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P Saliou

Publications and source records attributed to P Saliou.

At least 19 recordsLinked to original sources
PubMed2000

A TritonX-100-split virion influenza vaccine is safe and fulfills the committee for proprietary medicinal products (CPMP) recommendations for the European Community for Immunogenicity, in Children, Adults and the Elderly.

Influenza epidemics are an important cause of morbidity and mortality throughout the world. Current recommendations from Health Authorities emphasize annual immunization of people who are particularly at risk from an influenza virus infection; however, vaccination of working adults and of school children also has been shown to provide public health benefits. To give it a more advantageous reactogenicity profile than the diethylether-split influenza vaccines available previously, a split virion influenza vaccine has been produced with TritonX-100. In a series of clinical trials, Aventis Pasteur (formerly, Pasteur Mérieux Connaught) tested both the safety and immunogenicity of this TritonX-100-split virion influenza vaccine in 566 subjects (42 children, 296 adults, and 228 elderly adults) during three influenza seasons (1991, 1993, and 1995). The TritonX-100-split virion vaccine was well tolerated: no serious adverse events were recorded during the 21 days following immunization. Among the local reactions observed, mild pain, redness, or induration at the injection site were the most frequently reported. Fever (38.0 to 38.5 degrees C) was noted in five adults or elderly subjects (1%), and in two children (5%). Immunogenicity was determined by measuring serum haemagglutinin antibody titres specific to each vaccine virus strain. In each of the three vaccination campaigns, the TritonX-100-split virion influenza vaccine fulfilled the Notes for Guidance on Harmonization of Requirements for Influenza Vaccines outlined by the Committee for Proprietary Medicinal Products (CPMP) of the European Community for an influenza virus vaccine (i.e., seroprotection, seroconversion, or increase of geometric mean titre) in all age groups.

Adolescent↗
PubMed2000

Vaccines and infectious disease.

The exponential growth in vaccine research over the last decade, in which many infectious diseases now appear to be amenable to prevention through immunization, is built upon three factors: first, a richer understanding of the immune response (in particular, cellular immunity), second, a greater finesse in understanding the molecular biology of pathogenicity, and third, an expanding use of genetic engineering techniques either to create micro-organisms of greatly attenuated virulence that may be used as vaccines, or to sequence, and express, potential vaccine antigens. With respect to vaccines composed of purified antigens, parallel work is underway to develop immuno-modulating agents (adjuvants) that will selectively and safely induce the necessary immune response. Finally, within this plethora of vaccine candidates, vaccinologists are devoting much effort to alternatives to immunization via injection, such as administration of a vaccine through the mucosal route (e.g., oral, intranasal, intravaginal, etc.), through the transcutaneous route, and even by expression of vaccine antigens in edible fruits and vegetables.

Clinical Trials as Topic↗
PubMed1999

Safety and immunogenicity of Haemophilus influenzae type b-tetanus toxoid conjugate, presented in a dual-chamber syringe with diphtheria-tetanus-pertussis and inactivated poliomyelitis combination vaccine.

The safety and immunogenicity of combining two established vaccines, polyribosyl ribitol phosphate conjugated to tetanus toxoid (PRP-T) (ActHIB, Pasteur Mérieux Connaught, Lyon, France) and diphtheria-tetanus-whole cell pertussis and inactivated poliovirus vaccine (DTP-IPV) (Tetracoq, Pasteur Mérieux Connaught, Lyon, France) were evaluated using a new dual-chamber syringe delivery system. Results were compared with those obtained when the two combination vaccines were either administered separately (two sites) or reconstituted manually and injected at a single site. A total of 487 2-month-old infants were enrolled in this study by 61 paediatricians in France. Infants were randomised to receive three immunisations of PRP-T and DTP-IPV at 2, 3 and 4 months of age, given either with the dual-chamber syringe (n = 213), as separate injections (n = 215), or as a single manually reconstituted injection (n = 59). Blood samples were taken prior to the first immunisation and 4 weeks after the third immunisation for the measurement of antibody titres. Infants were monitored by the parents for 3 days after each immunisation to detect local and systemic reactions. Local and systemic reactions occurring the 3 days following immmunisation were as expected for the combination vaccines used. Safety of the vaccination using the dual-chamber syringe was as good as, if not slightly better than, that for the two vaccines administered separately. After the first immunisation, pain and unusual crying were significantly more frequent in infants who received two injections, compared to those who were immunised with the dual-chamber syringe. Serological responses were good for all antigens in the three groups and there was no evidence for any immunological interference. Almost all subjects in each group achieved levels of antibodies considered to be protective for all antigens. There were no clinically relevant differences in antibody response between any of the groups. The dual-chamber and separate injection methods of vaccination were equivalent according to a pre-defined criterion (percentage of infants with anti-PRP antibody titres > or =1.0 microg/ml). Results from this study suggest that the two vaccines, PRP-T and DTP-IPV, may be safely and effectively administered in infants using the new dual-chamber syringe. This presentation provides an innovative strategy to combine different vaccines that are not yet available as a single formulation.

