Safety and immunogenicity in young infants of Haemophilus b-tetanus protein conjugate vaccine, mixed in the same syringe with diphtheria-tetanus-pertussis-enhanced inactivated poliovirus vaccine.

Because inactivated poliovirus vaccine (IPV) and Haemophilus influenzae b vaccine are advised in many programs and may be incorporated further in other programs, we undertook a study to determine whether the administration of a tetravalent preparation of diphtheria-tetanus-pertussis-IPV mixed in one syringe with tetanus-conjugate H. influenzae b vaccine (DTP-IPV-PRPT) is associated with increased reactogenicity or interference with immunogenicity of individual vaccine components. In a placebo-controlled, double blind study, a total of 161 infants were enrolled (80 DTP-IPV-PRPT and 81 DTP-IPV-placebo). Vaccine was administered at 2, 4 and 6 months of age. Oral poliovirus vaccine was added at 7 months of age and a booster of oral poliovirus vaccine and DTP-IPV was also administered at 12 months of age, according to the policy in Israel. Local and systemic side effects were similar in both groups except for irritability after the second dose and use of acetaminophen which we observed slightly but significantly more often in the DTP-IPV-PRPT recipients. After the third dose the geometric mean titers of anti-polyribosyl-ribitol phosphate antibodies were 3.7 and 0.05 micrograms/ml in the PRPT and placebo groups, respectively (P < 0.001). Higher tetanus antitoxin titers were observed among recipients of DPT-IPV-placebo (1.1 IU/ml vs. 0.7 IU/ml, P = 0.003). A similar trend was found for pertussis agglutinin titers (93.4 vs. 65.4, P = 0.054). No difference was observed for anti-diphtheria toxoid and poliovirus 1, 2, and 3.(ABSTRACT TRUNCATED AT 250 WORDS)

Haemophilus influenzae type b polysaccharide-tetanus protein conjugate vaccine does not depress serologic responses to diphtheria, tetanus or pertussis antigens when coadministered in the same syringe with diphtheria-tetanus-pertussis vaccine at two, four and six months of age.

The safety and immunogenicity of a vaccine against Haemophilus influenzae type b consisting of purified polyribosylribitol phosphate conjugated to tetanus toxoid (PRP-T) were evaluated in 277 Chilean infants who were randomly assigned to one of three treatment groups: Group A, PRP-T mixed with diphtheria-tetanus-pertussis (DTP) vaccine in a single syringe and given as a single inoculation in one arm and placebo in the other arm; Group B, PRP-T given in one arm and DTP in the other arm; Group C, DTP given in one arm and placebo in the other. Infants were immunized at 2, 4 and 6 months of age and examined daily for 4 days after each immunization. Serum PRP antibodies; tetanus, diphtheria and pertussis antitoxin; pertussis agglutinins; and antibodies to Bordetella pertussis filamentous hemagglutinin were measured at baseline and 2 months after each dose. PRP-T was well-tolerated. After three doses of PRP-T vaccine 100% of infants attained PRP antibody concentrations > or = 0.15 micrograms/ml and 96 to 99% achieved high anti-PRP concentrations (> or = 1.0 micrograms/ml). The post-third dose anti-PRP geometric mean titer was high (6.94 micrograms/ml) in infants who were given PRP-T combined with DTP, although it was somewhat lower than the geometric mean titer of the group who received PRP-T in a separate arm (9.93 micrograms/ml) (P not significant).(ABSTRACT TRUNCATED AT 250 WORDS)

Safety and immunogenicity of Haemophilus type b-tetanus protein conjugate vaccine, mixed in the same syringe with diphtheria-tetanus-pertussis vaccine in young infants.

