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↗
Immunogenicity of a recombinant Pre-S2-containing hepatitis B vaccine versus plasma-derived vaccine administered as a booster.
GenHevac B Pasteur is a recombinant hepatitis B vaccine derived from a mammalian cell line and containing HBs as well as pre-S2 antigens. Its immunogenicity was compared to that of the plasma-derived vaccine Hevac B Pasteur in a population primovaccinated 5.5 years earlier with four injections of the same plasma vaccine. The booster injection with either GenHevac or Hevac was administered to 295 subjects with residual anti-HBs titres below 500 IU/l (group 1: 0-9; group 2: 10-99; group 3: 100-499 IU/l). After four weeks, GenHevac had induced higher anti-HBs responses than Hevac in all groups, particularly among the low responders of group 1. Response to the vaccine occurred earlier with GenHevac. Mean anti-pre-S2 production was moderate in all groups for both vaccines (GenHevac: 60 IU/l; Hevac: 31 IU/l) and was not found in the 32 subjects who produced less than 100 IU/l anti-HBs. The results of the present study indicate that GenHevac is at least as immunogenic as Hevac.
Adult↗
Familial clustering of hepatitis B virus infections and prevention of perinatal transmission by immunization with a reduced number of doses in an area of intermediate endemicity (Tunisia).
Hepatitis B surface antigen (HBsAg) was detected in 3.3% of 7162 pregnant Tunisian women tested and HBeAg in 9.6% of the HBsAg-positive mothers. Family members of 46 of these HBsAg-positive mothers (33 husbands and 61 children aged 1-6 years) were investigated for the presence of HBV markers. HBsAg was detected in 21% of the children and 18% of the husbands. Fifty children born to HBsAg-positive mothers received hepatitis B vaccine at birth, at the age of 2-3 months and at the age of 9 months. After immunization, anti-HBs were detected in 92% of them with an anti-HBs geometric mean titre of 415 mIU ml-1. Compared with the HBsAg carrier state in older siblings, the protective efficacy was estimated to be 60%. It was 100% for infants born to HBeAg-negative mothers, but only 31% for those born to HBeAg-positive mothers. For a better efficacy, the schedule of the EPI needs to be modified to include an immunization session at 1 month of age.
Adult↗
Combined vaccination against yellow fever and typhoid fever: a comparative trial.
In order to evaluate a combination of yellow fever and typhoid fever vaccine, we conducted a controlled trial comparing reactogenicity and immunogenicity of Vi polysaccharide (ViPS) vaccine and yellow fever 17D (YF) vaccine after single, simultaneous and combined administration. The combined YF/ViPS vaccine was prepared by using the liquid ViPS vaccine as a diluent for the YF vaccine. The stability of such a reconstitution had been assessed in vitro. Safety was evaluated using a self-surveillance form and by repeated clinical visits. Immunogenicity was evaluated by a plaque reduction test for YF and by radioimmunoassay for ViPS. Tolerability was satisfactory in all groups. There was no increase in local or general reactions in groups receiving both vaccines, whether given simultaneously or combined. The serological response to ViPS was similar after single and simultaneous or combined administration. Interestingly, the immune response to YF was significantly enhanced in groups receiving the vaccines simultaneously or combined, suggesting a potential adjuvant effect of ViPS.
Adult↗
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↗
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)
Diphtheria-Tetanus-Pertussis Vaccine↗
Immunogenicity of Haemophilus influenzae type b polysaccharide-tetanus toxoid conjugate vaccine in infants.
OBJECTIVE: To compare the safety and immunogenicity of three investigational lots of Haemophilus influenzae type b polysaccharide-tetanus toxoid (PRP-T) conjugate vaccine in infants. DESIGN: A multicenter, randomized immunogenicity trial. Infants were vaccinated at 2, 4, and 6 months of age with one of three lots of PRP-T. A control group received H influenzae type b oligomers conjugated to CRM197 (HbOC). Serum was obtained before each injection and 1 month after the third dose, and assayed blindly for antibody in one laboratory. SUBJECTS: Four hundred eighty-four infants from private pediatric practices located in five geographic areas. MEASUREMENTS AND RESULTS: There were no significant differences in the number of adverse events reported for infants receiving PRP-T or HbOC, and the rates did not exceed those observed previously in infants given diphtheria-tetanus-pertussis vaccine alone. Total serum anti-PRP antibody responses were analyzed in 336 infants who met strict inclusion criteria. After one, two, or three doses, the respective antibody responses to each of the three lots of PRP-T and to HbOC vaccine were similar. The only exception was one lot of PRP-T, which after one or two injections elicited significantly higher geometric mean antibody responses than the other two lots or the HbOC vaccine. After a third injection, there were no significant lot differences. Combining the data from the different lots, there were no significant differences in the geometric mean antibody concentration after three doses of PRP-T or HbOC (8.3 vs 7.7 micrograms/mL), and 95% and 91%, respectively, of infants had greater than 1.0 microgram/mL of antibody. There were no significant differences in the magnitudes of the respective IgG1-, IgG2-, and IgM-specific antibody concentrations between infants given PRP-T or HbOC. CONCLUSIONS: The three investigational lots of PRP-T tested were safe and were as immunogenic as or more so than the licensed HbOC conjugate vaccine.
Age Factors↗
Characterization of the serum antibody response induced by Haemophilus influenzae type b tetanus protein-conjugate vaccine in infants receiving a DTP-combined vaccine from 2 months of age.
The serum antibody response induced by Haemophilus influenzae type b capsular polysaccharide (CPS)-tetanus protein conjugate vaccine combined to DTP vaccine was characterized in infants receiving three injections from 2 months of age. Sixty-five per cent and 94% of infants had anti-CPS antibody levels > or = 1 micrograms ml-1 after the second and third dose, respectively. The antibody response was mostly made up of IgG with a marked IgG1 predominance. Significant rises in bactericidal and in complement-mediated opsonic activities were observed after immunization. These data clearly show that this vaccine can be successfully administered in one syringe together with DTP vaccine during the regular infant immunization programme.
Antibodies, Bacterial↗
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.
Adult↗
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)
Antibodies, Bacterial↗
[Immunogenicity and tolerability of Haemophilus b-tetanus protein conjugate (PRP-T) in children with sickle cell anemia].
BACKGROUND: Infants and young children with sickle cell anemia are at increased risk of infection with Haemophilus influenzae type b. This report describes the immunogenicity and safety of Haemophilus b conjugate vaccine in such children. POPULATION AND METHODS: One hundred and eleven children aged 6 months-11 years (mean: 3.7 years) were studied. They belonged to a cohort of over 600 children in the Paris area that have sickle cell anemia. After parental consent, they were given one injection (intramuscularly or subcutaneously) of Haemophilus influenzae type b-tetanus toxoid conjugate vaccine (0.5 ml). Any adverse reactions during the following 3 days were noted. Titers of specific antibodies were measured just before injection, one month, and one year later. RESULTS: The vaccine was well tolerated, with only local reactions: erythematous reactions in 5 children and pain in 30. In the children aged 6 months-3 years, the mean antibody titers increased from 0.09 to 20.6 micrograms/ml, 1 month after the vaccination; in those aged 3-11 years, the mean titer increased from 0.44 to 56.86 micrograms/ml. One year after vaccination, the titers measured in 61 children were over 1 microgram/ml in 92% of children aged 6 months-3 years and in 100% of the older children. CONCLUSION: This type of vaccine is immunogenic and well tolerated. Thus the vaccination schedule recommended for children with sickle cell anemia aged over 6 months is the same as that for normal children.
Anemia, Sickle Cell↗
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↗