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Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults

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ClinicalTrials.gov Identifier: NCT03541499
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
This is a randomized, partially blind, placebo controlled, clinical trial evaluating a single intranasal dose of BPZE1 in healthy adults. The study will evaluate a lyophilized formulation of the product, with the goal of testing for the optimal dose for subsequent clinical trials. Fifty healthy adults, 18-49 years of age will be randomized to one of the four following treatment groups in a 3:3:3:1 ratio: 10^7 colony forming units (CFU) of BPZE1 administered by VaxINator device, 10^9 CFU of BPZE1 administered by VaxINator device, placebo administered by VaxINator device, 10^9 CFU of BPZE1 administered by needleless tuberculin syringe. Study duration will be approximately 12 months with a subject participation duration of approximately 6 months. The primary objective of this study is to assess the safety and tolerability of a single intranasal dose of either 10^7 or 10^9 CFU of lyophilized BPZE1 vaccine.

Condition or disease Intervention/treatment Phase
Pertussis Pertussis Immunisation Biological: BPZE1 Other: Placebo Phase 2

Detailed Description:
This is a phase 2a, single center, randomized, partially blind, placebo controlled, clinical trial evaluating a single intranasal dose of either 10^7 colony forming units (CFU) or 10^9 CFU of BPZE1 in healthy adults. The study will evaluate a lyophilized formulation of the product, with the goal of testing for the optimal dose for subsequent clinical trials. Fifty healthy adults, 18-49 years of age will be randomized to one of the four following treatment groups in a 3:3:3:1 ratio: 10^7 CFU of BPZE1 administered by VaxINator device, 10^9 CFU of BPZE1 administered by VaxINator device, placebo administered by VaxINator device, 10^9 CFU of BPZE1 administered by needleless tuberculin syringe. Study duration will be approximately 12 months with a subject participation duration of approximately 6 months. The primary objective of this study is to assess the safety and tolerability of a single intranasal dose of either 10^7 or 10^9 CFU of lyophilized BPZE1 vaccine. The secondary objectives of this study are: 1) to assess the humoral immunogenicity of lyophilized BPZE1 vaccine at Day 15, Day 29 and Day 181 following receipt of one intranasal dose of 10^7 or 10^9 CFU of BPZE1; 2) to assess mucosal immunogenicity of lyophilized BPZE1 vaccine at Day 29 and Day 181 following receipt of one intranasal dose of 10^7 or 10^9 CFU of BPZE1; 3) to evaluate nasal clearance of BPZE1 by culture at Day 29 (and if still positive, at Day 46) following receipt of one intranasal dose of lyophilized BPZE1 vaccine of 10^7 or 10^9 CFU of BPZE1.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2A Partially-Blind Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Live Attenuated, Intranasal B. Pertussis Vaccine (BPZE1) in Healthy Adults
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Whooping Cough

Arm Intervention/treatment
Experimental: Group 1
800 microliters (10^7 CFU) of B. pertussis vaccine (BPZE1) administered intranasally with the VaxINator device on Day 1, n=15
Biological: BPZE1
Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of either 10^7 colony forming units (CFU) or 10^9 CFU.

Experimental: Group 2
800 microliters (10^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1, n=15
Biological: BPZE1
Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of either 10^7 colony forming units (CFU) or 10^9 CFU.

Placebo Comparator: Group 3
800 microliters of Placebo administered intranasally with the VaxINator device on Day 1, n=15
Other: Placebo
The placebo consists of the same constituents in the same quantities as the BPZE1 investigational vaccines, absent the attenuated B. pertussis cells, reconstituted with sterile water for injection (SWFI).

Experimental: Group 4
800 microliters (10^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1, n=5
Biological: BPZE1
Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of either 10^7 colony forming units (CFU) or 10^9 CFU.