As new vaccines are developed there is increasing interest in reducing the number of injections given to children by combining vaccines in one syringe. We studied the safety and immunogenicity of Haemophilus influenzae type b-tetanus protein conjugate vaccine (PRP-T) administered at ages 2, 4 and 6 months mixed in the same syringe with DTP vaccine and its effects on the seroresponse to DTP vaccine. A group of 112 healthy 2-month-old infants received DTP-PRP-T or DTP-placebo mixed immediately before immunization in the same syringe. The addition of PRP-T to DTP did not increase the rate of local or systemic reactions. After the first, second and third dose, the PRP-T recipients showed a geometric anti-PRP antibody mean of 0.13, 2.31 and 6.40 micrograms/ml vs. 0.07, 0.05 and 0.05 micrograms/ml among the DTP-placebo recipients, respectively. Of the PRP-T recipients, 94 and 98% attained antibody concentration of greater than or equal to 0.15 micrograms/ml protein after the second and third dose, respectively, and 65 and 94% attained a concentration of greater than or equal to 1.0 micrograms/ml after the second and third dose, respectively. At the age of 1 year 94 and 52% of the DTP-PRP-T recipients vs. 12% and 0% of the placebo recipients still maintained titers of greater than or equal to 0.15 and greater than or equal to 1.0 micrograms/ml, respectively. The administration of DTP in the same syringe with PRP-T did not affect significantly the antibody response to diphtheria and tetanus toxoid and to pertussis agglutinins. It is concluded that PRP-T vaccine could be administered in the same syringe as DTP.

The clinical and immunologic response of Chilean infants to Haemophilus influenzae type b polysaccharide-tetanus protein conjugate vaccine coadministered in the same syringe with diphtheria-tetanus toxoids-pertussis vaccine at two, four and six months of age.

The safety and immunogenicity of a vaccine against Haemophilus influenzae type b consisting of purified polyribosylribitolphosphate conjugated to tetanus toxoid (PRP-T) was evaluated in 278 Chilean infants who were randomly assigned to one of three treatment groups: Group A, PRP-T mixed with diphtheria-tetanus toxoids-pertussis (DTP) vaccine in a single syringe and given as a single inoculation in one arm and placebo in the other arm; Group B, PRP-T given in one arm and DTP in the other arm; Group C, DTP given in one arm and placebo in the other. Infants were immunized at 2, 4 and 6 months of age and examined daily for 4 days after each immunization; serum PRP antibodies were measured at baseline and 2 months after each dose. The only adverse systemic reaction attributable to PRP-T beyond that caused by DTP alone was a 7 to 20% increase in febrile responses in the first 24 hours after the first and second doses of vaccine; the fevers were largely low grade and not accompanied by increased irritability, diminished activity or loss of appetite, compared with the group who received DTP without PRP-T. After the first dose 72% of infants who received PRP-T combined with DTP and 67% who received it in a separate arm attained antibody concentrations greater than or equal to 0.15 micrograms/ml. After two doses of PRP-T, 93 and 95%, respectively, had concentrations greater than or equal to 0.15 microgram/ml and after three doses 100% of infants who received PRP-T had such titers.(ABSTRACT TRUNCATED AT 250 WORDS)

Quantitative analysis of laryngeal EMG in normal subjects.

A method for quantitative analysis of the electromyographic interference pattern called "turns/amplitude analysis" was carried out with recordings from the cricothyroid and thyroarytenoid muscles of 12 normal subjects, 6 males and 6 females. The purpose was to investigate how the two muscles vary contraction force in relation to variations in pitch and voice intensity. Sustained phonations with systematic variation of pitch and intensity were analysed. The contraction force, in terms of turns and amplitude, increased with increasing pitch in both the cricothyroid and thyroarytenoid. More variability in contraction activity as a function of intensity was noted in the cricothyroid than in the thyroarytenoid. The increase in turns and amplitude in the thyroarytenoid with increasing pitch was highly significant, while little effect was seen of intensity variation. No great differences between males and females were noted.

Evaluation of laryngeal muscle function by quantitative analysis of the EMG interference pattern.

A computerized method for quantitative analysis of the EMG interference pattern was tested in the cricothyroid and thyroarytenoid muscles with the purpose of evaluating its usefulness for clinical purposes. In a normal male subject the mean amplitude and the number of turns/s were extracted from the EMG signal of sustained chest register phonations, with systematic variation of vocal pitch and intensity. In the cricothyroid, as well as the thyroarytenoid muscle, there was a considerable increase in mean amplitude and turns/s with both increased pitch and increased intensity. Pitch variation was the most effective way to induce changes in turns and amplitude levels in both muscles. In contrast to results from studies of larger muscles, the increase in both amplitude and turns was proportional to muscle force also at the highest loads.

