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PubMed2002

Safety, reactogenicity, and immunogenicity of a tetravalent meningococcal polysaccharide-diphtheria toxoid conjugate vaccine given to healthy adults.

Healthy adults, 18-55 years old, were immunized once with a tetravalent (serogroups A, C, Y, and W-135) meningococcal vaccine conjugated to diphtheria toxoid at 1 of 3 doses and were monitored for safety, reactogenicity, and immunogenicity. No immediate reactions were observed. Only 1 of 89 subjects reported fever; only 1 reported any severe reactogenicity (local pain/soreness, chills, arthralgia, anorexia, and malaise). For each serogroup and in each dose group, the geometric mean serum bactericidal antibody (SBA) titer and immunoglobulin G concentration increased after immunization. In the 4- and 10-microg-dose groups, all subjects had SBA titers >/=8 against serogroups A and C, and 89% and 93% of subjects had SBA titers >/=8 against serogroups Y and W-135, respectively. The A, C, Y, and W-135 Neisseria meningitidis-diphtheria toxoid conjugate vaccine, when given to healthy adults as a single intramuscular injection of 1, 4, or 10 microg/serogroup, is acceptably tolerated and immunogenic and deserves further development.

Adult↗
PubMed1999

Nasal and parenteral immunizations with diphtheria toxoid using monoglyceride/fatty acid lipid suspensions as adjuvants.

A novel suspension system was developed where monoglycerides were formulated together with fatty acids and subsequently admixed with antigens. In the present study, diphtheria toxoid was used as a model antigen primarily due to its weak immunological properties as well as to its importance as a future human vaccine for mucosal, particularly nasal immunization. The formulations were administered parenterally and/or nasally to mice whereafter the immune response was determined. In the present study, we have shown that mono-olein/oleic acid vesicles enhance the immunogenicity of admixed diphtheria toxoid in mice to the same level as Alum adsorbed (or Freund's complete adjuvant) when administered parenterally or nasally. It was also shown that the immunogenicity was linked to the length of the acyl chain of the lipids, where shorter acyl chains resulted in reduced titers. Furthermore, shorter acyl chains also gave rise to more pronounced toxic reactions at the injections sites, such as necrosis and alopeci, both of which were lacking when the optimal formulation consisting of mono-olein and oleic acid was used. Thus, this lipid matrix has in our view a great potential as an immunological adjuvant with an exceptionally simple and efficient preparation procedure without organic solvents and with low cost endogenous lipid based raw materials.

Adjuvants, Immunologic↗
PubMed2005

Short-term booster effect of diphtheria toxoid in initially long-term protected individuals.

The main objective of this study was to investigate the booster antibody response in individuals with initially high levels of diphtheria antitoxin. Sixty individuals eligible for the routine booster by the age of 18 years each received a single dose of 5 Lf of diphtheria toxoid in diphtheria-tetanus vaccine. A double antigen ELISA was used for the assessment of the antibody levels. Chaotropic disruption in paired ELISA was used to test antibody avidity. The ratio between initial and maximum antibody concentrations after 1 month was >10 times higher and after 6 months still four times higher in those with initial antibody levels <1 IU/ml. In individuals with initial antibody levels >/=1 IU/ml a two-fold decrease was observed after 6 months compared to the initial levels. Thus, vaccination of individuals with initial long-term protection against diphtheria (antibody levels >/=1 IU/ml) is unnecessary and should be avoided.

Adolescent↗
PubMed1979

Dynamic changes of horse serum T-globulin immunization with snake venoms, tetanus and diphtheria toxoids.

In course of immunizing horses with snake venoms, tetanus and diphtheria toxoids, a new serum component, T-globulin, was formed and migrated between the beta- and gamma-globulins. The T-globulin content was parallel with the antibody titre after the middle course of immunization. There were many components in snake antivenin and T-globulin was composed of most of those components. The components of diphtheria T-globulin were the same as those of crude antitoxin and tetanus T-globulin except one precipitin.

Animals↗
PubMed1981

Diphtheria immunization in adolescents and adults with reduced doses of adsorbed diphtheria toxoid.

A study was undertaken in Schick-positive university students and schoolchildren to determine the diphtheria antitoxin response to vaccines containing a reduced dose of adsorbed diphtheria toxoid. It was found that the majority of participants, apparently previously sensitized, responded with an increase in antitoxin titre to protective levels after performance of the Schick test, or after the first dose of vaccine. A group of non-immune students required three doses of vaccine to reach adequate antitoxin levels to ensure durable immunity. Only one local reaction was observed in the group of 51 students, and this was attributed to an Arthus-type reaction involving the tetanus toxoid component of a combined adsorbed diphtheria and tetanus vaccine.

