Definition and clinical assessment of consistency lots for combination vaccines.
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Antibodies, Bacterial↗
Biomedical subjects
B Fritzell
Publications and source records attributed to B Fritzell.
Simultaneous injection of plasma-derived or recombinant hepatitis B vaccines with yellow fever and killed polio vaccines.
Previous studies have shown an absence of interaction between hepatitis B (HB) vaccine and other vaccines used in EPI programmes except for an apparent decrease of yellow fever antibody levels when hepatitis B and yellow fever vaccines are given simultaneously. We have therefore reinvestigated the interaction of these two vaccines and assessed the absence of interaction between inactivated polio vaccine and recombinant or plasma-derived HB vaccine. The immune responses to polio vaccine injected simultaneously with plasma-derived or recombinant HB vaccine were observed to be equivalent and similar to those observed in the literature. In this randomized study, the immune responses to yellow fever injected simultaneously with plasma-derived or recombinant HB vaccine were comparable to those observed after separate administration of each vaccine. Moreover, no increase in adverse reactions was noted.
Female↗
The immunogenicity and safety of Haemophilus influenzae type b-tetanus toxoid conjugate vaccine in Gambian infants.
In developing countries, Haemophilus influenzae type b is a major cause of meningitis and pneumonia in the 1st year of life. The safety and immunogenicity of a Haemophilus influenzae type b polysaccharide-tetanus toxoid conjugate vaccine (PRP-T) were evaluated in two studies of Gambian infants. In the first study, 131 infants were recruited and randomized into three groups to receive PRP-T at 1 and 3 months (group A), PRP-T at 2 and 4 months (group B) or no PRP-T (group C). The liquid form of PRP-T was used. The geometric mean titre (GMT) of anti-PRP antibody 1 month after the second dose was 0.26 microgram/ml in group A and 0.41 microgram/ml in group B. In the second study, 66 infants were given PRP-T in the lyophilized form at 2, 3 and 4 months of age. The GMT 1 month after the first dose was 0.09 microgram/ml, after the second 0.74 microgram/ml and after the third 2.32 micrograms/ml. After the third dose, 72% of children had antibody levels greater than 1.0 microgram/ml and 93% greater than 0.15 microgram/ml. No serious side-effects were observed and the rate of adverse reactions was consistent with the concurrent administration of diphtheria-tetanus-pertussis (DPT) vaccine.
Age Factors↗
Impact of Haemophilus influenzae type b polysaccharide-tetanus protein conjugate vaccine on responses to concurrently administered diphtheria-tetanus-pertussis vaccine.
OBJECTIVE: To assess whether serum antibody responses to diphtheria-tetanus-pertussis (DTP) vaccine were affected by coadministration of Haemophilus influenzae type b capsular polyribosylribitol phosphate polysaccharide-tetanus protein (PRP-T) conjugate vaccine when given to patients at 2, 4, and 6 months of age. DESIGN: Randomized, double-blind clinical trial. SETTING: Urban Santiago, Chile. PATIENTS: Healthy infants assembled from health centers. Two hundred seventy-eight (74%) of 375 eligible infants participated; 222, who complied with the complete protocol, constituted the primary group under analysis. INTERVENTIONS: One of three vaccine regimens was given to study participants at 2, 4, and 6 months of age, either DTP mixed in the same syringe as PRP-T (group 1); DTP and PRP-T given at separate injection sites (group 2); or DTP without PRP-T (group 3). PRIMARY OUTCOME MEASURES: Titers of serum antidiphtheria toxoid, antitetanus toxoid, and pertussis agglutinin antibodies were measured in blood samples taken from patients 2 months after each dose. RESULTS: Serum antidiphtheria toxoid and antitetanus toxoid responses showed no important depressions in the patients receiving PRP-T. In contrast, geometric mean titers (GMTs) of pertussis agglutinins, expressed as reciprocal serum dilutions, after both the second and third doses (GMT2, GMT3) were lowest in group 1 (GMT2 = 89; GMT3 = 1230), intermediate in group 2 (GMT2 = 123; GMT3 = 1995), and highest in group 3 (GMT2 = 210; GMT3 = 3090; P less than .05 for trend group 1 less than group 2 less than group 3 after each dose). Antipertussis toxin and antipertussis filamentous hemagglutinin antibody titers also were depressed in patients who received PRP-T. Follow-up of a subset at 18 months revealed an expected decline of pertussis agglutinin titers to near baseline levels in each group. CONCLUSIONS: Concurrent administration of PRP-T vaccine with DTP vaccine, either in the same syringe or at different sites, interfered with antipertussis responses to a primary series of immunizations. Although the clinical significance of this antagonism is uncertain, these data underscore the caution required in decisions to add new vaccines to existing immunization regimens.
Antibodies, Bacterial↗
Immunogenicity of Haemophilus influenzae type b capsular polysaccharide and its tetanus toxoid conjugate in patients with recurrent infections or humoral immunodeficiency.
