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Study of pertussis vaccines in infants: comparison of response to acellular pertussis DTP vaccines containing 25 micrograms of FHA and either 25 or 8 micrograms of PT with response to whole-cell pertussis DTP vaccine.

Clinical and serological responses of infants to primary vaccination with diphtheria-tetanus-acellular pertussis (DTPa) vaccines containing 25 micrograms of filamentous haemagglutinin (FHA) and either 25 or 8 micrograms of pertussis toxoid (PT) were compared in a double-blind randomized study with responses of infants receiving whole-cell pertussis DTP vaccine (DTPw). In total, 308 healthy infants were enrolled to receive three vaccine doses at 3, 4 and 5 months of age. DTPa recipients had significantly lower incidences of local reactions and fever than the DTPw recipients. No differences in reactogenicity were observed between DTPa groups receiving 8 and 25 micrograms doses of PT. After vaccination, an immune response to PT was seen in 96% of 25 micrograms PT DTPa recipients, 94% of DTPw recipients and 86% of 8 micrograms PT DTPa recipients. The geometric mean anti-PT neutralizing antibody titre was significantly higher for 25 micrograms PT dose recipients (34.9 Chinese hamster ovary (CHO)) as compared with 8 micrograms PT dose recipients (21.0 CHO). The results support the use of the higher dose of PT in acellular pertussis vaccine preparations.

Adhesins, Bacterial↗

Duration of the immune response in subjects inoculated with antimeningococcal A and C vaccines kept in storage at -20 degrees C and at 4 degrees C: influence of pre-vaccination titres on the vaccinal response.

The antibody titres in 250 subjects, aged 5 to 22 years, who were vaccinated with a mannitol-lyophilized antimeningococcal A + C vaccine, stable only when stored at -20 degrees C, were followed for two years. As measured by indirect haemagglutination (IHA) and indirect immunofluorescence (IF) techniques, titres for both A and C Neisseria meningitidis antibodies remained high. Two years after vaccination titres of antibodies against type A showed fourfold increase over the initial titres in from 46% to 100% of groups of subjects and against type C in from 42% to 80%. For 130 subjects vaccinated with a new lactose-lyophilized antimeningcoccal A + C vaccine (presumed stable at 4 degrees C) antibody titres were measured up to 16 months after inoculation with this vaccine stored at -20 degrees C and also after storage for several periods at 4 degrees C. Antibody titres in all these subjects had fallen to their initial titres by 16 months. The importance of evaluating the results on subjects showing low initial titres (less than or equal to 1/8 as measured by IHA) is discussed, as inclusion of high initial titres influences the extent of the response.

Adolescent↗

Vaccine risk perception among reporters of autism after vaccination: vaccine adverse event reporting system 1990-2001.

OBJECTIVES: We investigated vaccine risk perception among reporters of autism to the Vaccine Adverse Event Reporting System (VAERS). METHODS: We conducted structured interviews with 124 parents who reported autism and related disorders to VAERS from 1990 to 2001 and compared results with those of a published survey of parents in the general population. RESULTS: Respondents perceived vaccine-preventable diseases as less serious than did other parents. Only 15% of respondents deemed immunization extremely important for children's health; two thirds had withheld vaccines from their children. CONCLUSIONS: Views of parents who believe vaccines injured their children differ significantly from those of the general population regarding the benefits of immunization. Understanding the factors that shape this perspective can improve communication among vaccine providers, policymakers, and parents/patients.

Adult↗

Comparative studies on chick embryo cell rabies vaccine and human diploid cell vaccine: pre-exposure use and purity of the vaccines.

Neutralizing antibody responses to commercial Japanese-produced chick embryo cell (CEC) vaccines in Japanese and to commercial human diploid cell rabies vaccines (HDCV) in Filipinos were compared by the rapid fluorescent focus inhibition test (RFFIT). Neutralizing antibody titers of the Japanese after subcutaneous (sc) immunization with two doses of the CEC vaccines were not lower than those of the Filipinos with two or three doses of HDCV by intramuscular (i.m.) or intradermal (i.d.) route, respectively. Protein nitrogen content of the CEC vaccine was about 1/300th that of the HDCV. Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) and immunoblotting analysis showed that non-viral protein content in the CEC vaccine was much lower than that in the HDCV. The CEC rabies vaccine seems to be as safe and effective as the HDCV for human pre-exposure immunization.

Animals↗

Avidity maturation following immunization with two human cytomegalovirus (CMV) vaccines: a live attenuated vaccine (Towne) and a recombinant glycoprotein vaccine (gB/MF59).

