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PubMed2005

[Investigation concerning demand and vaccination applicants to traveler's vaccines (typhoid fever and meningococcal vaccines) not marketed in Japan].

In recent years, the number of Japanese traveling to foreign countries is increasing. Most of them travel to Asian regions where many infectious diseases that are rare or don't occur in Japan still remain endemic or epidemic. Of these infectious diseases typhoid fever and meningococcal infection are now preventable because safe and effective vaccines have been developed and now marketed. However, these vaccines are hardly available in Japan because the Japanese Government has not admitted them. To investigate the demand for the two vaccines, the author personally imported inactivated polysaccharide typhoid vaccine and groups A, C,Y and W135 combined polysaccharide meningococcal vaccine, both manufactured by Aventis-Pasteur. After obtaining approval of the ethical committee of our hospital, vaccination was started. From May 6, 2003 to September 30, 2004, 124 applicants received typhoid vaccine and 35 were injected with meningococcal vaccine. Of 124 vaccinees of typhoid vaccine, 46 went to Afghanistan, 15 to India, 8 to Thailand. Of 35 vaccinees of meningococcal vaccine 6 went to the USA, 5 to Guinea and 3 to England. In addition a total of 12 physicians and nurses having no international scheduled trip were also immunized with meningococcal vaccine. None of these vaccines are widely known in Japan now. Based on our results, however, the expansion of recognition and demand for these two vaccines is expected.

Adult↗
PubMed2006

Protection from challenge following administration of a canarypox virus-vectored recombinant feline leukemia virus vaccine in cats previously vaccinated with a killed virus vaccine.

OBJECTIVE: To compare protection against FeLV challenge obtained following administration of 2 doses of an adjuvanted, chemically inactivated, whole FeLV (FeLV-k) vaccine with protection obtained following administration of 1 dose of an FeLV-k vaccine followed by 1 dose of a canarypox virus-vectored recombinant FeLV (rCP-FeLV) vaccine. DESIGN: Prospective study. ANIMALS: Thirty-two 9-week-old domestic shorthair cats. PROCEDURE: Cats received 2 doses of the FeLV-k vaccine SC, 21 days apart (n = 11); 1 dose of the FeLV-k vaccine SC and, 21 days later, 1 dose of the rCP-FeLV vaccine transdermally (11); or 2 doses of physiologic saline (0.9% NaCl) solution (control; 10). Four weeks after the second vaccine dose, all cats were challenged with FeLV by means of oronasal administration. Blood samples were collected at weekly intervals beginning 21 days after challenge, and serum was tested for FeLV antigen. RESULTS: All 10 control cats became persistently infected (ie, FeLV antigen detected in > or = 3 consecutive serum samples) following FeLV challenge, whereas only 1 of 11 cats that received 2 doses of the FeLV-k vaccine and none of the 11 cats that received 1 dose of the FeLV-k vaccine and 1 dose of the rCP-FeLV vaccine did. CONCLUSIONS AND CLINICAL RELEVANCE: Results suggest that protection against FeLV challenge obtained following SC administration of a single dose of an FeLV-k vaccine followed, 21 days later, by transdermal administration of a single dose of an rCP-FeLV vaccine was similar to that obtained following SC administration of 2 doses of the FeLV-k vaccine 21 days apart.

Animals↗
PubMed1989

[Immune response and reactions to simultaneous administration of hepatitis B vaccine with routine vaccine in children. I. Immune response and reactions to simultaneous administration of DPT, TOPV and hepatitis B vaccine].

This paper reports the result of the immune response and reactions to simultaneous administration of DPT, TOPV and hepatitis B vaccine. 180 children (0-5 months of age) were divided into three groups. Group one was vaccinated with hepatitis B vaccine alone, group two was vaccinated with DPT, TOPV vaccine, and group three was vaccinated with hepatitis B vaccine, DPT and TOPV vaccine simultaneously. The result of the immune response to the combination of hepatitis B with DPT, TOPV vaccines were similar to that observed after immunization with each vaccine alone. The general reactions of all vaccines were mild, no significant difference between each group was noted. The study demonstrated that children can be immunized with hepatitis B vaccine and DPT, TOPV vaccines simultaneously.

