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At least 19 recordsLinked to original sources
PubMed1989

In vitro induction of antigen specific antibody synthesis and proliferation of T lymphocytes with acellular pertussis vaccines, pertussis toxin and filamentous haemagglutinin in humans.

The in vitro response of human B- and T-lymphocytes to the acellular vaccines JNIH-6 (containing pertussis toxoid and filamentous hemagglutinin), and JNIH-7 (containing pertussis toxoid), and to the purified components JNIH-4 (filamentous hemagglutinin) and JNIH-5 (pertussis toxin) was investigated. Pertussis toxoid and filamentous hemagglutinin induced specific Ig synthesis in vitro in lymphocytes obtained from convalescent pertussis patients as target cells. The antigen-dependent Ig production was demonstrated in lymphocyte culture supernatants by ELISA techniques and by a chinese hamster ovary cell toxin neutralization assay. Particularly with JNIH-4, -6 and -7, high antibody titers were obtained. At optimal antigen concentrations a marked lymphocyte blast transformation was found in lymphocyte cultures from whooping cough patients, but not in cultures of lymphocytes obtained from healthy volunteers. At high concentrations native pertussis toxin as well as the B oligomer (S2-5) of the toxin induced a strong proliferation of patient as well as control lymphocytes, indicating non-specific mitogenic activity. At lower concentrations lymphocyte blast transformation was seen in patient cultures only, which indicates an antigen-specific T-cell response. The A protomer (S1), dimer 1 (S2 + 4) and dimer 2 (S3 + 4) induced proliferation of patient lymphocytes, which demonstrates the presence of T-cell epitopes on these peptides. The in vitro B-cell response and the lymphocyte blast transformation assay are both useful tools for estimating the potency of acellular pertussis vaccines in man. Spontaneously acquired and vaccine induced immunity to Bordetella pertussis can be investigated at the level of B- and T-lymphocytes.

Antibody Formation↗
PubMed1992

Pertussis vaccination: acellular pertussis vaccine for reinforcing and booster use--supplementary ACIP statement. Recommendations of the Immunization Practices Advisory Committee (ACIP).

This supplementary statement provides information on and recommendations for the use of diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP). One such vaccine was recently licensed, ACEL-IMMUNE.* This vaccine is licensed for use only as the fourth and fifth doses of diphtheria, tetanus, and pertussis vaccination; it is not licensed for the initial three-dose series in infants and children, regardless of age. At least one other DTaP product is anticipated to be licensed in the future for use as the fourth and fifth doses. The current Immunization Practices Advisory Committee (ACIP) statement on diphtheria, tetanus, and pertussis issued August 8, 1991, gives general recommendations on pertussis prevention, including the use of whole-cell pertussis vaccines for primary and booster vaccination (1).

Child, Preschool↗
PubMed1992

Pertussis vaccination: acellular pertussis vaccine for the fourth and fifth doses of the DTP series update to supplementary ACIP statement. Recommendations of the Advisory Committee on Immunization Practices (ACIP).

General recommendations on pertussis prevention were issued August 8, 1991, in the ACIP statement on diphtheria, tetanus, and pertussis (1). A supplementary statement on the use of diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) was issued February 7, 1992 (2) after the licensure of ACEL-IMUNE, prepared by Lederle Laboratories. With the recent licensure of a second DTaP product, Tripedia, this statement updates the supplement. Tripedia has a formulation that differs from that of ACEL-IMUNE. Both DTaP vaccines are licensed for use only as the fourth and/or fifth doses of diphtheria, tetanus, and pertussis vaccination; they are not licensed for the initial three-dose series for infants and children, regardless of age. Whole-cell DTP should continue to be used for the initial three-dose series and remains an acceptable alternative for the fourth and fifth doses. For details on the background, indications, use, and precautions and contraindications of DTaP, refer to the earlier supplementary statement (2).

Antibodies, Bacterial↗
PubMed1984

In vivo effect of polymyxin B on pertussis vaccine.

