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PubMed2000

Implications of the diphtheria epidemic in the Former Soviet Union for immunization programs.

The massive diphtheria epidemic in the former Soviet Union provides important lessons for all diphtheria immunization programs: It is important to achieve a high level of childhood immunization, maintain immunity against diphtheria in older age groups, and use anti-epidemic measures, including immunization, to control epidemics in the early phase. The immunization coverage among children should be at least 90%. Further studies are needed to elaborate the most effective strategy to maintain immunity against diphtheria in adults (periodic booster doses, immunization of selected age groups in health care settings, use of Td [tetanus-diphtheria toxoids with reduced diphtheria toxoid content] vaccine instead of monovalent tetanus toxoid whenever tetanus toxoid is indicated [e.g., in treatment of wounds or in school-based immunization programs]). Efforts should be undertaken to monitor diphtheria immunity in different groups by conducting age-specific serologic studies.

Adolescent↗
PubMed1999

Similarities between the pathogenesis of and immunity to diphtheria and pertussis: the complex nature of serum antitoxin-induced immunity to these two diseases.

Despite data from animal studies, seroepidemiological surveys, and controlled clinical trials, skepticism persists about immunity to pertussis conferred by serum IgG neutralizing antibodies (antitoxin). This is largely prompted by the absence of a "protective" level of antitoxin. Examination of the similarities between the pathogenesis and immunity to pertussis and diphtheria provides an explanation for this dilemma. As with pertussis, diphtheria toxoid vaccination confers only approximately 70% immunity on an individual basis, individuals with protective levels of antitoxin may contract diphtheria, and about 50% of the entire population, especially adults, have less than protective levels of antitoxin. The virtual disappearance of diphtheria followed vaccination of the entire population with diphtheria toxoid, which blocked transmission of toxigenic Corynebacterium diphtheriae and thus reduced the pathogen to almost undetectable levels. The individual and community-based immunity induced by diphtheria toxoid, we hypothesize, is similar to that of pertussis and pertussis toxoid.

Antitoxins↗
PubMed1987

Acellular pertussis vaccine: immunogenicity and safety of an acellular pertussis vs. a whole cell pertussis vaccine combined with diphtheria and tetanus toxoids as a booster in 18- to 24-month old children.

An acellular pertussis vaccine principally containing two purified pertussis antigens, filamentous hemagglutinin and lymphocytosis-promoting factor, combined with diphtheria and tetanus toxoids was compared to conventional diphtheria-tetanus toxoids-whole cell pertussis for adverse effects and serologic responses in a group of 120 children who were from 18 to 24 months of age. Three vaccinations at 2, 4 and 6 months of age with diphtheria-tetanus toxoids-whole cell pertussis had been administered previously. Adverse effects occurred more frequently with the diphtheria-tetanus toxoids-whole cell pertussis than with diphtheria-tetanus toxoids-acellular pertussis vaccine. Fever occurred significantly more often and to a higher degree in the whole cell pertussis vaccine recipients with a peak difference occurring 6 hours after immunization (P = 0.00008). Local swelling, redness, warmth and tenderness at the injection site also occurred significantly more frequently following whole cell pertussis vaccination. No major sequelae were noted in either group. The antibody responses to lymphocytosis-promoting factor were similar for the two vaccines. The diphtheria-tetanus toxoids-acellular pertussis vaccine produced significantly lower pertussis agglutinin titers (P = 0.00001) but significantly higher antibody to filamentous hemagglutinin (P = 0.05) and to diphtheria (P = 0.03). The protective role of antibody to pertussis agglutinins vs. filamentous hemagglutinin and lymphocytosis-promoting factor continues as a central issue in the quest for a new pertussis vaccine. A clinical efficacy trial is needed.

Agglutinins↗
PubMed1998

Respiratory diphtheria in the United States, 1980 through 1995.