Primary Outcome Measures :
  1. Occurrence of adverse events of special interest [ Time Frame: Day 1 through Day 29 ]
  2. Occurrence of new onset chronic medical conditions (NOCMCs) [ Time Frame: Day 1 through Day 181 ]
  3. Occurrence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 181 ]
  4. Occurrence of solicited local reactogenicity [ Time Frame: Day 1 through Day 15 ]
  5. Occurrence of solicited systemic reactogenicity [ Time Frame: Day 1 through Day 15 ]
  6. Occurrence of unsolicited non-serious adverse events [ Time Frame: Day 1 through Day 29 ]

Secondary Outcome Measures :
  1. Fold rise of the ratio of filamentous hemagglutinin-specific IgA (FHA-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 through Day 181 ]
  2. Fold rise of the ratio of filamentous hemagglutinin-specific IgA (FHA-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 through Day 29 ]
  3. Fold rise of the ratio of fimbriae-specific IgA (FIM-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 through Day 181 ]
  4. Fold rise of the ratio of fimbriae-specific IgA (FIM-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 through Day 29 ]
  5. Fold rise of the ratio of pertactin-specific IgA (PRN-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 through Day 181 ]
  6. Fold rise of the ratio of pertactin-specific IgA (PRN-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 through Day 29 ]
  7. Fold rise of the ratio of pertussis toxin-specific IgA (PT-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 through Day 181 ]
  8. Fold rise of the ratio of pertussis toxin-specific IgA (PT-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 through Day 29 ]
  9. Geometric mean fold rise (GMFR) by serum IgA ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 1 ]
  10. Geometric mean fold rise (GMFR) by serum IgA ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 15 ]
  11. Geometric mean fold rise (GMFR) by serum IgA ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 181 ]
  12. Geometric mean fold rise (GMFR) by serum IgA ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 29 ]
  13. Geometric mean fold rise (GMFR) by serum IgA ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 1 ]
  14. Geometric mean fold rise (GMFR) by serum IgA ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 15 ]
  15. Geometric mean fold rise (GMFR) by serum IgA ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 181 ]
  16. Geometric mean fold rise (GMFR) by serum IgA ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 29 ]
  17. Geometric mean fold rise (GMFR) by serum IgA ELISA to pertactin (PRN) [ Time Frame: Day 1 ]
  18. Geometric mean fold rise (GMFR) by serum IgA ELISA to pertactin (PRN) [ Time Frame: Day 15 ]
  19. Geometric mean fold rise (GMFR) by serum IgA ELISA to pertactin (PRN) [ Time Frame: Day 181 ]
  20. Geometric mean fold rise (GMFR) by serum IgA ELISA to pertactin (PRN) [ Time Frame: Day 29 ]
  21. Geometric mean fold rise (GMFR) by serum IgA ELISA to pertussis toxin (PT) [ Time Frame: Day 1 ]
  22. Geometric mean fold rise (GMFR) by serum IgA ELISA to pertussis toxin (PT) [ Time Frame: Day 15 ]
  23. Geometric mean fold rise (GMFR) by serum IgA ELISA to pertussis toxin (PT) [ Time Frame: Day 181 ]
  24. Geometric mean fold rise (GMFR) by serum IgA ELISA to pertussis toxin (PT) [ Time Frame: Day 29 ]
  25. Geometric mean fold rise (GMFR) by serum IgG ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 1 ]
  26. Geometric mean fold rise (GMFR) by serum IgG ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 15 ]
  27. Geometric mean fold rise (GMFR) by serum IgG ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 181 ]
  28. Geometric mean fold rise (GMFR) by serum IgG ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 29 ]
  29. Geometric mean fold rise (GMFR) by serum IgG ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 1 ]
  30. Geometric mean fold rise (GMFR) by serum IgG ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 15 ]
  31. Geometric mean fold rise (GMFR) by serum IgG ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 181 ]
  32. Geometric mean fold rise (GMFR) by serum IgG ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 29 ]
  33. Geometric mean fold rise (GMFR) by serum IgG ELISA to pertactin (PRN) [ Time Frame: Day 1 ]
  34. Geometric mean fold rise (GMFR) by serum IgG ELISA to pertactin (PRN) [ Time Frame: Day 15 ]
  35. Geometric mean fold rise (GMFR) by serum IgG ELISA to pertactin (PRN) [ Time Frame: Day 181 ]
  36. Geometric mean fold rise (GMFR) by serum IgG ELISA to pertactin (PRN) [ Time Frame: Day 29 ]
  37. Geometric mean fold rise (GMFR) by serum IgG ELISA to pertussis toxin (PT) [ Time Frame: Day 1 ]
  38. Geometric mean fold rise (GMFR) by serum IgG ELISA to pertussis toxin (PT) [ Time Frame: Day 15 ]
  39. Geometric mean fold rise (GMFR) by serum IgG ELISA to pertussis toxin (PT) [ Time Frame: Day 181 ]
  40. Geometric mean fold rise (GMFR) by serum IgG ELISA to pertussis toxin (PT) [ Time Frame: Day 29 ]