Diphtheria Toxoid↗
PubMed2003

Comparison of the reactogenicity and immunogenicity of a combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio (DTPa-HBV-IPV) vaccine, mixed with the Haemophilus influenzae type b (Hib) conjugate vaccine and administered as a single injection, with the DTPa-IPV/Hib and hepatitis B vaccines administered in two simultaneous injections to infants at 2, 4 and 6 months of age.

An open, randomised, multicentre trial was performed to compare the reactogenicity and safety profile of the administration of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio (DTPa-HBV-IPV) vaccine administered in one injection mixed with Haemophilus influenzae type b (Hib) conjugate vaccine (Group 1) with that of a pentavalent DTPa-IPV vaccine mixed with a Hib vaccine (DTPa-IPV/Hib), simultaneously administered with HBV (Group 2) in two injections in opposite thighs, as a primary vaccination course, to healthy infants at 2, 4 and 6 months of age. A total of 235 completed the study, 120 from Group 1 and 115 from Group 2. Blood samples (pre-vaccination and 1 month after the third dose) were obtained from a subset of infants (Group 1: 40; Group 2: 31) to assess the immune response to vaccination. Local and general solicited symptoms were recorded by parents on diary cards. Seven hundred and five diary cards (Group 1: 360; Group 2: 345) were collected. The clinically relevant and most commonly reported local reaction was pain (infant cried when the limb was moved) in 2.5% (Group 1) and 1.2% (Group 2) of diary cards. Fever was more frequently reported in Group 1 (21% of diary cards) than in Group 2 (12% of diary cards). However only 3 and 2% of doses in Groups 1 and 2, respectively, were responsible for a rectal temperature between 38.6 and 39.5 degrees C and only one case (Group 2) had > or =39.5 degrees C. Other clinically relevant general symptoms were rarely recorded: irritability (2-2.8%), loss of appetite (0.3-0.6%) and drowsiness (0.3-0.3%). All subjects included in the immunogenicity analysis had seroprotective titres to diphtheria, tetanus, polio virus types 1 and 3, Hib. Almost all subjects were seroprotected for anti-polio type 2 and hepatitis B (with the exception of 1 subject in Group 1 for each antigen). The vaccines response rates to pertussis antigens were over 97 and 90% in Groups 1 and 2, respectively. This study shows that, from a clinical perspective, the DTPa-HBV-IPV/Hib vaccine given in a single injection has a similar reactogenicity and safety profile to that of two licensed vaccines (DTPa-IPV/Hib, HBV) given in two simultaneous injections to infants at 2, 4 and 6 months of age. This is a valuable advantage, since in some countries, such as Spain and the UK, an additional injection (for the administration of meningococcal C conjugate vaccine) has been recently included in the infants' vaccination calendars.

Antibodies, Bacterial↗
PubMed1991

[Immunization of healthy children with mumps-rubella bivalent live vaccine and simultaneous vaccination with mumps-rubella and varicella vaccines].

Bivalent virus vaccine, containing rubella TCRB-19 strain and mumps NK-M46 strain (MR vaccine), was administered to a total of 95 healthy children who had already received measles vaccine or had been infected with wild measles virus. The seroconversion rates for rubella and mumps viruses in subjects having no antibody to rubella or to mumps virus were 99% (75/76) and 97% (63/65), respectively, at 6-8 weeks after vaccination. The seroconversion rates for both rubella and mumps in vaccinees initially seronegative to both viruses were 95% (56/59). Immune responses after MR vaccine injection were comparable to those after administration of monovalent rubella or mumps vaccine. Clinical reactions observed in some subjects who received MR vaccine were mild fever (3.6%), exanthem (8%), lymphadenopathy (1.8%), and swelling of the parotis region (1.8%). MR vaccine could be simultaneously injected with varicella vaccine at the opposite site producing no adverse effect on immune response. Our results indicate that MR vaccine is a safe and effective vaccine, especially for children who have had wild measles or who have received measles vaccine.

Adolescent↗
PubMed2003

[Survey of the past history of measles and rubella and advocacy for vaccination and certificates of vaccination at entry to kindergarten, primary school and junior high school in Kurashiki City--to improve the vaccination rate].