Agglutinins↗
PubMed1998

[Vaccines inf the prevention of fecal hazards].

In addition to the imperative improvement of hygiene standards, vaccines can also be used for the prevention of diseases transmitted by the feco-oral route. Vaccination is essential to protect against poliomyelitis, the eradication of which is targeted through vaccination campaigns using the live, attenuated vaccine in countries where the disease is still endemic and the inactivated vaccine or a combination of both vaccines (mixed schedule) in countries where the disease is under control. The introduction of a specific routine vaccination program against hepatitis A in endemic countries is now starting to be considered. Travellers to these countries must be protected. Among bacterial diseases, only typhoid fever can be prevented by means of an effective vaccine. The difficulties encountered in improving hygiene standards in numerous countries have prompted the WHO to encourage search for new vaccines for the prevention of the diseases transmitted by the feco-oral route. A vaccine against rotavirus that has just been licensed in the USA should permit the global reduction of a significant number of deaths attributable to these viruses. Vaccine prospects for the prevention of hepatitis E are more distant. Several vaccines against Shigella (injectable polysaccharide conjugate vaccine or oral, live, attenuated vaccines obtained by construction of mutant strains) and enterogenic Escherichia coli (oral, inactivated vaccine containing several strains of ETEC and sub-unit B of the cholera toxin), not to mention candidate vaccines against cholera.

Bacterial Vaccines↗
PubMed1997

Clinical immunogenicity and tolerance studies of liquid vaccines delivered by jet-injector and a new single-use cartridge (Imule): comparison with standard syringe injection. Imule Investigators Group.

A new needleless jet-injector, Mini-Imojet, was developed that administers liquid vaccines from a single-use, pre-filled cartridge named Imule, which avoids the risk of cross-contamination. We conducted clinical trials in several settings in France and West Africa to compare the immunogenicity and tolerance of five vaccines (influenza vaccine, Vi capsular polysaccharide typhoid vaccine, tetanus toxoid vaccine, diphtheria-tetanus-whole cell pertussis vaccine, and inactivated hepatitis A vaccine) administered with the Imule system vs standard syringe technique. In each vaccine study, all subjects of either group were tested for serum antibody titres to calculate the geometrical mean titres and seroconversion rates after complete vaccination. Immediate local-reactions were noted after each injection, and local and general reactions were evaluated during a predetermined period of follow-up. When delivered by the Imule technique, all the administered vaccines were of equivalent or superior immunogenicity, compared to the syringe technique. The tolerance to vaccines injected by the Imule system was acceptable in all studies. The most frequently observed reactions were mild (e.g. minor bleeding, superficial papules, erythema and induration) and could be considered to be inherent to the injection technique. The technical and safety advantages of the Mini-Imojet/Imule system, compared to sterilizable, standard disposable or autodestruct syringes and to classical multi-dose vial jet-injectors, reinforces the interest of this new injection technique for collective immunizations.

Adolescent↗
PubMed1996

[Trial of prevention of severe Haemophilus influenzae type b infections and trial of tolerance, after PRP-T vaccination, in the Val-de-Marne region].

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.

Antibodies, Viral↗
PubMed1995

[Live vaccines].