OBJECTIVES: The purpose of this study was to describe the epidemiologic, laboratory, and clinical features of respiratory diphtheria cases reported in the United States during 1980 through 1995. METHODS: Respiratory diphtheria cases reported to the Centers for Disease Control and Prevention were reviewed. Cases were defined as physician-diagnosed cases with signs and symptoms compatible with respiratory diphtheria, including the presence of a pseudomembrane without other apparent cause. RESULTS: From 1980 through 1994, 41 respiratory diphtheria cases were reported; none were reported in 1995, and no secondary cases were identified. Nine (22%) case patients were 4 years of age or younger, and 28 (68%) were 15 years of age or older. None of the case patients were up to date with diphtheria vaccination; 4 unvaccinated children died. Seventeen (43%) of 40 case patients had positive culture results. CONCLUSIONS: Available surveillance data suggest that respiratory diphtheria has become a rare disease in the United States. However, importation and circulation of toxigenic strains continue to present a threat and require achieving and maintaining high coverage with diphtheria toxoid-containing vaccines in both children and adults.

Adolescent↗
PubMed1988

Immunity against diphtheria and tetanus in the age group 30-70 years.

In Denmark, childhood primary vaccination against diphtheria and tetanus has been recommended since 1950. No routine revaccinations or general vaccination of adults have been offered. In most other western countries revaccinations are recommended later in childhood. However, death still occurs from diphtheria and tetanus in countries with such vaccination programs although it is generally accepted that protective immunity can be obtained by vaccination. On this basis the immunity against diphtheria and tetanus was assessed in a random sample of 351 subjects in the age range 30-70 years. Diphtheria antitoxin titres were determined by in vitro neutralization technique using VERO cells. 26% had diphtheria antitoxin titres below protective level (0.01 international antitoxin units/ml serum). The highest number of unprotected against diphtheria was found among 30-39 year old women (68%) and 60-69 year old subjects (36%). Tetanus titres were determined by a combination of ELISA technique and an in vivo neutralization assay. 51% were unprotected against tetanus (less than 0.01 international antitoxin units/ml serum). The highest number of unprotected against tetanus was found among 60-69 year old subjects (68%) and especially among females in this age group (77%). To avoid epidemics of diphtheria in the future the immunity among adults must be raised within the coming years. Thus, revaccination must be recommended and high attendance ensured. One revaccination is sufficient only when complete primary vaccination is documented.

Adult↗
PubMed2005

Immunity to diphtheria and tetanus in Australia: a national serosurvey.

OBJECTIVE: To determine immunity to tetanus and diphtheria in the Australian population. DESIGN AND SETTING: Analysis, using double antigen enzyme immunoassays, of a representative sample of sera (1950 samples tested for diphtheria and 2884 for tetanus) collected opportunistically from Australian laboratories between July 1996 and May 1999. MAIN OUTCOME MEASURE: Immunity to diphtheria and tetanus, defined as negative (susceptible) when the antitoxin level was < 0.01 IU/mL, positive (immune) when it was > or = 0.1 IU/mL, and low positive (partially immune) when it was in the range 0.01-< 0.1 IU/mL. RESULTS: About 99% of children aged 5-9 years had diphtheria and tetanus antitoxin levels > or = 0.01 IU/mL (immune or partially immune). Antitoxin levels declined with age and generally more markedly for diphtheria than tetanus. For subjects aged 50 years and over, less than 60% were immune or partially immune to diphtheria and less than 75% to tetanus. Men and women had similar diphtheria antitoxin levels, while women had lower levels of tetanus antitoxin compared with men of the same age, with the difference being most marked in the age group > or = 70 years (37% v 60%; P < 0.001). CONCLUSIONS: Immunity in children appears to be good, but adults, especially older people, may not be adequately protected. Recent changes to the Australian Standard Vaccination Schedule should improve immunity in cohorts now aged < 50 years. However, additional efforts are required to protect those over 50 years (especially travellers), who are most susceptible.

Adolescent↗
PubMedDate not supplied

[Diagnostic problems in diphtheria infection].

