Trial Outcomes & Findings for Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients (NCT NCT03036930)

Last Updated: 2025-12-30

Results Overview

An estimate of the Human papillomavirus (HPV) vaccine-type-specific seroconversion rate provided along with exact Clopper-Pearson 95% confidence intervals (CIs). All participants who received a kidney transplant were included in the primary endpoint analysis, regardless of whether the last vaccine dose was administered ≥ 30 days prior to transplantation.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

At 12 months post-transplant

Results posted on

2025-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Prevention (Gardasil 9 HPV Vaccine) Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study. Biospecimen Collection: Undergo collection of blood samples HPV Self-Collection: Undergo self-collection of vaginal/cervical samples Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
Overall Study STARTED	51
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Prevention (Gardasil 9 HPV Vaccine) Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study. Biospecimen Collection: Undergo collection of blood samples HPV Self-Collection: Undergo self-collection of vaginal/cervical samples Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	3
Overall Study Not eligible to receive transplant within 12 months	15

Baseline Characteristics

Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prevention (Gardasil 9 HPV Vaccine) n=51 Participants Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study. Biospecimen Collection: Undergo collection of blood samples HPV Self-Collection: Undergo self-collection of vaginal/cervical samples Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
Age, Continuous	40 years n=174 Participants
Sex: Female, Male Female	21 Participants n=174 Participants
Sex: Female, Male Male	30 Participants n=174 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=174 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=174 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=174 Participants
Race (NIH/OMB) Asian	10 Participants n=174 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants
Race (NIH/OMB) Black or African American	12 Participants n=174 Participants
Race (NIH/OMB) White	26 Participants n=174 Participants
Race (NIH/OMB) More than one race	0 Participants n=174 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=174 Participants
Region of Enrollment United States	51 Participants n=174 Participants
Number of Gardasil 9 Doses Before Kidney Transplant One	5 Participants n=174 Participants
Number of Gardasil 9 Doses Before Kidney Transplant Two	14 Participants n=174 Participants
Number of Gardasil 9 Doses Before Kidney Transplant Three	13 Participants n=174 Participants
Number of Gardasil 9 Doses Before Kidney Transplant No Transplant	19 Participants n=174 Participants

PRIMARY outcome

Timeframe: At 12 months post-transplant

Population: Participants with HPV labs available 12 months post-transplant.

Outcome measures

Outcome measures
Measure	Prevention (Gardasil 9 HPV Vaccine) n=20 Participants Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study. Biospecimen Collection: Undergo collection of blood samples HPV Self-Collection: Undergo self-collection of vaginal/cervical samples Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM	Two Pre-Transplant Doses Kidney transplant recipients who received 2 doses of the HPV vaccine ≥ 30 days prior to transplantation.	Three Pre-Transplant Doses Kidney transplant recipients who received 3 doses of the HPV vaccine ≥ 30 days prior to transplantation.	Overall Pre-Transplants Doses Kidney transplant recipients who receive ≥ 1 doses of the HPV vaccine ≥ 30 days prior to transplantation.
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. HPV 18	65 percentage of participants Interval 40.8 to 84.6	—	—	—
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. HPV 6	70 percentage of participants Interval 45.7 to 88.1	—	—	—
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. HPV 11	95 percentage of participants Interval 75.1 to 99.9	—	—	—
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. HPV 16	90 percentage of participants Interval 68.3 to 98.8	—	—	—
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. HPV 31	90 percentage of participants Interval 68.3 to 98.8	—	—	—
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. HPV 33	90 percentage of participants Interval 68.3 to 98.8	—	—	—
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. HPV 45	50 percentage of participants Interval 27.2 to 72.8	—	—	—
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. HPV 52	45 percentage of participants Interval 23.1 to 68.5	—	—	—
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. HPV 58	85 percentage of participants Interval 62.1 to 96.8	—	—	—
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. HPV All 9 Subtypes	25 percentage of participants Interval 8.7 to 49.1	—	—	—
HPV Vaccine-type-specific Seroconversion Rates Among Kidney Transplant Recipients Who Received ≥ 1 Doses of the Vaccine. HPV ≥ 1 Subtype	95 percentage of participants Interval 75.1 to 99.9	—	—	—

SECONDARY outcome

Timeframe: At 6-months post-transplant

Population: Participants with HPV labs available 6 months post-transplant.

