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Duration of immunity after hepatitis B vaccination: efficacy of low-dose booster vaccine.

Although the efficacy of hepatitis vaccine is well documented, the duration of immunity of healthy adults after vaccination is unknown. We studied 245 hospital employees 3 years after primary vaccination with hepatitis B vaccine to determine the prevalence of immunity indicated by levels of antibody to hepatitis B surface antigen of 10 mIU/mL or greater; and to compare the immunogenicity of low-dose intradermal vaccine with standard-dose intramuscular vaccine in persons found to be seronegative. Thirty-eight percent of employees studied had antibody levels less than 10 mIU/mL. Low levels were associated with smoking, older age, and higher body-mass index. Seventy-eight percent of persons with low antibody levels responded to a single booster vaccine. Two micrograms of intradermal vaccine was as effective as 20 micrograms of intramuscular vaccine in inducing an antibody response; however, intradermal vaccine was associated with more local reactions (42% compared with 17%). Many healthy adults will need periodic boosters of hepatitis B vaccine to maintain production of antibody to hepatitis B surface antigen; low-dose intradermal booster schedules may be feasible.

Adult↗

[Malaria vaccines--which vaccines to whom?].

More than a third of the world's population is at risk of contracting malaria. It is estimated that 200 people, primarily children in Africa, die of malaria every hour of every day all year round. Malaria is one of the main obstacles to socio-economic development in Africa. Vaccines against malaria are considered to be the control tool most in need of development. Fundamentally there are three types of malaria vaccines: vaccines against the invading sporozoite or the parasite's development in the liver cells, vaccines directed against the parasite's invasion of and development in the red blood cells; vaccines directed against the fertilisation process in the mosquito. Each malaria vaccine has its own area of application. In spite of promising results in animals it has been difficult to reproduce the results in clinical trials in humans. Recently, however, an experimental vaccine containing a sporozoite protein coupled to a hepatitis B surface molecule with a new adjuvant has been tested in Gambia. The results of these tests are promising, but it is unlikely that the vaccine will be of use in endemic areas. Increased focus on one of the world's biggest health problems has to a certain extent promoted the funding of development work on malaria vaccines. Despite minimal interest from the pharmaceutical industry, a number of experimental vaccines for clinical phase I trials are on their way. However, it will take a huge increase in public financial resources to secure effective and safe malaria vaccines for those most in need of them: people in developing countries and particularly in Sub-Saharan Africa.

Adult↗

Induction of antitumor immunity with combination of HER2/neu DNA vaccine and interleukin 2 gene-modified tumor vaccine.

The therapeutic effects of both cytokine-secreting tumor vaccine and DNA vaccine were studied using mouse MBT-2 bladder cancer cells as a model. Cytokine-secreting MBT-2 cells were obtained by infecting cells with retroviral particles containing interleukin (IL) 2-, IL-4-, or granulocyte-macrophage colony-stimulating factor (GM-CSF)-expression vector. The MBT-2-IL-2 cells were not tumorigenic in syngenic C3H mice at all. Tumor formation decreased significantly for the MBT-2-GM-CSF cells. MBT-2-IL-2, -IL-4, and -GM-CSF cells were killed by irradiation and tested as tumor vaccines. The irradiated MBT2-IL-2 cells could complete protect mice from the growth of the preexisting tumor cells, and the immune memory lasted for 8 months. On the other hand, irradiated MBT-2-IL-4 and MBT-2-GM-CSF cells were less effective. When the loading tumor mass increased, all tumor vaccines lost protective effects. DNA vaccine encoding the tumor antigen neu was additionally tested to improve the therapeutic efficacy. Coinjection of 60 microg pSV-neu DNA was effective in enhancing the antitumor effects of MBT2-IL-2; however, DNA vaccine alone cannot prevent the progression of the preexisting tumor. Immunohistochemical analysis of tumor infiltrate revealed massive increase of CD4+ lymphoid cells in the group of mice treated with both DNA vaccine and IL-2-secreted tumor vaccine. Western blotting demonstrated the presence of anti-neu antibody in the serum from immunized mice. In contrast, combination of DNA vaccine and MBT-2-GM-CSF has no additive effect. The results indicate the combination of DNA vaccine and IL-2-secreting tumor vaccine can additionally improve therapeutic efficacy, and the efficacy is correlated with the increase of CD4+ T lymphocytes and anti-neu antibody.