Live vaccines are composed of viral or bacterial strains which are deprived of their pathogenicity but can still replicate in the organism. These vaccines can provoke a non pathogenic infection in vaccinated subjects, both inducing an antibody and a cellular immune response. Live attenuated vaccines such as measles, rubella, mumps or yellow fever vaccines have been widely used with proven efficacy. The oral poliomyelitis vaccine is composed of three attenuated strains prepared from the three wild virus types and is efficacious but mutations of the virus (in particular for type 3) can induce polio-associated paralysis by giving it back its original neurovirulence (number of cases 2:1,000,000). Other vaccines prepared from empirically attenuated strains such as varicella, dengue or cytomegalovirus strains are currently developed. The preparation of vaccine strains using gene deletion or attenuation directed mutagenesis makes it possible to develop highly genetically stable vaccines, in particular against orally transmitted bacterial diseases (e.g. typhoid fever, shigella, cholera). However, the future certainly belongs to combined live vaccines where genes encoding vaccine antigens are inserted into non pathogenic viruses or bacteria administered to man and are then expressed in the organism. The most promising model seems to be the one using poxviruses.

Adult↗
PubMed1995

[Rabies in France, 100 years after Pasteur].

Pasteur's vaccination, a huge step forward in infectiology, remains the fundamental element in the fight against rabies. Since 1968, when rabid foxes reappeared in France there have been no domestic cases of human rabies, but from 1970 to 1993, 14 patients contaminated in enzootic areas (usually Africa) died from rabies in France. The new circulation conditions created by the European Union emphasizes the importance of the inactivated Pasteur vaccine cultivated on Vero cell lines. The classic protocol for post-exposure vaccinations is based on 5 intramuscular injections on day 0, 3, 7, 14 and 30. In 1988, the World Health Organization established new recommendations: the 2-1-1 schedule for post-exposure vaccination. Two injections are given on day 0 at two different sites followed by boosters on day 7 and day 21. Tested worldwide by independent laboratories, this schedule has been shown to effectively induce seroconversion when modern cell-culture vaccines are used. Although there is still a certain amount of debate on the new schedule, no failures have been recorded. The Centers for Disease Control in Atlanta recommend preventive vaccination for exposed professions based on primary and booster injections on day 0, 7, 28 and 365. Protection lasts for 3 years and may be prolonged with supplementary vaccinations. One hundred years ago, Pasteur taught us that we could protect the human population by fighting against animal contamination. Today's progress is the reward of such foresight--and a challenge to both human and veterinary medicine.

France↗
PubMed1995

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↗
PubMed1994

[Recombinant vaccine and extracting vaccine against hepatitis B in patients with kidney insufficiency: comparative immunogenicity].

OBJECTIVES: Patients with chronic renal failure respond rather poorly to hepatitis B vaccines. A better response could be expected from recombinant vaccines including both the S and the pre-S2 antigens. We therefore prospectively compared the immunogenicity of plasma-derived Hevac B vaccine (H) with that of recombinant GenHevac B vaccine (G). METHODS: Vaccinations were performed in 120 non-dialyzed patients with chronic renal failure. The patients were randomly divided into two groups. Group G included 60 patients (24 males, mean age 58 +/- 16 years, mean creatinine clearance 25.3 +/- 12.6 ml/min) who were given the Hevac B vaccine at the dose of 5 micrograms. Group H included 60 patients (31 males, mean age 60 +/- 15 years, mean creatinine clearance 24.4 +/- 11.1 ml/min) who were given GenHevac B vaccine at the dose of 20 micrograms. All vaccinations were repeated at 0, 1, 2, 4 and 12 months. RESULTS: Following the fourth injection, seroconversion (anti-Hbs > or = 2 mlU/ml) was observed in 50/59 (85%) of the patients in group G versus 38/58 (67%) in group H (p < 0.02). Seroprotection (> or = 10 mlU/ml) was obtained in 42/59 (71%) vs 34/58 (59%), (NS) in the two groups respectively with a geometric mean titer of 112 versus 229 mlU/ml (NS) in responders. Following the booster injection at the 12th month, seroconversion was achieved in 48/51 (94%) vs 40/53 (76%) (p < 0.01) and seroprotection in 84% vs 70% (p = 0.053) respectively. The mean geometric titers were 879 and 1001 mlU/ml. CONCLUSIONS: Recombinant GenHevac B vaccine elicits seroconversion and seroprotection in a higher proportion of patients with chronic renal failure than the plasma-derived Hevac B vaccine, with comparably high antibody titers in responders. Therefore, GenHevac B vaccine should be recommended for vaccinating patients with chronic renal failure against hepatitis B.

Adult↗
PubMed1994

Crisis communication in the event of a flu pandemic.