Two human cytomegalovirus (CMV) vaccines have been previously evaluated for their immunogenicity: a recombinant gB/MF59 vaccine and an attenuated strain of CMV (Towne). In healthy adults, we measured the antibody avidity maturation indices that occurred after vaccination with each. For Towne, administered as a single dose, the rise in IgG antibody avidity to CMV glycoprotein gB occurred slowly and continued for 24 months post-immunization. For gB/MF59, administered as two priming doses and a booster dose given at 6 months, the booster rapidly induced IgG antibodies to gB whose avidity was maximal at 7 months after the initial priming dose. Both vaccines induced antibody levels and avidity maturation indices that equaled those induced by wild-type virus suggesting that both vaccines may be effective in controlling CMV infections.

Adolescent↗

Variable region expression in the antibody responses of infants vaccinated with Haemophilus influenzae type b polysaccharide-protein conjugates. Description of a new lambda light chain-associated idiotype and the relation between idiotype expression, avidity, and vaccine formulation. The Collaborative Vaccine Study Group.

Haemophilus influenzae b polysaccharide (Hib PS)-protein conjugate vaccines differ chemically and immunologically. To determine whether anti-Hib PS variable region expression might differ according to vaccine formulation, infants were vaccinated at 2, 4, and 6 mo of age with Hib PS coupled to either meningococcal outer membrane protein complex (Hib PS-OMPC) or tetanus toxoid (Hib PS-T), or Hib PS oligomers coupled to a mutant diphtheria toxin (Oligo-CRM). Two anti-Hib PS idiotypes were measured in sera obtained after the third injection: HibId-1, expressed by anti-Hib PS antibodies having the kappa II-A2 variable region, and HibId-2, a newly defined cross-reactive idiotype associated with a subset of anti-Hib PS antibodies having lambda VII variable regions. HibId-1 was present in 33, 68, and 64% of infants given either Hib PS-OMPC, Oligo-CRM, or Hib PS-T, respectively (P < 0.001). The respective values for HibId-2 were 47, 18, and 10% (P = 0.001). Subjects who were vaccinated with Hib PS-OMPC or Hib PS-T and who produced detectable HibId-1-positive antibody, had significantly higher mean antibody avidity than subjects who did not produce HibId-1 positive antibodies. In contrast, Oligo-CRM evoked high avidity anti-Hib PS antibodies, irrespective of the idiotypic profile. These findings indicate fundamental differences in both variable region content and antibody quality elicited by different Hib PS conjugate vaccines.

Antibodies, Bacterial↗

National Vaccine Injury Compensation Program (VICP): effective date provisions of coverage of certain vaccines to the vaccine injury table--HRSA. Final rule.

Section 904(b) of the Taxpayer Relief Act of 1997 provides for an excise tax for three new vaccines, effective August 6, 1997. Petitions for compensation for injuries or deaths related to hepatitis B, Hib, and varicella vaccines may now be filed under the Vaccine Injury Compensation Program (VICP). This technical amendment amends the Code of Federal Regulations (CFR) to include a date certain (August 6, 1997) in section 100.3(c) of the Vaccine Injury Compensation regulations, so that there will be no uncertainty as to the coverage of these three vaccines.

Chickenpox Vaccine↗

Safety and immunogenicity of TETRActHIB (a vaccine combining DTP vaccine and Haemophilus influenzae type B conjugate vaccine) administered to infants at 6, 10 and 14 weeks of age.

The safety and immunogenicity of TETRActHIB (a vaccine combining diphtheria and tetanus toxoids-pertussis vaccine (DTP) with Haemophilus influenzae type b (Hib) conjugate vaccine (polyribosyl ribitol phosphate conjugated to tetanus protein) (PRP-T)) was assessed in 131 Cape Town infants immunized at 6, 10 and 14 weeks of age. Serological responses to all component antigens were measured before the first dose and at 18 weeks of age. In addition, anti-PRP antibodies were measured at 9 and 18 months of age to determine long-term immunogenicity. The vaccine was well tolerated by infants and no significant side-effects were reported. Responses to Hib at 18 weeks of age were good in that most infants achieved a level of anti-PRP antibodies > or = 0.15 microgram/ml, indicative of short-term protection, and 70% achieved a level > or = 1 microgram/ml, indicative of long-term protection. The proportions of children with protective levels > or = 0.15 microgram/ml and > or = 1 microgram/ml were similar at 9 and 18 months of age, i.e. approximately 75% and 45%, respectively. Responses to tetanus and diphtheria toxoids were excellent and all infants achieved protective serological levels. Responses to pertussis were moderate in that approximately 65% achieved 'protective' serum levels of pertussis agglutinins, i.e. titres > or = 320. In conclusion, this study has shown that the DTP/PRP-T vaccine is safe, immunogenic and well tolerated in infants immunised at 6, 10 and 14 weeks of age. TETRActHIB is therefore suitable for inclusion in the World Health Organisation Expanded Programme on Immunisation (WHO EPI) schedule.

