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PubMed2003

Collaborative study for establishment of the European Pharmacopoeia BRP batch 1 for diphtheria toxin.

A stable liquid candidate Biological Reference Preparation (BRP) for diphtheria toxin was prepared in peptone buffer (nominal content of diphtheria toxin: 1 Lf/ml, 0.4 micro g/ml), filled in ampoules (filling volume: 1 ml) and characterised in a collaborative study. The toxin is to be used in the test "Absence of toxin and irreversibility of toxoid" as described in the current European Pharmacopoeia (Ph. Eur.) monograph Diphtheria Vaccine (Adsorbed) (2002:0443). Eleven laboratories assessed the specific activity of the preparation by in vivo and in vitro assays. The material is assumed to have satisfactory stability with a calculated predicted loss of activity of <1% per year at 4-8 degrees C. From the collaborative study, the specific activity was calculated as 77.6 (45-113) LD( 50)/ml (lethal challenge) and >75 000 Lr/Lf (intradermal challenge). The candidate BRP was successfully used in nine laboratories and confirmed suitable for use in the Vero cell test for "Absence of toxin and irreversibility of toxoid" as described in the Ph. Eur. monograph 2002:0443; i.e., concentrations of 5 x 10( -5) Lf/ml and below caused cytotoxic effects in the Vero cell test. Due to its liquid nature, the stability of the material will be monitored at regular intervals and preparation of a stable freeze-dried formulation will be considered for long-term use. Additional studies will be performed to confirm suitability of this BRP for other applications. The candidate BRP was adopted as the Ph. Eur. reference material for Diphtheria Toxin Batch 1 by the Ph. Eur. Commission at its session in March 2003.

Animals↗
PubMed2003

The 2001 serological survey in the Czech Republic--diphtheria.

Diphtheria morbidity in the Czech part of former Czechoslovakia showed a continuous downward trend between 1946 and 1974. Afterwards, sporadic cases of diphtheria were reported in some years. Compulsory vaccination against diphtheria was started in 1946 with a monovaccine, later replaced by bivaccine DiTe. Since 1958, newborns have been vaccinated with DiTePe vaccine. As many as 98% to 100% of the population of age groups under 50 years likely to have been vaccinated have antibody levels > 0.01 lU/ml. About 83% to 88% of the older age groups who represent a naturally immunized population have antibodies as well. This immune status excludes the possibility that diphtheria could spread massively if accidentally imported into the Czech Republic.

Adolescent↗
PubMedDate not supplied

[Blood antigens in the AB0 system and susceptibility of humans to diphtheria].

The analysis of a large number of diphtheria cases (1326) at the peak of diphtheria morbidity in Russia (1993-1994) revealed that the intensity of antidiphtheria antitoxic immunity was age-dependent with a sharp immunodeficiency in the population aged 35 years and older. As adaptive capacity of the organism decreases, the positive associative links between immunity to diphtheria and the AB0 blood groups become evident. Populations with phenotype B (III) had the largest diphtheria immune stratum at the age of 35 years and over as compared to 3 other phenotypes. The genotypic analysis of serological data may be of practical importance for the detection of the degree of predisposition of humans to infectious diseases.

ABO Blood-Group System↗
PubMedDate not supplied

[Pathogenicity of Corynebacterium diphtheriae circulating in Rostov-on-Don City and Rostov region during interepidemic period].

Main pathogenic characteristics (toxin production, tox-gene detection, adhesiveness) of 59 strains of C. diphtheriae circulating in Rostov-on-Don city and Rostov region in 2004-2005 were studied. Study of toxigenicity of 15 tox+ C.di phtheriae strains showed full coincidence of Elek immunoprecipitation test and polymerase chain reaction (PCR). Presence of part of A-fragment of tox-gene was detected in 5 (11.4%) of 44 C. diphtheriae strains that were negative in Elek test. Hemagglutinating activity of toxin producing strains was intermediate (40%) or high (60%). Among non-toxigenic strains those with intermediate adhesiveness were predominated (45,5%), the intermediate or high adhesiveness was detected in strains positive in PCR. Obtained characteristics of C. diphtheriae can be useful for surveillance for diphtheria infection during interepidemic period.