  41. Geometric mean titer ratios (GMTRs) of filamentous hemagglutinin-specific IgA (FHA-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 ]
  42. Geometric mean titer ratios (GMTRs) of filamentous hemagglutinin-specific IgA (FHA-IgA) to total IgA by nasal aspirate [ Time Frame: Day 181 ]
  43. Geometric mean titer ratios (GMTRs) of filamentous hemagglutinin-specific IgA (FHA-IgA) to total IgA by nasal aspirate [ Time Frame: Day 29 ]
  44. Geometric mean titer ratios (GMTRs) of fimbriae-specific IgA (FIM-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 ]
  45. Geometric mean titer ratios (GMTRs) of fimbriae-specific IgA (FIM-IgA) to total IgA by nasal aspirate [ Time Frame: Day 181 ]
  46. Geometric mean titer ratios (GMTRs) of fimbriae-specific IgA (FIM-IgA) to total IgA by nasal aspirate [ Time Frame: Day 29 ]
  47. Geometric mean titer ratios (GMTRs) of pertactin-specific IgA (PRN-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 ]
  48. Geometric mean titer ratios (GMTRs) of pertactin-specific IgA (PRN-IgA) to total IgA by nasal aspirate [ Time Frame: Day 181 ]
  49. Geometric mean titer ratios (GMTRs) of pertactin-specific IgA (PRN-IgA) to total IgA by nasal aspirate [ Time Frame: Day 29 ]
  50. Geometric mean titer ratios (GMTRs) of pertussis toxin-specific IgA (PT-IgA) to total IgA by nasal aspirate [ Time Frame: Day 0 ]
  51. Geometric mean titer ratios (GMTRs) of pertussis toxin-specific IgA (PT-IgA) to total IgA by nasal aspirate [ Time Frame: Day 181 ]
  52. Geometric mean titer ratios (GMTRs) of pertussis toxin-specific IgA (PT-IgA) to total IgA by nasal aspirate [ Time Frame: Day 29 ]
  53. Geometric mean titers (GMTs) by serum IgA ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 1 ]
  54. Geometric mean titers (GMTs) by serum IgA ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 15 ]
  55. Geometric mean titers (GMTs) by serum IgA ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 181 ]
  56. Geometric mean titers (GMTs) by serum IgA ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 29 ]
  57. Geometric mean titers (GMTs) by serum IgA ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 1 ]
  58. Geometric mean titers (GMTs) by serum IgA ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 15 ]
  59. Geometric mean titers (GMTs) by serum IgA ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 181 ]
  60. Geometric mean titers (GMTs) by serum IgA ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 29 ]
  61. Geometric mean titers (GMTs) by serum IgA ELISA to pertactin (PRN) [ Time Frame: Day 1 ]
  62. Geometric mean titers (GMTs) by serum IgA ELISA to pertactin (PRN) [ Time Frame: Day 15 ]
  63. Geometric mean titers (GMTs) by serum IgA ELISA to pertactin (PRN) [ Time Frame: Day 181 ]
  64. Geometric mean titers (GMTs) by serum IgA ELISA to pertactin (PRN) [ Time Frame: Day 29 ]
  65. Geometric mean titers (GMTs) by serum IgA ELISA to pertussis toxin (PT) [ Time Frame: Day 1 ]
  66. Geometric mean titers (GMTs) by serum IgA ELISA to pertussis toxin (PT) [ Time Frame: Day 15 ]
  67. Geometric mean titers (GMTs) by serum IgA ELISA to pertussis toxin (PT) [ Time Frame: Day 181 ]
  68. Geometric mean titers (GMTs) by serum IgA ELISA to pertussis toxin (PT) [ Time Frame: Day 29 ]
  69. Geometric mean titers (GMTs) by serum IgG ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 1 ]
  70. Geometric mean titers (GMTs) by serum IgG ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 15 ]
  71. Geometric mean titers (GMTs) by serum IgG ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 181 ]
  72. Geometric mean titers (GMTs) by serum IgG ELISA to filamentous hemagglutinin (FHA) [ Time Frame: Day 29 ]
  73. Geometric mean titers (GMTs) by serum IgG ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 1 ]
  74. Geometric mean titers (GMTs) by serum IgG ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 15 ]
  75. Geometric mean titers (GMTs) by serum IgG ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 181 ]
  76. Geometric mean titers (GMTs) by serum IgG ELISA to fimbriae 2/3 (FIM 2/3) [ Time Frame: Day 29 ]
  77. Geometric mean titers (GMTs) by serum IgG ELISA to pertactin (PRN) [ Time Frame: Day 1 ]
  78. Geometric mean titers (GMTs) by serum IgG ELISA to pertactin (PRN) [ Time Frame: Day 15 ]
  79. Geometric mean titers (GMTs) by serum IgG ELISA to pertactin (PRN) [ Time Frame: Day 181 ]
  80. Geometric mean titers (GMTs) by serum IgG ELISA to pertactin (PRN) [ Time Frame: Day 29 ]
  81. Geometric mean titers (GMTs) by serum IgG ELISA to pertussis toxin (PT) [ Time Frame: Day 15 ]
  82. Geometric mean titers (GMTs) by serum IgG ELISA to pertussis toxin (PT) [ Time Frame: Day 181 ]
  83. Geometric mean titers (GMTs) by serum IgG ELISA to pertussis toxin (PT) [ Time Frame: Day 29 ]
  84. Geometric mean titers (GMTs) by serum IgG ELISA to pertussis toxin (PT) [ Time Frame: Day1 ]
  85. Proportion of subjects achieving seroconversion by serum IgA ELISA to one or more pertussis antigens [ Time Frame: Day 1 through Day 181 ]
