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[Specific activity of an UV-inactivated antirabies vaccine made from brain tissue administered in a shortened schedule].

The results obtained in the study of the specific potency of rabies vaccine prepared from sheep brain tissue and inactivated by UV irradiation indicate that, even in the presence of the lowest immunogenicity index (0.5), 5-6 injections of the vaccine, made not daily, but at interval of 3 and 7 days, induced the production of antibodies in the titers not lower than those resulting from 14-20 daily injections of the same vaccine or Fermi vaccine. The preparation inactivated by UV irradiation should be introduced for therapy according to the shortened immunization schedule with intervals, taking into account the immunogenicity index.

Adolescent↗

Recombivax-HB: perspectives past, present and future.

Hepatitis B disease has caused a heavy burden worldwide. The development of an immunogenic, efficacious and safe vaccine to combat this problem has already eased this burden to some extent. The incorporation of the vaccine into the infant and childhood immunization schedule has led to a decrease in the number of new hepatitis B cases reported each year, and there has been a significant decline in hepatocellular carcinoma in children. This implies that the future will see less hepatitis B disease as the infant and adolescent population that has been immunized ages, meaning that the disease burden should fall even further.

Child↗

Immunogenicity of hepatitis A-inactivated vaccine administered to seronegative infants, and serological follow-up 12 months after second dose.

AIM: To evaluate a) the safety and immunogenicity of anti-HAV-inactivated vaccine administered during the first year of life to anti-HAV seronegative babies, and b) the antibody persistence in a low/intermediate endemic area. METHODS: After having obtained informed written consent from mothers, 92 babies were vaccinated at 4 and 10 mo of age. All babies were seronegative at birth and did not present HAV-RNA shedding in three serial stool samples taken at 1, 2 and 3 mo of age. RESULTS: No general side effects (fever > 38 degrees C) were observed. After the first dose of vaccine, 70/82 (85.4%) babies developed anti-HAV > 10 mIU/ml and 36/82 (43.9%) > 20 mIU/ml. After the second dose of vaccine, all babies developed a titre > 20 mIU/ml, and GMT was 877 mIU/ml. After 1 y of follow-up, the decreasing rate was similar to that reported for adult populations. Furthermore, three babies doubled the titre observed 1 mo after the second dose, indicating the possible spread of HAV even in a low/intermediate endemic area. CONCLUSION: Anti-HAV vaccine is safe, immunogenic and able to induce immune memory, and can be integrated into the routine infant immunization schedule during the first year of life.

Evaluation Studies as Topic↗

Family physician acceptance of universal hepatitis B immunization of infants.

BACKGROUND: The incidence of hepatitis B infection has risen 37% over the last decade; 300,000 new infections and 5000 deaths occur annually in the United States. Because immunization programs that targeted high-risk groups failed to abate this increase, the Centers for Disease Control (CDC) recommended in November 1991 universal hepatitis B immunization of infants. Details were published in an addendum to Morbidity and Mortality Weekly Report. The purpose of this study was to assess (1) the effectiveness of the CDC in disseminating a new immunization recommendation to family physicians, (2) the effect of the new recommendation on clinical practice, and (3) the degree to which noneconomic barriers may affect adoption of universal hepatitis B immunization. METHODS: A random sample of 300 family physicians in North Carolina was surveyed by mail. Descriptive statistics and chi-square analysis were used to assess the relationship of variables hypothesized to predict physician awareness of, and agreement with, the new recommendation. RESULTS: The response rate was 78%. Overall, 48% of family physicians who administered immunizations to children were aware of the new hepatitis B vaccine recommendation. However, only 17% agreed that it was warranted for all newborns in their practice. Twenty-five percent expected more than one half of the parents to refuse three injections at a single well-child visit, a result of adding this vaccine to the current primary immunization schedule. Additionally, 42% expected nurses to resist giving three injections at one visit. CONCLUSIONS: The CDC does not have an effective mechanism for disseminating information to all physicians who care for children. Improved coordination of recommendations between the CDC and relevant specialty societies may help to increase physician adoption of new immunization recommendations in their clinical practice. Additionally, practical concerns of physicians and their patients regarding multiple injections and other practice-relevant issues must be considered when formulating new immunization recommendations, if their implementation is to be successful. Additional research is needed to determine effective methods to disseminate immunization information and to address practical concerns of clinicians.

Adult↗

Longitudinal study of adverse reactions following diphtheria-tetanus-pertussis vaccine in infancy.