Pertussis vaccine contains lipopolysaccharide (endotoxin). Polymyxin B sulfate neutralizes endotoxin activity in vivo and in vitro from Enterobacteriaceae and Salmonella-derived endotoxin. In vitro, polymyxin B eliminates the endotoxin reaction of pertussis vaccine in the Limulus lysate test. In this study, platelet and WBC counts and antibody response were compared in rabbits given either pertussis vaccine alone or pertussis vaccine and polymyxin B intravenously. Pertussis vaccine-induced leukopenia and thrombocytopenia were eliminated in the polymyxin B group. The antibody titers in the animals receiving pertussis vaccine and polymyxin B were somewhat lower and rose more slowly. Since the toxicity of pertussis vaccine is related in part to endotoxin, we suggest that a clinical study using a combination of the vaccine with an endotoxin-neutralizing agent be done to assess both amelioration of side effects caused by the vaccine and any effect on immunogenesis.

Animals↗
PubMed1985

A biphasic glucose and insulin response in mice after vaccination with pertussis vaccine.

Pertussis vaccine consisting of inactivated whole Bordetella pertussis organisms appears to induce a biphasic response on the glucose metabolism of N:NIH mice. A heat stable component assumed to be the LPS induces a transient hyperglycaemia within 6 hours after vaccination. A heat labile component assumed to be LPF, induces a hypoglycaemia and hyperinsulinaemia 2-7 days after treatment. A purified vaccine examined in this study still showed some effects on the glucose metabolism at 3-4 days after vaccination. If hypoglycaemia contributes to the neurological side effects, incidentally observed after vaccination of infants, both LPS and LPF have to be considered to be responsible for these effects.

Animals↗
PubMed2003

Pertussis vaccine controversies and acellular pertussis vaccine.

Pertussis still continues to cause significant morbidity and mortality worldwide. Because of the high reactogenicity of whole cell pertussis vaccine, it had evoked public controversy in several countries. In 1970 Japan abandoned use of whole cell pertussis vaccine and mounted efforts to develop better vaccine. To date, nearly 24 acellular pertussis vaccines have been developed, using different number and quantity of components. No acellular vaccine is most or least immunogenic with respect to all included antigens. Vaccine efficacy and duration of immunity is comparable with whole cell pertussis vaccine. The adverse events are two thirds less compared to whole cell vaccine.

Clinical Trials as Topic↗
PubMed1995

Effect of priming with diphtheria and tetanus toxoids combined with whole-cell pertussis vaccine or with acellular pertussis vaccine on the safety and immunogenicity of a booster dose of an acellular pertussis vaccine containing a genetically inactivated pertussis toxin in fifteen- to twenty-one-month-old children. Italian Multicenter Group for the Study of Recombinant Acellular Pertussis Vaccine.

OBJECTIVE: To evaluate the safety and the immunogenicity of a booster dose of recombinant acellular pertussis vaccine combined with diphtheria and tetanus toxoids (DTaP, Biocine SpA) in 15- to 21-month-old children primed in infancy with either whole-cell diphtheria-tetanus-pertussis (DTwP) vaccine or DTaP vaccine. DESIGN: Open-label second phase of a double-masked, controlled trail, with masked analysis of serum samples. PARTICIPANTS AND SETTING: Three hundred fifty children, 15 to 21 months of age, who had been primed at 2, 4, and 6 months of age with either three doses of DTaP vaccine (n = 173) or DTwP vaccine (n = 177). The children were enrolled in eight vaccination centers in Italy. INTERVENTIONS: All children received a booster dose of the DTaP vaccine and were examined for safety at 48 hours and at 7 days after vaccination. Serum samples for evaluation of immunogenicity were obtained from 196 (55%) of the 350 children. MAIN OUTCOME MEASURES: IgG antibodies to pertussis toxin (Ptox), filamentous hemagglutinin, 69-kilodalton protein, and tetanus toxoid were measured by enzyme-linked immunosorbent assay. Pertussis toxin-neutralizing antibodies were measured by the Chinese hamster ovary cell toxin neutralization assay. MAIN RESULTS: Adverse reactions to DTaP were infrequent, and there was no difference in the incidence of local or systemic reactions in children given DTaP as a fourth dose in comparison with a first dose. One month after the DTaP booster vaccination, both groups had 6- to 40-fold increases in serum antibody concentrations to all antigens tested; the concentrations against the three pertussis antigens were higher in the DTaP-primed children (p < 0.05). The antibody titers to diphtheria and tetanus toxoids were higher in the DTwP-primed group (p < 0.05), but both groups had protective titers. The geometric mean ratio of anti-Ptox neutralizing antibody per unit of IgG anti-Ptox antibody was higher in the DTaP-primed group (p < 0.001). CONCLUSIONS: There are quantitative and qualitative differences in booster responses to DTaP vaccine in young children, depending on whether they were given DTaP or DTwP as primary immunization. This DTaP vaccine is safe and highly immunogenic as a booster.

