Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-02 @ 4:25 PM
Study NCT ID:
NCT02968420
Status:
COMPLETED
Last Update Posted:
2021-06-25
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634046', 'term': 'Human Papillomavirus Recombinant Vaccine nonavalent'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msadarangani@bcchr.ubc.ca', 'phone': '604-875-2422', 'title': 'Dr. Manish Sadarangani', 'organization': 'Vaccine Evaluation Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected at Day 7 (+/-1) and Day 30 (+/-3) following booster dose.', 'description': 'Provincially reportable and serious adverse events only were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3', 'description': 'Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'B Memory Cell Response (% of Memory B Cells That Are Antigen-specific)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}], 'classes': [{'title': 'HPV16', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '0.23', 'groupId': 'OG002'}]}]}, {'title': 'HPV18', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the B memory cell populations between girls that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose after 120 months', 'unitOfMeasure': '% of memory B cells that are Ag-specific', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasmablast Response (% of All B Cells That Are Plasmablasts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.37', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '3.14', 'spread': '3.53', 'groupId': 'OG001'}, {'value': '5.37', 'spread': '6.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the plasmablast populations between girls that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose after 120 months', 'unitOfMeasure': '% of all B cells that are plasmablasts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Variable Gene Usage (Comparison of the Nucleotide Sequences of Antigen-specific Antibody Heavy and Light Chain Variable Region Sequences)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}], 'timeFrame': 'At Day 7 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the extent of somatic hypermutation and the variable gene usage between girls that received either a primary 2 or 3 dose series', 'reportingStatus': 'POSTED', 'populationDescription': 'The extent of somatic hypermutation was planned by comparing the nucleotide sequences of the heavy and light chain variable region sequences of each antibody cloned in this study to germ line sequences of these genes in public databases. This was not possible due to insufficient quality of DNA for sequencing.'}, {'type': 'SECONDARY', 'title': 'Serum Antibody Response (cLIA) - Geometric Mean Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}], 'classes': [{'title': 'HPV6', 'categories': [{'measurements': [{'value': '338', 'groupId': 'OG000', 'lowerLimit': '111', 'upperLimit': '1027'}, {'value': '1864', 'groupId': 'OG001', 'lowerLimit': '1411', 'upperLimit': '2461'}, {'value': '699', 'groupId': 'OG002', 'lowerLimit': '129', 'upperLimit': '3780'}]}]}, {'title': 'HPV11', 'categories': [{'measurements': [{'value': '1277', 'groupId': 'OG000', 'lowerLimit': '592', 'upperLimit': '2753'}, {'value': '5071', 'groupId': 'OG001', 'lowerLimit': '2361', 'upperLimit': '10892'}, {'value': '3807', 'groupId': 'OG002', 'lowerLimit': '1096', 'upperLimit': '13224'}]}]}, {'title': 'HPV16', 'categories': [{'measurements': [{'value': '4922', 'groupId': 'OG000', 'lowerLimit': '1765', 'upperLimit': '13731'}, {'value': '15237', 'groupId': 'OG001', 'lowerLimit': '6966', 'upperLimit': '33328'}, {'value': '10122', 'groupId': 'OG002', 'lowerLimit': '3475', 'upperLimit': '29481'}]}]}, {'title': 'HPV18', 'categories': [{'measurements': [{'value': '855', 'groupId': 'OG000', 'lowerLimit': '461', 'upperLimit': '1585'}, {'value': '2140', 'groupId': 'OG001', 'lowerLimit': '897', 'upperLimit': '5105'}, {'value': '807', 'groupId': 'OG002', 'lowerLimit': '305', 'upperLimit': '2134'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the serum antibody responses (cLIA) to HPV 6, 11, 16 \\& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose', 'unitOfMeasure': 'antibody titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Antibody Response (cLIA) - Geometric Mean Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}], 'classes': [{'title': 'HPV6', 'categories': [{'measurements': [{'value': '1313', 'groupId': 'OG000', 