Journal of Vaccines & Clinical Trials

Jeffrey Jacobson

Editorial Board Member

Jeffrey Jacobson, MD
Department of Medicine, Neuroscience and Neurovirology,
Temple University, USA

Contact Jeffrey Jacobson

About the Journal

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Journal of Vaccines and Clinical Trials is a peer reviewed journal that focusses on the publication of advancements in the process of vaccine development encompassing laboratory and animal studies, preclinical stage studies, clinical trials and approval and licensure for novel vaccines and drugs. Vaccine research involves the study of antigenic biomolecules capable of instigating adaptive immune responses in individuals against specific diseases, their way of administration, study of their efficacy, large scale distribution and long term effects.

The journal also publishes findings on clinical trials of vaccines, drugs, dietary supplements and medical devices on human participants, in order to closely monitor its efficiency, associated safety issues, behavioral and physiological response, side effects and allergies if any. The journal aims at providing factual knowledge on the pros and cons of vaccination in adults and children. Manuscripts elucidating the molecular mechanism of adaptive immune responses concurrent with immunization with antigenic substances are solicited.The journal accepts original manuscripts in the form of research article, review article, short communication, case report, letter-to-the-Editor and Editorials for publication.

The following classifications and topics related to it will be considered for publication in Journal of Vaccines and Clinical Trials but, not limited to the following fields:

  • Human vaccines
  • Immunology
  • Vaccinology
  • Viral vaccines
  • Therapeutic vaccines
  • Antiviral therapy
  • DNA vaccine
  • Epidemiology
  • Vaccinations
  • Autoimmune disease

Manuscripts along with cover letters can be submitted to the journal via Editorial Manager System or via online submission system or as an e-mail attachment to the Editorial Office at [email protected] or [email protected]

Authors can also track the status of their manuscripts post submission through our manuscript tracking system.

Rabies

Rabies is unique among the viral diseases of man in that it kills virtually every individual it infects. The illness associated with the disease, in previous times referred to as hydrophobia, is particularly unpleasant for the victim but also for health care workers and relatives who have to witness it. Global estimates of death from rabies suggest that one person dies from the disease every 10 min, and more than 300 others are exposed. This claim is supported by a study of Malawian children with viral encephalitis, where 3 (11.5%) of 26 children originally clinically diagnosed with cerebral malaria were later laboratory-confirmed as having rabies suggesting that human disease is underreported in some rabies-endemic countries. The disease is distributed worldwide and is endemic in many countries causing an estimated 50,000–70,000 human deaths each year, although the true burden of the disease is unknown due to underreporting and poor surveillance systems in many areas of the world.

Bacterial Biothreat Agents

A range of bacterial pathogens might be used illegitimately to cause disease in humans or animals. The properties of these pathogens are dissimilar. Much of our information on the properties of these pathogens comes from past programs to develop biological weapons. In principle, disease caused by bacterial biothreat agents could be prevented or treated using antibiotics. However, there are limitations associated with the use of antibiotics in this way. Against this background vaccines will play a key role in protecting vulnerable populations from bacterial biothreats.

Cholera

Cholera is a life-threatening diarrheal disease with epidemic potential caused by the Gram negative bacterium Vibrio cholerae, serogroups O1 and O139. Since most cases of cholera are either not detected or not reported, the global burden of cholera is not known with certainty; however, cholera causes significant morbidity and mortality worldwide, with an estimated 5–7 million cases occurring each year, resulting in greater than 100,000 deaths per year. At present, the world is experiencing its seventh recorded pandemic, and cholera is endemic in many countries in Asia, Africa, and Latin America. Large outbreaks, especially among impoverished or displaced persons, occur on a regular basis, and cholera may spread through travel or migration of infected individuals, including even short-term travelers or visitors.

Dengue

Molecular evolution studies suggest that dengue virus (DENV) evolved 1000 years ago and entered a sustained human–mosquito cycle between 125 and 320 years ago. While it is unlikely that DENV would be used as a biothreat agent, DENV has emerged since World War II as the most important mosquito-borne viral pathogen infecting an estimated 100 million persons each year. Infection with any of the four DENV serotypes (DENV-1, 2, 3, and 4) can be inapparent, result in classic dengue fever with high fever, headache, eye pain and muscle ache, or progress at the time of defervescence to dengue hemorrhagic fever (DHF) characterized by hemorrhagic manifestations and plasma leakage that can lead to shock and death. The immunopathological mechanisms by which DENV causes the clinical features of DHF are intricate and include aberrant humoral and cellular immune responses. Previous DENV infections may predispose to more severe disease by the induction of enhancing antibody and cross-reactive T cells. Treatment is supportive relying upon careful fluid management which can be lifesaving.

