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UNLABELLED: A total of 222 adult subjects aged 19-51 years were enrolled in this multi-center, phase III study to evaluate immunogenicity and safety of the first booster immunization with a new tick-borne encephalitis (TBE) vaccine. This was an extension study that followed subjects who had received primary immunization 12-18 months previously with either the new or formerly licensed TBE vaccine according to the rapid immunization schedule (i.e. on Days 0, 7 and 21). Compared to the levels of primary immunization, prior to first booster, neutralizing TBE antibodies (geometric mean titers, GMTs) of both vaccination groups had remained on a high level and were far above the detection limit of the neutralization test used. All subjects showed a sharp increase of TBE antibodies following the booster. The booster was well tolerated by the subjects. CONCLUSION: These results in terms of both immunogenicity and safety indicate that the TBE vaccination with this new TBE vaccine can be used effectively and safely in adults. A long lasting immunity can be concluded from the strong immune response following the first booster.
Although the childhood immunization program in the United States has reduced the burden of vaccine-preventable disease substantially among children, substantial vaccine-preventable morbidity and mortality from diseases such as hepatitis A, hepatitis B, influenza, and pneumococcal infections continue to occur among adults. In February 2002, the Advisory Committee on Immunization Practices (ACIP) approved for the first time a schedule for the routine vaccination of persons aged > or = 19 years. The Adult Immunization Schedule has been accepted by the American Academy of Family Physicians (AAFP) and the American College of Obstetricians and Gynecologists (ACOG). ACIP will review and approve annually both the recommended adult and childhood immunization schedules. Together, these schedules provide a comprehensive summary of recommendations for prevention of vaccine-preventable diseases during the life span of persons in the United States.
A novel immunization schedule was tested to increase antibodies to Haemophilus influenzae type B in which a 0.5% formaldehyde-inactivated cellular antigen and a partially purified lipopolysacharid antigen obtained from a selective precipitation with organic solvents were combined as immunogens. High specificity and biological activity antibodies with titers up to 1:256 were obtained by counterinmunoelectrophoresis; they were purified through a selective precipitation with ammonium sulphate and an ion-exchange chromatography using a DEAE-Sapharose column. The method proposed in this paper facilitates the production of purified antibodies useful for the improvement of serological diagnosis and H. influenzae b strain serotyping techniques.
OBJECTIVE: Researchers for this project evaluated compliance with the sequential poliovirus immunization schedule that uses inactivated poliovirus vaccine (IPV) for the first 2 doses of the polio immunization series, and assessed immunization coverage rates before and after implementation of this schedule at 6 public health clinics serving 1 county in Georgia. DESIGN: Immunization histories for 3 birth cohorts of infants were compared: (1) the baseline cohort, born January 1 through June 30, 1995; (2) the evaluation cohort, born January 1 through June 30, 1997, after implementation of the schedule change; and (3) the dose-3 cohort, born August 1 through November 30, 1996 (i.e., old enough to be eligible for a third dose of poliovirus vaccine following implementation of the sequential schedule). RESULTS: Following implementation of the new poliovirus immunization recommendations, 94% (534 of 567) of infants who received their first dose of poliovirus vaccine by age 3 months received IPV. Among these infants, 99.6% (532 of 534) were also up to date (UTD) for first doses of diphtheria and tetanus toxoids and acellular pertussis vaccine (DTP1/DTaP1), 99.6% (532 of 534) were UTD for first doses of hemophilus influenza type b (Hib 1), and 98.6% (527 of 534) had received at least one dose of Hepatitis B. Among infants visiting the clinics for their first or second dose of poliovirus vaccine, DTaP/DTP, and/or Hib, 76% received 3 or 4 simultaneous injections. In the dose-3 cohort, 78% (145 of 185) of infants who received a third dose of poliovirus vaccine had received 2 doses of IPV and 1 dose of oral poliovirus vaccine. CONCLUSIONS: Compliance with the recommended use of IPV for the first 2 poliovirus immunization doses as part of the sequential schedule was very high in this low-income and ethnically diverse population. Furthermore, the need for additional injections did not impede the delivery of recommended childhood immunizations.