The problem of diagnosis of diphtherial infection has come to acquire especially significance at the present stage because here in Ukraine we have no legitimate standard procedure for identification of a case of diphtheria and because interpretation of results of bacteriological and serological studies in patients who might have diphtheria is often faulty. The diagnosis of atypical cases of mild localized diphtheria in the vaccinated subjects relies on the presence of chronic ENT-affections and a history of predisposition to sore throat. It is necessary that parallel culturing be done of smears obtained from the nasopharynx for diphtheria and pathogen microflora in order that no possibility of angina of other microbe etiology might be entertained. Isolation of nontoxicogenic strains C diphtheria in the absence of clinical signs of diphtheria should not prompt us to diagnose a patients as having this problem. Serologic investigation of the patients serum in the passive hemagglutination test for the presence of antitoxic antibodies can be recommended for use to verify the vaccination history in those having been taken ill rather than to aid in the differential diagnosis of diphtheria and bacteria-carrier states. Results of bacteriological and serological investigations do not give much ground for rejection or confirmation of the diagnosis made.

Adult↗
PubMed1999

[Immunity against diphtheria in Taiwan].

The vaccination of combined diphtheria, pertussis, and tetanus (DPT) vaccine provides good immunity against childhood diphtheria in Taiwan. However, a waning protective antibody level has been observed with an increase in age. Therefore, we assessed diphtheria immunoglobulin (DIG) level in Taipei City as representatives of urban dwellers and in King-Shan County as representatives of rural dwellers to evaluate the status of immunity against diphtheria in the population of Taiwan. In total, 1239 serum samples collected from the resident population, age 0-91 years, were detected by toxin neutralization test with VERO cells. The DIG level > or = 0.01 IU/mL was considered to be seropositive and > or = 0.1 IU/mL was considered to be fully protective. The positive rate and fully protective rate for all persons were 79.9% and 36.6%, respectively. The age specific positive rate and fully protective rate for children under 14 years of age were 97.0% and 78.0%, for 20-29 years of age group, were 38.0% and 8.3%, respectively, to be the lowest record among tested age groups. Then, both rates increased proportionately with age. Among those birth cohorts born in the diphtheria immunization era (since 1955), the antibody levels were inversely correlated with age, suggesting a decreased opportunity for exposure to natural diphtheria infection in the recent years and the duration of the vaccine inoculation. This finding indicates the need of a booster vaccination for young adults to ensure a full term protection and a long lasting diphtheria control.

Adolescent↗
PubMed1999

Respiratory diphtheria in three paediatric patients.

From August till November 1998, the Paediatric and Anaesthetic Units of Hospital Kuala Terengganu managed three patients from Kuala Terengganu District who were ventilated for respiratory diphtheria. Their ages were 5, 4 and 7 years old and their immunisation for diphtheria were not complete. All three patients presented with respiratory distress and were ventilated for upper airway obstruction. Their treatment included intravenous penicillin and diphtheria antitoxin. One patient died of cardiogenic shock with secondary pneumonia. Pharyngeal and tonsillar swabs of all three patients grew toxigenic Corynebacterium diphtheriae biotype mitis. There were 765 throat cultures taken from contacts. The confirmed positive cultures grew 2 toxigenic and 3 non-toxigenic Corynebacterium diphtheriae biotype mitis and surprisingly, 10 non-toxigenic biotype gravis. A prevalence study is needed to document the endemicity of diphtheria in Kuala Terengganu and to determine the carrier rate of both biotypes. Steps have been taken to increase the immunisation coverage in children. The giving of regular booster doses of diphtheria toxoid to the adult population should be considered.

Airway Obstruction↗
PubMed2000

[Immunity against diphtheria and tetanus in the adult Polish population].

The aim of the study was to evaluate immunity against diphtheria and tetanus in healthy adult population in Poland. For determination of antitoxin IgG antibody, toxoid enzyme-linked immunosorbent assay (Toxoid-ELISA) was used. Serum samples were obtained from different regions of Poland and titrated for diphtheria (n = 2442) and tetanus (n = 827) IgG antitoxin. For calibration of anti-toxins determination, the WHO standard of human diphtheria and tetanus antitoxin was used. About 32% (n = 787) of persons were non-protected against diphtheria (IgG-DTAb < 0.1 IU/ml) and 24% (n = 195) against tetanus (IgG-TTAb < 0.1 IU/ml). In 63% (n = 1528) individuals basic protection for diphtheria and 48% (n = 402) for tetanus (0.1-1.0 IU/ml IgG-DTAb and IgG-TTAb) were observed. Only 5% (n = 127) were fully protected for diphtheria and 28% (n = 230) for tetanus (IgG-DTAb and IgG-TTAb > 1.0 IU/ml). In adults between 30-64 years of age, not vaccinated at least during last 10 years, 43% of persons were non-protected. The study showed insufficient immunity against diphtheria in adults. We indicate booster immunisation for selected group of persons.