The antibody response to the capsular polysaccharide of Haemophilus influenzae type b was evaluated after vaccination with the capsular polysaccharide or its tetanus toxoid conjugate in 41 randomized patients with recurrent infections, IgA deficiency, common variable immunodeficiency, or the Wiskott-Aldrich syndrome. Serum antibodies were measured using a Farr assay for total antibodies and an enzyme-linked immunosorbent assay for antibodies of the three main immunoglobulin classes and of each IgG subclass. Antibody levels reached concentrations generally considered as protective in the majority of cases, the best response being observed after two injections of the conjugate vaccine with a 1-month interval. Vaccination with the conjugate therefore seems to be promising for the prevention of Haemophilus influenzae type b infections in such patients.
Adult↗
Comparative immunogenicity in children of mammalian cell-derived recombinant hepatitis B vaccine and plasma-derived hepatitis B vaccine.
Three doses of hepatitis B vaccine were given at 2, 4 and 9 months of age to 220 Senegalese infants living in the Dakar area of Senegal. Half of the infants received 5 micrograms plasma-derived hepatitis B vaccine (Hevac B) and the remainder 20 micrograms mammalian cell-derived recombinant hepatitis B vaccine (GenHevac B). Both vaccines contain S and pre-S2 encoded proteins; however, the recombinant vaccine had a much higher pre-S2 content than the plasma-derived vaccine. Adverse reactions to both vaccines were limited to mild and transient soreness at the injection site. Fever was reported in 14-21% of the infants and was likely to be related to DTP-polio vaccine which was given simultaneously. After the two first doses, seroconversion rates and geometric mean titres of anti-HBs were higher in infants receiving the recombinant vaccine than in infants receiving the plasma-derived vaccine. After completion of vaccination, all infants in both groups had protective levels of anti-HBs antibodies. The recombinant vaccine induced more rapidly antibodies directed against S and pre-S2 epitopes. Anti-pre-S2 antibodies were detected after the first injection of GenHevac B and only after the third injection of Hevac B. From the data, GenHevac B vaccine is expected to be as effective as Hevac B vaccine for controlling hepatitis B infection.
Amino Acid Sequence↗
Simultaneous injection of hepatitis B vaccine with BCG and killed poliovirus vaccine.
In most developing countries, hepatitis B virus is endemic and prevention has to be carried out early in life and on a mass scale. In these regions, simultaneous administration of multiple antigens is normal practice. We have therefore investigated the interaction of hepatitis B vaccine with BCG and inactivated polio vaccine. The serological antibody response to poliovirus and HBsAg as well as the cellular immune response to tuberculin post BCG immunization were assessed. The immune responses to HBsAg, BCG and polio vaccines injected simultaneously were comparable to those observed after separate administration of each vaccine. Moreover, no increase of adverse reactions was noted. Results confirmed that HB vaccine could be introduced into the WHO expanded programmes on immunization without impairing the expected protective efficacy against the targeted vaccine-preventable diseases.
BCG Vaccine↗
Efficacy and safety of a Haemophilus influenzae type b capsular polysaccharide-tetanus protein conjugate vaccine.
A polyribosylribitol phosphate (polysaccharide)-tetanus protein conjugate vaccine (PRP-T) against Haemophilus influenzae type b (Hib) was evaluated for safety and efficacy after vaccination of more than 100,000 infants. No major side effects were attributed to the vaccine. Immunogenicity studies showed an antibody response in 70% to 100% of infants after two doses, and in 98% to 100% of infants after three doses, within the first 6 months of life. Antibodies persisted in 90% of recipients, in whom significant anamnestic responses developed after a booster dose at 18 months of age. In comparison with other available Hib vaccines, PRP-T induces equal or higher mean titers after three doses. Although licensure of other vaccines interrupted controlled efficacy trials, up to that point five cases of Hib disease in those trials had occurred in placebo recipients, and no Hib disease has been reported in the more than 100,000 vaccinated infants who have received more than one dose of PRP-T. Thus PRP-T combined immunogenicity early in life with induction of immunologic memory.
Bacterial Vaccines↗
Immunogenicity of Haemophilus influenzae type b conjugate vaccine in allogeneic bone marrow recipients.
A randomized study was conducted in 40 allogeneic marrow recipients to compare the immunogenicity of two Haemophilus influenzae type b (Hib) vaccines (either the Hib capsular polysaccharide [Hib-CPS] or tetanus toxoid-conjugated Hib-CPS [Hib-CPS-T]). A second injection consisted of Hib-CPS-T. Before immunization, 3 patients had serum antibody levels > 1 microgram/mL. After the first injection, the response was better after Hib-CPS-T than after Hib-CPS but lower than in normal subjects; a number of patients lacked any IgG antibody response, especially after Hib-CPS. Of patients who received two injections of Hib-CPS-T, 85% achieved an antibody concentration > or = 1 microgram/mL. Hib-CPS-T induced a response in IgG2-deficient patients whereas Hib-CPS alone did not. IgG antibodies predominantly belonged to the IgG1 subclass. The antibody response was better in patients immunized late after graft. This study shows that Hib-CPS-T is more immunogenic than Hib-CPS in marrow recipients.
