Trial Outcomes & Findings for Assessing Durable Antibody Response to HPV Vaccination (NCT NCT05031078)
NCT ID: NCT05031078
Last Updated: 2025-10-23
Results Overview
Determining the number of participants with a minimum four-fold rise in post-vaccination HPV-16 and HPV-18 neutralizing antibody titers determined using an HPV pseudovirus neutralization assay
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
30 days after receiving the third and final vaccine dose (approximately Day 210 after first vaccine dose)
Results posted on
2025-10-23
Participant Flow
Participant milestones
| Measure |
Group 1: Lymph Node Sampling at D-30 to D0, D14 and D30
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Group 1 will undergo an FNA at D-30 to D0. Participants will repeat the procedure at D14±5 and D30±5.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
Group 2: Lymph Node Sampling at D60, D74 and D90
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Participants will undergo an FNA on the same day, but prior to, the second vaccine dose (D60±5; Visit 8) or up to 5 days before. Participants will repeat the procedure at Visit 8 + 14±5 days and Visit 8 + 30±5 days.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
Group 3: Lymph Node Sampling at D180, D194 and D210
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Group 3 will undergo an FNA on the same day, but prior to, the third vaccine dose (D180±5; Visit 13) or up to 5 days before. Participants will repeat the procedure at Visit 13 + 14±5 days and Visit 13 + 30±5 days.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
5
|
4
|
|
Overall Study
COMPLETED
|
8
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Lymph Node Sampling at D-30 to D0, D14 and D30
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Group 1 will undergo an FNA at D-30 to D0. Participants will repeat the procedure at D14±5 and D30±5.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
Group 2: Lymph Node Sampling at D60, D74 and D90
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Participants will undergo an FNA on the same day, but prior to, the second vaccine dose (D60±5; Visit 8) or up to 5 days before. Participants will repeat the procedure at Visit 8 + 14±5 days and Visit 8 + 30±5 days.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
Group 3: Lymph Node Sampling at D180, D194 and D210
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Group 3 will undergo an FNA on the same day, but prior to, the third vaccine dose (D180±5; Visit 13) or up to 5 days before. Participants will repeat the procedure at Visit 13 + 14±5 days and Visit 13 + 30±5 days.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Assessing Durable Antibody Response to HPV Vaccination
Baseline characteristics by cohort
| Measure |
Group 1: Lymph Node Sampling at D-30 to D0, D14 and D30
n=8 Participants
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Group 1 will undergo an FNA at D-30 to D0. Participants will repeat the procedure at D14±5 and D30±5.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
Group 2: Lymph Node Sampling at D60, D74 and D90
n=5 Participants
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Participants will undergo an FNA on the same day, but prior to, the second vaccine dose (D60±5; Visit 8) or up to 5 days before. Participants will repeat the procedure at Visit 8 + 14±5 days and Visit 8 + 30±5 days.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
Group 3: Lymph Node Sampling at D180, D194 and D210
n=4 Participants
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Group 3 will undergo an FNA on the same day, but prior to, the third vaccine dose (D180±5; Visit 13) or up to 5 days before. Participants will repeat the procedure at Visit 13 + 14±5 days and Visit 13 + 30±5 days.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
29.4 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
17 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 days after receiving the third and final vaccine dose (approximately Day 210 after first vaccine dose)Population: Participants that completed the primary outcome (n = 16) were included.
Determining the number of participants with a minimum four-fold rise in post-vaccination HPV-16 and HPV-18 neutralizing antibody titers determined using an HPV pseudovirus neutralization assay
Outcome measures
| Measure |
Group 1: Lymph Node Sampling at D-30 to D0, D14 and D30
n=8 Participants
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Group 1 will undergo an FNA at D-30 to D0. Participants will repeat the procedure at D14±5 and D30±5.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
Group 2: Lymph Node Sampling at D60, D74 and D90
n=4 Participants
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Participants will undergo an FNA on the same day, but prior to, the second vaccine dose (D60±5; Visit 8) or up to 5 days before. Participants will repeat the procedure at Visit 8 + 14±5 days and Visit 8 + 30±5 days.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
Group 3: Lymph Node Sampling at D180, D194 and D210
n=4 Participants
Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
Group 3 will undergo an FNA on the same day, but prior to, the third vaccine dose (D180±5; Visit 13) or up to 5 days before. Participants will repeat the procedure at Visit 13 + 14±5 days and Visit 13 + 30±5 days.
Bone marrow sampling will be done for all groups at D730 and D1825.
Gardasil-9: Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180.
The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.
Lidocaine injections: 1-2% lidocaine injections.
1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.
|
|---|---|---|---|
|
Number of Participants With a Minimum Four-fold Rise in Post-vaccination HPV-16 and HPV-18 Neutralizing Antibody Titers
|
8 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 30, Day 180, Day 210, Day 365, Day 730 post-interventionMagnitude of HPV specific Bmem responses will be assessed at baseline and following 9-valent HPV vaccination Baseline (Day 0), Day 30, Day 180, Day 210, Day 365, Day 730
Outcome measures
Outcome data not reported
Adverse Events
Group 1: Lymph Node Sampling at D-30 to D0, D14 and D30
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Lymph Node Sampling at D60, D74 and D90
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: Lymph Node Sampling at D180, D194 and D210
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