Although there have been measles outbreaks involving more than 100,000 patients every few years in Japan, vaccination is not compulsory under Japanese law and the vaccination rate remains low. In addition, because MMR vaccines have been suspended due to complications, monovalent measles vaccine is still used and administered only once for life. Under these circumstances, a new system was started to develop motivation for vaccination in order to try to eliminate measles and rubella. Although educational campaigns for vaccination are important, their effect is frequently temporary. To maintain a high vaccination rate after such campaigns, we advocated checking children for susceptibility, recommended vaccination and asked for certificates of vaccination at school entry. The participating subjects were 65/68 kindergartens, 55/55 primary schools and 24/24 junior high schools in Kurashiki City, Japan. The total number of subjects was 11,365. The susceptibility rate for measles and the unknown rate were 5.6% and 2.0% at kindergartens, 4.6% and 4.4% at primary schools, and 3.0% and 8.3% at junior high schools, whereas the susceptibility rate for rubella and the unknown rate were 14.0% and 2.3% at kindergartens, 21.8% and 5.4% at primary schools, and 35.2% and 11.7% at junior high schools. Among the children who were susceptible to measles, we confirmed that a certificate of vaccination was presented by 38.0% of pupils in kindergartens, 85.3% of those in primary schools and 43.7% of those in junior high schools. As for rubella, we confirmed 21.8% presented a certificate in kindergartens, 28.6% in primary schools and 11.6% in junior high schools. As a result, we achieved our goal for measles, which was previously determined as more than 90% for students with past history of infection or vaccination. However, we could not attain our goal for rubella. These systems were more effective than educational campaigns alone and were thought to increase the motivation for vaccination through their continuation. The rate of those who could not receive the vaccination due to allergy or seizure among the susceptible was 26% in total but more than 40% in some schools. We should educate not only parents but also doctors regarding vaccination and advocate that it be done.

Adolescent↗
PubMed2002

The risk of aseptic meningitis associated with the Leningrad-Zagreb mumps vaccine strain following mass vaccination with measles-mumps-rubella vaccine, Rio Grande do Sul, Brazil, 1997.

BACKGROUND: Few data are available on the risk of aseptic meningitis following vaccination with the Leningrad-Zagreb (L-Z) strain of mumps vaccine. In 1997 the mumps vaccine was introduced into the state of Rio Grande do Sul in Brazil through mass vaccination with mumps-measles-rubella (MMR), targeting children aged 1-11 years. Five municipalities used exclusively MMR vaccine containing the L-Z strain of mumps. An outbreak of aseptic meningitis was observed shortly after the mass campaign. METHODS: To estimate the risk of aseptic meningitis associated with this strain, we analysed vaccination and meningitis case surveillance data from the selected municipalities. A case of vaccine-associated aseptic meningitis was defined as one with a pleocytosis of 10-1,500 leukocytes/ml and occurring within 15-35 days after vaccine receipt. RESULTS: We estimated a risk of 2.9 cases per 10,000 doses of L-Z administered, equivalent to 1 case per 3,390 doses administered. The overall risk of aseptic meningitis following the campaign was increased 12.2-fold (95% CI: 6.0-24.7) compared with the same period in 1995-1996. Following the mass campaign, the incidence of mumps declined 93% during 1998-2000. CONCLUSIONS: Vaccination with the L-Z strain of mumps vaccine as part of a mass campaign was associated with a significantly increased risk of aseptic meningitis. Decisions about type of mumps vaccine and mumps vaccination strategies must consider vaccine safety issues in addition to other criteria.

Brazil↗
PubMedDate not supplied

Safety and immunogenicity of a new inactivated hepatitis A vaccine in concurrent administration with a typhoid fever vaccine or a typhoid fever + yellow fever vaccine.