Adult↗
PubMedDate not supplied

[Genetic structure of Corynebacterium diphtheriae strains isolated in Russia during epidemics of various intensity].

The genetic structure of C. dipthteriae toxigenic strains isolated in Russia during the period of more than 50 years was analysed. The use of the method of ribotyping made it possible to register 17 C. diphtheriae ribotypes. The study revealed that the genetic structure of C. diphtheriae population varied in the dynamics of the epidemic process: each epidemic cycle characterized by predominant spread of epidemic strains of definite biovars and ribotypes. Thus, C. diphtheriae strains of biovar gravis, ribotype M11, dominated in the 40-60 years and C. diphtheriae strains of biovar mitis, closely related ribotypes M1 and M1v, dominated in the 80 years. During the last epidemic rise of diphtheriae morbidity in the 90 s C. diphtheriae strains of biovar gravis, closely related ribotypes G1 and G4, dominated among circulating strains. The proportion of these ribotypes began to increase 3 years before the rise of morbidity. The data of microbiological monitoring are recommended for use in the prognostication of the development of the epidemic process of diphtheria infection.

Corynebacterium diphtheriae↗
PubMed2004

Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccines-part 1.

A collaborative study on the evaluation of an alternative functional assay, the Vero cell method, to the Ph. Eur. in vivo challenge procedures for potency determination of diphtheria toxoid in 6 different combined vaccines was initiated in January 2001. The study was an extension of a previous study for the validation of serological methods for potency testing of tetanus toxoid vaccines for human use. To allow interim evaluation of test results and to monitor study progress, the project was divided into three consecutive phases. The results of Phase I and II studies are presented in this report. Pre-validation (Phase I) study, performed in two laboratories, indicated that comparable diphtheria potency estimates were obtained in the Ph. Eur. direct intradermal challenge assay in guinea pigs, in Vero cell assay and in indirect ELISA for five vaccines of different potencies (range of estimates: ca. 20-200 IU/ml). The correlation coefficients between the challenge assay and the Vero cell assay corresponded to those between the challenge assay and ELISA, confirming that the antibodies play an important role in protection and that predominantly protective/neutralising antibodies are present in guinea pigs, at the time point investigated. It was observed, for Vero cell assays, that about 16-35 (9-28 in Phase II study) fold lower titre of individual serum samples were obtained when using equine, rather than guinea pig reference serum. The study also provided preliminary information that sera from the same guinea pigs may be used for potency determination of both diphtheria and tetanus toxoid components of vaccines. In Phase II, another five laboratories analysed a subset of the vaccines included in Phase I study plus an additional vaccine. Four laboratories performed the lethal challenge assay and one laboratory carried out the intradermal challenge assay. All laboratories also performed the Vero cell assay and both ELISA for diphtheria antitoxin and ELISA for tetanus antitoxin. One laboratory also performed the tetanus ToBI assay. The correlation coefficient (r) between Vero cell assay and ELISA for diphtheria antitoxin ranged from 0.76 to 0.91 in the different laboratories. The correlation between diphtheria serological assays and challenge assays were confirmed satisfactory as ca. 90 per cent of serum-estimates lead to correct prediction of mortality. All laboratories had identical rankings of the vaccines in all serological assays and in the valid challenge assays. The ranking order was identical to assumed/provided potency for the highest and the lowest vaccine. Two of the vaccines had an inversion in some assays and laboratories. As these two vaccines have almost identical potencies in all assays, these inversions are not significant. As the vaccine doses were optimised for the diphtheria component, serum anti-tetanus toxoid/toxin activities varied widely between the vaccines, making it questionable to apply a parallel line model to calculate exact potencies. However, the dose levels used showed a clear regression and good linearity in general. DTaP vaccines containing the IPV component did not always meet the present Ph. Eur. requirements in the serological assays. It should be further investigated in the Phase III study if this is a general feature of such combined vaccines. Preliminary investigations on samples from two laboratories indicate that the neutralising activity of type 1, 2 and 3 polioviruses can also be detected, in a dose-dependent way. Further studies are in progress with serum samples from other laboratories. In the light of results obtained in the first two phases, it is recommended to proceed with Phase III study to investigate reliability of the in vitro assays. In Phase III it will also be further investigated whether the serological assays for D and T components are suitable for the control of the multi-component vaccines currently marketed in Europe.