Animals↗

Impact of the 1999 AAP/USPHS joint statement on thimerosal in vaccines on infant hepatitis B vaccination practices.

On July 8,1999, the American Academy of Pediatrics (AAP) and the U.S. Public Health Service (PHS) jointly recommended reducing infant exposure to thimerosal, a commonly used vaccine preservative that contains mercury. Specific recommendations were made to postpone the first hepatitis B vaccine dose until 2-6 months of age for infants born to hepatitis B surface antigen (HBsAg)-negative (i.e., not hepatitis B virus [HBV]-infected) women. Infants born to HBsAg-positive (i.e., HBV-infected) women, or to women whose HBsAg status was unknown, were recommended to receive postexposure prophylaxis with the first dose of hepatitis B vaccine administered within 12 hours of birth. By mid-September 1999, when adequate supplies of preservative-free hepatitis B vaccine became available, PHS advocated a return to previous infant hepatitis B vaccination practices, including administering the first dose of hepatitis B vaccine to newborns in hospitals that had discontinued the practice. In 2000, preliminary assessments of the impact of these policy changes on routine hepatitis B vaccination practices were conducted by public health officials in Wisconsin, Oklahoma, Oregon, and Michigan. This report summarizes the results of these analyses, which indicate that many hospitals in Wisconsin have not reinstated policies to ensure routine administration of hepatitis B vaccine to newborns despite the availability of preservative-free hepatitis B vaccine, that the number of hepatitis B vaccine doses given to newborns in Oklahoma and Oregon has declined, and that an unvaccinated Michigan infant died from fulminant hepatitis B. Restoring routine newborn hepatitis B vaccination practices may require active advocacy by professional and government groups.

Hepatitis B↗

[Poultry vaccination against N.C.D. by means of an intramuscular injection with LaSota strain vaccine; a practical investigation (author's transl)].

An intramuscular N.D.C. vaccination with LaSota vaccine, in animals of less than ten weeks which were previously vaccinated by the spray method at about 5 days and 25 days against N.C.D., leads to an immunity of at least three months, as expressed by a high concentration of haemagglutination inhibiting antibodies in the circulatory system. If the vaccinated animals are older than twenty weeks, the resulting immunity is very high indeed and shows practically no impairment within a year after vaccination (longer periods have not been investigated), so that it may be assumed that revaccination will not be necessary during the laying period. Antibody variations between different animals of a flock are slight. The residual immunity of previous vaccinations did not appear to affect the development or maintenance of the antibodies. No spread of vaccine was observed. Here it should be noted that animals with a low residual immunity were used for control. It would be desirable to use specifically pathogenfree animals for this purpose, but this is not really practicable in field conditions. Half a hen dose of the LaSota vaccine, dissolved in 1/2 ml physiological saline, was injected into the pectoralis muscle with the help of the Cornwall Pipetting Unit. Twenty flocks, involving 6900 animals, were vaccinated in field conditions. Not a single vaccination gave rise to any vaccination reaction. The method does have a high labour content; which is an objection.

Animals↗

Influenza vaccination and self-reported reasons for not receiving influenza vaccination among Medicare beneficiaries aged > or =65 years--United States, 1991-2002.

Annual influenza vaccination of the U.S. elderly population has been demonstrated as safe and effective in reducing the risks of illness, hospitalization, and death. The Medicare Current Beneficiary Survey (MCBS) has measured annual influenza vaccination rates since 1991; the latest data available are for the 2001-02 influenza season. Since 1996, self-reported reasons for not receiving influenza vaccine also have been measured. During 1991-2002, MCBS indicated a steady upward trend in vaccination coverage among Medicare beneficiaries, with the exception of the 2000-01 influenza season, when vaccine distribution was delayed. The most frequently cited reasons for not receiving influenza vaccine were 1) not knowing that influenza vaccination was needed and 2) concerns that vaccination might cause influenza or side effects. During the 2000-01 influenza season, vaccine shortage or unavailability was noted for the first time as an important reason for nonvaccination. Further efforts are needed to educate the elderly regarding the benefits of influenza vaccination and to address any concerns regarding the safety of the vaccine.