A prospective study of immunogenicity and adverse effects of 1553 doses of diphtheria and tetanus toxoids and whole cell pertussis vaccine (DTP) was performed in 538 children observed longitudinally from 2 months to 20 months of age. Subjects were randomized to the standard four-dose immunization schedule or to a three-dose schedule (with a saline injection substituted for DTP at 6 months of age). The three-dose schedule could not be recommended on the basis of serologic data. Compliance for completing a clinical observation form in the 48 hours following injections was greater than 99%. Fever, local reactions, or adverse behavioral effects were described in association with 96% of DTP doses and 36% of placebo injections. Contraindications to DTP immunization developed in 3% of study children. No convulsion, hypotonic hyporesponsive episode, encephalopathy, or temperature greater than 40.5 degrees C occurred. Behavioral and local inflammatory effects occurred maximally in the first 6 hours following vaccine but fever peaked later. There was no interrelationship between occurrence of local reaction and fever. Data suggest that age has more effect on the type and rate of adverse clinical events than does vaccine dose number. Existing antibody levels to vaccine components, lot of vaccine, breast-feeding, or gestational age did not affect rate or type of clinical reactions. Neither occurrence of reactions nor the use of acetaminophen affected antibody response to vaccine.

Acetaminophen↗

Effects of repeated Corynebacterium parvum and BCG therapy on immune parameters: a weekly sequential study of melanoma patients. I. Changes in non-specific (NK, K and T cell) lymphocytotoxicity, peripheral blood counts and delayed hypersensitivity reactions.

Increased lymphocyte cytotoxicity, particularly of 'killer' K cell type was recorded with repeated immunizations of either C. parvum or BCG. A 3 week interval between immunizations was capable of maintaining the increase in cytotoxicity. No marked alterations of 'recall' skin hypersensitivity reactions nor of peripheral blood counts were noted. Expression of cytotoxicity results as percentage 51Cr release, lytic units/ml and cytotoxic capacity (after logit transformation of the cytotoxicity-lymphocyte curves) are described. A 3 week immunization schedule is suggested where BCG and C. parvum are used as immunotherapeutic agents, in the doses quoted.

Adult↗

Immunogenicity and reactogenicity of Takeda acellular pertussis-component diphtheria-tetanus-pertussis vaccine in 2- and 3-month-old children in Japan.

OBJECTIVE: To compare the reactogenicity and immune response to the Takeda acellular pertussis-component diphtheria-tetanus-pertussis (APDT) vaccine in children when immunization commenced at 2 months (group A) vs 3 months (group B) of age. DESIGN: Longitudinal, nonblinded, comparative study. SETTING: Pediatric well-child clinics. PARTICIPANTS: Healthy 50- to 98-day-old infants. RESULTS: Good antibody responses to lymphocytosis-promoting factor, filamentous hemagglutinin, agglutinogens, and pertactin occurred in both age groups after both the third and fourth vaccine doses. Both young age and transplacentally acquired maternal antibody independently and together have a suppressive effect on the response to the four antigens in this APDT vaccine. However, these effects appear to be minor. Vaccine reactions were mild; group A children had slightly but not significantly higher rates than group B children. CONCLUSION: The present US diphtheria and tetanus toxoids and pertussis vaccine immunization schedule should also be satisfactory with this acellular pertussis component vaccine.

Age Factors↗

Immunization procedures for anti-idiotypic antibody induction in mice and rats.

Anti-idiotypic antibodies (Ab2) mimicking antigens (Ags)-defined by antibodies (Ab1) directed to tumors or pathogens have elicited Ag-specific humoral, cellular and/or protective immunity in experimental animals and in humans. In immunizations of rodents with Ab1, factors such as animal species, form of Ab1 and choice of adjuvant are crucial for the successful induction of Ab2 as candidate vaccines against tumors and pathogens. Here we survey the outcome of 362 fusion events (each event representing one animal), using nine immunization schedules in mice and seven schedules in rats and including 10 different Ab1 directed against human tumor- and immunodeficiency virus (HIV-1)-associated Ags. Ab1 IgG or F(ab')2 were administered uncoupled or coupled to keyhole limpet hemocyanin (KLH). As adjuvants, complete and incomplete Freund's adjuvant (CFA/IFA), lipid A, aluminum hydroxide, TiterMax or vaccinia virus were used. In syngeneic immunizations with murine Ab1 in mice, F(ab')2 coupled to KLH and emulsified in CFA/IFA preferentially induced Ab2 mimicking tumor or HIV-1 associated epitopes. In xenogeneic immunizations with mouse Ab1 in rats, various forms of Ab1 and adjuvants successfully induced Ab2 mimicking tumor Ags.

Animals↗

Response to tetanus toxoid immunization after allogeneic bone marrow transplantation.