Antibodies, Bacterial↗
PubMed1987

Protective effectiveness of an endotoxin-depleted pertussis vaccine.

Pertussis vaccine depleted of endotoxin by the polymyxin-Sepharose affinity chromatography method was tested for toxic activity and protective effectiveness in mice. Preparations containing 1000-fold and 1 000 000-fold less endotoxin fulfilled the established experimental criteria for freedom from toxicity. A fourfold concentrate of the former demonstrated a protection rate only 10% less than that of standard, untreated pertussis vaccine.

Animals↗
PubMed1987

Synergistic teratogenic effect produced in mice by whole cell pertussis vaccine.

Pertussis whole cell bacterial vaccine was injected in mice during early pregnancy to disclose any teratogenic effect on the brain of the fetuses. Cytochalasin D by itself induced exencephaly in a dose dependent way in fetal mice. When pregnant mice received a single injection of pertussis vaccine on day 8 of gestation and a subteratogenic dose of cytochalasin D on days 8, 9 and 10 of gestation a synergistic teratogenic action of pertussis vaccine and cytochalasin D in mice was observed. When autopsy was performed after a further 9 to 10 days a significant number of brain malformations was found. In order to analyse which component in the vaccine might be responsible for the co-teratogenic effect, purified pertussis components, pertussis toxin and filamentous haemagglutinin were used in combination with cytochalasin D, but no malformations occurred. The same results were obtained by using diphtheria-tetanus-polio (DiTePol) vaccine and acellular pertussis component vaccine, whereas the use of whole cell typhoid vaccine resulted in a high rate of fetuses with exencephalies. Experiments with purified Bordetella pertussis and Escherichia coli lipopolysaccharides indicated that lipopolysaccharides in whole cell pertussis vaccine as well as in typhoid vaccine were the factors causing teratogenicity in fetal mice.

Abnormalities, Drug-Induced↗
PubMed1979

Modification of antibody response to type III pneumopolysaccharide by route of injection of pertussis vaccine.

Pertussis vaccine (PV) or diphtheria toxoid-PV-tetanus toxoid (DPT) altered the antibody response of BALB/c female mice to type III pneumococcal polysaccharide antigen (S3). The key factor affecting the magnitude of the response to S3 was the route of injection of PV or DPT, whereas the route of injection of S3 was not crucial. Subcutaneous injections of DPT augmented the antibody response to low, optimal, and tolerogenic (high) doses of S3 injected either subcutaneously or intraperitoneally. This enhancement was persistent and was observed both when S3 and DPT were mixed and injected subcutaneously and when S3 and DPT were injected concurrently at separate subcutaneous sites. When either PV or DPT was injected intraperitoneally, the antibody response to subcutaneously or intraperitoneally injected S3 was significantly decreased. These experiments demonstrate a dichotomy of effect dependent on the route of administration of PV. Most studies in mice utilizing PV employ the intraperitoneal injection route, and it is important to consider whether PV treatment by this route may have unique effects. Our data suggest that intraperitoneal injection of PV suppresses B cells, possibly by influencing regulatory cell function.

Animals↗
PubMed1996

Epidemiologic aspects and diagnostic criteria for a protective efficacy field trial of a pertussis vaccine.

Pertussis was a major childhood disease in parts of West Germany in 1990. Before a prospective household contact trial into the efficacy of an acellular pertussis vaccine was undertaken, the epidemiology of the disease was studied in one area. This study showed that pertussis had an annual incidence of 4%-6% in the first 6 years of life. During the trial, a total of 1223 pertussis cases were diagnosed by laboratory methods. Isolation rates of Bordetella organisms varied by the pediatrician who did the nasopharyngeal swab and decreased with time required for swab transport. Analysis of the serologic results showed that if IgG and IgA anti-pertactin antibodies had been considered, overall sensitivity would have been only marginally increased. Several pertussis patients had antibodies to parapertussis antigens, indicating a lack of complete cross-protection. The serologic response in secondary household contacts differed by vaccination status. However, this difference was unlikely to have influenced the point estimate of efficacy of the acellular vaccine.

