A Japanese study to assess immunogenicity and safety of a typhoid Vi polysaccharide vaccine.

Background: Although typhoid fever is rare in Japan, imported cases have been reported occasionally in travelers returning from endemic areas. To achieve licensing of a typhoid Vi polysaccharide vaccine (Typhim Vi(®)) and make it widely available in Japan, this study was conducted at the request of the Japanese Ministry of Health Labor and Welfare to assess the immunogenicity and safety of this vaccine when given as a single dose (the recommended schedule of administration) in a Japanese population.

Methods: In this multi-center, open-label, non-comparative, intervention study performed in Japan, 200 healthy volunteers (188 adults [≥ 18 years of age], 7 adolescents [12-17 years of age] and 5 children [2-11 years of age]) were administered Typhim Vi(®).

Randomized controlled study of fractional doses of inactivated poliovirus vaccine administered intradermally with a needle in the Philippines.

Objective: Comparison of a fractional inactivated poliovirus vaccine (IPV) dose administered intradermally (ID) to a full dose administered intramuscularly (IM).

Methods: Healthy Filipino infants were randomized to receive IPV as either a fractional (1/5(th)) dose ID by needle injection or a full dose IM at 6, 10, and 14 weeks and a booster at 15-18 months of age. Pre- and post-vaccination anti-polio 1, 2, and 3 titers were estimated.

Safety of a second dose of varicella vaccine administered at 4 to 6 years of age in healthy children in Argentina.

Varicela Biken [Live varicella Biken vaccine (strain Oka)] is an effective and safe vaccine for the prevention of varicella infection. Although the recommended schedule in all age groups (children, adolescents and adults) is a single dose, physicians in some countries follow the 2007 recommendation of the US Advisory Committee on Immunization Practices (ACIP) which recommends "implementation of a routine 2-dose varicella vaccination program for children, with the first dose administered at age 12--15 months and the second dose at age 4--6 years." ( 1) Therefore, cases can arise when two doses of Varicela Biken are given even though the ACIP guidelines are a response to the US epidemiological situation and for US licensed products based on the Oka/Merck and the Oka-RIT strains (Varicela Biken is not registered in US).

[Effectiveness of inactivated poliomyelitis vaccine for primary vaccination].

Objective: To study the immunological effectiveness of inactivated poliomyelitis vaccine (IPV) for children's primary vaccination in China and to compare with the oral poliomyelitis vaccine (OPV) used in routine vaccination.

Methods: The 2-month-old children were randomly immunized with IPV and OPV, with 208 subjects in each group. The pre- and post-vaccination blood samples were collected.

Seroprevalence of anti-polio antibodies in a population 7 months to 39 years of age in Uruguay: Implications for future polio vaccination strategies.

This study evaluated the seroprevalence of poliovirus types 1, 2 and 3 antibodies and vaccination coverage in 780 subjects aged between 7 months and 39 years in Montevideo, Uruguay, where oral polio vaccine (OPV) is used. Antibody titers were measured and seroprotection rates and geometric mean titers (GMTs) were compared among four age groups. Vaccination histories were recorded from documents and interviews.

World wide experience with inactivated poliovirus vaccine.

As part of the global poliovirus eradication strategy, oral poliovirus vaccine (OPV) has successfully contributed to reduce polio incidence rates globally. However, because of the OPV-related risks of vaccine associated paralytic poliomyelitis (VAPP) and vaccine-derived polioviruses (VDPVs) OPV cessation is required in order to achieve complete eradication of polio. Inactivated poliovirus vaccine (IPV) is a viable option for incorporation into existing vaccination schedules so as to avoid these risks.

Clinical phase I intratumoral administration of two recombinant ALVAC canarypox viruses expressing human granulocyte-macrophage colony-stimulating factor or interleukin-2: the transgene determines the composition of the inflammatory infiltrate.

Immunotherapy employs cytokines for modifying local inflammatory reactions. Granulocyte-macrophage colony-stimulating factor (GM-CSF) has been shown to activate dendritic cells, macrophages, and granulocytes leading to clinical trials using GM-CSF-based cancer vaccine approaches. Interleukin-2 (IL-2) is an important T cell stimulatory cytokine approved as exogenous antitumor agent.

