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Elizabeth Miller - One of the best experts on this subject based on the ideXlab platform.

Eliete Da Cunha Araujo - One of the best experts on this subject based on the ideXlab platform.

  • seguranca imunogenicidade e eficacia protetora de duas doses da vacina rix4414 contendo rotavirus atenuado de origem humana
    Jornal De Pediatria, 2007
    Co-Authors: Eliete Da Cunha Araujo, Consuelo Silva De Oliveira, Pilar Rubio, Yvone Benchimol Gabbay, Veronilce B Da Silva, Sue Ann Costa Clemens, Maria Cleonice Aguiar Justino, Joana Darc Pereira Mascarenhas, Vânia Lucia Noronha, Ralf Clemens
    Abstract:

    OBJECTIVE: To determine the safety, immunogenicity and efficacy of two doses of rotavirus Vaccine in healthy Brazilian infants. METHODS: A randomized, multicenter, double-blind, placebo-controlled trial was conducted in Brazil, Mexico and Venezuela. Infants received two Oral doses of Vaccine or placebo at 2 and 4 months of age, concurrently with routine immunizations, except for Oral Poliomyelitis Vaccine (OPV). This paper reports results from Belem, Brazil, where the number of subjects per group and the viral Vaccine titers were: 194 (104.7 focus forming units - FFU), 196 (105.2 FFU), 194 (105.8 FFU) and 194 (placebo). Anti-rotavirus (anti-RV) antibody response was assessed in 307 subjects. Clinical severity of gastroenteritis episodes was measured using a 20-point scoring system with a score of > 11 defined as severe GE. RESULTS: The rates of solicited general symptoms were similar in Vaccine and placebo recipients. At 2 months after the second dose, a serum IgA response to RV occurred in 54.7 to 74.4% of Vaccinees. No interference was seen in the immunogenicity of routine Vaccines. Vaccine efficacy against any rotavirus gastroenteritis (RVGE) was 63.5% (95%CI 20.8-84.4) for the highest concentration (105.8 FFU). Efficacy was 81.5% (95%CI 44.5-95.4) against severe RVGE. At its highest concentration (105.8 FFU), RIX4414 provided 79.8% (95%CI 26.4-96.3) protection against severe RVGE by G9 strain. CONCLUSIONS: RIX4414 was highly immunogenic with a low reactogenicity profile and did not interfere with seroresponse to diptheria, tetanus, pertussis, hepatitis B and Hib antigens. Two doses of RIX4414 provided significant protection against severe GE caused by RV.

  • safety immunogenicity and protective efficacy of two doses of rix4414 live attenuated human rotavirus Vaccine in healthy infants
    Jornal De Pediatria, 2007
    Co-Authors: Eliete Da Cunha Araujo, Consuelo Silva De Oliveira, Pilar Rubio, Yvone Benchimol Gabbay, Veronilce B Da Silva, Sue Ann Costa Clemens, Maria Cleonice Aguiar Justino, Joana Darc Pereira Mascarenhas, Vânia Lucia Noronha, Ralf Clemens
    Abstract:

    Objective: To determine the safety, immunogenicity and efficacy of two doses of rotavirus Vaccine in healthy Brazilian infants. Methods: A randomized, multicenter, double-blind, placebo-controlled trial was conducted in Brazil, Mexico and Venezuela. Infants received two Oral doses of Vaccine or placebo at 2 and 4 months of age, concurrently with routine immunizations, except for Oral Poliomyelitis Vaccine (OPV). This paper reports results from Belem, Brazil, where the numberofsubjectspergroupandtheviralVaccinetiterswere:194(104.7focusformingunits–FFU),196(105.2FFU),194 (10 5.8 FFU) and 194 (placebo). Anti-rotavirus (anti-RV) antibody response was assessed in 307 subjects. Clinical severity of gastroenteritis episodes was measured using a 20-point scoring system with a score of ≥ 11 defined as severe GE. Results:TheratesofsolicitedgeneralsymptomsweresimilarinVaccineandplaceborecipients.At2monthsafterthe second dose, a serum IgA response to RV occurred in 54.7 to 74.4% of Vaccinees. No interference was seen in the immunogenicity of routine Vaccines. Vaccine efficacy against any rotavirus gastroenteritis (RVGE) was 63.5% (95%CI 20.8-84.4) for the highest concentration (10 5.8 FFU). Efficacy was 81.5% (95%CI 44.5-95.4) against severe RVGE. At its highest concentration (105.8 FFU), RIX4414 provided 79.8% (95%CI 26.4-96.3) protection against severe RVGE by G9 strain. Conclusions: RIX4414 was highly immunogenic with a low reactogenicity profile and did not interfere with seroresponse to diptheria, tetanus, pertussis, hepatitis B and Hib antigens. Two doses of RIX4414 provided significant protection against severe GE caused by RV.