Aged↗

Efficacy of intradermal hepatitis B vaccination compared to intramuscular vaccination in hemodialysis patients.

BACKGROUND: Hepatitis B virus infection remains an important problem in hemodialysis patients. Only 50 to 60% of the patients develop seroconversion (anti-HBs Ab titer > 10 IU/L) after intramuscular hepatitis B vaccination. Small dose intradermal inoculation method of hepatitis B vaccine has been reported to be effective as well as economical, and could provide rapid seroconvesion of immunity. The aim of the present study was to compare the efficacy of intradermal hepatitis B vaccination with intramuscular vaccination in hemodialysis patients. MATERIAL AND METHOD: Fifty one hemodialysis patients were randomly assigned to two groups, 25 patients received a total 7 doses of 10 mmicrog of recombinant hepatitis B vaccine (Engerix B) intradermally every 2 weeks (ID group), whereas 26 patients received 40 microg intramuscularly at 0, 1, 2 and 6 months (IM group). Anti-HBs Ab titer was measured at 2, 3, 4 and 7 months after the first vaccination in both groups. Vaccination responses were classified into 3 subgroups according to anti-HBs Ab titer and these included excellent response (> 1,000 IU/L), good response (10-999 IU/L) and non-response (< 10 IU/L). RESULTS: The seroconversion rates at 2, 3, 4, and 7 months in the ID group were 56%, 76%, 88%, and 92% compared with 31%, 42%, 65%, and 69% in the IM group, respectively. Only the seroconversion rates at 3 months were significantly higher in the ID group (76% versus 42%, p = 0.03). At 7 months after the first vaccination, good and excellent responders in the ID group were 72% (18/25) and 20% (5/25) compared with 34.5% (9/26) and 34.5% (9/26), respectively (p > 0.05). Only minor side effects were observed. CONCLUSION: Seven doses of 10 mg intradermal vaccination induced a high seroconversion rate and were comparable with intramuscular regimen. Intradermal vaccination may be helpful for the rapid induction of protective level of antibodies and may be a cost-saving alternative to intramuscular vaccination in hemodilaysis patients.

Female↗

Accelerated versus classical hepatitis B virus vaccination programs in healthcare workers accelerated vs. classical HBV vaccination.

BACKGROUND: The aim of this study was to compare the efficacy of a standard hepatitis B virus vaccination program (day 0-30-60) with an accelerated vaccination program (day 0-10-21) in healthy healthcare workers. MATERIAL/METHODS: Participants were randomly assigned to a classical (group 1, days 0, 30, and 60) or an accelerated vaccination program (group 2, days 0, 10, and 21). The vaccine used was 20 pg recombinant hepatitis B vaccine (recombinant hepatitis B vaccine derived from yeast cells, Engerix B, Smith Cline Beachum). HBV markers were re-examined for the emergence of anti-HBsAg and also to detect the development of a possible acute HBV infection one, two, and three months after the last dose of vaccine. Anti-HBsAg titers >10 mIU/l were accepted as protective. RESULTS: The seroprotection rates were similar one, two, and three months after the last dose of vaccine in both groups. Anti-HBsAg titers in group 1 were higher than in group 2 two and three months after the last dose of vaccination (p<0.05). CONCLUSIONS: Our data indicate that the accelerated HBV vaccination program was as effective as the classical vaccination program.

Adult↗

[Comparison of a bivalent anti-foot-and-mouth disease vaccine with oil adjuvant to a vaccine with DEAE-dextran adjuvant in swine].

