches due to their favorable cost-to-benefit ratio. Some widely expressed candidate tumor antigens and methods to discover additional widely expressed tumor antigens are discussed here. While the armamentarium of potential tools to cancer vaccine development seems to be endless, only those that are scientifically sound yet economically reasonable will in the end have a chance to become clinically useful cancer vaccines.

Antigens, Neoplasm↗

PubMed1988

The present status of rotavirus vaccine development.

Rotavirus infection is one of the most important causes of morbidity in young children throughout the world. The high associated mortality in Southeast Asia (and elsewhere) warrants the development of a vaccine. It is probable that most of the life-threatening watery diarrhoea due to rotavirus infection occurs as a result of primary infection in children aged 6-18 months after protection due to maternal antibody has diminished. Thus rotavirus vaccines are targeted at young infants from birth to 3 months of age. At present three candidate rotavirus vaccines (RIT-4237, MMU-18007, WC3) have undergone trials in young children. A bovine rotavirus strain (RIT-4237), was shown to be safe, immunogenic and efficacious in prevention of severe rotavirus diarrhoea in young children in Finland. However it was found to be weakly immunogenic in infants in developing countries, and to have only low efficacy in prevention of disease. A simian rotavirus strain (RRV, MMU-18006) has proved to be highly immunogenic and its reactinogenicity to be diminished by pre-existing maternal antibody (in infants aged 1-4 months). It has high efficacy against clinically severe rotavirus infection. However protection is homotypic against human serotype 3 only so that eventually a multivalent vaccine incorporating reassortant rotavirus strains that protect against human serotypes 1, 2, 4 (and other newer serotypes) may be required. It is hoped that, once safe immunogenic and protective candidate rotavirus vaccines are identified, they can be administered in an acceptable form with no alteration to existing immunization schedules.

Adult↗

PubMed2003

Strategies in cancer vaccines development.

The recent definition of tumour-specific immunity in cancer patients and the identification of tumour-associated antigens have generated renewed enthusiasm for the application of immune-based therapies for the treatment of malignancies. Recent developments in cancer vaccines have also been based on an improved understanding of the cellular interactions required to induce a specific anti-tumour immune response. Consequently, a number of cancer vaccines have entered clinical trials. Targeting broad-spectrum tumour-associated antigens has emerged as a strategy to lower the risk of tumour escape due to the loss of specific nominal antigen. Amongst the most challenging of tumour-associated antigens to which to target in active specific immunotherapy applications are carbohydrate antigens. As carbohydrates are intrinsically T-cell-independent antigens, more novel approaches are perhaps needed to drive specific-T-cell-dependent immune responses to carbohydrate antigens. In this context peptide mimetics of core structures of tumour-associated carbohydrate antigens might be developed to augment immune responses to these broad-spectrum antigens.

Antibody Formation↗

PubMed1992

Prevention of neonatal group B streptococcal infections: advances in maternal vaccine development.

OBJECTIVE: We describe the current state of prevention of neonatal group B streptococcal infections and present recent advances toward the development of a maternal vaccine for prevention of this disease. DATA SOURCES: We used a MEDLINE search of the Index Medicus from 1976-1992 for articles regarding group B streptococcus classification and immunology. Group B streptococcus was also cross-referenced with bacterial antigens, antibodies, and vaccines. Relevant textbooks were reviewed. METHODS OF STUDY SELECTION: Fifty-seven articles were selected as providing important background and new findings pertinent to this topic. DATA EXTRACTION AND SYNTHESIS: The literature supports prophylactic use of intrapartum antibiotics in mothers who are known carriers of group B streptococcus but highlights the need for more sensitive rapid screening techniques to identify this high-risk population. The promise of intravenous immunoglobulin for neonatal prophylaxis has not been borne out, although hyperimmune and monoclonal preparations offer renewed hope for prophylaxis and adjuvant therapy. Native bacterial polysaccharides, conjugated oligosaccharides and polysaccharides, and C proteins have been investigated as antigens for candidate vaccines. Antibodies elicited in human and animal studies provide protection against bacterial strains possessing these determinants. The theoretical existence of a "universal antigen" is significant because polysaccharide and C protein formulations are required to be polyvalent. CONCLUSIONS: The development of a vaccine for prevention of neonatal group B streptococcal sepsis is an attainable goal. Further study of the immunogenic properties of bacterial-cell-wall polysaccharides and their conjugates, C proteins, and the potential universal antigen is required.

Bacterial Vaccines↗