Bacterial Adhesion↗
PubMed1987

[Dynamics of diphtheria morbidity and population immunity].

Observations on the stratum immune to diphtheria among the population, carried out over a period of many years and involving more than 37,000 people, have shown its gradual decrease in all adult age groups. In recent years the number of adults susceptible to diphtheria exceeded the number of susceptible children by 10.6%, and in some age groups by 18.5-21.8%, which makes for the total increase of diphtheria morbidity in recent years owing to its rise among adults. Regular revaccination of the adult population against diphtheria, made simultaneously with that against tetanus, is recommended.

Adult↗
PubMed1988

[Epidemiological surveillance of diphtheria infection in the territory of the Azerbaijan SSR].

A complex of measures carried out with a view of effecting the epidemiological surveillance of diphtheria infection has made it possible to study the level and intensity of immunity to diphtheria and tetanus, determined in the passive hemagglutination test, in the child and adult population and to reveal groups, least protected against diphtheria infection. Bacteriological studies on the biological properties of Corynebacterium diphtheriae have revealed the contamination of various groups of children with this infective agents and permitted its complete characterization with the determination of its sero-, phago- and corycinovariants.

Adolescent↗
PubMed1981

[Further improvements in schedules for immunizing children against diphtheria and tetanus].

The study of the rational schedule of revaccinations made at different ages for the prevention of diphtheria and tetanus was carried out on 800 children belonging to the age groups of 6-9 years and 11-14 years. The content of diphtheria antitoxin was determined by Jensen's method, and the content of tetanus antitoxin in the passive hemagglutination test. In the first age group immunity to the above-mentioned infections was determined after the primary immunization, and in the second age group after the first revaccination made at an age indicated in the schedule. The high level of immunity to both diphtheria and tetanus was shown to preserve for 6-7 years. For this reason intervals between revaccinations scheduled for children achieving a definite age in accordance with the existing scheme of immunization against diphtheria and tetanus may be increased. the most rational time for such revaccinations is the age of 9 (instead of 6) years and 16 (instead of 11) years.

Age Factors↗
PubMed1994

[Detection by molecular biology techniques of diphtheria toxin production in corynebacteria].

The ability to secrete a potent protein-toxin called diphtheria toxin (DT) is of outstanding importance for the outcome of diphtheria epidemics. Rapid molecular-biological screening methods are shown that can improve the differentiation between toxinogenic and non-toxinogenic Corynebacterium diphtheriae strains. The recently reported infection with an endemic, putative toxinogenic Corynebacterium diphtheriae strain in Lower Saxony is discussed.

Corynebacterium diphtheriae↗
PubMed1995

Low prevalence of diphtheria antitoxin in children and adults in northern Germany.

Recent outbreaks of diphtheria in neighbouring eastern European countries and in the Russian Federation prompted us to evaluate immunity to diphtheria in a sample of 400 healthy individuals (210 male, 190 female) from northern Germany. An age-stratified study population was chosen, including newborns, children, adults and elderly persons over 60 years divided into 8 subgroups of 50 persons each. Diphtheria antitoxin was tested by enzyme immunoassay. The median antitoxin titre was 0.39 IU/ml. There was no difference in the median antitoxin titres of men and women. Inadequate immunity to diphtheria was detected in more than 90% of the 400 individuals tested, including 4% who completely lacked immunity (titre < 0.01 IU/ml), a further 20% with minimal protection (titre 0.01-0.1 IU/ml) and the majority of 69% who showed relative protection for less than one year (titre 0.1-1.0 IU/ml). Only 7% exhibited lasting protection for more than five years (titre > 1.1). Newborns and persons over 50 years of age constituted the least protected groups, with significantly lower median antitoxoid titres than the other age groups (p < 0.001). The absence of protective immunity in 7 of the 50 newborns examined (14%) reflects the inadequate protection of women of reproductive age. Children aged 1 to 10 years were the best immunized and protected group. The results suggest that routine booster immunizations of the majority of the adult population would be advisable in view of the ongoing migration from and the visits to high-risk areas.

Adolescent↗
PubMed2004

Effect of a diphtheria booster vaccination in adults with a documented history of an incomplete primary series vaccination.