An ELISA was used to study long-term immunity and immunization responses to tetanus toxoid in 48 bone marrow transplant recipients. Among patients who were seropositive to tetanus before transplant, 51% had lost their seropositivity 1 year later. All patients who were not reimmunized with tetanus toxoid were seronegative 2 years after transplant. All patients who were seronegative before transplant remained seronegative 1 year later regardless of the donor's serologic status. There was no difference in the ability to remain seropositive to tetanus toxoid between patients with and without chronic graft-versus-host disease. Of 21 patients immunized with one dose of tetanus toxoid 1 year after transplant, 14 were seronegative at the time of immunization (response rate, 64%). At 1 year after immunization, 7 remained seropositive. Ten patients were reimmunized with two doses of tetanus toxoid. All responded and 90% remained seropositive 1 year later. When 21 patients were primarily immunized with three doses of tetanus toxoid, all patients seronegative at immunization responded and all tested patients remained seropositive 2 years later. The immunization responses were significantly superior in patients receiving three doses compared with those who received one. Reimmunization with tetanus toxoid of long-term survivors after marrow transplant seems necessary. A three-dose immunization schedule is recommended to obtain an adequate immune response.

Antibodies, Bacterial↗

Tracking Immunization.

Immunization registries are critical to our ability to maintain high levels of immunization, particularly as new vaccines are introduced and immunization schedules become more complex. In the future, immunization registries increasingly will become components of integrated child health information systems. The lessons learned in developing immunization registries will facilitate development of these larger, more comprehensive systems.

Child↗

Safety and immunogenicity of a pentavalent combination vaccine (diphtheria, tetanus, acellular pertussis, polio, and haemophilus influenzae type B conjugate) when administered as a fourth dose at 15 to 18 months of age.

A DTaP-IPV//PRP-T combination vaccine (Pentacel) has been universally used in Canada to provide immunization against diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b with single injections at 2, 4, 6 and 18 months of age. This randomized, multicenter study was conducted to evaluate administration of a fourth dose of DTaP-IPV//PRP-T at 15 to 18 months of age, similar to the US immunization schedule. Participants who had received three doses of DTaP-IPV//PRP-T by 8 months of age were enrolled at 12 months and randomized to receive a fourth dose at 15, 16, 17 or 18 months. Antibody levels for each vaccine antigen were measured prior to and four weeks following booster vaccination. Overall, 1782 subjects were immunized and monitored for adverse events, and 735 were evaluated for immune responses. Preimmunization antibody levels differed minimally by age, for all antigens. The immune responses elicited by DTaP-IPV//PRP-T were comparable between participants vaccinated at 15 or 16 months and those vaccinated at 17 or 18 months, as demonstrated by specific antibody geometric mean titers, seroprotection/seroresponse rates, and reverse cumulative distribution curves. The fourth dose was well tolerated in all age groups. Toddlers at 15, 16, 17 or 18 months of age are equally suitable recipients for booster immunization with the DTaP-IPV//PRP-T vaccine.

Age Distribution↗

A recombinant glycoprotein vaccine for herpes simplex virus type 2: safety and immunogenicity [corrected].

OBJECTIVE: To evaluate the safety and immunogenicity of a recombinant glycoprotein vaccine for herpes simplex virus type 2 (HSV-2), which contains glycoproteins gD2 and gB2 combined with the novel MF59 adjuvant emulsion, in HSV-2-seronegative persons. DESIGN: Integrated summary of two phase I and two phase II studies. SETTING: University and private outpatient clinics. PATIENTS: 137 persons seronegative for HSV-2 antibodies as determined by HSV Western blot assay. INTERVENTION: Open-label vaccine administration with a dose-escalating design (phase I) was followed by randomized vaccine administration (phase II). Vaccine was administered intramuscularly into the deltoid at 0, 1, and 6 months. MEASUREMENTS: Neutralizing, HSV-2-binding antibodies and HSV-2-stimulated proliferative responses were measured before and after immunization. RESULTS: Among HSV-seronegative patients, the gD2 and gB2 enzyme-linked immunosorbent assay (ELISA) and HSV-2-neutralizing antibody titers increased to levels equal to or higher than those seen in naturally acquired HSV-2 infection after the full three-dose immunization schedule. Among HSV-1-seropositive patients, one immunization produced increases in gD2 and gB2 ELISA antibody titers and HSV-2-neutralizing antibody titers that were 3 to 5 times greater than those in persons with naturally acquired HSV-2 infection. Among HSV-seronegative patients, frequency analysis assays showed a marked increase in the precursor frequency of gD2- and gB2-specific T cells after vaccination: T-cell responses after two immunizations were equal to the responses of HSV-2-seropositive patients and were sustained at day 180. The vaccine was well tolerated. CONCLUSIONS: This subunit vaccine induces both humoral and cellular responses to HSV-2 that are equal to or greater than those of persons with naturally acquired HSV-2 infection. Studies to evaluate this vaccine for the prevention of genital herpes appear warranted.