Adolescent↗
PubMed1999

Induction of systemic and mucosal antibody responses in mice immunized intranasally with aluminium-non-adsorbed diphtheria toxoid together with recombinant cholera toxin B subunit as an adjuvant.

Nasal mucosal immunization is very attractive for vaccination to prevent various bacterial and viral infectious diseases because of induction of systemic and mucosal immune responses. The aim of the present study was to investigate the possibility of changing the immunization procedure of diphtheria toxoid (DT) from intramuscular or subcutaneous injection to intranasal administration. Intranasal immunization with aluminium-non-adsorbed diphtheria toxoid (nDT) together with recombinant cholera toxin B subunit (rCTB, 10 microg) induced, at a concentration of 5 Lf, high levels of serum DT-specific IgG antibody responses and high or moderate levels of the specific IgA antibody responses in all mice and only a slight level of the specific IgE antibody responses in some mice. Furthermore, sufficiently high diphtheria antitoxin titres more than 0.1 international units (IU) ml(-1) were obtained from mice which showed high levels of serum DT-specific IgG antibody responses. Under the same experimental conditions, induction of significant levels of mucosal DT-specific IgA antibody responses occurred in the nasal cavity, the lung, the saliva and vaginal secretions and the small and large intestines of all mice, although there were different titres between individual mice. Similar results were also obtained with rCTB-specific serum IgG and IgA and mucosal IgA antibody responses; serum rCTB-specific IgE antibody titres were not detected. These results show that intranasal administration of nDT with rCTB must be a very useful means for vaccination against diphtheria.

Adjuvants, Immunologic↗
PubMed1987

Efficacy of Haemophilus influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine in infancy.

Haemophilus influenzae type b capsular polysaccharide-diphtheria toxoid conjugate vaccine has recently been shown to be capable of inducing antibodies to H. influenzae in infants. In an evaluation of its clinical efficacy, 60,000 children were enrolled in an open trial in Finland. Children born on odd-numbered days between October 1, 1985, and September 30, 1986, received the vaccine at 3, 4, 6, and 14 months; those born on even-numbered days served as controls. The geometric mean antibody titer measured in a cohort of 99 children rose from a prevaccination level of 0.08 microgram per milliliter at three months of age to 0.42 microgram per milliliter at seven months. Only minor adverse reactions were reported. Up to February 1987, two cases of invasive H. influenzae infection had occurred among the children who had received three doses of vaccine, whereas 12 cases had occurred among the controls (P = 0.0005 by Poisson one-tailed test). The rate of short-term (average follow-up time, five months) protection provided by this conjugate vaccine in infancy was thus 83 percent.

Antibodies, Bacterial↗
PubMed2005

Effect of vitamin E TPGS on immune response to nasally delivered diphtheria toxoid loaded poly(caprolactone) microparticles.

The nasal mucosa has many advantages as a potential site for drug and vaccine delivery. The present study has sought to exploit this route of delivery using microparticles composed of D-alpha-tocopheryl polyethylene glycol 1000 succinate (TPGS) as a matrix material blended with poly(caprolactone) for nasal immunisation with diphtheria toxoid. Particles were prepared by a double emulsion method, followed by spray drying and the effect of TPGS on size, zeta potential, loading and release of antigen was assessed. Particles composed of TPGS-PCL blends were spherical, smooth and monodisperse, displaying increasing yields after spray drying with increasing concentrations of TPGS. The immune response to diphtheria toxoid loaded PCL-TPGS microspheres after nasal administration was shown to be higher than that achieved using PCL microspheres alone. We conclude that TPGS shows significant potential as a novel adjuvant either alone or in combination with an appropriate delivery system.

Administration, Intranasal↗
PubMed2004

Ionic interfaces and diphtheria toxoid interactions.