When we talk about planning we cannot avoid discussing information, prevention and reaction, three notions that underlie communication in times of emergency. From a management point of view, emergency information in the event of an influenza pandemic comes under two headings: preventive information and reactive information. An example of preventive information provided by GEIG has aimed to sensitize public opinion about the phenomenon of influenza, correcting various preconceived ideas about the illness and reinforcing faith in the influenza vaccine. The strategy adopted by GEIG is founded on a few simple rules: (1) One message/one voice, GEIG unites its areas of competence by relying on a Scientific Council that guarantees the legitimacy of its influenza information, (2) the collection and coordination of information, (3) the identification and prioritisation of target groups, (4) an understanding of the media based on working relationships, making GEIG a reference when it comes to opinion, (5) the conception of information packs adapted to different categories of the public (press packs, documents for health professionals, leaflets for the general public, etc.), and (6) side-by-side with its role as broadcaster, the GEIG has set up a mechanism for listening and for evaluation (public opinion surveys, special enquiries, etc.). These are reliable monitoring tools allowing constant updating of our information policy. Emergency strategy: reactive information. An influenza pandemic is a special kind of crisis, since it is a crisis of collective responsibility, requiring a rapid deployment of adapted communication techniques.(ABSTRACT TRUNCATED AT 250 WORDS)

Communication↗
PubMed1994

A 5-year immunization field trial against hepatitis B using a Chinese hamster ovary cell recombinant vaccine in French Polynesian newborns: results at 3 years.

A hepatitis immunization field trial, using a Chinese hamster ovary (CHO) cell recombinant vaccine, was implemented for newborns in the Austral archipelago of French Polynesia in 1988. Three different schedules were used: (1) four vaccine doses at months (M) M0, M1, M2 and M12; (2) three vaccine doses at M0, M1 and M6; and (3) three vaccine doses at M0, M1 and M12. The programme evaluation was performed yearly at fixed dates, i.e. October-November 1989, 1990 and 1991. After the third year, of the 582 children who received one or more doses of vaccine, four were HBsAg carriers. After one or two doses, 88 and 98%, respectively, had seroconverted for at least one of the two measured antibodies, anti-HBs or anti pre-S2. After three doses, seroconversion rates and geometric mean anti-HBs titres were, respectively, 94% and 187 mIU ml-1 using schedule M0, M1, M2; 95% and 507 mIU ml-1 using schedule M0, M1, M6 and 96% and 476 mIU ml-1 using schedule M0, M1, M12. After four doses (M0, M1, M2, M12) the corresponding results were 99% and 1518 mIU ml-1. One of the 16 vaccinated neonates born to HBsAg/HBeAg-positive mothers was an HBsAg carrier, implying a protective rate for the prevention of perinatal transmission of 93%. Overall, these results indicate that, in field conditions, indiscriminate vaccination of newborns with a CHO-recombinant vaccine without hepatitis B immunoglobulin (HiBG) resulted in high immunogenicity. Final evaluation in 1993-1994 will permit confirmation of the effectiveness of the two three-dose vaccine schedules.

Animals↗
PubMed1994

Immunogenicity of the recombinant GenHevac B Pasteur vaccine against hepatitis B in chronic uremic patients.

Immunogenicity of the recombinant GenHevac B vaccine (G), containing both the S and the preS2 antigen, was compared with that of the plasma-derived Hevac B (H) vaccine in 120 chronic uremic predialysis patients. Sixty received 20 micrograms/dose of G and 60 received 5 micrograms/dose of H at 0, 1, 2, 4, and 12 months. Two months after the fourth injection, seroconversion (antibody to hepatitis B surface antigen [HBs], > or = 2 mIU/mL) was seen in 85% of group G and 67% of group H patients (P < .02); seroprotection (anti-HBs, > or = 10 mIU/mL) was seen in 71% and 59%, respectively. The geometric mean titers (GMT) of anti-HBs in responders were 112 and 229 mIU/mL, respectively. After booster injection at month 12, seroconversion occurred in 94% and 76% and seroprotection in 84% and 70%, with anti-HBs GMTs of 879 and 1001 mIU/mL in groups G and H, respectively. The recombinant GenHevac B vaccine elicited seroconversion and seroprotection in a higher proportion of chronic uremic patients, with comparably high anti-HBs antibody titers in responders.

Adult↗