'lowerLimit': '376', 'upperLimit': '4586'}, {'value': '2722', 'groupId': 'OG001', 'lowerLimit': '1472', 'upperLimit': '5033'}, {'value': '815', 'groupId': 'OG002', 'lowerLimit': '135', 'upperLimit': '4924'}]}]}, {'title': 'HPV11', 'categories': [{'measurements': [{'value': '3430', 'groupId': 'OG000', 'lowerLimit': '1418', 'upperLimit': '8299'}, {'value': '6042', 'groupId': 'OG001', 'lowerLimit': '3255', 'upperLimit': '11214'}, {'value': '5778', 'groupId': 'OG002', 'lowerLimit': '2919', 'upperLimit': '11439'}]}]}, {'title': 'HPV16', 'categories': [{'measurements': [{'value': '21135', 'groupId': 'OG000', 'lowerLimit': '11337', 'upperLimit': '39399'}, {'value': '21768', 'groupId': 'OG001', 'lowerLimit': '11797', 'upperLimit': '40170'}, {'value': '18930', 'groupId': 'OG002', 'lowerLimit': '11126', 'upperLimit': '32208'}]}]}, {'title': 'HPV18', 'categories': [{'measurements': [{'value': '3326', 'groupId': 'OG000', 'lowerLimit': '1197', 'upperLimit': '9245'}, {'value': '2615', 'groupId': 'OG001', 'lowerLimit': '1033', 'upperLimit': '6620'}, {'value': '1312', 'groupId': 'OG002', 'lowerLimit': '676', 'upperLimit': '2548'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the serum antibody responses (cLIA) to HPV 6, 11, 16 \\& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose', 'unitOfMeasure': 'antibody titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Antibody Response (Total IgG) - Geometric Mean Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}], 'classes': [{'title': 'HPV6', 'categories': [{'measurements': [{'value': '1263', 'groupId': 'OG000', 'lowerLimit': '437', 'upperLimit': '3650'}, {'value': '6079', 'groupId': 'OG001', 'lowerLimit': '3682', 'upperLimit': '10036'}, {'value': '3712', 'groupId': 'OG002', 'lowerLimit': '1036', 'upperLimit': '13302'}]}]}, {'title': 'HPV11', 'categories': [{'measurements': [{'value': '1009', 'groupId': 'OG000', 'lowerLimit': '308', 'upperLimit': '3306'}, {'value': '5184', 'groupId': 'OG001', 'lowerLimit': '2644', 'upperLimit': '10164'}, {'value': '3371', 'groupId': 'OG002', 'lowerLimit': '947', 'upperLimit': '11997'}]}]}, {'title': 'HPV16', 'categories': [{'measurements': [{'value': '4715', 'groupId': 'OG000', 'lowerLimit': '1358', 'upperLimit': '16368'}, {'value': '10962', 'groupId': 'OG001', 'lowerLimit': '3489', 'upperLimit': '34438'}, {'value': '7607', 'groupId': 'OG002', 'lowerLimit': '1379', 'upperLimit': '41972'}]}]}, {'title': 'HPV18', 'categories': [{'measurements': [{'value': '1418', 'groupId': 'OG000', 'lowerLimit': '450', 'upperLimit': '4473'}, {'value': '3694', 'groupId': 'OG001', 'lowerLimit': '1522', 'upperLimit': '8964'}, {'value': '946', 'groupId': 'OG002', 'lowerLimit': '296', 'upperLimit': '3026'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the serum antibody responses (total IgG) to HPV 6, 11, 16 \\& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose', 'unitOfMeasure': 'antibody titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Antibody Response (Total IgG) - Geometric Mean Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}], 'classes': [{'title': 'HPV6', 'categories': [{'measurements': [{'value': '4579', 'groupId': 'OG000', 'lowerLimit': '1930', 'upperLimit': '10865'}, {'value': '7308', 'groupId': 'OG001', 'lowerLimit': '4781', 'upperLimit': '11172'}, {'value': '7371', 'groupId': 'OG002', 'lowerLimit': '3757', 'upperLimit': '14460'}]}]}, {'title': 'HPV11', 'categories': [{'measurements': [{'value': '3234', 'groupId': 'OG000', 'lowerLimit': '1016', 'upperLimit': '10297'}, {'value': '6637', 'groupId': 'OG001', 'lowerLimit': '3810', 'upperLimit': '11559'}, {'value': '6271', 'groupId': 'OG002', 'lowerLimit': '3309', 'upperLimit': '11884'}]}]}, {'title': 'HPV16', 'categories': [{'measurements': [{'value': '25808', 'groupId': 'OG000', 'lowerLimit': '10472', 'upperLimit': '63603'}, {'value': '32051', 'groupId': 'OG001', 'lowerLimit': '18808', 'upperLimit': '54618'}, {'value': '12364', 'groupId': 'OG002', 'lowerLimit': '2957', 'upperLimit': '51689'}]}]}, {'title': 'HPV18', 'categories': [{'measurements': [{'value': '6363', 'groupId': 'OG000', 'lowerLimit': '2371', 'upperLimit': '17082'}, {'value': '4985', 'groupId': 'OG001', 'lowerLimit': '1737', 'upperLimit': '14304'}, {'value': '1813', 'groupId': 'OG002', 'lowerLimit': '805', 'upperLimit': '4082'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the serum antibody responses (total IgG) to HPV 6, 11, 16 \\& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose', 'unitOfMeasure': 'antibody titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'FG002', 'title': 'Group 3', 'description': 'Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'BG002', 'title': 'Group 3', 'description': 'Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.