  86. Proportion of subjects achieving seroconversion by serum IgA ELISA to one or more pertussis antigens [ Time Frame: Day 15 ]
  87. Proportion of subjects achieving seroconversion by serum IgA ELISA to one or more pertussis antigens [ Time Frame: Day 181 ]
  88. Proportion of subjects achieving seroconversion by serum IgA ELISA to one or more pertussis antigens [ Time Frame: Day 29 ]
  89. Proportion of subjects achieving seroconversion by serum IgA ELISA to two or more pertussis antigens [ Time Frame: Day 1 through Day 181 ]
  90. Proportion of subjects achieving seroconversion by serum IgA ELISA to two or more pertussis antigens [ Time Frame: Day 15 ]
  91. Proportion of subjects achieving seroconversion by serum IgA ELISA to two or more pertussis antigens [ Time Frame: Day 181 ]
  92. Proportion of subjects achieving seroconversion by serum IgA ELISA to two or more pertussis antigens [ Time Frame: Day 29 ]
  93. Proportion of subjects achieving seroconversion by serum IgG ELISA to one or more pertussis antigens [ Time Frame: Day 1 through Day 181 ]
  94. Proportion of subjects achieving seroconversion by serum IgG ELISA to one or more pertussis antigens [ Time Frame: Day 15 ]
  95. Proportion of subjects achieving seroconversion by serum IgG ELISA to one or more pertussis antigens [ Time Frame: Day 181 ]
  96. Proportion of subjects achieving seroconversion by serum IgG ELISA to one or more pertussis antigens [ Time Frame: Day 29 ]
  97. Proportion of subjects achieving seroconversion by serum IgG ELISA to two or more pertussis antigens [ Time Frame: Day 1 through Day 181 ]
  98. Proportion of subjects achieving seroconversion by serum IgG ELISA to two or more pertussis antigens [ Time Frame: Day 15 ]
  99. Proportion of subjects achieving seroconversion by serum IgG ELISA to two or more pertussis antigens [ Time Frame: Day 181 ]
  100. Proportion of subjects achieving seroconversion by serum IgG ELISA to two or more pertussis antigens [ Time Frame: Day 29 ]
  101. Proportion of subjects that achieve seroconversion (> / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to at least 1 B. pertussis vaccine antigen by nasal aspirate IgA ELISA [ Time Frame: Day 0 through Day 181 ]
  102. Proportion of subjects that achieve seroconversion (> / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to at least 1 B. pertussis vaccine antigen by nasal aspirate IgA ELISA [ Time Frame: Day 0 through Day 29 ]
  103. Proportion of subjects with detectable B. pertussis from nasopharyngeal cultures [ Time Frame: Day 29 ]
  104. Proportion of subjects with detectable B. pertussis from nasopharyngeal cultures who were B. pertussis positive at Day 29 [ Time Frame: Day 46 ]
  105. Ratio of filamentous hemagglutinin-specific IgA (FHA-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 0 ]
  106. Ratio of filamentous hemagglutinin-specific IgA (FHA-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 181 ]
  107. Ratio of filamentous hemagglutinin-specific IgA (FHA-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 29 ]
  108. Ratio of fimbriae-specific IgA (FIM-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 0 ]
  109. Ratio of fimbriae-specific IgA (FIM-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 181 ]
  110. Ratio of fimbriae-specific IgA (FIM-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 29 ]
  111. Ratio of pertactin-specific IgA (PRN-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 0 ]
  112. Ratio of pertactin-specific IgA (PRN-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 181 ]
  113. Ratio of pertactin-specific IgA (PRN-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 29 ]
  114. Ratio of pertussis toxin-specific IgA (PT-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 0 ]
  115. Ratio of pertussis toxin-specific IgA (PT-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 181 ]
  116. Ratio of pertussis toxin-specific IgA (PT-IgA) ELISA to total IgA by nasal aspirate [ Time Frame: Day 29 ]
  117. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to filamentous hemagglutinin (FHA) by serum IgA ELISA [ Time Frame: Day 1 through Day 181 ]
  118. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to filamentous hemagglutinin (FHA) by serum IgA ELISA [ Time Frame: Day 15 ]
  119. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to filamentous hemagglutinin (FHA) by serum IgA ELISA [ Time Frame: Day 181 ]
  120. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to filamentous hemagglutinin (FHA) by serum IgA ELISA [ Time Frame: Day 29 ]
  121. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to filamentous hemagglutinin (FHA) by serum IgG ELISA [ Time Frame: Day 1 through Day 181 ]
  122. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to filamentous hemagglutinin (FHA) by serum IgG ELISA [ Time Frame: Day 15 ]
  123. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to filamentous hemagglutinin (FHA) by serum IgG ELISA [ Time Frame: Day 181 ]