An estimate of the HPV vaccine-type-specific seroconversion rates at 6-months post-transplantation stratified by number of doses (1, 2, or 3) of the vaccine given pre-transplant was provided along with 95% confidence intervals (CIs). Clopper-Pearson CIs were provided for the overall and stratified estimates.

Outcome measures

Outcome measures
Measure	Prevention (Gardasil 9 HPV Vaccine) n=3 Participants Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study. Biospecimen Collection: Undergo collection of blood samples HPV Self-Collection: Undergo self-collection of vaginal/cervical samples Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM	Two Pre-Transplant Doses n=10 Participants Kidney transplant recipients who received 2 doses of the HPV vaccine ≥ 30 days prior to transplantation.	Three Pre-Transplant Doses n=10 Participants Kidney transplant recipients who received 3 doses of the HPV vaccine ≥ 30 days prior to transplantation.	Overall Pre-Transplants Doses n=23 Participants Kidney transplant recipients who receive ≥ 1 doses of the HPV vaccine ≥ 30 days prior to transplantation.
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 6	100 percentage of participants Interval 43.9 to 100.0	30 percentage of participants Interval 10.8 to 60.3	90 percentage of participants Interval 59.6 to 98.2	65.2 percentage of participants Interval 42.7 to 83.6
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 11	100 percentage of participants Interval 43.9 to 100.0	70 percentage of participants Interval 39.2 to 89.2	100 percentage of participants Interval 72.2 to 100.0	87 percentage of participants Interval 66.4 to 97.2
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 16	100 percentage of participants Interval 43.9 to 100.0	90 percentage of participants Interval 59.6 to 98.2	100 percentage of participants Interval 72.2 to 100.0	95.7 percentage of participants Interval 78.1 to 99.9
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 18	66.7 percentage of participants Interval 20.8 to 93.9	70 percentage of participants Interval 39.7 to 89.2	80 percentage of participants Interval 49.0 to 94.3	73.9 percentage of participants Interval 51.6 to 89.9
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 31	66.7 percentage of participants Interval 20.8 to 93.9	80 percentage of participants Interval 49.0 to 94.3	90 percentage of participants Interval 59.6 to 98.2	82.6 percentage of participants Interval 61.2 to 95.0
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 33	66.7 percentage of participants Interval 20.8 to 93.9	90 percentage of participants Interval 59.6 to 98.2	90 percentage of participants Interval 59.6 to 98.2	87 percentage of participants Interval 66.4 to 97.2
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 45	66.7 percentage of participants Interval 20.8 to 93.9	20 percentage of participants Interval 5.7 to 51.0	90 percentage of participants Interval 59.6 to 98.2	56.5 percentage of participants Interval 34.5 to 76.8
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 52	66.7 percentage of participants Interval 20.8 to 93.9	30 percentage of participants Interval 10.8 to 60.3	60 percentage of participants Interval 31.3 to 83.2	47.8 percentage of participants Interval 26.8 to 69.4
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 58	66.7 percentage of participants Interval 20.8 to 93.9	70 percentage of participants Interval 39.7 to 89.2	80 percentage of participants Interval 49.0 to 94.3	73.9 percentage of participants Interval 51.6 to 89.8
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV All 9 Subtypes	66.7 percentage of participants Interval 20.8 to 93.9	10 percentage of participants Interval 1.8 to 40.4	50 percentage of participants Interval 23.7 to 76.3	34.8 percentage of participants Interval 16.4 to 57.3
To Assess HPV Vaccine-type-specific Seroconversion Rates at 6-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV ≥ 1 Subtype	100 percentage of participants Interval 43.9 to 100.0	90 percentage of participants Interval 59.6 to 98.2	100 percentage of participants Interval 72.2 to 100.0	95.7 percentage of participants Interval 78.1 to 99.9

SECONDARY outcome

Timeframe: At 12- months post-transplant

Population: Participants with HPV labs available 12 months post-transplant.

An estimate of the HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation stratified by number of doses (1, 2, or 3) of the vaccine given pre-transplant was provided along with 95% confidence intervals (CIs). Clopper-Pearson CIs were provided for the overall and stratified estimates.