Adjuvants, Immunologic↗

[A new rabies vaccine in public health practice in the USSR].

A new antirabies vaccine prepared on the basis of virus grown in the ovine brain, purified from 85-90% of brain-tissue ballast substances and inactivated with beta-propilactone has been developed at the Moscow Research Institute of Viral preparations (USSR Acad. Med. Sci.). The preparation produces no neuro-allergenic effect in tests on guinea pigs. When injected to humans, the vaccine shows much lower reactogenicity than Fermi vaccine. High antigenic and immunogenic activity of the new vaccine has made it possible to work out a less intensive immunization schedule in comparison with that used for immunization with Fermi vaccine and nonconcentrated tissue-culture vaccine, viz. doses of 3 ml for 12 days or doses of 3 ml for 20 days with two booster immunizations. The preparation has been introduced into medical practice.

Adolescent↗

Protection of piglets against neonatal colibacillosis based on antitoxic immunity.

Substantial protection against colibacillosis in neonatal piglets was provided by transfer of colostral antitoxic antibody to suckling piglets from dams immunized with procholeragenoid. The physical properties of procholeragenoid, an aggregate with a high-molecular weight formed during the heating of cholera toxin, were dependent upon the buffer and the duration of heating used for production. Procholeragenoid possessed a higher molar ratio of subunit A to subunit B than native cholera toxin. The biological activity of procholeragenoid was greatly decreased in several assay systems as compared to cholera toxin. Immunization of pregnant dams with 50 micrograms of procholeragenoid 5 weeks and 2 weeks prior to delivery elicited high titers of antitoxic-IgG and toxin-neutralizing antibody in the serum and colostrum at parturition. In field trials, immunization with procholeragenoid markedly decreased the incidence of diarrhea (85%) and death (84%) due to colibacillosis in neonatal piglets. Reimmunization of dams with procholeragenoid during the following gestation period afforded comparable levels of protection against death in piglets (mortality rate of 0.86% compared to 0.77% following the first immunization schedule). These results demonstrate that only antitoxic immunity can afford a high degree of protection against colibacillosis in neonatal piglets.

Animals↗

A study on impact of an educational programme on immunization behaviour of parents.

A study was conducted to measure the knowledge, attitude and practices (KAP) of parents of children 0-5 years of age in respect of expanded programme on immunization (EPI) target diseases. These variables were studied before and after educational programme. Before education of the parents, it was observed that increase in awareness of the target diseases was quite impressive, while improvement in knowledge about signs and symptoms of diseases, vaccines to prevent the diseases and immunization schedule were less evident. The attitude towards immunization was good and improved further with education. It was also observed that the increase in knowledge with regard to location of immunization centre and days on which services available was significant. Compared with improvement in knowledge and attitude ranging from 30 to almost 100 percent, the improvement in acceptance of vaccines was only within 6 to 10 per cent. Since the study time was short, the acceptance of all the required doses of all the vaccines could not be ascertained. Furthermore, the gap between KAP was as expected. However, strong motives are required or if motives are week, a compensatory strengthening of situational factors is called for to make the KAP easy and possible.

Bangladesh↗

Hepatitis B infection in infants after neonatal immunization.

A double-blind randomized placebo-controlled study to prevent hepatitis B infection in 235 babies born to chronic hepatitis B, HBeAg carriers was carried out. Babies in three treatment groups all received heat-inactivated hepatitis B vaccine. In addition multiple doses of HBIG and a single dose of HBIG were given in groups I and II respectively. After three years of follow-up, 4/60 (Group I), 3/64 (Group II), and 1/64 (Group III) developed chronic infection. For those who escaped chronic infection, other hepatitis events also occurred. They were transient HBs-antigenaemia, anti-HBc conversion and significant rise in anti-HBs titre without seroconversion for anti-HBc. It was deduced that 30% of babies born to hepatitis carriers are naturally protected from chronic infection. Immunization, with vaccine only, protects another 46%. The addition of single and multiple doses of HBIG protects another 10% and 5%, respectively. 2% acquired intrauterine infection and 7% failed to respond to the most intensive immunization schedule.

Double-Blind Method↗

New protection against Haemophilus influenzae type b infections in infants and young children.

Invasive Haemophilus influenzae type b (Hib) infections carry high morbidity and mortality, primarily due to meningitis among infants less than 1 year of age. Two new vaccines, HbOC and PRP-OMP, have been developed and licensed to prevent invasive Hib infections in infants and young children. New recommendations advise clinicians to begin immunization for Hib at 2 months of age and to complete the designated series. This article details the new Hib immunization schedule for all pediatric clients between 2 months and 5 years. Additionally, public-health measures toward the prevention of serious pediatric morbidity and mortality are covered.

Bacterial Vaccines↗