The report compares the compatibility, efficacity and serology response of two bivalent anti-foot-and-mouth disease vaccines (OC). One is oil-adjuvanted and the other based on diethyl-amino-ethyl-dextran (DEAE-Dextran). After vaccination no general clinical or local reactions are normally observed. Tissular reactions at the inoculation site are more severe with the oil-adjuvanted vaccine than with the DEAE-Dextran vaccine. Meat inspection, about three months after injection of the vaccine, showed the lesions to be in regression and negligible. The control of activity has been performed by the virulence test. For the oil-adjuvanted vaccine, protection against O1-Lausanne, 5, 21 and 90 days after vaccination is 90%, 80-100% and 55% respectively. For the DEAE-Dextran vaccine, these levels of protection are 80% after 5 days and 20-70% after 21 days. The percentage of swine protected against C-Noville 35 days after vaccination is 100% for the oil-adjuvanted vaccine and 70% for the DEAE-Dextran vaccine. The evolution of the amount of serum antibodies was followed for three months by the method of seroneutralization on cell cultures.

Adjuvants, Immunologic↗

A study of the effect of simultaneous vaccination with BCG and smallpox vaccine in newborn infants.

In order to determine whether the BCG and smallpox vaccinations of newborn infants could be combined, thus saving staff, time and money, particularly in the developing countries, 696 newborn infants in Taiwan were divided into three groups and vaccinated by one of the following three methods: simultaneous vaccination with BCG and smallpox vaccine, vaccination with BCG only, and vaccination with smallpox vaccine only. On follow-up, no difference was observed between the "simultaneous" group and the "smallpox only" group in respect of either no-take rate and frequency distribution by size of vaccination lesions or reactions to smallpox revaccination at 12 weeks. Tuberculin tests at 12 weeks revealed a normal distribution in the size of tuberculin reactions with a mean of 11.94 mm and 12.19 mm respectively in the "simultaneous" group and the "BCG only" group; in the "smallpox only" group all the reactions were below 9 mm, the great majority being 0-3 mm. The author concludes that there is no interaction between primary BCG and smallpox vaccination when both vaccines are administered simultaneously, and that, despite the reported complications, simultaneous administration of BCG and smallpox vaccine in newborn infants is a safe procedure.

BCG Vaccine↗

Smallpox vaccination by intradermal jet injection. 3. Evaluation in a well-vaccinated population.

Smallpox vaccinations were performed in a well-vaccinated prison population by multiple-pressure technique and by intradermal jet injection using serial dilutions of vaccine. A total of 140 subjects were divided into groups, and each group was vaccinated by the multiple-pressure technique or by jet injection using 1 of 3 vaccine dilutions with the following calculated titres: ID-Jet 1 = 10(7.0) TCID(50)/ml, ID-Jet 1a = 10(6.3) TCID(50)/ml, ID-Jet 2 = 10(6.0) TCID(50)/ml. Clinical observations were made at intervals during the first week after vaccination. Prevaccination and post-vaccination serum samples were obtained immediately before and 30 days after the vaccination. Results based on clinical and serological evaluations indicated that smallpox vaccination by jet injection with the ID-Jet 1 vaccine was at least as efficacious as vaccination by the standard multiple-pressure technique.

Adult↗

An ELISA study of the antibody response after vaccination with a combined meningococcal group B polysaccharide and serotype 2 outer membrane protein vaccine.

The antibody response of a group of adult volunteers given a combined meningococcal group B polysaccharide and serotype 2 outer membrane protein vaccine, has been studied by the ELISA technique. The antigen was an outer membrane preparation from a non-capsular strain of Neisseria meningitidis (the vaccine strain). The vaccination was performed as a double-blind experiment where one group of 27 persons was given the vaccine and a similar group of 28 persons was given a placebo. In addition, five volunteers from the laboratory staff were given the vaccine. Two weeks after the primary vaccination, 31 of the 32 vaccinated persons demonstrated a significant increase of specific IgG antibodies. The number with significant IgA and IgM increase was 21 and 12, respectively. A booster effect after revaccination four weeks later was found in 18 persons for IgG, in 10 for IgA and in one for IgM. Twenty-five weeks after the primary vaccination the ELISA values were significantly reduced, mostly for IgM antibodies. The mean values for IgG, IgM and IgA were then 150%, 130% and 110%, respectively, of the values before vaccination. A new way of analysing the data has also been tried for IgG determination. Instead of comparing OD values, we calculate the expression: B = D/2 . In(1 + OD/A)/(1-OD/A), where A is an experimental constant and D is the serum dilution. B then becomes linearly proportional to the antibody concentration. This way of expressing the results shows the geometric mean IgG titer 25 weeks after vaccination to be three times higher for the vaccinated than for the placebo group.