Outcome measures

Outcome measures
Measure	Prevention (Gardasil 9 HPV Vaccine) n=2 Participants Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study. Biospecimen Collection: Undergo collection of blood samples HPV Self-Collection: Undergo self-collection of vaginal/cervical samples Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM	Two Pre-Transplant Doses n=9 Participants Kidney transplant recipients who received 2 doses of the HPV vaccine ≥ 30 days prior to transplantation.	Three Pre-Transplant Doses n=9 Participants Kidney transplant recipients who received 3 doses of the HPV vaccine ≥ 30 days prior to transplantation.	Overall Pre-Transplants Doses n=20 Participants Kidney transplant recipients who receive ≥ 1 doses of the HPV vaccine ≥ 30 days prior to transplantation.
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 6	100 percentage of participants Interval 15.8 to 100.0	55.6 percentage of participants Interval 21.2 to 86.3	77.8 percentage of participants Interval 40.0 to 97.2	70 percentage of participants Interval 45.7 to 88.1
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 11	100 percentage of participants Interval 15.8 to 100.0	88.9 percentage of participants Interval 51.8 to 99.7	100 percentage of participants Interval 66.4 to 100.0	95 percentage of participants Interval 75.1 to 99.9
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 16	100 percentage of participants Interval 15.8 to 100.0	88.9 percentage of participants Interval 51.8 to 99.7	88.9 percentage of participants Interval 51.8 to 99.7	90 percentage of participants Interval 68.3 to 98.8
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 18	100 percentage of participants Interval 15.8 to 100.0	44.4 percentage of participants Interval 13.7 to 78.8	77.8 percentage of participants Interval 40.0 to 97.2	65 percentage of participants Interval 40.8 to 84.6
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 31	100 percentage of participants Interval 15.8 to 100.0	88.9 percentage of participants Interval 51.8 to 99.7	88.9 percentage of participants Interval 51.8 to 99.7	90 percentage of participants Interval 68.3 to 98.8
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 33	100 percentage of participants Interval 15.8 to 100.0	88.9 percentage of participants Interval 51.8 to 99.7	88.9 percentage of participants Interval 51.8 to 99.7	90 percentage of participants Interval 68.3 to 98.8
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 45	100 percentage of participants Interval 15.8 to 100.0	33.3 percentage of participants Interval 7.5 to 70.1	55.6 percentage of participants Interval 21.2 to 86.3	50 percentage of participants Interval 27.2 to 72.8
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 52	100 percentage of participants Interval 34.2 to 100.0	55.6 percentage of participants Interval 21.2 to 86.3	22.2 percentage of participants Interval 2.8 to 60.0	45 percentage of participants Interval 23.1 to 68.5
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV 58	100 percentage of participants Interval 15.8 to 100.0	88.9 percentage of participants Interval 51.8 to 99.7	77.8 percentage of participants Interval 40.0 to 97.2	85 percentage of participants Interval 62.1 to 96.8
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV All 9 Subtypes	100 percentage of participants Interval 15.8 to 100.0	22.2 percentage of participants Interval 2.8 to 60.0	11.1 percentage of participants Interval 0.3 to 48.2	25 percentage of participants Interval 8.7 to 49.1
To Assess HPV Vaccine-type-specific Seroconversion Rates at 12-months Post-transplantation Stratified by Number of Doses (1, 2, or 3) Given Pre-transplant Among Kidney Transplant. HPV ≥ 1 Subtype	100 percentage of participants Interval 15.8 to 100.0	88.9 percentage of participants Interval 51.8 to 99.7	100 percentage of participants Interval 66.4 to 100.0	95 percentage of participants Interval 75.1 to 99.9

OTHER_PRE_SPECIFIED outcome

Timeframe: At 12 months post-transplant

Descriptive statistics, such as probabilities and exact 95% CIs, will be used to summarize probability of seroconversion at 12 months post-transplant for the following groups: a) time elapsed between last vaccine dose and the transplant procedure, e.g. \< 3 months versus (vs.) \> 3 months. Different groupings will be considered based on observed (e.g. median) and clinical considerations. Time will be summarized using descriptive statistics, e.g. median, interquartile range, or range; groups defined by dosing and types of post-transplant immunosuppressant medications, as well as; b) type of transplant surgery (living donor/deceased donor); c) differences in human leukocyte antigen histocompatibility between donor and recipient; d) differences by biological sex (i.e., male vs. female) of the transplant recipient.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 6 and 12 months post-transplant

