Clinical evaluation to confirm the manufacturing consistency of three lots of an adjuvanted glycoprotein D genital herpes vaccine in healthy seronegative pre-teen and adolescent girls: A phase III multi-center double-blind randomized trial
Conclusions This study demonstrated the lot-to-lot consistency of three commercial scale production lots of herpes simplex candidate vaccine. The vaccine was immunogenic and had a clinically acceptable safety profile when administered in HSV type 1 and HSV-2 seronegative girls aged 10–17years. The study was registered at clinicaltrials.gov (identifier NCT00224471). (Source: Trials in Vaccinology)
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

Efficacy of vaccination of 3-week-old piglets with Circovac® against porcine circovirus diseases (PCVD)
Publication date: 2013 Source:Trials in Vaccinology, Volume 2 Author(s): Bernhard Heißenberger , Christiane Weissenbacher-Lang , Isabel Hennig-Pauka , Mathias Ritzmann , Andrea Ladinig In this controlled, blinded and randomised study, Circovac®, an inactivated PCV2 vaccine was used for active immunisation of 3-week-old piglets (0.5ml, i.m., one-shot). In a PCVD affected farm, a total of 1105 piglets from three consecutive farrowing batches were included. The vaccine efficacy was assessed by clinical parameters such as mortality, underweight pigs and improvement of average daily weight gain (ADWG) during the fatt...
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

Analysis of recombinant, multivalent dengue virus containing envelope (E) proteins from serotypes-1, -3 and -4 and expressed in baculovirus
This study indicates that recombinant E protein expressed in a baculovirus system can induce humoral and cellular immune responses. (Source: Trials in Vaccinology)
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

Neem leaf glycoprotein optimizes effector and regulatory functions within tumor microenvironment to intervene therapeutically the growth of B16 melanoma in C57BL/6 mice
Publication date: Available online 6 December 2013 Source:Trials in Vaccinology Author(s): Subhasis Barik , Saptak Banerjee , Madhurima Sarkar , Avishek Bhuniya , Soumyabrata Roy , Anamika Bose , Rathindranath Baral Therapy with neem leaf glycoprotein (NLGP) inhibits murine B16-melanoma in vivo and improves survivability. Studies on tumor-microenvironment (TME) from NLGP treated mice (NLGP-TME) suggests that anti-tumor effect is directly associated with enhanced CD8+T cell activity, dominance of type 1 cytokines/chemokine network with downregulation of suppressive cellular functions. NLGP-TME educated CD8+T cell...
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

Non-specific immunity of BCG vaccine: A perspective of BCG immunotherapy
Publication date: 2014 Source:Trials in Vaccinology, Volume 3 Author(s): Najeeha Talat Iqbal , Rabia Hussain BCG is a widely used vaccine worldwide for neonates including Pakistan. BCG has more than 90% coverage through the EPI program which was introduced in 1965 in Pakistan. BCG has limited efficacy against the transmissible form of pulmonary tuberculosis in high TB endemic countries. However, BCG vaccination continues in these countries because BCG confers protection against the disseminated form of TB in children. BCG has also shown some protection against leprosy and certain forms of cancers. One reason for such...
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

Long-peptide therapeutic vaccination against CRPV-induced papillomas in HLA-A2.1 transgenic rabbits
Publication date: 2014 Source:Trials in Vaccinology, Volume 3 Author(s): Jiafen Hu , Lynn R. Budgeon , Karla K. Balogh , Xuwen Peng , Nancy M. Cladel , Neil D. Christensen Long peptide immunization is a promising strategy to clear established tumors. In the current study, we investigated the therapeutic effect of a naturally existing long peptide that contained two HLA-A2.1 restricted epitopes (CRPVE1/149–157 and CRPVE1/161–169) from cottontail rabbit papillomavirus (CRPV) E1 using our CRPV/HLA-A2.1 transgenic rabbit model. A universal Tetanus Toxin helper motif (TT helper) was tagged at either the N-terminus...
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

Virological confirmation of suspected dengue in a Phase 2 Latin American vaccine trial: Implications for vaccine efficacy evaluation
Publication date: 2014 Source:Trials in Vaccinology, Volume 3 Author(s): Mark Boaz , Helene Janosczyk , Seema Garg , Stacy Yost , Stephen W. Hildreth , Gustavo Dayan , Linda Starr-Spires The CYD tetravalent dengue vaccine candidate is being evaluated for protective efficacy against symptomatic dengue in Phase 3 efficacy trials. The laboratory test algorithm to confirm dengue cases was evaluated prior to Phase 3 trials. During a Phase 2 trial in Latin America a dengue epidemic occurred in the study countries. A total of 72 suspected dengue cases were reported and assessed: virological confirmation comprised qRT-P...
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