We present here a systematic study on the purification of the diphtheria toxoid (Dtxd) produced at the Instituto Butantan, by adding only one step on the entire process of its production. Aliquots of 1.0 ml of Dtxd were added to an equal amount of Q-Sepharose previously equilibrated with 500 mM Tris, pH 5.0-9.0 (increments of 0.5 pH units). The best condition for the Dtxd monomer adsorption was achieved at pH 9.0. The best condition for desorption was obtained with 300 mM NaCl. After studying the gel binding capacity for Dtxd, a column (C20/20) equilibrated with 500 mM Tris, pH 9.0, was prepared. The purification factor for Dtxd was 1.5. The final recovery of Dtxd was 68.75%, with 90.31% purity. The process methodology presented here is a very realistic sequence of separation steps, which is perfectly compatible with the production requirements. Vaccination with "toxoid highly purified toxin" is known to confer a strong immunity on people in the absence of undesirable reactions, which led experts of European Pharmacopoeia to recommend its use both for children and adult vaccination.

Adsorption↗
PubMed1976

[Immunological response of mice to diphtheria toxoid].

Following the determination of immunological response in mice, by titration, 1.5 Lf diphtheria toxoid was found as an optimal plasma cell activator. Groups of mice were subcutaneously injected with 1.5 Lf diphteria toxoid and on 2, 3, 4, 6, 10, 15 and 25th days of injection mice were killed and their blood, spleen, thymus, lymph nodes and lungs preserved. Section from these specimens were stained by methyl-green, pyronine and toluidine. Lymphocytes, plasma cells, and mast cells were counted in 10-20 fields in each preparation. Mature plasma cell ratio was calculated against lymphocyte counts. Mature plasma cell and mast cell counts and ratios of test mice were found increased when compared with that of normal control mice. The difference in thymus, spleen and lungs was found to be insignificant, however it was significant, p less than 0.05 in lymph. nodes. Maximum cell counts were seen at ten days. The sera of the test mice were also examined for humoral antibodies with precipitation and Römer's skin test. on 2, 3, 4, 6 and 10th days no antitoxin could be demonstrated in the sera of the test mice in controls either. In the sera taken on 15 and 25th days antitoxin was detected.

Animals↗
PubMed1998

Comparative safety of tetanus-diphtheria toxoids booster immunization in students in Grades 6 and 9.

BACKGROUND: Tetanus-diphtheria toxoids (Td) booster immunization is generally recommended for Grade 9 students (14- to 16-year-olds) but targeting younger students may enhance vaccine uptake or facilitate simultaneous vaccinations. However, earlier vaccination might cause greater side effects. This study was undertaken to compare the safety of Td vaccinations in students in Grade 6 (11 to 12 years old) and Grade 9. METHODS: A controlled, sequential assessment of Td vaccine, adsorbed, was conducted in one urban school district, starting with Grade 9 students. Grade 6 students were given Td concurrently with Dose 3 of hepatitis B vaccine. Adverse effects were assessed during visits 2 days after vaccination. Participation criteria, immunization technique and assessment procedures were standardized. RESULTS: Of 410 students vaccinated, 204 in Grade 9 and 206 in Grade 6, 391 (95.4%) were assessed in person. Nineteen missed follow-up visits but telephone interviewers established that none missed school because of vaccine side effects. At follow-up Grade 6 students more often reported deltoid pain with arm movement (35.2% vs. 10.8%, P < 0.001). Injection site redness > or = 50 mm in diameter was present in 12.2% of Grade 6 and 3.6% of Grade 9 students (P < 0.001) whereas swelling > or = 50 mm diameter was present in 22.4 and 10.8%, respectively (P < 0.01). Fewer than 10% of subjects took analgesics for injection site pain. Only 5 students (1.3%) rated Td site morbidity as severe/unacceptable. Hepatitis B site morbidity was minimal in comparison. CONCLUSION: Td boosters were moderately reactogenic in adolescents. Younger students more often experienced injection site morbidity but considered it bearable. Booster immunizations can reasonably be offered within the age range of 11 to 16 years.

Adolescent↗
PubMed1980

The dose of diphtheria toxoid in combined vaccines and their use in children.

The currently recommended immunization scheme consists of diphtheria, tetanus and pertussis vaccine (DTP) given at the ages of 3, 4 1/2 and 6 months, followed by a reinforcing dose of the same vaccine at 18 months, and one of diphtheria and tetanus vaccine (DT) before school entry. Children injected according to this scheme may be over-immunized. The amount of diphtheria toxoid (25 Lf per dose) contained in DTP should not be reduced, because some of the children missing the third primary dose would be left unprotected until after the 18-month injection had been given. It is likely that the 18-month dose could be omitted without great danger if the preschool booster dose were assured, and more than likely that preschool boosting with DT is unnecessary if the full course, including the 18-month dose, has been given. Reinforcing doses of tetanus toxoid need not be given as often as every 10 years. They are probably not required except in the case of injury and may, even then, be omitted if less than 5 years have lapsed since the completion of basic immunization, or since the injection of the last booster dose. Non-adsorbed diphtheria and tetanus toxoids may be the preparations of choice whenever immunity has to be reinforced.