\n\nHuman Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.05', 'spread': '.89', 'groupId': 'BG000'}, {'value': '21.95', 'spread': '1.66', 'groupId': 'BG001'}, {'value': '30.02', 'spread': '3.34', 'groupId': 'BG002'}, {'value': '24.67', 'spread': '4.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Chinese', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Other/mixed', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.60', 'spread': '18.03', 'groupId': 'BG000'}, {'value': '72.25', 'spread': '26.51', 'groupId': 'BG001'}, {'value': '73.75', 'spread': '15.40', 'groupId': 'BG002'}, {'value': '73.53', 'spread': '19.31', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.37', 'spread': '6.69', 'groupId': 'BG000'}, {'value': '24.23', 'spread': '6.15', 'groupId': 'BG001'}, {'value': '25.63', 'spread': '3.42', 'groupId': 'BG002'}, {'value': '25.74', 'spread': '5.42', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-19', 'size': 330692, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-06T14:29', 'hasProtocol': True}, {'date': '2019-03-15', 'size': 273107, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-23T18:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-23', 'studyFirstSubmitDate': '2016-08-19', 'resultsFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-23', 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'B Memory Cell Response (% of Memory B Cells That Are Antigen-specific)', 'timeFrame': 'At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the B memory cell populations between girls that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose after 120 months'}, {'measure': 'Plasmablast Response (% of All B Cells That Are Plasmablasts)', 'timeFrame': 'At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the plasmablast populations between girls that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose after 120 months'}], 'secondaryOutcomes': [{'measure': 'Variable Gene Usage (Comparison of the Nucleotide Sequences of Antigen-specific Antibody Heavy and Light Chain Variable Region Sequences)', 'timeFrame': 'At Day 7 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the extent of somatic hypermutation and the variable gene usage between girls that received either a primary 2 or 3 dose series'}, {'measure': 'Serum Antibody Response (cLIA) - Geometric Mean Titer', 'timeFrame': 'At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the serum antibody responses (cLIA) to HPV 6, 11, 16 \\& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose'}, {'measure': 'Serum Antibody Response (cLIA) - Geometric Mean Titer', 'timeFrame': 'At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the serum antibody responses (cLIA) to HPV 6, 11, 16 \\& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose'}, {'measure': 'Serum Antibody Response (Total IgG) - Geometric Mean Titer', 'timeFrame': 'At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the serum antibody responses (total IgG) to HPV 6, 11, 16 \\& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose'}, {'measure': 'Serum Antibody Response (Total IgG) - Geometric Mean Titer', 'timeFrame': 'At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine', 'description': 'To compare the serum antibody responses (total IgG) to HPV 6, 11, 16 \\& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Papillomavirus']}, 'referencesModule': {'references': [{'pmid': '17499406', 'type': 'BACKGROUND', 'citation': 'Olsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, Iversen OE, Hoye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, von Krogh G, Lehtinen M, Paavonen J, Tamms GM, Giacoletti K, Lupinacci L, Esser MT, Vuocolo SC, Saah AJ, Barr E. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine. 2007 Jun 21;25(26):4931-9. doi: 10.1016/j.vaccine.2007.03.049. Epub 2007 Apr 20.'}, {'pmid': '39914257', 'type': 'DERIVED', 'citation': 'Carter JJ, Smith RA, Scherer EM, Skibinski DAG, Sankaranarayanan S, Luxembourg A, Kollmann T, Marty KD, Sadarangani M, Dobson S, Galloway DA. Term immune memory responses to human papillomavirus (HPV) vaccination following 2 versus 3 doses of HPV vaccine. Vaccine. 