DNA Vaccines

Continued improvements in vaccination technologies have led to remarkable progress in the control of human infectious diseases. Our fundamental view of the nature of a vaccine was changed with the discovery of DNA immunization in the early 1990s when it was determined that the genetic material that encodes for antigens, rather than the actual antigens themselves, can be effective in eliciting an immune response. Given the ever increasing threat of emerging and reemerging infectious diseases and a renewed concern regarding the use of biological agents for bioterrorism purposes, the opportunities that DNA vaccine technology provides could not have come at a more critical time in history.

Infectious Diseases

Dramatic improvements in the control of infectious diseases in developed countries owing to socioeconomic changes, vaccines, and antibiotics during the first seven decades of the 20th century led to the mistakened concept that infectious diseases would no longer be a concern. Since the declaration of victory in the war against infectious diseases in 1967, approximately 50 new disease agents have been identified. 

Nearly every type of etiologic agent and clinical manifestation have been involved including acute respiratory infections (e.g., H5N1 influenza A, SARS, hantaviral cardiopulmonary syndrome, and Legionnaires’ disease), central nervous system involvement (e.g., West Nile encephalitis, Nipah virus encephalitis, and prion diseases), enteric infections (e.g., Helicobacter pylori gastric and duodenal diseases, cryptosporidiosis, microsporidioses, and Shiga toxin diseases), systemic bacterial diseases (e.g., Lyme disease, six new rickettsioses, three new human ehrlichioses, bartonelloses, and staphylococcal and streptococcal toxic shock syndrome), viral hemorrhagic fevers (e.g., Marburg, Ebola, Lassa, Bolivian, Argentine, and Venezuelan hemorrhagic fevers), human retroviral infections (e.g., HIV1 and 2 and HTLV-I and II), new human herpesviruses (HHV6, HHV7, and HHV8), and the viral agents of hepatitis A, B, C, D, and E.

Influenza

Influenza virus is a globally important respiratory pathogen which is associated with a high degree of morbidity and mortality annually. The rapid evolution of influenza A and B viruses contributes to the annual seasonal epidemics (localized outbreaks) in humans as well as occasional pandemic (worldwide) outbreaks. Despite improvements in development of antiviral therapies during the last decade, vaccination remains the most effective method of prophylaxis. For those at risk of developing complications from influenza infection, annual vaccination is recommended as it induces a good degree of protection and is generally well tolerated by the recipient. Currently there are two types of influenza vaccines in use, the live-attenuated vaccine (LAV) given intranasally/orally, and the inactivated vaccine (IV) delivered subcutaneously or intramuscularly. The available trivalent IV (TIV) elicits good serum antibody responses but induces poor mucosal IgA antibody and cell-mediated immunity.

Malaria

Malaria is the most important parasitic disease with its vast distribution across the tropics and subtropics, immense public health burden, and tremendous economic impact on affected populations. Efforts to control malaria are being conducted on multiple fronts including vector control through residual house spraying, distribution of insecticide-treated bednets and improved diagnosis and treatment, including the development of new drugs and drug combinations effective against resistant strains. Despite these efforts, malaria remains prevalent in at least 87 countries with approximately 40% of the world’s population living at risk; the greatest burden of malaria falls on young children with one child dying from malaria every 30 s. Civil disturbance, inadequate health infrastructure, and poverty contribute to the lack of effective control. Experience with other infections such as smallpox, measles, and polio demonstrates that vaccines can be a highly effective and cost-efficient method of controlling an infectious agent with global impact.

Mycobacterium tuberculosis

Tuberculosis (TB) is one of the most prevalent infectious diseases worldwide and accounts for a large portion of all preventable deaths. Latent TB infection is also extremely common, affecting as many as one-third of humans alive today. Fortunately, only about 10% of TB infection leads to active TB disease. TB is curable with proper treatment, but treatment programs are labor intensive and increasingly threatened by drug resistance. Furthermore, the long treatment regimen poses compliance problems, and lack of access to TB care is common. As a consequence of these combined factors, TB continues to claim 2 million lives per year. An effective vaccine reliably preventing TB disease in adults would significantly reduce the number of deaths due to TB; however, no such vaccine is available. A live attenuated strain of Mycobacterium bovis, bacille Calmette–Guérin (BCG), is used with variable efficacy to vaccinate children against TB in many countries throughout the world.

Plague

Killed whole cell vaccines for plague were first produced as long ago as the late 1890s and modified versions of these are still used, with evidence that they are efficacious against bubonic plague. Renewed efforts with modern technology have yielded new candidate vaccines that are less reactogenic, can be produced in a conventional pharmaceutical manufacturing plant, and are protective against the life-threatening pneumonic form of the disease. This chapter reviews the threat still posed by plague in the world today, the rationale for the research and development of new vaccine formulations and assesses the likely impact of a prophylactic vaccine for pneumonic plague.

