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A booster dose of Haemophilus influenzae type b conjugate vaccine in the second year of life is the final step in the recommended series of doses to protect infants from invasive infection. This study assessed the safety and immunogenicity of PRP-T conjugate vaccine booster doses (Act-HIB(R), Connaught Laboratories Ltd). The participants were 367 healthy children who had taken part in a study of primary...
A canarypox-based (ALVAC) recombinant expressing the rabies G glycoprotein has been utilized to assess in vitro and in vivo biological properties of the canarypox virus vector system. In vitro studies have shown that no replication of the virus can be detected on six human-derived cell lines, nor can the virus be readily adapted to replicate on non-avian cells. Expression of the rabies G can be detected...
A pair of studies designed to assess the clinical safety and potency of hyperimmune plasma administration was undertaken in neonatal calves. Bovine plasma from Holstein heifers hyperimmunized with a mutant Escherichia coli 0111:B4 (J5) vaccine which had a geometric mean (GM) immunoglobulin G (IgG) ELISA titer of 3.5 10 4 , was administered subcutaneously to ≤2-day-old calves. In the first...
Splenectomized children as well as those suffering from nephrotic syndrome or recurrent asthmatic bronchitis have an increased susceptibility to systemic pneumococcal infections compared to healthy children. To determine the immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine (PPV), 119 children (21 healthy, 26 splenectomized children, 48 with nephrotic syndrome and 24 with...
Avian poxvirus recombinants undergo abortive replication in nonavian cells, yet can achieve expression of extrinsic gene products. Canarypox-vectored vaccines have been innocuous and immunogenic in several mammalian species. ALVAC-RG, a canarypox recombinant expressing the rabies glycoprotein gene, was inoculated intramuscularly into adult volunteers on days 0, 28, and 180. Sequential cohorts received...
Rabies continues to be an important public health problem in India and many other developing countries. In India, annually some 700,000 persons are given post-exposure vaccine prophylaxis using Semple (sheep brain) vaccine. It is manufactured by government institutions and given free to the public. It is presumed to be cheap, although the actual cost of production may not be low. However, it is...
The safety and immunogenicity of REMUNE TM , an HIV-specific immune based therapy for HIV infection, was evaluated in a cohort of 30 HIV infected subjects in Thailand. This therapy utilizes a gp120 depleted inactivated virus (HZ 321 ), which exhibits a high degree of conservation with the core antigens of both type B and E strains of HIV, the predominant Thailand...
Recurrence of adverse events, the effect of site of injection, and concurrent administration of oral polio vaccine (OPV) and hepatitis B vaccine (HBV) on reactogenicity were assessed in recipients of two acellular pertussis vaccines given in combination with diphtheria and tetanus toxoids (DTaP), one whole-cell DTP vaccine (DTPwc) and one DT vaccine during a double blind, randomized, controlled clinical...
We performed a randomized trial to compare the safety and immunogenicity of two combined measles, mumps and rubella vaccines in healthy children 14-24 months of age. Triviraten Berna Vaccine (Swiss Serum and Vaccine Institute), contains the Edmonston Zagreb 19 strain of measles virus, the Rubini mumps virus strain and the Wistar RA 273 rubella strain while MMR-Vax (Merck, Sharp...
The safety and immunogenicity of a new formulation of the inactivated hepatitis A vaccine, Avaxim , was evaluated in 189 children, aged 18 months to 15 years in a monocentric, open trial. Two vaccinations were given six months apart. Enrollment was balanced within three age groups: 18 months to 3 years, 4-8 years and 9-15 years. Antibody titers were measured blindly by an independent laboratory using...
The reactogenicity of a three-dose catch-up acellular pertussis (aP) immunization of children at 21-40 months of age was evaluated. Vaccination was well-tolerated: fever =<38 o C was reported after 5% of administered doses and local reactions after 14-15%. The onset of adverse events was not associated with age at vaccination, interval between doses or previous presence of antibodies against...
Among 277 healthy Venezuelan children, aged between 4 and 15 years, who were screened for hepatitis A virus (HAV) antibodies, 118 seronegative children were enrolled in an open study. Each child received one dose of the Pasteur Merieux Connaught inactivated hepatitis A vaccine (AVAXIM , 160 antigen units), followed by a booster dose 24 weeks later. All seronegative subjects seroconverted 2 weeks...
Mucosal immune responses are known to play important roles in the establishment of protective immunity to microbial infections through mucosa. We examined the toxic effects of recombinant cholera toxin B subunit (rCTB) secreted by Gram-positive bacterium Bacillus brevis as a mucosal adjuvant. Incubation of guinea-pig peritoneal macrophages with cholera toxin (CT) or aluminium hydroxide gel (Al-gel)...
Combination vaccines to minimize injections required for infant vaccination, and new vaccines with improved safety profiles, will pose increasingly complex choices for vaccine purchasers in the future. How much of a premium to pay for such vaccines might be determined by taking into account (1) the psychological burden of multiple injections during a single clinic visit, and the costs of any additional...
We have recently developed a transmissible vaccine to immunize rabbits against myxomatosis and rabbit haemorrhagic disease based on a recombinant myxoma virus (MV) expressing the rabbit haemorrhagic disease virus (RHDV) capsid protein [Bárcena et al. Horizontal transmissible protection against myxomatosis and rabbit haemorragic disease using a recombinant myxoma virus. J. Virol. 2000;74:1114–23]....
Several preparations of MMR vaccines and their progenitor monovalent vaccine bulks produced by two different manufacturers were examined serologically for the presence of chicken myelin basic protein (MBP) residues. The products were challenged against several commercial preparations of anti-hMBP antisera that reacted positively with the control MBP preparations of human and chicken origins. There...
In a longitudinal study in the epidemiology of Leishmania donovani infection in an endemic focus in eastern Sudan, we observed that previous exposure or infection with Leishmania major appeared to protect against visceral leishmaniasis caused by L. donovani. We therefore conducted a study to test the safety and immunogenicity of a vaccine consisting of autoclaved L. major (ALM) plus BCG in inducing...
The immunogenicity and safety of a chromatographically purified rabies vaccine (CPRV) was evaluated using US veterinary medical students. In the first study, 242 healthy adults were enrolled in a randomized, modified double-blind, multicenter trial and received five doses of either CPRV or human diploid cell vaccine (HDCV) by intramuscular injection on days 0, 3, 7, 14, and 28 concurrently with human...
In an open, randomized, multicenter, controlled clinical trial in the US, 773 adults were administered either a combination hepatitis vaccine (Twinrix: 720 EL.U inactivated hepatitis A antigen and 20 mcg recombinant hepatitis B surface antigen per milliliter) on a 0, 1, 6 month schedule or corresponding monovalent vaccines concurrently (Havrix, 1440 EL.U/ml of hepatitis A antigen at 0, 6 months and...
A study was conducted to assess the safety of a new, liquid hexavalent vaccine (Hexavac ® , Aventis Pasteur MSD, Lyon, France) in a large population of 1783 children in Germany vaccinated at 2, 4, 6 and 12–14 months of age. Immediate reactions, local and systemic reactions, and serious adverse events (SAEs) were monitored. The frequencies of redness ≥2cm and swelling ≥2cm were 6.7 and 7.1%...
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