2025 Mar 19;50:126817. doi: 10.1016/j.vaccine.2025.126817. Epub 2025 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to further understand the memory response to HPV vaccination in subjects who have received 2 versus 3 doses of quadrivalent HPV vaccine. Although memory responses can be detected shortly after immunization, the best approach to measure the long-lasting anamnestic response is to challenge with a booster dose years (\\> 5) after the original exposure.', 'detailedDescription': 'This is a single center, interventional study to evaluate long term memory response to Q-HPV vaccination and to natural infection. Memory response will be assessed by measuring seroprotection 8-10 years post Q-HPV vaccination and to challenge with a booster dose years after the original exposure to measure the long-lasting anamnestic response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent provided by the participant.\n* Participant whom the investigator believes can and will comply with the requirements of the protocol.\n* General good health.\n* Immunized with Q-HPV vaccine between the ages of 9-13 or 16 to 26 years on the BCGov01 study or the BC provincial program.\n* Participant who is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study. Examples of effective methods of birth control include:\n\n * Abstinence (no sexual activity)\n * Hormonal contraceptives including oral, injectable, implants \\& skin patches\n * Intrauterine device (IUD)\n * Male partner sterilization\n * Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository)\n * Male condom combined with a female diaphragm, whether with or without a vaginal spermicide (foam, gel, cream, or suppository)\n * Adequate contraception does not apply to participants with same sex partners, when this is their preferred and usual lifestyle\n\nExclusion Criteria:\n\n* Received more than 3 doses of Q-HPV vaccine\n* Received any doses of HPV9 vaccine\n* Systemic hypersensitivity to Q-HPV vaccine or HPV9 vaccine or severe reaction to any previous dose of Q-HPV vaccine.\n* Receipt of blood or blood product within 3 months prior to Visit 1.\n* Receipt of a live vaccine within 28 days or an inactive vaccine within 14 days of Visit 1\n* Immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months prior to Visit 1.\n* Inadequate participant fluency in English to provide fully informed consent.\n* Participant who is currently pregnant or planning a pregnancy during the course of the trial'}, 'identificationModule': {'nctId': 'NCT02968420', 'acronym': 'Merck08', 'briefTitle': 'Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Long Term Immune Memory Responses to Human Papillomavirus (HPV) Vaccination Following 2 Verses 3 Doses of Quadrivalent HPV Vaccine', 'orgStudyIdInfo': {'id': 'H16-00700'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.', 'interventionNames': ['Biological: Human Papillomavirus 9-valent Vaccine, Recombinant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.', 'interventionNames': ['Biological: Human Papillomavirus 9-valent Vaccine, Recombinant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.', 'interventionNames': ['Biological: Human Papillomavirus 9-valent Vaccine, Recombinant']}], 'interventions': [{'name': 'Human Papillomavirus 9-valent Vaccine, Recombinant', 'type': 'BIOLOGICAL', 'otherNames': ['Gardasil9'], 'description': 'All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4H4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Vaccine Evaluation Center, BC Children's Hospital Research Institute", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Tobi Kollmann, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vaccine Evaluation Center, University of British Columbia'}, {'name': 'Manish Sadarangani, BM BCh DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vaccine Evaluation Center, University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'If IPD is required, please contact the study team for further discussions- any sharing will be dependent on alignment with original informed consent obtained from study participants and in agreement with the study team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Canada Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Manish Sadarangani', 'investigatorAffiliation': 'University of British Columbia'}}}}