BACKGROUND: An incomplete series of diphtheria vaccination is frequently found in the vaccination documents of adult patients. This paper investigates the effect of a booster vaccination in adults with an incomplete series of primary vaccination. MATERIALS AND METHODS: The effect of one diphtheria booster vaccination in adults with a documented history of only two childhood vaccinations has been investigated in 21 adults. Before the vaccination and 4 to 8 weeks thereafter, blood samples were taken and analyzed with an in vitro neutralization assay. RESULTS: None of the participants had prevaccinal full protective diphtheria antitoxin levels (AT) > or = 0.1 IU/ml and four (19%) had limited serological protection (AT 0.01 to 0.1 IU/ml). After the vaccination, 14 individuals (67%) had protective LeveLs and six (29%) had limited protective levels. The risk for post-booster non-protection (AT < 0.1 IU/ml) was 7.7 times higher in comparison with a group of 170 adults with a history of at least one booster vaccination. CONCLUSION: A specific immunologic memory exists in adults with a history of only two previous diphtheria vaccinations. However, our results also indicate the need for a second booster vaccination in this group if long-term protection is to be achieved.

Adult↗
PubMed1989

The use of the Toxin Binding Inhibition (ToBI) test for the estimation of the potency of the diphtheria component of vaccines.

The Toxin Binding Inhibition (ToBI) test, previously developed for the estimation of diphtheria and tetanus antitoxin in human sera, was adapted for the estimation of the potency of diphtheria components in vaccines. Data are presented to show that antitoxin titres of individual sera of mice obtained by the ToBI test are in good agreement with those obtained in the Vero cell test. In addition, diphtheria potency and 95% confidence interval of twelve batches of vaccine in different compositions were estimated by the ToBI test and the results were compared with those obtained in Vero cells. A significant correlation could be demonstrated. It is concluded from this study that the ToBI test is a valuable model in the potency assay of diphtheria toxoids, based on antitoxin induction in mice.

Animals↗
PubMed1992

Immunogenicity of combined diphtheria, tetanus, and pertussis vaccine given at 2, 3, and 4 months versus 3, 5, and 9 months of age.

In the UK an accelerated schedule for immunisation against diphtheria, tetanus, and pertussis (injections at 2, 3, and 4 months of age) was introduced in 1990 to replace the more widely spaced schedule of 3, 5, and 9 months. There is concern, however, that the new schedule may be less immunogenic and therefore less protective than the old schedule. We have measured serum concentrations of antibodies against diphtheria, pertussis, and tetanus in infants immunised according to the two regimens. Both schedules resulted in protective concentrations of antibody against tetanus and diphtheria and in satisfactory antibody responses to three pertussis antigens (filamentous haemagglutinin, pertussis toxin, fimbriae). However, immunisation by the old schedule led to significantly higher antibody concentrations against both diphtheria and tetanus than did immunisation by the new schedule (p less than 0.01). In infants immunised with the new schedule, postimmunisation antibody concentrations against tetanus toxoid and against two pertussis antigens (pertussis toxin and fimbriae) were significantly lower in infants in whom preimmunisation (maternally derived) antibody concentrations were high (p less than 0.02). The findings suggest that with an accelerated immunisation schedule maternal antibodies can have an inhibitory effect on the responses to immunisation against tetanus and pertussis.

Antibodies, Bacterial↗
PubMed1995

The return of Corynebacterium diphtheriae: the rise of non-toxigenic strains.

With the decline in incidence of diphtheria in Europe and the USA, many laboratories no longer routinely culture throat swabs for Corynebacterium diphtheriae. However, there is an outbreak of infection with toxigenic strains in Russia and most adults do not have protective levels of antibody. Non-toxigenic strains are known to cause local disease and lysogenic conversion probably occurs in vivo as well as in vitro. Non-toxigenic C. diphtheriae var. gravis, formerly quite rare, has been isolated with increasing frequency in the UK over the last five years. During prospective screening at one Sexually Transmitted Disease Clinic, six (1%) of 578 homosexual men were found to harbour the organism in the throat, four of them with clinical pharyngitis. Only one of 1696 heterosexual men and women were found to be carriers. Seven cases of endocarditis due to this organism were reported in a single year in Sydney, Australia and non-toxigenic C. diphtheriae var. mitis has caused four cases of endocarditis in Switzerland. Non-toxigenic strains are responsible for pharyngitis and occasional invasive disease and should be treated. Routine screening of throat swabs should not be abandoned.