Different immunization schedules for oral B subunit-whole cell (B-WC) cholera vaccine were evaluated in Swedish volunteers to obtain information for recommendations of vaccine use in non-endemic areas. Two peroral doses of B-WC vaccine were as effective as three doses in inducing IgA and IgG antitoxin as well as vibriocidal antibody responses in serum. Administration of two vaccine doses either at 7, 14 or 28-42 day intervals resulted in comparable antitoxin responses in serum, whereas a 3-day immunization interval resulted in significantly lower titre increases. Vibriocidal antibody responses were comparable after the different time intervals tested (3-42 days). The B-WC vaccine can be effectively administered together with a cheap, commercially available sodium bicarbonate powder dissolved in water to protect the vaccine from gastric acid.
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The need for a single childhood immunization schedule prompted the unification of previous vaccine recommendations made by the American Academy of Pediatrics (AAP) and the Advisory Committee on Immunization Practices (ACIP). In addition to presenting the newly recommended schedule for the administration of vaccines during childhood, this report addresses the previous differences between the AAP and ACIP childhood vaccination schedules and the rationale for changing previous recommendations.
Neuroscience nurses, whether they practice in an outpatient or hospital setting, should be aware of the new adult immunization schedule. In particular, they should be prepared to discuss vaccines needed after a traumatic injury and the risk of GBS or MS associated with vaccines. Anytime a vaccine is given, the patient needs to be observed for a reaction. Any post-vaccination reaction should be reported to the VAERS. The VAERS telephone number is 800/822-7967 and the Web site is http://www.vaers.org (Pinkowish, 2002).
The results of studies on the immunization of people in developing countries with vaccines adsorbed on calcium phosphate are presented in this paper. Several programs which were studied with various organizations cooperating and which were intended to simplify vaccination campaigns brought us to the following conclusions: --that immunization against diphtheria and tetanus by two injections with an interval of one year between them is effective, --that two injections of inactivated trivalent poliomyelitis vaccine followed up by booster one year later ensure that 90% of the infants are protected, --that it is possible to vaccinate pregnant women by one or two injections of tetanus vaccine and protect both mothers and newborn babies against tetanus, and --that combined vaccines which enable simultaneous immunization of subjects against a maximum of infections are possible.
The aim of the present study was to compare two immunization schedules for a Pseudomonas aeruginosa outer membrane proteins (OMPs) vaccine in burn patients. In a double-blind, randomized and placebo-controlled clinical trial, 95 adult patients with burn injuries in 10% or greater of total body surface area were randomly allocated to either placebo or immunization groups. Three doses of the vaccine (0.5 or 1.0 mg) were administered intramuscularly at either 3- or 7-day intervals. The vaccine was well tolerated, and no severe adverse reactions were observed in any of the vaccinees. After three immunizations, 88 patients were available for evaluation of serum antibody titers. Elevation of OMPs-specific antibody titers in the immunization groups was significantly higher as compared with the placebo group, and the highest antibody response was obtained by immunization with 1.0-mg doses at 3-day intervals. Conventional blood culture, tissue culture of wound biopsy specimens and a nested polymerase chain reaction (PCR) assay of blood specimens were performed to determine the protective efficacy. The results of the nested PCR indicated that the overall detection rate of P. aeruginosa in blood was significantly lower among immunized patients than placebo patients (6.1 vs. 40.0%, P<0.001). Based on these results, we concluded that the P. aeruginosa OMPs vaccine is safe and highly immunogenic in burn patients, especially with 1.0-mg doses at 3-day intervals, and may be effective in conferring protection against P. aeruginosa bacteremia in burn patients.
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The mouse toxin-neutralization test procedure described has been used for antitoxin titration of sera of New Guinea women following primary immunization with plain and adjuvant tetanus toxoids and following booster immunization, and for titration of guinea-pig sera.The responses of guinea-pigs immunized with the same toxoids and immunization schedule to simulate the human field trial studies were observed for 6 months. The relative antitoxin responses of guinea-pigs to the different toxoids were similar to those of the women.