  124. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to filamentous hemagglutinin (FHA) by serum IgG ELISA [ Time Frame: Day 29 ]
  125. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to fimbriae 2/3 (FIM 2/3) by serum IgA ELISA [ Time Frame: Day 1 through Day 181 ]
  126. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to fimbriae 2/3 (FIM 2/3) by serum IgA ELISA [ Time Frame: Day 15 ]
  127. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to fimbriae 2/3 (FIM 2/3) by serum IgA ELISA [ Time Frame: Day 181 ]
  128. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to fimbriae 2/3 (FIM 2/3) by serum IgA ELISA [ Time Frame: Day 29 ]
  129. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to fimbriae 2/3 (FIM 2/3) by serum IgG ELISA [ Time Frame: Day 1 through Day 181 ]
  130. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to fimbriae 2/3 (FIM 2/3) by serum IgG ELISA [ Time Frame: Day 15 ]
  131. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to fimbriae 2/3 (FIM 2/3) by serum IgG ELISA [ Time Frame: Day 181 ]
  132. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to fimbriae 2/3 (FIM 2/3) by serum IgG ELISA [ Time Frame: Day 29 ]
  133. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertactin (PRN) by serum IgA ELISA [ Time Frame: Day 1 through Day 181 ]
  134. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertactin (PRN) by serum IgA ELISA [ Time Frame: Day 15 ]
  135. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertactin (PRN) by serum IgA ELISA [ Time Frame: Day 181 ]
  136. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertactin (PRN) by serum IgA ELISA [ Time Frame: Day 29 ]
  137. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertactin (PRN) by serum IgG ELISA [ Time Frame: Day 1 through Day 181 ]
  138. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertactin (PRN) by serum IgG ELISA [ Time Frame: Day 15 ]
  139. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertactin (PRN) by serum IgG ELISA [ Time Frame: Day 181 ]
  140. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertactin (PRN) by serum IgG ELISA [ Time Frame: Day 29 ]
  141. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertussis toxin (PT) by serum IgA ELISA [ Time Frame: Day 1 through Day 181 ]
  142. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertussis toxin (PT) by serum IgA ELISA [ Time Frame: Day 15 ]
  143. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertussis toxin (PT) by serum IgA ELISA [ Time Frame: Day 181 ]
  144. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertussis toxin (PT) by serum IgA ELISA [ Time Frame: Day 29 ]
  145. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertussis toxin (PT) by serum IgG ELISA [ Time Frame: Day 1 through Day 181 ]
  146. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertussis toxin (PT) by serum IgG ELISA [ Time Frame: Day 15 ]
  147. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertussis toxin (PT) by serum IgG ELISA [ Time Frame: Day 181 ]
  148. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise from baseline) to pertussis toxin (PT) by serum IgG ELISA [ Time Frame: Day 29 ]
  149. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to filamentous hemagglutinin (FHA) by nasal aspirate IgA ELISA [ Time Frame: Day 0 through Day 181 ]
  150. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to filamentous hemagglutinin (FHA) by nasal aspirate IgA ELISA [ Time Frame: Day 181 ]
  151. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to filamentous hemagglutinin (FHA) by nasal aspirate IgA ELISA [ Time Frame: Day 29 ]
  152. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to fimbriae 2/3 (FIM 2/3) by nasal aspirate IgA ELISA [ Time Frame: Day 0 through Day 181 ]
  153. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to fimbriae 2/3 (FIM 2/3) by nasal aspirate IgA ELISA [ Time Frame: Day 181 ]
  154. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to fimbriae 2/3 (FIM 2/3) by nasal aspirate IgA ELISA [ Time Frame: Day 29 ]
  155. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to pertactin (PRN) by nasal aspirate IgA ELISA [ Time Frame: Day 0 through Day 181 ]
  156. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to pertactin (PRN) by nasal aspirate IgA ELISA [ Time Frame: Day 181 ]
  157. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to pertactin (PRN) by nasal aspirate IgA ELISA [ Time Frame: Day 29 ]
  158. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to pertussis toxin (PT) by nasal aspirate IgA ELISA [ Time Frame: Day 0 through Day 181 ]
  159. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to pertussis toxin (PT) by nasal aspirate IgA ELISA [ Time Frame: Day 181 ]
  160. The proportion of subjects that achieve seroconversion (defined as > / = 2-fold rise of the ratio of antigen-specific IgA to total IgA from baseline) to pertussis toxin (PT) by nasal aspirate IgA ELISA [ Time Frame: Day 29 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects eligible to participate in this study must meet all inclusion criteria:

  1. Provide written informed consent prior to initiation of any study procedures.
  2. Able to understand and comply with planned study procedures and be available for all study visits.
  3. Males or non-pregnant females, 18-49 years of age, inclusive.
  4. In good health*.

    *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days that would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days. This includes no change in chronic prescription medication, dose, or frequency because of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, if it is in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes after enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical and inhaled medications (with the exception of inhaled or nasal corticosteroids within 30 days prior to enrollment), herbals, vitamins, and supplements are permitted.

  5. Oral temperature is < / = 100 degrees Fahrenheit.
  6. Pulse is 45 to 100 bpm, inclusive*. *Pulse can be 45 to 50 bpm, inclusive, if no other symptoms are present. Otherwise, pulse should be 50-100 bpm.
  7. Systolic blood pressure is 85 to 150 mm Hg, inclusive.
  8. Diastolic blood pressure is 55 to 95 mm Hg, inclusive.
  9. White blood cell count is 3,900 cells/microliter or greater*.

    *Abnormalities in white blood count, hemoglobin, platelet count, alanine aminotransferase, and serum creatinine that are suspected to be due to laboratory anomalies may be repeated once to ensure accuracy; additionally, otherwise eligible subjects with grade 1 abnormalities in these values may be considered for enrollment if, in the opinion of the investigator (or clinician on the 1572), the abnormalities are not clinically significant and do not pose additional risk to the study or the volunteer.

  10. Hemoglobin is 13.0 g/dL or greater (men) or 11.8 g/dL or greater (women)*. *Abnormalities in white blood count, hemoglobin, platelet count, alanine aminotransferase, and serum creatinine that are suspected to be due to laboratory anomalies may be repeated once to ensure accuracy; additionally, otherwise eligible subjects with grade 1 abnormalities in these values may be considered for enrollment if, in the opinion of the investigator (or clinician on the 1572), the abnormalities are not clinically significant and do not pose additional risk to the study or the volunteer.
  11. Platelet count is 135,000 cells/microliter or greater*.

    *Abnormalities in white blood count, hemoglobin, platelet count, alanine aminotransferase, and serum creatinine that are suspected to be due to laboratory anomalies may be repeated once to ensure accuracy; additionally, otherwise eligible subjects with grade 1 abnormalities in these values may be considered for enrollment if, in the opinion of the investigator (or clinician on the 1572), the abnormalities are not clinically significant and do not pose additional risk to the study or the volunteer.