Two clinical studies were conducted to evaluate the safety and immunogenicity of concomitant administration of a new inactivated hepatitis A (HA) vaccine and either a typhoid fever (Vi) vaccine or a combination of Vi and yellow fever (YF) vaccines. In study 1, 62 healthy adults received HA+Vi into the deltoid muscle on contralateral sides. In study 2, 59 healthy adults received HA and a combined Vi/YF vaccine into the contralateral deltoid muscles. Reactogenicity was evaluated for 14 days following vaccination. Blood samples (for antibody titration) were obtained prior to vaccination on days 0 and 28 in study 1 and prior to vaccination on day 0 and on days 14 and 28 in study 2. The overall rate of local reactions was 19% at the HA injection site and 75% at the Vi injection site in study 1; the rate of systemic reactions was 41%. In study 2, local reactions occurred at 27% and 78% of the HA and Vi/YF injection sites; the rate of systemic reactions was 42%. All reactions were transient. Twenty-eight days after vaccination, the seroconversion rate was 100% for HA antibodies and 90% for the Vi vaccine in study 1. Rates of seroconversion in study 2 were 100% for the HA vaccine, 92% for the Vi vaccine, and 100% for the YF vaccine. Although this study was not comparative, both tested combinations were safe and immunogenic, and their routine use for persons at risk, such as travelers, can be recommended.

Adolescent↗
PubMed2005

Vaccine effectiveness and severity of varicella among previously vaccinated children during outbreaks in day-care centers with low vaccination coverage.

BACKGROUND: Varicella vaccine effectiveness (VE) during outbreaks has been reported to be 71-100% against any disease and >90% against moderate/severe disease even in day-care centers (DCCs) and schools with low vaccination rates. A recent report suggested an effectiveness rate of 44% during a DCC outbreak despite a high vaccination rate. AIMS: To reassess vaccination coverage, VE and severity of disease among previously vaccinated children after exposure during DCC outbreaks in northern Israel, where vaccination rates are low. METHODS: During January to June 2003, active surveillance for varicella among children in northern Israel revealed outbreaks in 8 DCCs with children 3-6 years of age. Data concerning symptoms of the disease and the age at vaccination (for previously vaccinated children) were obtained from parents and health care providers for children who contracted the disease. Analysis of VE was limited to children who were continuously enrolled in DCCs during the outbreaks. RESULTS: The overall vaccination rate was 37%. The incidences of natural varicella and breakthrough varicella (BV) were 79 of 153 [52%; 95% confidence interval (CI) 44-60%] and 37 of 89 (41.5%; 95% CI 31-52%), respectively. VE was 20% (95% CI 0-40%) against disease of any severity and 93.4% (95% CI 75-98%) against moderate/severe disease. Ninety-four percent and 14% of children with BV and natural varicella, respectively, had mild disease (P < 0.001). The odds ratio for BV was 17 (95% CI 2.18-118) for children vaccinated >2 years before the outbreak. CONCLUSIONS: During varicella outbreaks in DCCs with low vaccine coverage, previous vaccination provided poor protection against chickenpox, mostly among children who had been vaccinated >2 years earlier, but the disease appeared to be much milder among children with BV than among nonvaccinated children.

Age Distribution↗
PubMed1999

Evaluation of a guinea pig model to assess interference in the immunogenicity of different components of a combination vaccine comprising diphtheria, tetanus and acellular pertussis (DTaP) vaccine and haemophilus influenzae type b capsular polysaccharide conjugate vaccine.

A guinea pig model to assess the immunogenicity of a combination vaccine containing diphtheria, tetanus and acellular pertussis (DTaP) vaccine and Haemophilus influenzae type b (Hib) capsular polysaccharide conjugated to tetanus toxoid (HibT) was evaluated comparatively with the mouse immunogenicity test to study the effect of combining these antigens on the immunogenicity of various components. The immunogenicity test in mice was performed by subcutaneous injection of groups of 10 animals twice at an interval of four weeks with 1/10 of a single human dose of various formulations of combination vaccines, DTaP or HibT vaccine. The animals were bled at 4 and 6 weeks and IgG or total antibodies to various components were determined by ELISA or RIA. The guinea pig immunogenicity model included groups of animals injected subcutaneously twice at an interval of six weeks with 1.5 times the single human dose of various formulations. The animals were bled at 4, 6 and 8 weeks and serum samples were tested for antibodies to various components by ELISA, RIA and/or neutralization tests. Additionally, potency of tetanus and diphtheria components was assessed as per the US Food and Drug Administration's regulations. Aluminium phosphate (AIPO(4)) adsorbed HibT vaccine or HibT as a combination with AIPO(4)adsorbed DTaP vaccine showed significant increases in IgG antibodies to tetanus toxin in mice as well increased tetanus antitoxin levels in guinea pigs as compared to soluble HibT vaccine. In general, combining DTaP and HibT vaccines did not affect the antibody levels to tetanus and diphtheria toxoids whereas DTaP-HibT combination vaccine elicited significantly lower IgG antibodies to pertussis toxin and filamentous haemagglutinin than DTaP vaccine alone, particularly after first injection. Mice showed similar Hib antibody responses for the combination and HibT alone whereas guinea pigs consistently showed lower anamnestic responses to Hib for combination formulations than for HibT alone. Reducing the amount of HibT and/or tetanus toxoid in the combination formulations reduced this suppression of Hib antibody response in guinea pigs. Suppression of Hib antibody response in combination vaccines has also been reported from recent clinical trials. Based on the results from this study, it appears that the guinea pig model may be able to predict the human response to various components of combination vaccines.

