scholarly journals 152. Protective Antibody Levels 7.5 Years After Primary Vaccination in Adolescence With a Recombinant, 4-Component, Meningococcal Serogroup B Vaccine (4CMenB) and Response to a Booster Dose in Adolescents and Young Adults: Phase IIIb Clinical Findings

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S11-S11
Author(s):  
Terry Nolan ◽  
Miguel O’Ryan ◽  
María Elena Santolaya ◽  
Ferdinandus De Looze ◽  
Helen Marshall ◽  
...  
Keyword(s):  
Young Adults ◽  
Booster Dose ◽  
Booster Vaccination ◽  
Primary Vaccination ◽  
Adolescents And Young Adults ◽  
Research Support ◽  
Open Label ◽  
Antibody Persistence ◽  
Antibody Levels ◽  
Research Grant

Abstract Background 4CMenB has been shown to be immunogenic with an acceptable safety profile in infants and young adolescents. However, no data on long-term persistence after primary vaccination in adolescents are available. This is the first study to assess antibody persistence, booster response, and safety of 4CMenB in adolescents and young adults up to 7.5 years following the primary vaccination in adolescence. Methods This phase 3b, open-label, extension study (NCT02446743) assessed the antibody persistence and booster response at 4 years (Canada and Australia, NCT01423084) or 7.5 years (Chile, NCT00661713) after primary vaccination with 4CMenB (following 0 + 1-, 0 + 2-, or 0 + 6-month schedules), compared with vaccine-naïve (VN), healthy controls. Chilean follow-on (FO) and VN participants aged 18–24 years received either a booster dose of 4CMenB 7.5 years postprimary series (Group FO, N = 131) or 2 primary doses, 1 month apart (Group VN, N = 150). Immunogenicity was measured using human serum bactericidal antibody assay (hSBA) against antigen-specific strains. Immune response was evaluated 1 month post-booster vaccination and compared with VN controls at 1 month post-first dose. Kinetics of antibody responses were measured at 3, 7, and 30 days post-vaccination. Safety was assessed. Results Antibody levels waned at 7.5 years postprimary vaccination in Group FO, but were higher than in Group VN at baseline, for all antigens except NHBA (table). At 1 month post-booster/post-first dose, 93–100% (Group FO) and 62–93% (Group VN) of participants had hSBA titres ≥4; GMTs ranged between 41 and 1,951 (Group FO) and 9.43–46 (Group VN) (table). The percentages of FO participants with hSBA titres ≥4 remained similar to prebooster for all 4 antigens at 3 days, increased at 7 days, and remained unchanged or increased further 30 days post-booster. The reactogenicity of 4CMenB was consistent with previous observations in this age group; no safety concerns were identified during the study. Conclusion Antibody levels in adolescents and young adults declined at 7.5 years after a 2-dose primary series of 4CMenB, but were higher than baseline levels in VN controls. An additional dose of 4CMenB elicited strong anamnestic responses—substantially higher than 1 dose in VN controls. Funding: GlaxoSmithKline Biologicals SA. Disclosures T. Nolan, GSK: Research Contractor and Scientific Advisor, Research grant. Pfizer: Research Contractor, Research grant. M. O’Ryan, GSK: Investigator, Research support. F. De Looze, GSK: Investigator and Research Contractor, Research grant and Research support. H. Marshall, Pfizer: Grant Investigator and Investigator, Research grant. GSK: Grant Investigator and Investigator, Research grant. P. Richmond, GSK: Grant Investigator and Scientific Advisor, Grant recipient. S. Henein, SKDS Research Inc.: Investigator, Research payment. K. Heaton, Devonshire Clinical Research Inc.: Investigator, Research payment. M. Ferguson, GSK: Investigator, Salary from independent research clinic,CRG. D. D’Agostino, GSK: Employee, Salary. D. Toneatto, GSK: Employee and Shareholder, Salary.

scholarly journals Persistence of Bactericidal Activity at 4 Years After 2 Primary Doses of a Recombinant, 4-Component, Meningococcal Serogroup B Vaccine (4CMenB) and Response to a Booster Dose in Adolescents and Young Adults

