Trial Outcomes & Findings for Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine (NCT NCT02968420)
NCT ID: NCT02968420
Last Updated: 2021-06-25
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
Results posted on
2021-06-25
Participant Flow
Participant milestones
| Measure |
Group 1
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 2
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 3
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine
Baseline characteristics by cohort
| Measure |
Group 1
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 2
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 3
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.05 years
STANDARD_DEVIATION .89 • n=5 Participants
|
21.95 years
STANDARD_DEVIATION 1.66 • n=7 Participants
|
30.02 years
STANDARD_DEVIATION 3.34 • n=5 Participants
|
24.67 years
STANDARD_DEVIATION 4.41 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other/mixed
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Weight
|
74.60 kg
STANDARD_DEVIATION 18.03 • n=5 Participants
|
72.25 kg
STANDARD_DEVIATION 26.51 • n=7 Participants
|
73.75 kg
STANDARD_DEVIATION 15.40 • n=5 Participants
|
73.53 kg
STANDARD_DEVIATION 19.31 • n=4 Participants
|
|
BMI
|
27.37 Kg/m^2
STANDARD_DEVIATION 6.69 • n=5 Participants
|
24.23 Kg/m^2
STANDARD_DEVIATION 6.15 • n=7 Participants
|
25.63 Kg/m^2
STANDARD_DEVIATION 3.42 • n=5 Participants
|
25.74 Kg/m^2
STANDARD_DEVIATION 5.42 • n=4 Participants
|
PRIMARY outcome
Timeframe: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccineTo 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
Outcome measures
| Measure |
Group 1
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 2
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 3
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
|---|---|---|---|
|
B Memory Cell Response (% of Memory B Cells That Are Antigen-specific)
HPV16
|
0.61 % of memory B cells that are Ag-specific
Standard Deviation 0.49
|
0.94 % of memory B cells that are Ag-specific
Standard Deviation 0.94
|
0.36 % of memory B cells that are Ag-specific
Standard Deviation 0.23
|
|
B Memory Cell Response (% of Memory B Cells That Are Antigen-specific)
HPV18
|
0.08 % of memory B cells that are Ag-specific
Standard Deviation 0.18
|
0.11 % of memory B cells that are Ag-specific
Standard Deviation 0.13
|
0.03 % of memory B cells that are Ag-specific
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccineTo 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
Outcome measures
| Measure |
Group 1
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 2
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 3
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
|---|---|---|---|
|
Plasmablast Response (% of All B Cells That Are Plasmablasts)
|
2.37 % of all B cells that are plasmablasts
Standard Deviation 2.51
|
3.14 % of all B cells that are plasmablasts
Standard Deviation 3.53
|
5.37 % of all B cells that are plasmablasts
Standard Deviation 6.46
|
SECONDARY outcome
Timeframe: At Day 7 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccinePopulation: 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.
To compare the extent of somatic hypermutation and the variable gene usage between girls that received either a primary 2 or 3 dose series
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccineTo 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
Outcome measures
| Measure |
Group 1
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 2
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 3
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
|---|---|---|---|
|
Serum Antibody Response (cLIA) - Geometric Mean Titer
HPV6
|
338 antibody titer
Interval 111.0 to 1027.0
|
1864 antibody titer
Interval 1411.0 to 2461.0
|
699 antibody titer
Interval 129.0 to 3780.0
|
|
Serum Antibody Response (cLIA) - Geometric Mean Titer
HPV11
|
1277 antibody titer
Interval 592.0 to 2753.0
|
5071 antibody titer
Interval 2361.0 to 10892.0
|
3807 antibody titer
Interval 1096.0 to 13224.0
|
|
Serum Antibody Response (cLIA) - Geometric Mean Titer
HPV16
|