Stability will be evaluated in relation to changes in the type-specific GMTs between the two post-transplant time points (6- and 12-months post-transplant) and reported as follows: (i) decrease: more than 2-fold decrease, (ii) stable: within 2-fold change, and (iii) increase: greater than 2-fold increase. Stability will also be described in relation to the number of vaccine doses (1, 2 or 3) received in the pre-transplant period.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 13 months post-transplant

The magnitude of increase in type-specific GMTs at the 13-month post-transplant visit (i.e., 1 month after the booster dose) will be described in relation to the type-specific GMTs at the other post-transplant visits (6 and 12-months post -transplant). Patterns over time will also be explored using graphical techniques. Post-booster dose increase in type-specific GMTs will also be described in relation to the number of vaccine doses (1, 2 or 3) received in the pre-transplant period.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 13 months post-transplant

Will be summarized using descriptive statistics, stratified by number of vaccine doses and time between the last vaccine dose and the transplant procedure.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Self-collected at baseline (pre-vaccination) and at 6- and 12- months post-vaccination

HPV detection in samples from the cervix/vagina, and oral cavity at baseline (pre-vaccination) and at 6- and 12-months post-vaccination, overall and by number of vaccine doses (1, 2, or 3), sexual behavior, type-specific seroconversion rates, and time elapsed between the last vaccine dose and the transplant procedure will be evaluated. All rates of HPV detection will be specified, overall and stratified by number of doses (1, 2, or 3) and time to transplant.

Outcome measures

Outcome data not reported

Adverse Events

Prevention (Gardasil 9 HPV Vaccine)

Serious events: 8 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prevention (Gardasil 9 HPV Vaccine) n=51 participants at risk Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Participants are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Participants may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Participants also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study. Biospecimen Collection: Undergo collection of blood samples HPV Self-Collection: Undergo self-collection of vaginal/cervical samples Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
Metabolism and nutrition disorders Hyperglycemia	2.0% 1/51 • Number of events 1 • Pre-transplant up to 15 months post-transplant.
Infections and infestations Sepsis	2.0% 1/51 • Number of events 1 • Pre-transplant up to 15 months post-transplant.
Infections and infestations Abdominal infection	2.0% 1/51 • Number of events 1 • Pre-transplant up to 15 months post-transplant.
Vascular disorders Hypertension	2.0% 1/51 • Number of events 1 • Pre-transplant up to 15 months post-transplant.
Gastrointestinal disorders Diarrhea	2.0% 1/51 • Number of events 1 • Pre-transplant up to 15 months post-transplant.
Cardiac disorders Heart failure	2.0% 1/51 • Number of events 1 • Pre-transplant up to 15 months post-transplant.
Infections and infestations Infections and infestations - Other, specify	2.0% 1/51 • Number of events 1 • Pre-transplant up to 15 months post-transplant.
Renal and urinary disorders Acute kidney injury	2.0% 1/51 • Number of events 1 • Pre-transplant up to 15 months post-transplant.
Renal and urinary disorders Renal and urinary disorders - Other, specify	3.9% 2/51 • Number of events 3 • Pre-transplant up to 15 months post-transplant.

Other adverse events

Other adverse events
Measure	Prevention (Gardasil 9 HPV Vaccine) n=51 participants at risk Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Participants are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Participants may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series. Participants also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study. Biospecimen Collection: Undergo collection of blood samples HPV Self-Collection: Undergo self-collection of vaginal/cervical samples Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
Respiratory, thoracic and mediastinal disorders Cough	5.9% 3/51 • Number of events 3 • Pre-transplant up to 15 months post-transplant.
Nervous system disorders Headache	11.8% 6/51 • Number of events 6 • Pre-transplant up to 15 months post-transplant.
Infections and infestations Infections and infestations - Other, specify	11.8% 6/51 • Number of events 6 • Pre-transplant up to 15 months post-transplant.
General disorders Injection site reaction	21.6% 11/51 • Number of events 12 • Pre-transplant up to 15 months post-transplant.
Gastrointestinal disorders Nausea	7.8% 4/51 • Number of events 4 • Pre-transplant up to 15 months post-transplant.
Nervous system disorders Paresthesia	5.9% 3/51 • Number of events 3 • Pre-transplant up to 15 months post-transplant.

Additional Information

Seema A. Khan

Northwestern University

Phone: 312-503-4236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60