Antibody persistence to meningococcal serogroups A, C, W and Y in toddlers two years after vaccination with a quadrivalent meningococcal ACWY-tetanus toxoid conjugate (MenACWY-TT) vaccine as measured by bactericidal antibody assays using rabbit or human complement
Publication date: 2014 Source:Trials in Vaccinology, Volume 3 Author(s): Timo Vesikari , Aino Forsten , Veronique Bianco , Marie Van der Wielen , Jacqueline M. Miller Long term protection against invasive meningococcal disease relies on persistence of bactericidal antibodies. We studied the persistence of serum bactericidal antibodies using rabbit and human complement (rSBA, hSBA assays) two years after vaccination with a meningococcal serogroup A, C, W, Y tetanus toxoid conjugate vaccine (MenACWY-TT, N =253) or a licensed monovalent serogroup C conjugate vaccine (MenC-CRM197, N =42) in Finnish toddlers who were a...
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

A Phase III, randomized study to evaluate the immunogenicity and safety of an MF59®-adjuvanted A/H1N1 pandemic influenza vaccine in HIV-positive adults
Conclusion Antibody responses in HIV-positive subjects were acceptable but lower than those in healthy control subjects, whether subjects were immunized with one or two doses of adjuvanted or unadjuvanted vaccine. Vaccination did not affect rates of HIV replication, CD4+ T cells counts, or levels of CD38 expression among patients under successful antiretroviral treatment. (Source: Trials in Vaccinology)
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

Influence of maternally-derived antibodies in 6-week old dogs for the efficacy of a new vaccine to protect dogs against virulent challenge with canine distemper virus, adenovirus or parvovirus
In conclusion, two doses of the DHPPi/L4R vaccine administered to dogs from six weeks of age in the presence of maternal antibodies aided in the protection against virulent challenge with CDV, CAV-1 or CPV. (Source: Trials in Vaccinology)
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

The administration of a single dose of a multivalent (DHPPiL4R) vaccine prevents clinical signs and mortality following virulent challenge with canine distemper virus, canine adenovirus or canine parvovirus
In conclusion, we demonstrated that a single administration of a minimum titre, multivalent vaccine to dogs of six weeks of age is efficacious and prevents clinical signs and mortality caused by CAV-1 and CDV; prevents clinical signs and significantly reduces virus shedding caused by CAV-2; and prevents clinical signs, leucopoenia and viral excretion caused by CPV. (Source: Trials in Vaccinology)
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

Bupivacaine enhances the magnitude and longevity of HIV-specific immune response after immunization with a CD4 epitope-based DNA vaccine
Publication date: 2014 Source:Trials in Vaccinology, Volume 3 Author(s): Susan Pereira Ribeiro , Juliana de Souza Apostólico , Rafael Ribeiro Almeida , Jorge Kalil , Edecio Cunha-Neto , Daniela Santoro Rosa The development of an effective HIV vaccine is still a major scientific challenge. HIV vaccine trials conducted until now were not able to induce broad neutralizing antibodies or effective cell mediated immune responses. More recently, CD4+ T cells have been shown to play an important role in viral control and better disease prognosis. We have recently developed a DNA vaccine encoding 18 conserved multiple HL...
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

Novel neutralizing monoclonal antibodies protect rodents against lethal filovirus challenges
In this study, we generated two neutralizing monoclonal antibodies (MAbs), termed S9 and M4 that recognize the GP of EBOV or multiple strains of Marburg virus (MARV), respectively. We characterized the putative binding site of S9 as a linear epitope on the glycan cap of the GP1 subunit of the EBOV-GP. The M4 antibody recognizes an unknown conformational epitope on MARV-GP. Additionally, we demonstrated the post-exposure protection potential of these antibodies in both the mouse and guinea pig models of filovirus infection. These data indicate that MAbs S9 and M4 would be good candidates for inclusion in an antibody cocktai...
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

A novel dual promoter DNA vaccine induces CD8+ response against Toxoplasma gondii sporozoite specific surface protein “SporoSAG” through non-apoptotic cells
Publication date: 2014 Source:Trials in Vaccinology, Volume 3 Author(s): Sultan Gülçe İz , Mert Döşkaya , Ayşe Caner , Aysu Değirmenci Döşkaya , Fernando Rodriguez , Yüksel Gürüz , S. İsmet Deliloğlu Gürhan Toxoplasma gondii is a protozoan parasite that can infect all warm blooded animals including humans. During natural course of T. gondii infection, bradyzoites or sporozoites invade the intestinal cells and turn into tachyzoite form in 12–18h. Therefore, a vaccine against toxoplasmosis is required to induce protective immune response initially in intestines against bradyzoites or sporozoites....
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research

DNA vaccination for rabies: Evaluation of preclinical safety and toxicology
Publication date: 2014 Source:Trials in Vaccinology, Volume 3 Author(s): Rajni Garg , Manpreet Kaur , Ankur Saxena , Rakesh Bhatnagar The worldwide incidence of rabies and high rates of therapy failure, despite availability of effective vaccines indicate the need for timely and improved prophylactic approaches. DNA vaccination based on optimized formulation of lysosome-targeted glycoprotein of the rabies virus provides potential platform for preventing and controlling rabies. As per the pre-clinical requirements, listed in guidelines of Schedule Y, FDA and that of The European Agency for evaluation of Medicinal Pro...
Source: Trials in Vaccinology - October 12, 2014 Category: Infectious Diseases Source Type: research