  12. Alanine aminotransferase is < 45 U/L (women) or 62 U/L (men)*.

    *Abnormalities in white blood count, hemoglobin, platelet count, alanine aminotransferase, and serum creatinine that are suspected to be due to laboratory anomalies may be repeated once to ensure accuracy; additionally, otherwise eligible subjects with grade 1 abnormalities in these values may be considered for enrollment if, in the opinion of the investigator (or clinician on the 1572), the abnormalities are not clinically significant and do not pose additional risk to the study or the volunteer.

  13. Serum creatinine is < / = 1.25 mg/dL (men) or 1.11 mg/dL (women)*.

    *Abnormalities in white blood count, hemoglobin, platelet count, alanine aminotransferase, and serum creatinine that are suspected to be due to laboratory anomalies may be repeated once to ensure accuracy; additionally, otherwise eligible subjects with grade 1 abnormalities in these values may be considered for enrollment if, in the opinion of the investigator (or clinician on the 1572), the abnormalities are not clinically significant and do not pose additional risk to the study or the volunteer.

  14. Negative serum HIV antibody assay.
  15. Women of childbearing potential* must use an acceptable contraception method** from 30 days before study vaccination until 60 days after vaccination.

    *Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or < 1 year has passed since the last menses if menopausal.

    • Includes non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving study vaccination, barrier methods such as condoms or diaphragms/cervical caps with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
  16. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.

Exclusion Criteria:

  1. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
  2. Have known or suspected active chronic autoinflammatory condition.
  3. Have known active neoplastic disease (excluding non-melanoma skin cancer) or a history of any hematologic malignancy.
  4. Have a history of persistent asthma, major anatomic nasopharyngeal abnormality, or sinus polyp disease due to chronic sinusitis*.

    *If a patient has a history of nasopharyngeal surgery such as, but not limited to rhinoplasty, tonsillectomy or sinus surgery, adequate healing time per the judgement of the investigator must occur prior to enrollment.

  5. Have known hepatitis B or hepatitis C infection.
  6. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
  7. Currently untreated or clinically unstable (in the opinion of the investigator) schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
  8. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
  9. Have received corticosteroids (including oral, parenteral, inhaled, nasal, or intra-articular) of any dose within 30 days prior to study vaccination.
  10. Individual with PT serum IgG antibodies > / = 20 IU/mL and / or PRN serum IgG antibodies > / = 125 IU/ml.
  11. Unwilling to refrain from smoking tobacco for 28 days post vaccination.
  12. Receipt of immunoglobulin or blood derived products within 90 days of enrollment.
  13. Receipt of a vaccine against pertussis in the past 2 years.
  14. Receipt of a live vaccine within 30 days of study vaccination or an inactivated vaccine within 14 days of study vaccination.
  15. Planned vaccination with a licensed vaccine within 28 days of study vaccination.
  16. History of severe allergic reaction (e.g., anaphylaxis) or Bell's palsy, or Guillain-Barre syndrome, after a previous dose of any diphtheria toxoid-tetanus toxoid-, or pertussis-containing vaccine, or encephalopathy within 7 days of administration of a previous pertussis containing vaccine.
  17. History of a progressive neurologic disorder.
  18. In close contact* with children less than 1 year of age or contact with persons with known immunocompromising conditions.

    *Close contact includes sharing a household, serving as a healthcare worker, or working professionally in settings with repeated exposures.

  19. Receipt of B. pertussis-active antibiotics* within 7 days prior to vaccination.

    *B. pertussis active antibiotics include macrolides, fluoroquinolones, trimethoprim-sulfamethoxazole, tetracyclines.

  20. Known hypersensitivity to any component of the study vaccine.
  21. Hypersensitivity to azithromycin, which may be used in the event of ongoing BPZE1 colonization.
  22. Any condition that, in the opinion of the investigator, might interfere with objectives of the study or safety to the individual.
  23. Acute illness, including temperature > 100 degrees Fahrenheit within one week prior to vaccination*.

    • Enrollment may be postponed if acute illness occurs; subjects must remain within the screening window, however, and must be rescreened if > 30 days elapses prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541499


Contacts
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Contact: Clarence Buddy Creech 16159362186 buddy.creech@vumc.org

Locations
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United States, Tennessee
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center Recruiting
Nashville, Tennessee, United States, 37232-2573
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03541499     History of Changes
Other Study ID Numbers: 17-0010
HHSN272201300023I
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: September 26, 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
B. pertussis Vaccine
BPZE1
Immunogenicity
Safety
Additional relevant MeSH terms:
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Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs