PubMed Health⌕ Search

Biomedical subjects

L Hessel

Publications and source records attributed to L Hessel.

At least 19 recordsLinked to original sources
PubMed2001

Impact of osmolality on burning sensations during and immediately after intramuscular injection of 0.5 ml of vaccine suspensions in healthy adults.

A randomised placebo controlled double-blind cross-over trial was performed on twenty healthy adults to assess the effect of osmolality (300,600,850 and 1100 mOsm) on local tolerance of an intramuscular injection (0.5 ml) of five suspensions containing the same components as the excipients of a combined Diphtheria-Tetanus-acellular Pertussis-inactivated Poliomyelitis-Haemophilus influenzae type b paediatric vaccine (DtacP-IPV-Hib, PENTAVAC). The results did not show any dose-effect relationship between burning or pain sensations and the different osmolalities tested. Although mild and not clinically relevant, these sensations seemed to occur more frequently following injection of an isotonic saline solution (P<0.05). Thus, the osmolality of vaccine like suspensions does not appear to be a potential cause of local pain or burning sensation after their administration.

Adolescent↗
PubMed2000

Immunogenicity and safety of a new liquid hexavalent combined vaccine compared with separate administration of reference licensed vaccines in infants.

OBJECTIVE: The immunogenicity and safety of a new liquid hexavalent vaccine (diphtheria-tetanus-acellular pertussis-inactivated polio vaccine-hepatitis B-polyribosyl ribitol phosphate conjugated to tetanus protein; Hexavac; Aventis Pasteur MSD, Lyon, France) are compared with those of reference vaccines [diphtheria-tetanus-acellular pertussis-inactivated polio vaccine reconstituting lyophilized purified Haemophilus influenzae polysaccharide conjugated to tetanus protein vaccine (Pentavac; Aventis Pasteur MSD) and hepatitis B vaccine (H-B-Vax II; Aventis Pasteur MSD)] injected separately at the same visit in a prospective multicenter, comparative, open label trial. METHODS: Infants were randomized to receive Hexavac (n = 423) or Pentavac and H-B-Vax II (n = 425) as a primary immunization series at 2, 4 and 6 months of age. Seroprotection and seroconversion rates against all antigens at 1 month after the primary series were compared between the two vaccine groups with 95% confidence intervals (CI0.95) and were considered clinically equivalent (not inferior) when the upper limit of the 95% confidence interval on the difference (reference, hexavalent) was below predefined differences. RESULTS: Hexavac met and surpassed the pre-defined criteria for clinical equivalence to Pentavac and H-B-Vax II given concomitantly. It elicited similar seroprotection and seroconversion rates against all antigens. Seroprotection and seroconversion rates obtained 1 month after the third dose of Hexavac were >90% for all antigens. The postimmunization antibody geometric mean titers (GMT) for hepatitis B and purified Haemophilus influenzae polysaccharide were about 2-fold higher in infants who received the reference vaccines than in infants who had received Hexavac. GMTs for poliovirus antibodies tended to be enhanced in infants vaccinated with Hexavac. GMTs for all other antigens were very similar among both groups. Hexavac was generally well-tolerated. At least one local reaction was reported in 20.3% of Hexavac injections compared with 15.8% at the Pentavac injections site and 3.8% at the H-B-Vax II injections site. These reactions were generally mild and transient. At least one systemic adverse event was reported in 45.7% of Hexavac injections compared with 42.2% of Pentavac and H-B-Vax II injections (mild fever, irritability and drowsiness were most frequently reported). The frequency of adverse events was not significantly different between groups. No vaccine-related serious adverse event occurred during the study. CONCLUSION: This liquid hexavalent vaccine was generally well-tolerated and provided immune responses adequate to be protective against six infectious diseases with a single injection, given at 2, 4 and 6 months of age.

Antibodies, Bacterial↗
PubMed1999

Experience with Salmonella typhi Vi capsular polysaccharide vaccine.

Typhoid fever remains an important health threat in many parts of the world, with an estimated 16 million cases and 600,000 deaths occurring each year. The emergence of Salmonella typhi strains multiply resistant to antibiotics has complicated the treatment of this disease. Field experience of 8 years shows that a vaccine composed of purified Vi capsular polysaccharide of Salmonella typhi, given as a single intramuscular or deep subcutaneous injection, has consistent immunogenicity and efficacy. Side effects, based on reports since 1989, are infrequent and mild. Furthermore, the Vi vaccine may be administered simultaneously with other common "travel" vaccines, at two different sites of injection, without affecting immunogenicity and tolerability. This review presents an update of the development and clinical experience with the Salmonella typhi Vi polysaccharide vaccine (Typhim Vi; Pasteur Mérieux Connaught, France).

Antibodies, Bacterial↗
PubMed1998

Human diploid cell strains (HDCS) viral vaccines.