Antibodies, Bacterial↗

[Vaccine coverage after integration of a vaccination program in a health center].

OBJECTIVE: To find the variation in the vaccinal coverage of two-year old children after incorporating the vaccination programme into the Health Centre's activities. DESIGN: An analytical observation study of cases and check-ups. SETTING: Primary Care. An urban Health Centre in Badajoz. PATIENTS: Two random samples of 150 children. The Study Group (SG) was composed of children who began their vaccinations at the Health Centre after the incorporation of the vaccination programme. The Control Group (CG) was made up of children who were over 18 months old at the start of the vaccinal programme (October 1990) and therefore received their vaccinations outside the Health Centre. MEASUREMENTS AND MAIN RESULTS: 84.8% of the CG childrens correctly completed the vaccination programme as against 98.7% of the SG (p < 0.01). 99.3% of the SG children had the triple viral vaccination as against 95.2% of the CG (p < 0.05). 99.3% of the SG completed three DTP-Polio vaccinations as against 93.1% CG (p < 0.01). And 98.7% SG had four DT-Polio as against 86.9% CG (p < 0.01). CONCLUSIONS: The level of vaccinal coverage of the under-two population improved after the vaccination programme was incorporated into the Health Centre's activities, data which supports the usefulness and appropriateness of such a programme.

Case-Control Studies↗

[Post anthrax vaccine delayed hypersensitivity. II--delayed hypersensitivity in humans vaccinated against anthrax].

To detect cell immunity characterized by delayed postvaccination hypersensitivity to anthrax in man and assess its dynamics, vaccination using unencapsulated live anthrax vaccine was performed in 668 healthy volunteers. Vaccination was performed either by scarification (n = 172), subcutaneous injection (n = 202), or low-dose (n = 202) or high-dose (n = 83) inhalation. The anthraxin intradermal tests were performed in each patient at various times during the year following vaccination (D7, D15, D90, D180, D365). This study confirm that, regardless of the mode of administration, the vaccine induces cell-mediated immunity in man, as determined by positive anthraxine skin test. The incidence of positive tests decreases with time regardless of the mode of vaccination. After one year, the test remained positive in 34.8% of subjects vaccinated by subcutaneous injection, 37.5% vaccinated by low-dose inhalation, 34.2% vaccinated by high-dose inhalation, and 22.4% vaccinated by scarification. These findings are in agreement with those obtained in clinical epidemiological studies documenting the effectiveness of encapsulated live anthrax vaccine in man.

Administration, Inhalation↗

International clinical trials of HIV vaccines: I. Phase I trial of an HIV-1 synthetic peptide vaccine in Bangkok, Thailand.

A randomized, double blind, placebo controlled Phase I trial of a prototype human immunodeficiency virus type 1 (HIV-1) synthetic peptide vaccine was conducted in Bangkok, Thailand, to evaluate the safety and immunogenicity of the vaccine in a population of healthy adults at low risk for HIV infection, and to establish essential infrastructure for future HIV vaccine trials in Thailand. Thirty volunteers (25 males; 5 females) were recruited and randomized into 3 groups, receiving 3 intramuscular injections of either 100 micrograms vaccine (N = 12) or 500 micrograms vaccine (N = 12) or alum placebo (N = 6) on weeks 0, 4 and 25. The vaccine was well tolerated without any serious adverse effects. HIV-1 specific ELISA responses were detected in 20/24 subjects who received the vaccine, with V3 binding antibody titers ranging from 1:69 to 1:5,041. HIV-1 (MN) specific neutralizing antibody was detected in 19/20 of subjects with detectable HIV-1 specific binding antibody. Neutralization titers ranged from 1:14 to 1:1,294, which were less than titers observed in HIV-infected subjects. The results of this study indicate that the vaccine was well tolerated, and that the vaccine stimulated anti-HIV humoral immune responses in Thai subjects. The successful undertaking of this first HIV vaccine trial conducted in Thailand provided important preparatory information surrounding volunteer recruitment and motivations, and paves the way for future trials of HIV vaccines in Thailand.