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Vaccines intended to prevent mucosal transmission of HIV should be able to induce multiple immune effectors in the host including Abs and cell-mediated immune responses at mucosal sites. The aim of this study was to characterize and to enhance the immunogenicity of a recombinant modified vaccinia virus Ankara (MVA) expressing HIV-1 Env IIIB Ag (MVAenv) inoculated in BALB/c mice by mucosal routes. Intravaginal inoculation of MVAenv was not immunogenic, whereas intranasally it induced a significant immune response to the HIV Ag. Intranasal codelivery of MVAenv plus cholera toxin (CT) significantly enhanced the cellular and humoral immune response against Env in the spleen and genitorectal draining lymph nodes, respectively. Heterologous DNAenv prime-MVAenv boost by intranasal immunization, together with CT, produced a cellular immune response in the spleen 10-fold superior to that in the absence of CT. A key finding of these studies was that both MVAenv/MVAenv and DNAenv/MVAenv schemes, plus CT, induced a specific mucosal CD8(+) T cell response in genital tissue and draining lymph nodes. In addition, both immunizations also generated systemic Abs, and more importantly, mucosal IgA and IgG Abs in vaginal washings. Specific secretion of beta-chemokines was also generated by both immunizations, with a stronger response in mice immunized by the DNA-CT/MVA-CT regimen. Our findings are of relevance in the area of vaccine development and support the optimization of protocols of immunization based on MVA as vaccine vectors to induce mucosal immune responses against HIV.
In a prospective study over a 2-year period we compared two practical dosage schedules to vaccinate dialysis patients against hepatitis B virus (HBV) infection using a yeast-derived recombinant hepatitis B vaccine (Engerix-B). In addition, the natural history of this acquired immunity was compared with that developed through HBV infection in dialysis patients and healthy subjects. Patients on dialysis treatment (haemo or peritoneal) who were tested to be negative for hepatitis B surface antigen (HBsAg), anti-HBs and anti-HB core were allocated at random to receive HB vaccine according to one of the two schedules. The two groups receiving the vaccine were matched for age, sex, mean duration on dialysis and the form of dialysis treatment received. The group of patients who received a four-dose schedule (at 0, 1, 2 and 6 months) of 40 micrograms of HB vaccine each time (group 2) achieved a seroconversion rate of 79% 1 month after the last dose (at month 7) compared with a seroconversion rate of 55% in those who received three doses (at 0, 1 and 6 months) of 40 micrograms each (group 1). Healthy controls who received half the amount of vaccine on a three-dose schedule (group 3) attained 100% seroconversion (p < 0.05). When retested at 24 months, 30% of seroconverters in group 1 had lost their protective immunity, compared with only 6% in group 2 and 15% in group 3. The magnitude of antibody response (total and anti-(a)-specific) was assessed in the vaccinees at 24 months and compared with that of two other control groups, dialysis patients (group 4) and healthy volunteers (group 5), who had acquired immunity from HBV infection. In general, the total and anti-(a)-specific HBs titres in the dialysis patients (groups 1, 2 and 4) were lower than in their corresponding healthy controls (groups 3 and 5), irrespective of whether the protective immunity was acquired by vaccination or HBV infection. However, the anti-HBs titres in dialysis patients who received four doses were significantly higher than in those who received only three doses (p < 0.05), which indicated a better protective immunity in favour of the former regime. The magnitude of antibody response in the vaccinees of groups 2 and 3 compared well with their respective controls, groups 4 and 5, who had acquired their immunity through HBV infection. This implied that the yeast-derived vaccine was sufficiently immunogenic and provided lasting protection in patients and healthy subjects vaccinated by an appropriate dosage schedule.(ABSTRACT TRUNCATED AT 400 WORDS)
In order to evaluate the need for further booster immunizations, 222 subjects aged 20-52 years, who had received the first booster dose with a new tick-borne encephalitis (TBE) vaccine in a preceding study, were invited for a serological follow-up. A total of 191 and 182 adult subjects were analyzed for the persistence of neutralizing TBE antibodies at 1 and 2 years following the first booster immunization, respectively. Both serological follow-ups revealed high levels of neutralizing TBE antibodies in more than 99% of subjects. Although an expected decline of the respective geometric mean titers (GMTs) was noted after booster immunization, the titers were still far above the values noted after primary immunization at the 2-year follow-up. The kinetic curve clearly indicates a longer persistence of neutralizing TBE antibodies than currently expected. To conclude, these results suggest that the administration of a further booster dose 3 years after the first one (according to current recommendations) does not seem to be necessary in this study population.