Animals↗
PubMed2005

Establishment of vaccination clinics; user fees for investigational new drug (IND) influenza vaccine services and vaccines. Interim final rule and request for comments.

We are amending 42 CFR part 70 to establish vaccination clinics and a user fee in connection with the administration of vaccination services and vaccine. On December 7, 2004, HHS Secretary Tommy G. Thompson announced the purchase of 1.2 million doses of GlaxoSmithKline (GSK) influenza vaccine, Fluarix, for distribution to areas most in need as determined by State public health authorities. The Fluarix vaccine has been approved in seventy-eight foreign countries, and FDA has recently reviewed extensive manufacturing and summary clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine, although not licensed in the United States, is suitable for use under an Investigational New Drug application (IND). The Food and Drug Administration (FDA) reviewed GSK's IND application as well as the clinical protocol and manufacturing data. CDC and CDC's Institutional Review Board approved the GSK flu vaccine response protocol including the informed consent document. To ensure that the vaccine is properly administered to individuals identified to be most at risk and facilitate compliance with IND requirements, CDC is establishing vaccination clinics. CDC is proceeding without delay because of the unprecedented nature of this season's influenza vaccine shortage caused by contamination problems with Chiron Corporation's production facility in the United Kingdom, which effectively cut in half the expected United States supply of inactivated influenza vaccine. A user fee is being established in order to recoup the costs associated with administering the vaccine and for the vaccine itself. All individuals, other than those who are enrolled in Medicare Part B, will be required to pay the user fee.

Adolescent↗
PubMed1998

Therapeutic periocular vaccination with a subunit vaccine induces higher levels of herpes simplex virus-specific tear secretory immunoglobulin A than systemic vaccination and provides protection against recurrent spontaneous ocular shedding of virus in latently infected rabbits.

Rabbits latently infected with herpes simplex virus type 1 (HSV-1) were vaccinated either periocularly or systemically with a subunit vaccine (gB2 + gD2) plus adjuvant or adjuvant alone. Tear films were collected daily to measure recurrent infectious HSV-1 shedding. After systemic vaccination, the latently infected rabbits were not protected against recurrent ocular viral shedding (HSV-1-positive tear film cultures/total cultures) compared with either the systemic or periocular adjuvant controls (systemic vaccination = 49 of 972, 5.0%; systemic control = 46 of 972, 4.7%; periocular control = 43 of 930, 4.6%; P > 0.8). In contrast, latently infected rabbits vaccinated periocularly with the same vaccine had significantly reduced recurrent shedding (20 of 1026, 2.0%) compared with controls (P < 0.001) or systemic vaccination (P = 0.0002). Thus, recurrent HSV-1 shedding was significantly reduced by therapeutic local periocular subunit vaccination but not by therapeutic systemic subunit vaccination. Neutralizing antibody titers in the serum of systemically and ocularly vaccinated rabbits was similar. In contrast, HSV-specific tear secretory immunoglobulin A was significantly higher in the ocularly vaccinated group (P < 0.01). These results strongly suggest that in the rabbit, and presumably in humans, the local ocular (mucosal) immune response is much more important than the systemic immune response for therapeutic protection against recurrent ocular HSV-1. Thus development of a therapeutic vaccine against recurrent ocular HSV-1 should be directed at enhancing the local ocular (mucosal) immune response.

Animals↗
PubMed1978

A/New Jersey/76 influenza vaccine trial in seronegative schoolchildren: comparison of a subunit vaccine with a whole-virus vaccine.