Mumps vaccine virus strains and aseptic meningitis.

Mumps immunization can easily be included in national schedules, particularly if combined with measles or measles and rubella vaccines, but debate continues concerning the relative safety of various licensed mumps vaccine strains. The opportunities for control of mumps are also being affected by differences in the cost of the vaccines prepared with different strains of mumps virus. The present report evaluates available data on the association of the Urabe and other strains of mumps vaccine with the occurrence of aseptic meningitis.

Tumoral and immunologic response after vaccination of melanoma patients with an ALVAC virus encoding MAGE antigens recognized by T cells.

Purpose: To evaluate the toxicity, antitumoral effectiveness, and immunogenicity of repeated vaccinations with ALVAC miniMAGE-1/3, a recombinant canarypox virus containing a minigene encoding antigenic peptides MAGE-3(168-176) and MAGE-1(161-169), which are presented by HLA-A1 and B35 on tumor cells and can be recognized by cytolytic T lymphocytes (CTLs).

Materials And Methods: The vaccination schedule comprised four sequential injections of the recombinant virus, followed by three booster vaccinations with the MAGE-3(168-176) and MAGE-1(161-169) peptides. The vaccines were administered, both intradermally and subcutaneously, at 3-week intervals.

Stabilization of rasburicase and physico-chemical characterization of the resulting injectable formulation.

Rasburicase (Fasturtec/Elitek) is a new generation of recombinant urate oxidase administred therapeutically by intravenous infusion for the prevention or treatment of hyperuricemia during chemotherapy. To ensure a long storage period, a freeze-dried formulation was developed to guarantee the molecular integrity and enzyme activity. Screening of potential excipients was the first stage of the preformulation study.

Effect of dosage on immunogenicity of a Vi conjugate vaccine injected twice into 2- to 5-year-old Vietnamese children.

In a double-blind, randomized, and placebo-controlled previous trial, the efficacy of Vi-rEPA for typhoid fever in 2- to 5-year-olds was 89.0% for 46 months. Vi-rEPA contained 25 microg of Vi and induced a greater-than-eightfold rise in immunoglobulin G (IgG) anti-Vi in all of the vaccinees tested.

Immunization of colorectal carcinoma patients with a recombinant canarypox virus expressing the tumor antigen Ep-CAM/KSA (ALVAC-KSA) and granulocyte macrophage colony- stimulating factor induced a tumor-specific cellular immune response.

Purpose: Colorectal carcinoma cells express the tumor-associated antigen epithelial cellular adhesion molecule (Ep-CAM)/KSA. Passive immunotherapy with monoclonal antibodies using this antigen has shown promising results. Ep-CAM might also be a target for active specific immunotherapy.

Safety of intravenous administration of a canarypox virus encoding the human wild-type p53 gene in colorectal cancer patients.

Overexpression of p53 occurs in more than 50% of colorectal cancers. Therefore, p53 represents an attractive target antigen for immunotherapy. We assessed the safety of a canarypox virus encoding the human wild-type p53 gene given intravenously to end-stage colorectal cancer patients in a three-step dose escalation study aimed at inducing p53 immune responses.

A colorimetric 96-well microtiter plate assay for the determination of urate oxidase activity and its kinetic parameters.

Urate oxidase (E.C.1.

Modification of a reactive cysteine explains differences between rasburicase and Uricozyme, a natural Aspergillus flavus uricase.

Urate oxidase is used in humans for the control of uric acid in patients receiving chemotherapy. Rasburicase (Fasturtec/Elitek), a recombinant urate oxidase expressed in Saccharomyces cerevisiae, was compared with Uricozyme, the natural enzyme produced by Aspergillus flavus. Rasburicase has a higher purity as demonstrated by SDS/PAGE and chromatographic analysis and a better specific activity.

Induction of p53-specific immune responses in colorectal cancer patients receiving a recombinant ALVAC-p53 candidate vaccine.

Purpose: The tumor-associated auto-antigen p53 is commonly overexpressed in various types of human cancer, including colorectal cancer. Experiments in preclinical models have shown that it can serve as a target for T-cell-mediated tumor-eradication. The feasibility of a p53-specific therapeutic vaccination was investigated in cancer patients.