Rabies

Rabies is unique among the viral diseases of man in that it kills virtually every individual it infects. The illness associated with the disease, in previous times referred to as hydrophobia, is particularly unpleasant for the victim but also for health care workers and relatives who have to witness it. Global estimates of death from rabies suggest that one person dies from the disease every 10 min, and more than 300 others are exposed. This claim is supported by a study of Malawian children with viral encephalitis, where 3 (11.5%) of 26 children originally clinically diagnosed with cerebral malaria were later laboratory-confirmed as having rabies suggesting that human disease is underreported in some rabies-endemic countries. The disease is distributed worldwide and is endemic in many countries causing an estimated 50,000–70,000 human deaths each year, although the true burden of the disease is unknown due to underreporting and poor surveillance systems in many areas of the world.

Smallpox

Throughout history mankind has been ravaged by smallpox, a devastating disease which touched every corner of the earth and was capable of destroying entire civilizations. Through repeated epidemics and pandemics smallpox altered the course of history and is thought to have killed more people than any other infectious disease. Although attempts to control and mitigate the disease had been practiced for thousands of years, it still took nearly two centuries after Jenner’s initial experiments with cowpox and vaccination before smallpox was brought under control. The eventual eradication of smallpox in 1980 is undoubtedly one of mankind’s greatest medical achievements. It is a sad commentary on human nature that, only a few decades after this dreadful scourge was eradicated, smallpox is once again a subject of international concern, due to its potential as a biological weapon.

Typhoid Fever

Typhoid fever, caused by Salmonella enterica serotype Typhi, is an infection of global importance with an estimated 21.5 million infections and 200,000 deaths per year (estimated in the year 2000). S. Typhi is a potential bioterrorist agent that could be disseminated in untreated water supplies and food, resulting in moderate morbidity and low mortality. Resistance to chloramphenicol, ampicillin and trimethoprim/sulfamethoxazole is widespread and resistance to the fluoroquinolones is currently spreading throughout Asia. Typhoid has been a target for vaccine development for decades and whole cell, live oral and subunit vaccines have been developed and proved both safe and efficacious. Two currently licensed vaccines are available but are not commonly used in endemic areas and the need for extensive vaccination programmes are of critical importance.

Vaccine Adjuvants

It is widely believed that adjuvants are important, and in some cases critical, for the success of most modern vaccines, particularly for new types of vaccines that have highly purified or synthetic antigens. Although aluminum salts are the most commonly used type of adjuvant for human vaccines, they are weak adjuvants that have complex mechanisms that favor induction of antibodies rather than cellular immunity. Aluminum salts do have a long record of relative safety, but they are also often responsible for local reactions at the site of injection, particularly for reactions that are associated with subcutaneous administration. Adjuvant selection for human vaccines still relies strongly on direct empirical testing of candidate adjuvants for safety and efficacy in humans. However, principles of innate immunity have been developed that provide some guidance for rational selection of adjuvants. New forms of vaccine adjuvants that have been proposed for various vaccines feature oil-based emulsions; bacterial products, such as lipid A, heat-labile E. coli enterotoxin, or CpG nucleotides; viral products, such as virus-like particles; plant products, such as saponin derivatives; biodegradable particles, such as liposomes; molecular adjuvants; and synthetic adjuvants.

Vaccine Immunology

The use of vaccination as a strategy to reduce the impact of disease on society has a long-standing history of success, particularly for viral and bacterial-mediated diseases. The demand for safe and effective vaccine products is increasing due to the potential use of biothreat agents, and the emergence and reemergence of various pathogens. The implementation and use of vaccines in immunologically naive recipients in outbreak settings places extraordinary demands on the timing of the onset of immunity in a relatively broad population base, including those populations which may not always be ideal for delivery of vaccines (e.g., neonates, pregnant women, and the elderly). Each of these populations has its own unique demands for the induction of protective immunity and safety. 

Viral Biothreat Agents

The risk posed by viruses as biological threat agents is discussed primarily from a public health perspective, with the potential occurrence of significant morbidity and mortality as a result of infection via natural or intentional exposure. Parameters of risk associated with the spectrum of viruses considered as biological threat agents are discussed, to include examples of intentional use. In consideration of the threat posed by viruses, mitigating illness and preventing death are the principal goals of medical countermeasure development efforts. The existence of safe and efficacious vaccines is critical to establishing a robust posture of preparedness to address the spectrum of viral threat agents.

Viral Vectors

Traditional vaccine development platforms such as live-attenuated virus, killed virus, or recombinant subunit-based vaccines are often effective in eliciting long-term immunity to a number of infectious human pathogens. However, for many human pathogens, vaccine platforms such as these are unsuitable for human use due to safety concerns, poor efficacy, or simple impracticality. As a result, much work has focused on the use of recombinant virus vectors as a means for vaccination against human pathogens. Viral vectors can express foreign proteins at high levels in host cells, resulting in strong, long-lasting immune responses against the target proteins. This chapter describes the use of virus vectors in the context of vaccination against human pathogens. Various vector platforms are discussed, compared, and contrasted.

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