Antibodies, Bacterial↗
PubMed1995

Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: pertussis vaccination.

The first efficacy trial of pertussis vaccines with defined purified antigens failed to demonstrate a serologic correlate of protection, although both tested vaccines were shown to give significant protection against typical whooping cough. The antibody response to pertussis toxoid was dose dependent. A lower anti-PT response in the two-component vaccine, containing one-half the amount of PT in the one-component vaccine, seemed to be compensated by a significant anti-FHA response, since both vaccines conferred similar protection against typical illness. However, the immunologic mechanisms whereby protection is conferred remain unclear. At present antibody responses to the antigens included in the first tested vaccines could be used as pseudoindicators of protection. The group of vaccinated infants who were protected did differ in their antibody profile as compared to unvaccinated infants. Tentatively, candidate vaccines should elicit no less antibody responses to PT and FHA as those elicited by the above one- and two-component vaccines, respectively. The response to other antigens such as pertactin and fimbriae cannot be related to protection at present. Ongoing efficacy trials of a number of pertussis vaccines of varying composition may or may not provide immunological correlates of protection against pertussis. The trials ought to be subjected to a preplanned, independent (meta)analysis with defined end points to increase the understanding of the contribution of various antigens to the protective efficacy of pertussis vaccines.

Antibodies, Bacterial↗
PubMedDate not supplied

[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↗
PubMed2006

Lung pathology and immediate hypersensitivity in a mouse model after vaccination with pertussis vaccines and challenge with Bordetella pertussis.

While evaluating vaccine efficacy against clinical Bordetella pertussis isolates in mice, after challenge vaccinated mice showed increased lung pathology with eosinophilia, compared to challenged, non-vaccinated animals. This led us to study bacterial clearance, lung pathology, lung TNF-alpha expression, and parameters of immediate hypersensitivity (IH), being serum IgE levels, eosinophil numbers in the bronchoalveolar lavage fluid, and ex vivo IL-4, IL-5, IL-10, IL-13, and IFN-gamma production by the bronchial lymph node cells. BALB/c mice received a combined Diphtheria (D), Tetanus (T), Poliomyelitis, and whole-cell Pertussis vaccine (WCV), a combined D, T, and three-component acellular Pertussis vaccine (ACV), aluminium hydroxide adjuvant, or PBS, 28 and 14 days before B. pertussis infection. Similarly treated non-infected mice were taken as a control. Infection induced pathology; this induction was stronger after (especially WCV) vaccination. WCV but not ACV vaccination induced TNF-alpha expression after challenge. After challenge, IH parameters were strongly increased by (especially ACV) vaccination. Vaccinated IL-4 KO mice showed similar clearance and pathology, in the absence of IgE and with reduced numbers of eosinophils. Vaccinated (Th1-deficient) T-bet KO mice showed reduced clearance and similar pathology. In summary, after challenge vaccination increased lung pathology, TNF-alpha expression (only WCV), and IH parameters. Th1 cells were critical for clearance.

Administration, Intranasal↗
PubMed1998

Single radial immunodiffusion as a method for the assay of the acellular pertussis vaccine components, pertussis toxoid, filamentous haemagglutinin and pertactin.

The development of acellular pertussis vaccines has raised a number of issues relevant to the control of these products. Of particular importance is the need for robust and accurate in vitro assays for the antigen content of the vaccines which might contain up to five different antigen components, each of which needs to be independently assayed. This paper describes a simple method for the quantification of three component antigens. Because relatively high doses of purified antigens are used in those preparations, the elimination of residual toxicity is a major concern. This is achieved by genetic modification of chemical treatment. The latter results in modification of the immunological reactivity of the antigens making direct assay by such methods as ELISA ineffective. A single radial diffusion technique using polyclonal antisera for the assay of pertussis toxoid (PTxd), chemically treated filamentous haemagglutinin (FHA) and pertactin (69 kDa) has been developed. The method uses low concentrations of antisera, allowing accurate and reproducible quantification of antigen content as low as 25 microg/ml of protein for pertussis toxoid and filamentous haemagglutinin and 5 microg/ml for pertactin. Since by the addition of detergent, diffusible subunits are produced irrespective of the original physical state of the antigens, the assay is suitable for assay of these antigens after detoxification/or stabilization by chemical treatment and is able to determine the differences between preparations which have the same protein concentration but different antigenic contents. This provides a means for assuring the consistency of the antigens after detoxification/or chemical stabilization which could be used as an in-process control method for acellular pertussis vaccines.