Adult↗
PubMed2004

Immunogenicity of a combined diphtheria-tetanus-acellular pertussis vaccine in adults.

Two clinical studies were undertaken to evaluate the immunogenicity of an adult-type dTpa booster vaccine (Boostrix by GlaxoSmithKline Biologicals). Blood samples taken prior to vaccination showed that 24.4 and 13.0% of subjects were seronegative for diphtheria and tetanus antibodies, respectively. Moreover, about one-third of the vaccinees had no detectable levels of antibodies to pertussis toxoid (PT) or pertactin (PRN). One month post-vaccination, more than 93% of all individuals, regardless of age or type of vaccine received, had seroprotective antibody levels for diphtheria and tetanus (> or = 0.1IU/ml). In those individuals vaccinated with the adult-type dTpa vaccine (Boostrix), more than 98% were found to be seropositive for antibodies to all three pertussis antigens (PT, filamentous haemogluttin (FHA), and PRN). These data suggest that immunity to diphtheria, tetanus and pertussis (DTP) in adults wanes and that booster vaccination with an adult-type combined dTpa vaccine would boost the serological response to diphtheria antitoxin, tetanus antitoxin and antibodies to Bordetella pertussis PT, FHA and PRN.

Adolescent↗
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↗
PubMed2000

Immunity to diphtheria among children in Northern Norway and North-Western Russia.

In 1990, diphtheria re-emerged in Russia and during the following four-year period the resulting epidemic reached all the Newly Independent States (NIS) of the former Soviet Union. Several neighbouring countries of NIS, Norway included, have experienced sporadic imported cases. A sero-epidemiological study among children in Northern Norway and North-Western Russia was performed in order to evaluate protection against diphtheria and how differences in vaccination programmes affect immunity. A total of 664 sera, 400 from Norwegian and 264 from Russian children, were examined for antibodies against diphtheria, using an in vitro toxin neutralisation method. The Russian children studied had satisfactory protection in all age groups examined. The Norwegian children had poor protection against diphtheria from the age of 7 years until they received the booster dose at the age of 11. Therefore, a revision of the Norwegian vaccination programme, including a booster dose at school-entry age, seems warranted.

Antibodies, Bacterial↗
PubMed1999

Seroprevalence and determinants of diphtheria, tetanus and poliomyelitis antibodies among adults in Berlin, Germany.

The immunity levels against diphtheria, tetanus and poliomyelitis were investigated among blood donors (n = 2079) in Berlin. Of all participants, only 60% had full, long-term protection against diphtheria, 72% against tetanus, 87% against poliomyelitis type 1, 77% against poliomyelitis type 2 and 73% against type 3. There was a striking decrease of tetanus and diphtheria immunity levels by age. Immunity levels against tetanus were higher among males, whereas females were better protected against poliomyelitis. After adjusting for confounding effects in logistic regression diphtheria immunity in those aged <40 years was significantly higher in participants from East-Berlin, whereas the immunity levels against poliomyelitis were higher in West-Berlin. These differences reflect the different vaccination policies in East-Germany and West-Germany before 1989. There is a need to improve the immunity levels of the adult population in Berlin.

Adolescent↗
PubMed1999

Diphtheria booster vaccination: one or two injections?

In a prospective, controlled, randomized, multicenter study the immunogenicity and tolerance of a single vaccination (day 0) and two (day 0, 28) booster vaccinations against diphtheria were compared in subjects who had received their last diphtheria vaccination more than 10 years ago. 415 subjects received the first booster vaccination, and 203 were vaccinated twice. The geometric mean diphtheria antitoxin concentration after the first booster (day 28) was 2.354 I.U./ml, and after the second booster (day 56) 2.238 I.U./ml. Prior to the first vaccination 48.9% of the subjects had a diphtheria antitoxin level below 0.1 I.U./m; after the first and second boosters 95.4% and 97.5% of subjects, respectively, showed a level of at least 0.1 I.U./ml. A clear serological effect of a second booster 4 weeks after the first one could not be demonstrated.

Adolescent↗