Perceptual and acoustic correlates of abnormal voice qualities.

A set of 17 voices representing various voice disorders were presented to a jury of voice experts who rated them on a 5-point scale for each of 28 terms frequently used for describing voices. A statistical treatment of these ratings yielded 5 bipolar factors accounting for 85% of the total variance. Significant correlations were found between four of these factors and certain acoustic data extracted fron long-time-average spectra and fundamental frequency distribution analysis of the same voice sample.

Long-term results of recurrent laryngeal nerve resection for adductor spasmodic dysphonia.

From a total of 43 adductor spasmodic patients over a 10-year period, 11 underwent resection of a portion of the recurrent laryngeal nerve on one side. The initial results were excellent but a varying degree of recurrence took place in 8 patients. In 4, a reoperation was done. At the final follow-up, 2-8 years after the primary operation, 4 patients were no longer suffering from spasmodic dysphonia, another 5 were better off than before surgery, and 1 remained unchanged. Only 1 was worse off. Electromyographic findings indicated that the recurrence of symptoms was due to regeneration of the nerve fibers.

[Trial of prevention of severe Haemophilus influenzae type b infections and trial of tolerance, after PRP-T vaccination, in the Val-de-Marne region]. / Essai de prévention des infections graves à Haemophilus Influenzae type b et essai de tolérance, après vaccination PRP-T, dans le département du Val-de-Marne.

BACKGROUND: Protein-polysaccharide conjugate H influenzae vaccine is now routinely recommended for infants. To assess the vaccine's protective efficacy against invasive H influenzae infections and its safety, we conducted a study in the Val-de-Marne area of France. METHODS: From April 1991 to April 1993, 22,443 children less than 5 years of age were given PRP-T vaccine. Infants less than 6 months were given three doses whereas those between 6 and 12 months received only two doses, and children over 1 year of age received one dose. According to the infant's DTP-IPV vaccination status, PRP-T was administered alone or reconstituted extemporaneously with DTP-IPV. The immunogenicity of the conjugate vaccine was assessed after three doses in 100 infants under the age of 6 months. RESULTS: The PRP-T vaccine administered alone was safe. The reactions were more frequent when PRP-T vaccine was combined with DTP-IPV vaccine but they were comparable in frequency and severity to those observed after DTP-IPV vaccination. Before 1992, 18 Hib infections were reported each year in the Val-de-Marne region. During the study, only three Hib infections were reported each year. CONCLUSIONS: The fall in incidence of Hib infections, greater than expected, suggests a widespread immune effect of the vaccine, possibly due to a decrease in Hib nasopharyngeal carriage. The antibody titres to each component of vaccine were comparable to those observed in previous clinical infant studies.

Dynamic of pneumococcal nasopharyngeal carriage in children with acute otitis media following PCV7 introduction in France.

To determine whether the use of seven valent pneumococcal conjugate vaccine (PCV7) caused a shift in the Streptococcus pneumoniae serotypes distribution and whether it modified the resistance to antibiotics, 3291 nasopharyngeal swabs were obtained between 2001 and 2006, from children aged 6-24 months with acute otitis media. Following the implementation of PCV7, we observed a slight reduction in the overall pneumococcal carriage, a marked decrease of vaccine serotypes, an increase in non-vaccine serotypes carriage and a reduction in the carriage of penicillin non-susceptible strains. Most of the serotype 19A replacement was related to the clonal expansion of ST276 which was found to be the predominant ST among penicillin non-susceptible isolates.

Report of the 2nd "French Clinical Vaccinology Meeting Jean-Gerard Guillet": immunization and respiratory diseases.

The 2nd French Clinical Vaccinology conference held on 20th April 2009 in Paris (France) was a unique opportunity to discuss basic and translational research in vaccinology and its implications for patients for respiratory diseases. This conference is organized by the Clinical Research Center Cochin-Pasteur, that has been involved for several years clinical research in vaccines. We report on here the key findings of the conference, especially the immunization of the chronic respiratory diseases, the clinical effectiveness of vaccines and the development of new vaccines in pulmonology.