Adult↗
[A routine vocal cord examination in throat surgery is not justified].
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Adult↗
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.
Antibodies, Bacterial↗
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)
Antibodies, Bacterial↗
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.
Adult↗
[Evaluation of the vaccination of 3-month-old infants with Haemophilus influenzae type B (Hi b) capsular polysaccharide conjugated to tetanus protein (PRT-T) Pediatric Group of the Lyon Region].
Haemophilus influenzae type b (Hi b) is responsible for severe invasive infections, particularly meningitis, in children under 5 years of age, with the greatest frequency between 6 and 18 months. The antigenicity of Hib is related to its capsular polysaccharide (polyribosyl-ribitol-phosphate or PRP) which is at the origin of the production of bactericide anti-PRP antibodies. Vaccine using PRP alone have been shown to be well tolerated and immunogenic, but only in children above 2 years of age. We vaccinated 365 infants starting at the age of 3 months with a vaccine using a PRP-tetanus toxoid conjugate (PRP-T), coupled with the DTP pertussis vaccine. Local and general tolerance was found to be very good. Quantitative serum antibody measurements showed excellent immunogenicity. None of the vaccinated infants presented an invasive Hib infection. It therefore appears that early systematic vaccination of infants with PRP-T vaccine should be encouraged.
Antibodies↗
Study of combined vaccination against yellow fever and measles in infants from six to nine months.
A study has been carried out in the Ivory Coast to assess the efficacy of a combined vaccine against yellow fever and measles relative to that of each vaccine administered separately. Healthy children aged six to nine months were recruited and divided into two age groups: less than seven months (group I) and more than eight months (group II). In each group, they were randomly assigned to receive either yellow fever vaccine only (A), measles vaccine only (B), or the combined vaccine (C). The serological responses to measles and yellow fever were assessed in 219 initially seronegative children 45 days after immunization. More than 90% of the children developed yellow fever haemagglutination inhibiting antibodies. Neither age nor combination with measles vaccine influenced the responses to yellow fever vaccine. Measles haemagglutinational inhibiting antibodies were found in 97% of the children and the seroconversion rate was influenced neither by age nor by combination with yellow fever vaccine. Younger infants had lower titres of measles antibody. No particular adverse reactions were notified during the follow up. This study shows that combined yellow fever and measles vaccines are immunogenic in infants from the age of six months. Controlling yellow fever in endemic areas and the prevention of measles in young infants may greatly benefit by this combination.
Antibodies, Viral↗
Trial of economical regimens of suckling mouse brain rabies vaccine for postexposure prophylaxis in Lagos, Nigeria.
The suckling mouse brain rabies vaccine, recommended for production and routine use in Nigeria from our previous study, was investigated in the present study in an effort to reduce the cost of antirabies treatment in the country. This is needed for economic reasons. Instead of seven daily doses followed by three boosters, we tried five daily doses followed by three boosters, with or without equine hyperimmune serum given on day 0 (40 IU per kg body weight). Fifty dog-bite, victims, aged 3-81 years, were placed on this regimen, 25 with serum and 25 without serum, according to the history of the case. The serum had no effect on the kinetics of antibody development and both serum and vaccine were well tolerated. The geometric mean titres (GMTs) of antirabies antibodies in the sera of recipients of vaccine alone on days 10, 28 and 90 were 3.05 equivalent units ml-1 (EU ml-1), 4.35 EU ml-1 and 2.54 EU ml-1 respectively. Among those who had received antiserum and vaccine the titres were respectively 3.19 EU ml-1, 4.35 EU ml-1 and 3.02 EU ml-1. Of the 50 subjects, 49 showed detectable antibodies by day 28, and all the 50 survived. This regimen is therefore recommended for further trial in countries where rabies is endemic but potent antirabies vaccines are scarce and expensive. Another 23 subjects, considered not to be at risk of rabies, were given a one-tenth dose, two-site intradermal inoculation of the same vaccine on days 0, 3, 7, 14, 28 and 90.(ABSTRACT TRUNCATED AT 250 WORDS)
Adolescent↗
Treatment of spasmodic dysphonia by means of resection of the recurrent laryngeal nerve.
Over the last twelve years 44 patients suffering from spasmodic dysphonia have been seen at Huddinge hospital. There were 34 women and 10 men. 22 of these patients were for various reasons not regarded as candidates for surgery. The opposite applied to the remaining 22 patients. The outcome of a temporary nerve block guided us (the surgeons and the patients) whether to operate or not. 12 patients were thus operated upon by means of resection of the right recurrent laryngeal nerve. The immediate post-operative result was excellent in 11 of 12 patients but the voice deteriorated in 4 patients. They had revision surgery with a successful result in 3 of them. Also the other 7 patients deteriorated to some extent but not to the degree that revision surgery was necessary. It is our hypothesis that recurrencies are caused by reinnervation of the sectioned nerve.
Female↗
Low-dose hepatitis B vaccine immunisation in children.
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Clinical Trials as Topic↗