Animals↗
PubMed1991

Adverse reactions to the preschool (fifth) dose of adsorbed diphtheria-pertussis-tetanus vaccine in Canadian children.

OBJECTIVE: To quantify accurately the rate of adverse reactions after the preschool (fifth) dose of adsorbed diphtheria toxoid-pertussis vaccine-tetanus toxoid (DPT) vaccine and to test the hypothesis that large local reactions are attributable to the diphtheria toxoid. DESIGN: Double-blind randomized controlled trial. SETTING: Suburban community public health unit. PARTICIPANTS: Healthy children 4 to 5 years of age with a history of having received four doses of adsorbed DPT vaccine. INTERVENTIONS: Subjects were given either the standard DPT vaccine (with 25 Lf units of diphtheria toxoid) or a modified DPT vaccine (with 10 Lf units of diphtheria toxoid). They were assessed 24 hours later by a nurse. Serum samples obtained before vaccination were tested for diphtheria and tetanus antitoxin levels by means of neutralization assay and enzyme-linked immunosorbent assay. MAIN OUTCOME MEASURES: Rates of large local reactions (an area of redness or swelling or both of 5 cm or greater) 24 hours after vaccination in the two groups. Relation between serum antitoxin levels before vaccination and the rate of large local reactions in each group. RESULTS: Of the 250 subjects enrolled 124 received the standard vaccine and 126 the modified one. Large local reactions occurred in 71% of the subjects receiving the standard vaccine and 52% of those receiving the modified one (p less than 0.01). In the former group large erythematous reactions occurred significantly more often in those with an elevated prevaccination diphtheria antitoxin level than in those without an elevated level; no relation was found between such reactions and the prevaccination tetanus antitoxin level. Reduced arm movement was evident in 45% of the children in the two groups. Few had systemic adverse reactions. CONCLUSIONS: Large local reactions occur frequently after the preschool administration of the DPT vaccine. These reactions are uncomfortable but not serious. They result in part from the large amount of diphtheria toxoid in the standard DPT vaccine.

Child, Preschool↗
PubMed1998

[Cutaneous diphtheria in returning vacationers--mirror of inappropriate vaccination practice?].

The causative agent for diphtheria is Corynebacterium diphtheriae, which is transmitted from person to person from the throat of carriers or from patients with active cutaneous diphtheria. The disease occurs in preexisting ulcers, but it may also appear on apparently normal skin. Although primary cutaneous diphtheria starts as a vesicle or pustule, most patients feature a reddish ulcer with undermined borders. The lesion is tender but hypesthesia develops after 2 weeks. The clinical diagnosis is based on the history of travelling in endemic regions and bacteriological studies. The current increase of diphtheria in the Western world is partly caused by rising tourism and a decline of booster vaccination in adults. After trauma with ulcerations of the skin we suggest to perform a booster vaccination not only for tetanus but also for diphtheria. In addition, persons travelling to endemic regions should receive a booster vaccination for tetanus and diphtheria, which is available as a combined preparation.

Adult↗
PubMed2000

Epidemiology and control of diphtheria in the Republic of Moldova, 1946-1996.

In 1994-1996, the Republic of Moldova was stricken with an epidemic of diphtheria after >30 years of routine diphtheria immunization and the near absence of the disease for nearly 20 years. The intensity of the epidemic gradually grew, reaching a peak in 1994-1995. The epidemiology of diphtheria in Moldova during this period is described along with laboratory findings and control measures. Pharyngeal diphtheria was the predominant clinical form of the disease (97% of cases), and it most often developed in a localized form (70%), with 20% in the toxic form. The clinical diagnosis of diphtheria was bacteriologically confirmed in 91% of cases: Of the cases tested for biotype, 91.3% were gravis, 8.5% were mitis, and 0. 2% were intermedius. Of 494 toxigenic isolates from cases and carriers at the beginning of the epidemic, 47% were nonphagotypeable strains, and 25.7% were phagotype VI strains. Aggressive population-based diphtheria control measures, a mass immunization campaign, rapid case identification, antibiotic prophylaxis and supplemental immunization of close contacts in clusters of infection, and high coverage with routine immunization rapidly controlled the epidemic within Moldova.