Child↗
PubMed1987

Immunogenicity in infants of a vaccine composed of Haemophilus influenzae type b capsular polysaccharide mixed with DPT or conjugated to diphtheria toxoid.

Fifty-three healthy infants received either Haemophilus influenzae type b capsular polysaccharide (PRP) mixed with diphtheria-pertussis-tetanus vaccine (DPT) or PRP conjugated covalently to diphtheria toxoid (PRP-D). The immunizations were given at 3, 5, 7, and either 14 or 18 months of age and were well tolerated. The geometric mean titers of antibody to PRP at eight months of age (after the first immunizations) were 0.26 micrograms/ml in the PRP + DPT group and 1.56 micrograms/ml in the PRP-D group. After the fourth dose, an IgG response was seen in both groups. The PRP + DPT group had a geometric mean level of antibody to PRP of 3.98 micrograms/ml at 19 months and the PRP-D group, 31.22 or 24.00 micrograms/ml at 15 or 19 months, respectively. Compared with previously published data of children immunized with one dose of PRP at 18 months, the mean level of antibody to PRP in the PRP-D group at 19 months was significantly (P less than .001) higher, whereas that in the PRP + DPT group was not.

Antibodies, Bacterial↗
PubMed1996

Comparison of the conformation, hydrophobicity, and model membrane interactions of diphtheria toxin to those of formaldehyde-treated toxin (diphtheria toxoid): formaldehyde stabilization of the native conformation inhibits changes that allow membrane insertion.

Toxoids are inactivated protein toxins that are used in vaccines. The behavior of diphtheria toxin reacted with formaldehyde (diphtheria toxoid) was compared to that of diphtheria toxin in order to understand the nature of the changes that occur in toxoids upon protein reaction with formaldehyde. Despite the intramolecular cross-links in the toxoid, the conformations of the toxoid and the toxin were very similar in both the native and low pH-induced membrane-penetrating states as judged by fluorescence and hydrophobicity properties. However, the toxoid underwent thermal-, low-pH-, and guanidinium chloride-induced conformational changes only at more extreme conditions than needed to induce such changes in the toxin. This implies that formaldehyde modification stabilizes the native conformation relative to several conformations that involve different degrees of unfolding. The stabilization to conformational changes induced by low pH is particularly interesting because low pH induces partial unfolding of the toxin to a molten globule-like state. It was found that the toxoid only gained the ability to interact with model membrane vesicles at a lower pH than the toxin. Because low-pH-induced unfolding and membrane interaction are critical steps in the entry of diphtheria toxin into cells, the resistance of the toxoid to these changes may be linked to its lack of toxicity. The implications of these results for the construction of toxoids are discussed.

Binding Sites↗
PubMed1991

Efficacy of Haemophilus influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine in US children aged 18-59 months. Haemophilus Influenzae Vaccine Efficacy Study Group.

Vaccines prepared from the polyribosylribitol phosphate (PRP) capsule of Haemophilus influenzae b (Hib) have not consistently shown good efficacy in protecting children aged over 18 months from invasive Hib disease. To evaluate the efficacy of conjugate-PRP vaccines in this age-group, and to compare their effect with that of PRP vaccines, a post-marketing case-control study was conducted among 10,400,000 persons. Between Oct 1, 1988, and Feb 28, 1990, 75 patients with Hib disease and 161 control children between 18 and 60 months of age were enrolled. To minimise potentially confounding socioeconomic variables, controls were selected either from among patients' classmates at their day-care centre or from among family acquaintances. 9 of the 75 patients had received the diphtheria toxoid conjugate Hib vaccine more than 2 weeks before onset of illness. After adjusting for age and household crowding, the efficacy of PRP Hib vaccine was 64% (95% Cl = -20,89) and efficacy of the diphtheria toxoid conjugate Hib vaccine was 74% (95% Cl = 30,90). The study shows that the protective efficacy of this conjugate vaccine is less than ideal and highlights the need for additional post-licensing studies to confirm and expand understanding of the efficacy of these new products.

Analysis of Variance↗