  • safety immunogenicity and protective efficacy of two doses of rix4414 live attenuated human rotavirus Vaccine in healthy brazilian infants seguranca imunogenicidade e eficacia protetora de duas doses da vacina rix4414 contendo rotavirus atenuado de origem humana
    2007
    Co-Authors: Eliete Da Cunha Araujo, Sue Ann, C Clemens, Consuelo Silva De Oliveira, Maria Cleonice, A Justino, Pilar Rubio, Yvone Benchimol Gabbay, Veronilce B Da Silva, Joana Dp Mascarenhas
    Abstract:

    Objective: To determine the safety, immunogenicity and efficacy of two doses of rotavirus Vaccine in healthy Brazilian infants. Methods: A randomized, multicenter, double-blind, placebocontrolled trial was conducted in Brazil, Mexico and Venezuela. Infants received two Oral doses of Vaccine or placebo at 2 and 4 months of age, concurrently with routine immunizations, except for Oral Poliomyelitis Vaccine (OPV). This paper reports results from Belem, Brazil, where the number of subjects per group and the viral Vaccine titers were: 194 (10 4.7

Ralf Clemens - One of the best experts on this subject based on the ideXlab platform.

  • seguranca imunogenicidade e eficacia protetora de duas doses da vacina rix4414 contendo rotavirus atenuado de origem humana
    Jornal De Pediatria, 2007
    Co-Authors: Eliete Da Cunha Araujo, Consuelo Silva De Oliveira, Pilar Rubio, Yvone Benchimol Gabbay, Veronilce B Da Silva, Sue Ann Costa Clemens, Maria Cleonice Aguiar Justino, Joana Darc Pereira Mascarenhas, Vânia Lucia Noronha, Ralf Clemens
    Abstract:

    OBJECTIVE: To determine the safety, immunogenicity and efficacy of two doses of rotavirus Vaccine in healthy Brazilian infants. METHODS: A randomized, multicenter, double-blind, placebo-controlled trial was conducted in Brazil, Mexico and Venezuela. Infants received two Oral doses of Vaccine or placebo at 2 and 4 months of age, concurrently with routine immunizations, except for Oral Poliomyelitis Vaccine (OPV). This paper reports results from Belem, Brazil, where the number of subjects per group and the viral Vaccine titers were: 194 (104.7 focus forming units - FFU), 196 (105.2 FFU), 194 (105.8 FFU) and 194 (placebo). Anti-rotavirus (anti-RV) antibody response was assessed in 307 subjects. Clinical severity of gastroenteritis episodes was measured using a 20-point scoring system with a score of > 11 defined as severe GE. RESULTS: The rates of solicited general symptoms were similar in Vaccine and placebo recipients. At 2 months after the second dose, a serum IgA response to RV occurred in 54.7 to 74.4% of Vaccinees. No interference was seen in the immunogenicity of routine Vaccines. Vaccine efficacy against any rotavirus gastroenteritis (RVGE) was 63.5% (95%CI 20.8-84.4) for the highest concentration (105.8 FFU). Efficacy was 81.5% (95%CI 44.5-95.4) against severe RVGE. At its highest concentration (105.8 FFU), RIX4414 provided 79.8% (95%CI 26.4-96.3) protection against severe RVGE by G9 strain. CONCLUSIONS: RIX4414 was highly immunogenic with a low reactogenicity profile and did not interfere with seroresponse to diptheria, tetanus, pertussis, hepatitis B and Hib antigens. Two doses of RIX4414 provided significant protection against severe GE caused by RV.

  • safety immunogenicity and protective efficacy of two doses of rix4414 live attenuated human rotavirus Vaccine in healthy infants
    Jornal De Pediatria, 2007
    Co-Authors: Eliete Da Cunha Araujo, Consuelo Silva De Oliveira, Pilar Rubio, Yvone Benchimol Gabbay, Veronilce B Da Silva, Sue Ann Costa Clemens, Maria Cleonice Aguiar Justino, Joana Darc Pereira Mascarenhas, Vânia Lucia Noronha, Ralf Clemens
    Abstract:

    Objective: To determine the safety, immunogenicity and efficacy of two doses of rotavirus Vaccine in healthy Brazilian infants. Methods: A randomized, multicenter, double-blind, placebo-controlled trial was conducted in Brazil, Mexico and Venezuela. Infants received two Oral doses of Vaccine or placebo at 2 and 4 months of age, concurrently with routine immunizations, except for Oral Poliomyelitis Vaccine (OPV). This paper reports results from Belem, Brazil, where the numberofsubjectspergroupandtheviralVaccinetiterswere:194(104.7focusformingunits–FFU),196(105.2FFU),194 (10 5.8 FFU) and 194 (placebo). Anti-rotavirus (anti-RV) antibody response was assessed in 307 subjects. Clinical severity of gastroenteritis episodes was measured using a 20-point scoring system with a score of ≥ 11 defined as severe GE. Results:TheratesofsolicitedgeneralsymptomsweresimilarinVaccineandplaceborecipients.At2monthsafterthe second dose, a serum IgA response to RV occurred in 54.7 to 74.4% of Vaccinees. No interference was seen in the immunogenicity of routine Vaccines. Vaccine efficacy against any rotavirus gastroenteritis (RVGE) was 63.5% (95%CI 20.8-84.4) for the highest concentration (10 5.8 FFU). Efficacy was 81.5% (95%CI 44.5-95.4) against severe RVGE. At its highest concentration (105.8 FFU), RIX4414 provided 79.8% (95%CI 26.4-96.3) protection against severe RVGE by G9 strain. Conclusions: RIX4414 was highly immunogenic with a low reactogenicity profile and did not interfere with seroresponse to diptheria, tetanus, pertussis, hepatitis B and Hib antigens. Two doses of RIX4414 provided significant protection against severe GE caused by RV.

Nicholas Kitchin - One of the best experts on this subject based on the ideXlab platform.

Luis Barreto - One of the best experts on this subject based on the ideXlab platform.

  • an evaluation of the safety and immunogenicity of a five component acellular pertussis diphtheria and tetanus toxoid Vaccine dtap when combined with a haemophilus influenzae type b tetanus toxoid conjugate Vaccine prp t in taiwanese infants
    Pediatrics, 1999
    Co-Authors: Chinyun Lee, John Thipphawong, Limin Huang, Pinging Lee, Hsiuhui Chiu, Wendy Lin, Henri Debois, Dana Harrison, Fang Xie, Luis Barreto
    Abstract:

    OBJECTIVE Immunologic interference particular to the Haemophilus influenzae type b (Hib) response has been observed with previous acellular pertussis-Hib combination Vaccines. To test this hypothesis a clinical trial to assess the safety and immunogenicity of a five-component (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], and fimbriae 2 and 3 [FIM]), pertussis Vaccine combined with diphtheria and tetanus toxoids (DTaP) when given simultaneously with a lyophilized Hib-tetanus toxoid conjugate Vaccine (PRP-T) in infants at 2, 4, 6, and 18 months of age was conducted. The study compared two methods of administration: both Vaccines combined in a single syringe and administered as a single injection, or both Vaccines administered concurrently but at separate sites of injection. METHODS Healthy 2-month-old infants were enrolled at the National Taiwan University Hospital. DTaP, PRP-T, and Oral Poliomyelitis Vaccine (OPV) were given at 2, 4, 6, and 18 months. Reaction information was collected by telephone 2 days after each vaccination. Serum was collected at 2, 6, 7, 18, and 19 months of age. RESULTS One hundred thirty-five healthy infants were enrolled in Taiwan, of which 127 (94%) completed the 18-month booster: 68 received the combined Vaccine and 67 the separate Vaccines. All Vaccines were well tolerated. No differences in rates of local and systemic reactions were seen between the two methods of administration. No serious adverse events were reported. Serologic responses were comparable between the groups. Pertussis responses (enzyme-liked immunoabsorbant assay units [EU]/mL) at 7 months were, for combined versus separate, PT (131 vs 105), FHA (116 vs 116), PRN (100 vs 77), and FIM (922 vs 702). At 19 months, pertussis results were, for combined versus separate, PT (216 vs 182), FHA (203 vs 200), PRN (263 vs 197), and FIM (892 vs 732). Only the 7-month PT response in the combined group was significantly higher (combined 131 EU/mL vs separate 105 EU/mL). After the third dose (age 6 months), all subjects achieved serologic serum antibody levels indicative of protection against Hib, diphtheria, tetanus, and poliovirus types 1, 2, and 3. In fact, 96% of children had anti-PRP levels indicative of protection (>/=0.15 microgram/mL) against Hib after only two doses. At 7 months, anti-PRP geometric mean titer values were 11.8 micrograms/mL in the combined group compared with 13.0 micrograms/mL in the separate group. The anti-PRP geometric mean titers after the 18-month booster were 58.5 micrograms/mL in the combined group versus 55.3 micrograms/mL in the separate group. CONCLUSION The five-component DTaP Vaccine may be combined with PRP-T Vaccine without clinically significant immunologic interaction when given in a 2-, 4-, 6-, and 18-month schedule.