Since the development in 1961 by Hayflick and Moorhead of a human diploid cell strain (HDCS) culture system for isolating viruses, HDCS-derived human vaccines have been licensed worldwide for polio IPV and OPV (multiple strains), rabies (Pitman-Moore L503 3M strain); rubella (RA27/3 strain); measles (Edmonston-Zagreb strain); varicella-zoster (Oka strain); mumps (Rubini strain) and hepatitis A (HM-175, CR-326-F', and GBM strains). Many of these widely-used vaccines now have at least a 20-year record of safety after extensive, ongoing pharmacovigilance. Serious vaccine-associated events are rare, and appear to reflect the activity of the live viruses replicated in the HDCS or of the inactivated viruses or other proteins added during manufacture. There is no credible association of reactions to the HDCS substrate or a hypothetical contaminant derived from it.

Cell Line↗
PubMed1998

[Efficacy of pneumococcal vaccination].

POLYVALENT VACCINE: Pneumococcal vaccination is based on the antigenic properties of polysides carried on the bacterial capsule which induce production of bactericidal serotype-specific antibodies. The 23 serotypes contained in the current vaccine cover 85 to 90% of all strains observed in pneumococcal infections in Europe. PROVEN EFFICACY: Prospective and retrospective studies have demonstrated that pneumococcal vaccination can prevent 60 to 80% of invasive pneumococcal infections in immunocompetent elderly subjects and/or persons in high-risk groups with underlying disorders. TARGET POPULATION: Immunocompetent persons in the 60-65 year and older age group comprise the target population for pneumococcal vaccination. Incidence and mortality of pneumococcal infections is high in this group. Simple vaccination strategies should be implemented.

Adult↗
PubMed1996

Aseptic meningitis following mumps vaccine. A retrospective survey by the French Regional Pharmacovigilance centres and by Pasteur-Mérieux Sérums & Vaccins.

Since 1989 many case series and observational studies of aseptic meningitis (AM) associated with the use of live attenuated mumps vaccines containing the Urabe AM9 strain have been reported worldwide. The aim of this retrospective reported AM in France following mumps vaccination with monovalent or multivalent vaccines containing the Urabe strain. Fifty-four cases of AM were reported to the Regional Pharmacovigilance centres or to the manufacturer from the time each vaccine was launched up until June 1992. Twenty cases were temporally associated with the administration of a monovalent mumps vaccine and 34 with a trivalent measles, mumps and rubella vaccine (MMR). A mumps virus was isolated in four cases in the cerebrospinal fluid and an Urabe-like strain was characterized twice by polymerase chain reaction (PCR). A probable mumps origin was assumed in 17 other cases where the patients presented with other clinical or biological signs of mumps infection. The clinical outcome of AM, known in 87% of the population, was always favourable. The global incidence of mumps vaccine-associated AM was 0.82/100,000 doses, which is significantly lower than the incidence in the unvaccinated population. Even considering that the actual incidence of AM is much higher when assessed by active surveillance studies, the risk/benefit ratio of mumps vaccine remains in favour of vaccination.

Journal Article↗
PubMed1996

Thrombocytopenic purpura after measles, mumps and rubella vaccination: a retrospective survey by the French regional pharmacovigilance centres and pasteur-mérieux sérums et vaccins.

BACKGROUND: Thrombocytopenic purpura (TP) after vaccination with measles, mumps and rubella has occasionally been reported. OBJECTIVES: To evaluate the incidence and characteristics of thrombocytopenic purpura reported in France after measles, mumps or rubella vaccination with monovalent or multivalent vaccines. METHODS: A retrospective epidemiologic survey was conducted. All confirmed cases of TP reported spontaneously either to the French Regional Pharmacovigilance Centres or to the manufacturer (Pasteur-Mérieux Sérums et Vaccins) between 1984 and June 30, 1992, were reviewed. RESULTS: Sixty cases of TP in children between 1 and 11 years of age occurred 2 to 45 days after administration of 1 of 7 vaccines. The reported incidence of TP varied from 0.17 and 0.23/100,000 doses of measles or rubella vaccines, respectively, given alone to 0.87/100,000 doses of combined measles-rubella vaccines and 0.95/100,000 doses of the measles-mumps-rubella vaccine. The mean platelet count was 8000 +/- 6000/mm3 and was lower than 10,000/mm3 in 58% of cases. The immediate outcome was favorable in 89.5% of cases. CONCLUSIONS: According to the clinical course and biologic findings, vaccine-associated TP appears to be similar to that occurring after natural measles or rubella infections and is not distinguishable from acute childhood idiopathic thrombocytopenic purpura not associated with vaccination. Such observations, combined with a clear temporal relationship between measles-mumps-rubella vaccination and the occurrence of TP, make a causal relationship highly plausible. Nevertheless the incidence of these events remains relatively low with a favorable immediate outcome.