Adhesins, Bacterial↗
PubMed1994

Comparative study of a whole-cell pertussis vaccine and a recombinant acellular pertussis vaccine. The Italian Multicenter Group for the Study of Recombinant Acellular Pertussis Vaccine.

The safety and immunogenicity of an acellular pertussis vaccine containing the genetically detoxified pertussis toxin PT-9K/129G, filamentous hemagglutinin, and pertactin, together with diphtheria and tetanus toxoids, were compared with those of a whole-cell pertussis component-diphtheria-tetanus vaccine. Four hundred eighty infants were enrolled into this prospective, multicenter, double-blind study. Each infant was randomly given three doses of one of the two vaccines at 2, 4, and 6 months of age. Both local and systemic adverse reactions, reported within 48 hours and 7 days of each injection, were less frequent after the acellular vaccine than after the whole-cell vaccine. The enzyme-linked immunosorbent assay titers to pertussis toxin, filamentous hemagglutinin, and pertactin, as well as the pertussis toxin-neutralizing titer measured by the Chinese hamster ovary cell assay, were significantly higher after the acellular vaccine was given. Both vaccines induced adequate levels of anti-diphtheria and anti-tetanus antibodies. We conclude that the recombinant acellular pertussis vaccine produces fewer reactions than the whole-cell vaccine and provides a high antibody response against the antigens of Bordetella pertussis involved in bacterial adhesion and systemic toxic effects.

Antibodies, Bacterial↗
PubMed1991

Comparison of toxicities of acellular pertussis vaccine with whole cell pertussis vaccine in experimental animals.

There is no suitable animal model for pertussis encephalopathy in humans. In this study, we have compared the toxicity of acellular pertussis vaccine with whole cell pertussis vaccine in mice or guinea pigs. Two lots of acellular and two lots of whole cell vaccine produced in different countries were assayed in the test. 1. There was no statistical difference in mouse protective potency between these acellular or whole cell pertussis vaccines. 2. There were no differences in chemical ingredients between acellular and whole cell pertussis vaccines except for protein nitrogen content. The protein nitrogen content of whole cell vaccine was at least three times higher than that of the acellular product. 3. Anti-PT antibody productivity of the acellular vaccine was higher than that of the whole cell vaccine. 4. Anti-agglutinogen antibody productivity of the whole cell vaccine was higher than that of the acellular vaccine. 5. There was no pyrogenic activity with the acellular vaccine, but high pyrogenicity was seen with whole cell vaccine. 6. There was high body-weight decreasing toxicity in mice and guinea pigs by the whole cell vaccine. 7. The mice died when they received whole cell pertussis vaccine iv, but no deaths occurred in the mice which received acellular pertussis vaccine.

Adhesins, Bacterial↗
PubMed2006

An adolescent and adult formulation combined tetanus, diphtheria and five-component pertussis vaccine.

Pertussis causes substantial morbidity among adolescents and adults, as well as other persons in contact with affected individuals. In the context of widespread childhood immunization, vaccination of adolescents and adults is a relatively new strategy for reducing the disease in all age groups. ADACEL is a tetanus-diphtheria-acellular pertussis combination vaccine (incorporating pertussis toxoid, filamentous hemagglutinin, pertactin and fimbriae type 2 and 3 antigens) formulated for use in adolescents and adults based on similar products designed for infants and children. ADACEL vaccine is approved for use in Australia, Canada, Germany and the USA, and has been demonstrated to induce robust immune responses and acceptable levels of reactogenicity in clinical trials. Surveillance data from Canada, where ADACEL vaccine has been used in adolescents and adults in conjunction with ongoing childhood vaccination for several years, indicate an enhanced overall reduction in pertussis disease.

Adolescent↗