Age Factors↗

[Immunomodulation activity of new vaccines for pertussis prophylaxis--acellular pertussis vaccine and adsorbed DPT vaccine with acellular component].

The immunomodulating activity of acellular pertussis vaccine (APV) and adsorbed DPT vaccine with acellular pertussis component (DPTA vaccine) was studied. The study revealed that only large doses of APV, 10 immunizing doses (ID), suppressed humoral and cell-mediated response to sheep red blood cells (SRBC). 1 ID produced no influence on the formation of antibody producing cells, but increased the development of delayed hypersensitivity (DH) to SRBC. The modulation of cell-mediated immune response, induced by APV, returned to normal after the injection of purified staphylococcal toxoid, used as immunomodulator, in doses of 0.15 BU per mouse and 1.5 BU per mouse. DPTA vaccine containing 1 ID, as well as 10 ID, produced no immunomodulating effect. This was established by the evaluation of humoral response to SRBC in CBA mice and the study of the formation of DH to SRBC in BALB/c mice. As indicated by the total of the presented data, the inclusion of APV into DPTA vaccine enhanced the immunological safety of its pertussis component.

Adjuvants, Immunologic↗

[Pertussis vaccination with acellular vaccines. Tolerance--effectiveness--current vaccination recommendations].

Pertussis is one of the most common infectious diseases in children, affecting in particular nonimmunized babies and young children, but increasingly also adolescents and adults. Complications occur for the most part in infants and in addition to infectious complications may also even lead to death from apnea. Since 1991, general pertussis vaccination has been recommended again, but because of the relatively high rate of side effects associated with the whole-cell vaccines available, has remained at a low level. This led to the development of acellular pertussis vaccines with appreciably improved tolerability. A number of these acellular vaccines offer good protection, and are approved for immunization. Owing to their excellent tolerability and the resulting better acceptance, acellular pertussis vaccines can considerably improve the immunization rate. Only in this way will it be possible to reduce the incidence of one of the most common infectious diseases of childhood that is also associated with the highest rate of complications.

Adult↗

Dengue tetravalent DNA vaccine increases its immunogenicity in mice when mixed with a dengue type 2 subunit vaccine or an inactivated Japanese encephalitis vaccine.

We previously developed a dengue tetravalent DNA vaccine that can induce neutralizing antibodies against four dengue viruses in mice. Here, we demonstrated that immunogenicity of our tetravalent vaccine is synergistically increased in mice by co-immunization with dengue type 2 virus (DENV2) subviral extracellular particles (D2EPs) or inactivated Japanese encephalitis vaccine (JEVAX). A single immunization with a mixture of 100 microg of the tetravalent vaccine and 150 ng of D2EPs or a 1/10 dose of JEVAX induced moderate levels of neutralizing antibodies in a 90% plaque reduction assay. Immunized mice were protected from "artificial" viremia created by intravenous injection with DENV2.

Animals↗

Dose-response to acellular pertussis vaccine and comparison with whole cell pertussis vaccine at 15-24 months and 4-6 years of age. Acellular Pertussis Vaccine Study Team.

In a randomized double-blind trial 55 children of 15-24 months and 56 children of 4-6 years of age previously immunized with whole-cell DTP (WC-DTP) received acellular pertussis DTP vaccines containing 12.5 micrograms (AC-12.5) or 25 micrograms (AC-25) each of pertussis toxoid (PT) and filamentous haemagglutinin (FHA) per dose of WC-DTP. No differences in antibody responses or adverse events were noted for children who received AC-25 as compared with AC-12.5. All three groups had significant increases in pertussis agglutinins, but the geometric mean titre (GMT) for 4-6-year-old children who received WC-DTP was higher than the GMT for children who received acellular vaccine. No significant differences were noted in the GMT of antibodies to FHA or PT between children who received WC-DTP and recipients of acellular vaccine. The rates of several adverse reactions were significantly (p less than or equal to 0.05) higher for recipients of WC-DTP, and children given WC-DTP were significantly (p less than or equal to 0.00001) more likely to have received acetaminophen. These acellular vaccines are safe and as immunogenic for FHA and PT as WC-DTP when administered as the fourth or fifth dose to children who received three doses of WC-DTP in infancy. The lower (12.5 micrograms) dose of acellular vaccine was as effective as the higher (25 micrograms) dose in inducing antibodies to FHA and PT in children 15-24 months and 4-6 years of age.

Antibodies↗