Child↗
PubMed1995

Immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine in healthy children and in children at increased risk of pneumococcal infection.

Splenectomized children as well as those suffering from nephrotic syndrome or recurrent asthmatic bronchitis have an increased susceptibility to systemic pneumococcal infections compared to healthy children. To determine the immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine (PPV), 119 children (21 healthy, 26 splenectomized children, 48 with nephrotic syndrome and 24 with recurrent asthmatic bronchitis), aged 2-18 years, received one subcutaneous injection of a 23-valent PPV. Anti-capsular antibodies (Ab) to types 6B, 9V, 14, 18C, 19F and 23F were measured by ELISA before and 4 weeks after immunization. In all cases the adverse reactions were mild and transient, consisting of local pain and/or erythema or swelling in 41% and fever above 38.5 degrees C in 2% of the children. The healthy children responded well to vaccination with a mean fold increase (FI) of 2.6 in postvaccination Ab titers compared to prevaccination titers. The combined geometric mean Ab concentrations in the high-risk children were significantly lower than those of healthy children both before and after vaccination. However, the combined geometric mean FI were not significantly different between high-risk and healthy children. These results indicate that PPV is immunogenic and safe in high-risk as well as in healthy Korean children.

Adolescent↗
PubMed1994

Haemophilus type B conjugate vaccine: postimmunization kinetics of IgM and IgG antibody responses in ten vaccinated children.

A new Haemophilus type b conjugate vaccine coupling capsular polysaccharide of Haemophilus influenzae b to tetanus toxoid is available in France and other countries. We have studied the kinetics of the immune response in ten children aged 17 to 50 months during the 4 weeks after immunization with one dose of Haemophilus type b conjugate vaccine. Eight serum samples were collected from each child at day 0 (D0), D2, D4, D7, D10, D14, D21 and D28. An ELISA method has been used to discriminate between IgM and IgG classes of anti-polyribosylribitol phosphate antibodies. A high level of IgM appeared at D7 and persisted until D28. The increase in IgG was regular and progressive from D7.

Antibodies, Bacterial↗
PubMed1992

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↗
PubMed1991

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↗
PubMed1989

[Tolerance and immunogenicity of the capsular polyoside vaccine against Haemophilus influenzae type b. A study of 325 children 15 to 71 months of age].

The antigenic properties of the capsule polyoside (PRP) from Haemophilus influenzae type b (Hib) are adequate to form the basis for immunization designed to prevent the severe infections caused by this organism. The tolerance and immunogenicity of a vaccine containing either 12.5 or 25 micrograms PRP were studied in 325 healthy children aged 15 to 71 months after informed consent had been obtained from the parents. Each child was given one subcutaneous injection of 0.5 ml vaccine. Antibodies against Hib were assayed before and one month after the injection. Clinical tolerance was outstanding both locally (moderate and transient pain in 13% of cases) and systematically, with only eight (2.6%) febrile reactions in excess of 38.5 degrees C within 24 hours after the injection. A very significant rise in antibody titers was seen in all age groups, but a mean titer of 1 microgram/ml was achieved only in children aged 24 months or more. No significant difference was found between the two dosages. Individual analysis showed that following immunization antibody titers reached 0.15 micrograms/ml or more in 65% of infants aged 15 to 17 months, 71% of infants aged 18 to 23 months, 80% of infants aged 24 to 30 months and 95% of children older than 30 months. Despite the inadequate immune response evidenced in the younger age groups, our results confirm that Hib infections are preventable from the age of 2 years. Our results are consistent with those recorded with a similar vaccine in Finland.

Antibody Formation↗
PubMed1987

Alterations in the human immune response to the hepatitis B vaccine among the elderly.

The specific binding of hepatitis B (HBs) antigen by lymphocytes from old people immunized with hepatitis B vaccine was explored. For that purpose HBs antigen was combined with fluorescent microspheres, and labeled antigen was allowed to react with lymphocytes from HBs vaccine-responsive or unresponsive people. Lymphocytes from 10 responders and 14 nonresponders were tested for their antigen-binding ability. For controls, lymphocytes were incubated with microspheres bearing human albumin. Lymphocytes from 8 out of 10 responders were able to recognize HBs antigen; for the nonresponders the ratio was 9 out of 14. HBs-binding lymphocytes were B cells but not T lymphocytes. B and T cells from responders and nonresponders were combined and cultivated for 8 days in the presence of HBs antigen, and antibody-producing cells were counted. Neither B cells alone nor B cells plus T cells from nonresponders were able to produce antibody. On the other hand B cells from unresponsive old people produced antibodies when they were cultivated in the presence of HBs antigen and T cells from responsive old people. These data suggest that some elderly individuals who do not produce antibody after in vivo immunization by HBs vaccine do have antibody-producing cells. Instead of a gap in their immune repertoire, these people are suffering from immune dysfunction.

Aged↗