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S322-S322 ◽  
Author(s):  
Terry Nolan ◽  
Hartley Garfield ◽  
Anil Gupta ◽  
Murdo Ferguson ◽  
Helen Marshall ◽  
...  
Keyword(s):  
Young Adults ◽  
Immune Responses ◽  
Bactericidal Activity ◽  
Booster Dose ◽  
Geometric Mean ◽  
Primary Vaccination ◽  
Adolescents And Young Adults ◽  
Open Label ◽  
Antibody Levels ◽  
Research Grant

Abstract Background This phase 3b, open label, controlled, multi-center, extension study (NCT02446743) assessed the persistence of bactericidal activity at 4 years post-primary vaccination with a recombinant, 4-component, meningococcal serogroup B vaccine (4CMenB) in adolescents who participated in the parent study NCT01423084 and their response to a booster dose, compared with that in vaccine-naïve healthy controls. Methods Adolescents and young adults previously primed with 4CMenB (2 doses; following a 0,1-month schedule) in study NCT01423084 (group 3B) and vaccine-naïve 15–22 year olds (group B0_1) were enrolled. Group 3B received a booster dose of 4CMenB at 4 years post-primary vaccination; group B0_1 received 2 catch-up doses of 4CMenB (following a 0,1-month schedule). Antibody persistence (primary objective) was evaluated at 4 years post-primary vaccination (in group 3B) vs. baseline (in group B0_1) using human serum bactericidal assay (hSBA), in terms of geometric mean titer (GMT) and percentage (%) of individuals with hSBA titer at least 4. Immune responses at 1 month after booster dose (in group 3B) vs. those at 1 month after first dose (in group B0_1) were also assessed. Results In group 3B, antibody levels declined from 1 month to 4 years post-primary vaccination against all antigens except NHBA, but were higher than in group B0_1 at baseline (Table), with a GMT ratio ≥1.3 and a difference in % of individuals with hSBA titer at least 4 of ≥9%. After one dose of 4CMenB (booster in 3B or first dose in B0_1), GMTs increased (≥4.6-fold in group 3B; ≥2.3-fold in group B0_1), and ≥94% of participants in group 3B and ≥41% of participants in group B0_1 had hSBA titer at least 4 (Table). Conclusion Antibody levels in adolescents and young adults primed with 4CMenB waned over time but were higher at 4 years post-primary vaccination than for vaccine-naïve individuals at baseline. A booster dose of 4CMenB in vaccine-primed individuals elicited higher immune responses than one dose of 4CMenB in vaccine-naïve individuals. The research was supported by GlaxoSmithKline Biologicals SA. Disclosures T. Nolan, GSK group of companies: Research Contractor and Scientific Advisor, Research grant. Pfizer: Research Contractor, Research grant. H. Garfield, Novartis/GSK group of companies: Investigator, Research support. A. Gupta, Novartis/GSK group of companies: Investigator, payment for research-related activities; M. Ferguson, GSK group of companies: Investigator, I receive salary from CRG. CRG has contracts with GSK. H. Marshall, GSK group of companies: Grant Investigator and Investigator, Research grant. Pfizer: Grant Investigator and Investigator, Research grant; sanofi pasteur: Grant Investigator, Research grant. Novavax: Investigator, Research grant. D. D’Agostino, GSK group of companies: Consultant, Consulting fee. D. Toneatto, GSK group of companies: Employee, Salary.

scholarly journals Hepatitis B Virus Antibody Levels 7 to 9 Years after Booster Vaccination in Alaska Native Persons

2014 ◽  
Vol 21 (9) ◽  
pp. 1339-1342 ◽  
Author(s):  
James W. Keck ◽  
Lisa R. Bulkow ◽  
Gregory A. Raczniak ◽  
Susan E. Negus ◽  
Carolyn L. Zanis ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Alaska Native ◽  
Hepatitis B Surface Antigen ◽  
Booster Vaccination ◽  
Primary Vaccination ◽  
Antibody Persistence ◽  
Vaccine Booster ◽  
Almost All ◽  
Antigen Antibody ◽  
Antibody Levels

ABSTRACTHepatitis B antibody persistence was assessed in individuals who had previously received a vaccine booster. We measured hepatitis B surface antigen antibody (anti-HBs) levels 7 to 9 years post-hepatitis B booster in individuals with primary vaccination at birth. While 95 (91.3%) of 104 participants had detectable anti-HBs (minimum, 0.1 mIU/ml; maximum, 1,029 mIU/ml), only 43 (41%) had protective levels of ≥10 mIU/ml. Pre- and week 4 postbooster anti-HBs levels were significant predictors of hepatitis B immunity at follow-up (P< 0.001). Almost all participants had detectable anti-HBs 7 to 9 years after the hepatitis B vaccine booster, but less than half had levels ≥10 mIU/ml.