In the present vaccination trial, 202 seronegative schoolchildren comprising both sexes and aged 11 to 12 years were vaccinated i.m. in the upper arm with either the subunit vaccine at a dosage of 600 CCA or 200 CCA or with a whole-virus vaccine at a dosage of 200 CCA, using the double-blind procedure. Both vaccines were prepared from the strain A/New Jersey/76 (x 53a-recombinant). The vaccination was followed four weeks later by a booster injection. In tests of local and systemic reactogenicity, it was found that at both dosages the subunit vaccine caused a low frequency of minor adverse reactions. The whole-virus vaccine was marked by a significantly higher rate of adverse reactions, whether of the local or systemic variety. The whole-virus vaccine had, however, a higher immunogenicity than the subunit vaccine, and due to the relatively high rate of adverse reactions it causes, it is not recommended for the vaccination of seronegative children. Because of its low reactogenicity, the subunit vaccine can be given at higher dosage, and it is a matter for consideration whether a better antibody response might not result from two booster injections.

Antibodies, Viral↗
PubMed2005

To vaccinate or not to vaccinate--that is the question: why are some mothers opposed to giving their infants hepatitis B vaccine?

OBJECTIVE: To identify the characteristics of mothers who prevent their newborn babies from receiving the hepatitis B vaccine. METHODS: Women who gave birth and prevented the administration of routine hepatitis B vaccine to their newborn infants (study group) were compared to women who complied with vaccination (control group). During their hospital stay, both groups were asked to answer a questionnaire constructed to evaluate relevant demographic data, knowledge and attitudes liable to differ between the two groups. RESULTS: The 51 women in the Prevent (study) group were more educated and had a higher income level. They expressed more knowledge about the vaccine, and held more naturalistic and less conventional medical attitudes than did the women in the Comply (control) group (153 women). Some of the reasons given by the Prevent group for vaccine rejection included the following: "The child is too young"; "vaccines are dangerous"; "Doctors vaccinate without consideration"; "Vaccines causes trauma to the baby". The Comply group's reasons for giving the vaccine were mainly "to protect the baby" and "trust in the doctors". Differences between the groups were also found with respect to their future intended behavior. The study group planned to breastfeed for a longer period than the control group. Only 16% of the study group compared to 98% of the control group stated they intended to comply with the full vaccination program offered to developing children. On the basis of the answers to the questionnaire, the Comply group was further subdivided into two groups: those with knowledge and those lacking knowledge (determined by subjective evaluation). This subdivision showed that the differences between the Prevent Group and the Comply group exist, even though knowledge was controlled for. CONCLUSIONS: Mothers prevent administration of the hepatitis B vaccine to their newly born children based upon their overall approach, and not due to ignorance. In order to overcome this harmful trend, the medical community must supply counter information that encourages vaccinations.

Adult↗
PubMed1993

Adverse reactions in healthy and immunocompromised children under six years of age vaccinated with the Danish BCG vaccine, strain Copenhagen 1331: implications for the vaccination policy in Sweden.

A retrospective analysis of the adverse reactions reported between 1979 and 1991, in the 139,000 children under six years of age vaccinated in Sweden with the Danish BCG vaccine, strain Copenhagen 1331, showed an incidence of 1.9 per 1000 vaccinated children. Regional lymphoglandular swellings and/or abscesses were most commonly reported in 1.4 per 1000. Serious, disseminated, BCG infections developed in four infants vaccinated neonatally. Three of the infants suffered from severe, combined, immunodeficiency syndrome, undiagnosed at the time of vaccination. The incidence of severe, combined, immunodeficiency syndrome was higher in the BCG-vaccinated population (4 per 100,000 infants vaccinated within a year of their births), compared with all newborns in Sweden (1 per 100,000). The mean age at the onset of symptoms was 2.4 months for the seven non-BCG-vaccinated infants versus 1.3 months for the four BCG-vaccinated ones, while the immunodeficiency syndrome was diagnosed at an average age of 7.6 months in those who were not vaccinated versus 5.3 months in those BCG-vaccinated. It is recommended that the selective BCG vaccination of infants at high risk of exposure to tuberculosis should be postponed to six months of age to reduce the risk of inoculating infants suffering from immunodeficiency syndromes.

Age Factors↗