AIDS Vaccines↗

Simultaneous administration of hepatitis B vaccine with other E.P.I. vaccines.

Development of recombinant DNA vaccine against hepatitis B grown on cultured yeast cell has made it possible to mount a world-wide effort to control and eradicate Hepatitis B infection. However, the currently recommended schedules (0, 1 & 2 months, and 0-1 and 6 months) do not coincide with the scheduled visits for other E.P.I. vaccines, and necessitate additional visits for Hepatitis B vaccination. This study was therefore carried out to find out if adequate seroconversion occurs to Hepatitis B vaccine when given with other EPI vaccines or not? Thirty nine infants born to Australia antigen positive mothers from among 850 screened pregnant mothers were recruited to receive Hepatitis B vaccine (Engerix B-10 micro gram each) at 0, 6 and 14 wks (group A) or at 0, 1 and 2 months (group B). Thirty-one infants were recruited in group A and 8 in group B. The cord blood was collected and the first dose of vaccine was given within 48 hours of birth. Simultaneous B.C.G. was given at the left deltoid. Other E.P.I. vaccines were given qt 6, 10 and 14 wks in group A and at 2, 3 and 4 months in group B. Repeat blood samples were collected prior to giving each dose of Hepatitis B vaccine, and 4 weeks after the last dose. All blood samples were assayed for HBsAg and HBsAb at the National Institute Of Communicable Diseases, utilizing standard ELISA kits. The seroconversion rates following one, two and three doses of Hepatitis B vaccine were 3.33%, 55.5%, 96.15% and 0%, 62.5% and 100% in group A and B respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Age Factors↗

Immune response to simultaneous administration of a recombinant DNA hepatitis B vaccine and multiple compulsory vaccines in infancy.

The reactogenicity and immunogenicity of simultaneous administration of recombinant DNA hepatitis B vaccine with diphtheria and tetanus toxoids (DT) and oral poliovirus vaccine (OPV) in 111 infants were compared with those of DT and OPV alone in a control group of 21 infants. All subjects received three doses of the vaccine according to one of three different schedules of vaccination. Reactions following simultaneous administration of vaccines were all but absent, with mild pain reported for four out of 111 subjects, compared with one of 21 in the control group. Seroconversion rates of 98-100% and high anti-HBs geometric mean titres (GMTs) were observed in all study groups after three doses of hepatitis B vaccine. Significantly higher anti-HBs were seen in Group III, where six months is allowed between the second and the third hepatitis B vaccine doses, compared with Group I and II, where only 1-2 months separate the second and third doses. A fourth dose of vaccine was needed in both these groups to obtain anti-HBs levels as high as seen in Group III after three vaccine doses at 3, 4 and 10 months of age. The immune response to DT and OPV was similar in the study groups and the control group. It is concluded that a course of 10 micrograms doses of recombinant hepatitis B vaccine given simultaneously with DT and OPV elicits a strong anti-HBs response and does not interfere with the immune response to the other antigens.

Antibodies, Viral↗

Interference assessment of yellow fever vaccine with the immune response to a single-dose inactivated hepatitis A vaccine (1440 EL.U.). A controlled study in adults.

The objective of this open, controlled clinical trial was to assess whether Yellow Fever (YF) vaccine would interfere with one single dose of an inactivated hepatitis A (HAV) vaccine 1440 El.U. when they are administered simultaneously. One hundred and ten healthy adults (24 +/- 4 years old, 65% females) were included and randomized to receive one single dose of HAV vaccine (Group 1) or HAV vaccine plus YF vaccine (Group 2). All subjects received a booster dose of HAV vaccine (month 6). Anti-HAV antibodies were measured (ELISA method) at screening and at months 1, 6 and 7. One month after the first inoculation, the seroconversion rates and geometric mean titers for anti-HAV were 98% and 275 mIU ml-1 in Group 1 and 100% and 239 mIU ml-1 in Group 2. After the booster dose all vaccinees had become seropositive. Administration of YF vaccine did not alter the safety profile of HAV vaccine. These results indicate that simultaneous administration of YF vaccine does not interfere with the immune response to HAV vaccine (1440 El.U.) in young healthy adults.

Adolescent↗