scholarly journals Four-year antibody persistence and response to a booster dose of a pentavalent MenABCWY vaccine administered to healthy adolescents and young adults

2018 ◽  
Vol 14 (5) ◽  
pp. 1161-1174 ◽  
Author(s):  
Xavier Sáez-Llorens ◽  
Johnny Beltran-Rodriguez ◽  
Jose M. Novoa Pizarro ◽  
Ilhem Mensi ◽  
Pavitra Keshavan ◽  
...  
Keyword(s):  
Young Adults ◽  
Booster Dose ◽  
Adolescents And Young Adults ◽  
Antibody Persistence

scholarly journals 120. An open-label comparative trial of SUBA-itraconazole (SUBA) versus conventional itraconazole (c-itra) for treatment of proven and probable endemic mycoses (MSG-15): a pharmacokinetic (PK) and adverse Event (AE) analysis

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S72-S72
Author(s):  
Peter G Pappas ◽  
Andrej Spec ◽  
Marisa Miceli ◽  
Gerald McGwin ◽  
Rachel McMullen ◽  
...  
Keyword(s):  
Research Study ◽  
Scientific Research ◽  
Panel Member ◽  
Serum Levels ◽  
Research Support ◽  
Open Label ◽  
Review Panel ◽  
Study Investigator ◽  
Endemic Mycoses ◽  
Research Grant

Abstract Background C-itra is the drug of choice for treatment of most non-CNS, non-life-threatening forms of endemic mycoses (EM), including histoplasmosis, blastomycosis, coccidioidomycosis, sporotrichosis and talaromycosis. SUBA represents a new formulation of itraconazole that utilizes nanotechnology to improve bioavailability when administered orally. SUBA is formulated as nanoparticles allowing for absorption in the small bowel while not relying on gastric acidity for optimal absorption. MSG-15 is an open-label, comparative clinical trial comparing SUBA to c-itra for the treatment of EM. Herein we report the final PK and AE profiles of these two compounds. Methods Subjects with proven and probable EM were eligible this open-label comparative study. The protocol allowed up to 14 d of prior therapy with any antifungal for this episode of EM. Subjects were randomized to receive either SUBA 130 mg po bid or c-itra 200 mg po bid for up to 6 months. Follow up occurred at 7, 14, 28, 42, 84 and 180 d post-enrollment. PK samples were obtained at 7, 14, and 42 d. Clinical assessment, including symptom assessment, AEs, overall drug tolerance, and quality of life were assessed at each visit. We used descriptive statistics for this analysis. Results 89 subjects with EM entered the trial, including 43 on SUBA and 46 on c-itra. We measured PK serum levels of itra and hydroxyl-itra at days 7, 14, and 42 and these data are depicted in Figures 1-3. There were no significant differences in these levels, including combined itra/hydroxyl-itra levels, among the two study arms. AUC for itra and hydroxyl-itra were similar for both arms. AEs as assessed at each study evaluation were also quite similar among the two study arms. Overall, any AE occurred in 74% vs 85% of SUBA and c-itra recipients, respectively (NS). Drug-related AEs occurred in 35% vs 41% of SUBA and itra recipients, respectively (NS). Most common drug-related AEs included cardiovascular (edema and hypertension), nausea and loss of appetite. Combined Itraconazole and Hydroxy-itraconazole Concentration Over Time Conclusion Compared to c-itra, SUBA demonstrates almost identical serum levels despite being dosed at roughly 60% standard dosing for c-itra (130 mg po bid vs 200 mg po bid). SUBA is slightly better tolerated than c-itra, although the specific AEs are similar. Disclosures Peter G. Pappas, MD, Astellas (Research Grant or Support)Cidara (Research Grant or Support)F2G (Consultant)Matinas (Consultant, Scientific Research Study Investigator)Mayne Pharma (Research Grant or Support)Scynexis (Research Grant or Support) Andrej Spec, MD, MSCI, Mayne Pharma (Grant/Research Support) Marisa Miceli, MD, SCYNEXIS, Inc. (Advisor or Review Panel member) George R. R. Thompson III, III, MD, Amplyx (Consultant, Grant/Research Support)Appili (Consultant)Astellas (Consultant, Grant/Research Support)Avir (Grant/Research Support)Cidara (Consultant, Grant/Research Support)F2G (Consultant, Grant/Research Support)Mayne (Consultant, Grant/Research Support)Merck (Scientific Research Study Investigator)Pfizer (Advisor or Review Panel member)

scholarly journals IMMUNOGENIC RESPONSE WITH EFFICACY OF CERTAIN GUMBORO VACCINES IN BROILER