4922 antibody titer
Interval 1765.0 to 13731.0
|
15237 antibody titer
Interval 6966.0 to 33328.0
|
10122 antibody titer
Interval 3475.0 to 29481.0
|
|
Serum Antibody Response (cLIA) - Geometric Mean Titer
HPV18
|
855 antibody titer
Interval 461.0 to 1585.0
|
2140 antibody titer
Interval 897.0 to 5105.0
|
807 antibody titer
Interval 305.0 to 2134.0
|
SECONDARY outcome
Timeframe: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccineTo 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
Outcome measures
| Measure |
Group 1
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 2
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 3
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
|---|---|---|---|
|
Serum Antibody Response (cLIA) - Geometric Mean Titer
HPV6
|
1313 antibody titer
Interval 376.0 to 4586.0
|
2722 antibody titer
Interval 1472.0 to 5033.0
|
815 antibody titer
Interval 135.0 to 4924.0
|
|
Serum Antibody Response (cLIA) - Geometric Mean Titer
HPV11
|
3430 antibody titer
Interval 1418.0 to 8299.0
|
6042 antibody titer
Interval 3255.0 to 11214.0
|
5778 antibody titer
Interval 2919.0 to 11439.0
|
|
Serum Antibody Response (cLIA) - Geometric Mean Titer
HPV16
|
21135 antibody titer
Interval 11337.0 to 39399.0
|
21768 antibody titer
Interval 11797.0 to 40170.0
|
18930 antibody titer
Interval 11126.0 to 32208.0
|
|
Serum Antibody Response (cLIA) - Geometric Mean Titer
HPV18
|
3326 antibody titer
Interval 1197.0 to 9245.0
|
2615 antibody titer
Interval 1033.0 to 6620.0
|
1312 antibody titer
Interval 676.0 to 2548.0
|
SECONDARY outcome
Timeframe: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccineTo 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
Outcome measures
| Measure |
Group 1
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 2
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 3
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
|---|---|---|---|
|
Serum Antibody Response (Total IgG) - Geometric Mean Titer
HPV6
|
1263 antibody titer
Interval 437.0 to 3650.0
|
6079 antibody titer
Interval 3682.0 to 10036.0
|
3712 antibody titer
Interval 1036.0 to 13302.0
|
|
Serum Antibody Response (Total IgG) - Geometric Mean Titer
HPV11
|
1009 antibody titer
Interval 308.0 to 3306.0
|
5184 antibody titer
Interval 2644.0 to 10164.0
|
3371 antibody titer
Interval 947.0 to 11997.0
|
|
Serum Antibody Response (Total IgG) - Geometric Mean Titer
HPV16
|
4715 antibody titer
Interval 1358.0 to 16368.0
|
10962 antibody titer
Interval 3489.0 to 34438.0
|
7607 antibody titer
Interval 1379.0 to 41972.0
|
|
Serum Antibody Response (Total IgG) - Geometric Mean Titer
HPV18
|
1418 antibody titer
Interval 450.0 to 4473.0
|
3694 antibody titer
Interval 1522.0 to 8964.0
|
946 antibody titer
Interval 296.0 to 3026.0
|
SECONDARY outcome
Timeframe: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccineTo 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
Outcome measures
| Measure |
Group 1
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 2
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
Group 3
n=6 Participants
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.
Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
|
|---|---|---|---|
|
Serum Antibody Response (Total IgG) - Geometric Mean Titer
HPV6
|
4579 antibody titer
Interval 1930.0 to 10865.0
|
7308 antibody titer
Interval 4781.0 to 11172.0
|
7371 antibody titer
Interval 3757.0 to 14460.0
|
|
Serum Antibody Response (Total IgG) - Geometric Mean Titer
HPV11
|
3234 antibody titer
Interval 1016.0 to 10297.0
|
6637 antibody titer
Interval 3810.0 to 11559.0
|
6271 antibody titer
Interval 3309.0 to 11884.0
|
|
Serum Antibody Response (Total IgG) - Geometric Mean Titer
HPV16
|
25808 antibody titer
Interval 10472.0 to 63603.0
|
32051 antibody titer
Interval 18808.0 to 54618.0
|
12364 antibody titer
Interval 2957.0 to 51689.0
|
|
Serum Antibody Response (Total IgG) - Geometric Mean Titer
HPV18
|
6363 antibody titer
Interval 2371.0 to 17082.0
|
4985 antibody titer
Interval 1737.0 to 14304.0
|
1813 antibody titer
Interval 805.0 to 4082.0
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place