Adolescent↗
PubMedDate not supplied

[An evaluation of the epidemiological and immunological efficacy of the vaccinal prophylaxis of diphtheria and tetanus].

The extensive use of adsorbed diphtheria-tetanus toxoid with reduced antigen content was found to be ineffective in the prophylaxis of diphtheria: 86.3% of diphtheria patients among those who had been immunized with this preparation fell only a year after the first booster immunization, and the proportion of those who proved to be unprotected against diphtheria on years 3, 4 and 5 after immunization reached, respectively, 21.0%, 35.5% and 49.4%. The number of children immunized with this preparation at common preschool institutions may reach 50% and more, and with an increase in the coverage of children with immunization from 10% to 50% the proportion of unprotected children may rise from 7.4% to 17.8%. The proportion of preschool institutions, insufficiently protected from diphtheria and, as a consequence, running a considerable risk of becoming (in case of the penetration of this infection) the foci of diphtheria, was found to reach 32.9%.

Adult↗
PubMed2000

Evaluation of a single dose of diphtheria-tetanus toxoids among adults in Odessa, Ukraine, 1995: immunogenicity and adverse reactions.

Epidemic diphtheria spread to Ukraine in 1991, where it peaked in 1995 with >5,000 reported cases. To refine epidemic control strategies, immunogenicity of a tetanus-diphtheria toxoids vaccine (Td) containing 2 limits of flocculation (Lf) diphtheria toxoid was evaluated. During a mass vaccination campaign, adults at a clinic in Odessa received one dose of Td. At enrollment, 57.2% of 341 study participants had levels of diphtheria antitoxin (DAT) >/=0.1 IU/mL. Thirty and 180 days after receiving one dose of Td, 91.5% and 84.5% of the participants, respectively, had DAT levels >/=0.1 IU/mL. However, among 40- to 49-year-old participants, only 78.8% and 73.8% had DAT levels >/=0.1 IU/mL at 30 and 180 days, respectively. This study suggests that one dose of 2 Lf diphtheria toxoid is highly effective in raising DAT to protective levels in most adults; however, the study also shows that certain age groups, particularly persons 40-49 and, to a lesser degree, 30-39 years old may require additional doses or a complete three-dose primary vaccination series for optimal protection against diphtheria.

Adolescent↗
PubMed1987

Double-antibody sandwich enzyme-linked immunosorbent assay for rapid detection of toxin-producing Corynebacterium diphtheriae.

An enzyme-linked immunosorbent assay for determining the toxigenicity of Corynebacterium diphtheriae is presented. The assay uses hyperimmune horse diphtheria antitoxin as a capture antibody and mouse monoclonal diphtheria antitoxin as a detecting antibody. Growth of bacteria and capture of diphtheria toxin by antitoxin are carried out in one step. Toxin produced by as little as 100 toxin-producing corynebacteria is detectable, corresponding to a sensitivity of 10 ng of diphtheria toxin per ml. Demonstration of toxin after incubation of the bacteria for 4.75 h, as well as after 18 h, was in accordance with the modified Elek gel diffusion method and the guinea pig inoculation test. However, heavy inocula incubated overnight produced significantly lower optical density than did diluted inocula; thus, the higher optical density was used as an indicator of toxin production. A decrease in optical density was also seen by shortening the incubation time. For laboratory safety, ethanol was added to the microtiter plate wells before washing out of the bacteria. This resulted in a further decrease in optical density. Using 4.75-h incubation time gave a single false-negative result. No false-positive results were ever seen. Incubation for 18 h is suitable for large-scale screening, and 4.75 h of incubation is suitable for rapid identification of toxin-producing C. diphtheriae.

Corynebacterium diphtheriae↗