2012 ◽  
Vol 3 (1) ◽  
pp. 07-12
Author(s):  
MT Islam ◽  
MA Samad ◽  
MI Hossain
Keyword(s):  
Antibody Titre ◽  
Broiler Chickens ◽  
Booster Dose ◽  
Animal Health ◽  
Research Work ◽  
Booster Vaccination ◽  
Primary Vaccination ◽  
Challenge Infection ◽  
Unvaccinated Control ◽  
Immunogenic Response

The research work was carried out to determine the immunogenic response with efficacy of six commercial Gumboro, vaccines (Nobilis® Gumboro D78 and Nobilis® Gumboro 228E, Intervet, The Netherlands; Bur-706®, Merial, France; TAD Gumboro vac® and TAD Gumboro vac forte®, Lohmann Animal Health, Germany; BursaplexTM, Merial Select, Inc. Gainesville, USA) under experimental condition in broiler chickens during the period from November 2002 to May 2003. The chickens of two groups were vaccinated with Nobilis® Gumboro D78 and Nobilis® Gumboro 228E at 14 days of age with a booster dose at 21 days of age and were challenged at 40 days of age with vvIBDV. TAD Gumboro vac® and TAD Gumboro vac forte® were inoculated into the two groups of chickens at 14 and 28 days of age and the chickens were challenged at 35 days of age with vvIBDV. Bur-706® vaccine was given to the chickens of another group at one-day-old and 14 days of age and the chickens were challenged at 28 days of age. One group of chickens was vaccinated with Bursaplex™ vaccine at 1-day-old with no booster dose and was challenged at 21 days of age. The percentage of protection in birds receiving Nobilis® Gumboro D78 and Nobilis® Gumboro 228E vaccines by intraocular route was 92.30 and 96.29 respectively, whereas the percentages of protection in birds receiving TAD Gumboro vac®, TAD Gumboro, vac forte® and Bur-706® vaccines were 95.65, 100 and 95.83 respectively. BursaplxTM provided 100% protection against challenge with vvIBDV. Chickens vaccinated with Nobilis® Gumboro D78, Nobilis® Gumboro 228E, TAD Gumboro vac®, and Bur-706®, showed significant (p < 0.05, p < 0.01) decrease in ELISA antibody titre up to the day of challenge infection. BursaplexTM vaccinated group also showed significant decrease in ELISA antibody titre by 7 days (p < 0.05) and by 14 and 21 days (p < 0.01) after primary vaccination. In case of TAD Gumboro vac forte®, 7 days (839 ± 219.34) and 14 days (258 ± 44.80) after primary vaccination, the ELISA antibody titre significantly (p < 0.01) decreased but 7 days after booster vaccination, the ELISA antibody titre significantly (p < 0.01) increased (1299 ± 37.51). All the control sera revealed significant (p < 0.01) decrease of ELISA antibody titre up to day of challenge infection. There was an insignificant increase in ELISA antibody titre 7 days after booster vaccination in case of unvaccinated control groups for TAD Gumboro vac® and TAD Gumboro vac forte® only. Nobilis® Gumboro D78, TAD Gumboro vac® and Bur-706® vaccinated groups revealed significant (p < 0.01) increase of ELISA antibody titre 7 days post-challenge while Nobilis® Gumboro 228E and BursaplexTM vaccinated groups showed significant (p < 0.05) increase of antibody titre after 7 days of challenge. Insignificant increase of antibody titre was recorded in TAD Gumboro vac forte® vaccinated group. It may be concluded that TAD Gumboro vac forte® (intermediate plus) and BursaplexTM (Merial Select, Inc. Gainesville, USA) can be used to immunize the broiler birds sufficiently against IBD. However, it is necessary to estimate the optimum vaccination timing, i.e., to determine when maternal antibodies in chicks will decline to levels that the vaccines can overcome.

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