Trial Outcomes & Findings for HPV Vaccination Study in Postpartum Women (NCT NCT04274153)

Last Updated: 2023-08-29

Results Overview

Measure the immunogenicity of a two-dose 9-valent HPV vaccination regimen in postpartum women previously unvaccinated against the HPV 16 virus. Immunogenicity will be assessed by the antibody responses. The Geometric mean titers will be measured using milli Merck units (mMU)/mL.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

225 participants

Primary outcome timeframe

Up to 23 months

Results posted on

2023-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Gardasil9 Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. Gardasil9: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Overall Study STARTED	225
Overall Study COMPLETED	169
Overall Study NOT COMPLETED	56

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HPV Vaccination Study in Postpartum Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gardasil9 n=225 Participants Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. Gardasil9: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Age, Continuous	29.9 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	225 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/Latino	134 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black/African American	43 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	9 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White/Caucasian	36 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Two or more races	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	1 Participants n=5 Participants
Region of Enrollment United States	225 Participants n=5 Participants
Highest level of education Grade 11 or less	71 Participants n=5 Participants
Highest level of education Grade 12 to some college	99 Participants n=5 Participants
Highest level of education Bachelor's degree or higher	55 Participants n=5 Participants
Employed Yes	74 Participants n=5 Participants
Employed No	151 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 23 months

Population: We excluded participants whose anti-HPV 16 titer was above the seroconversion limit and the baseline. Therefore, only 129 were included in this analysis

Outcome measures

Outcome measures
Measure	Gardasil9 n=129 Participants Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. Gardasil9: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer	7177.6 mMU/mL Interval 6041.0 to 8528.0

SECONDARY outcome

Timeframe: Up to 23 months

Population: During analysis, we exclude participants who had antibodies titers above the seroconversion limit at the baseline for each HPV subtype seperately. Therefore, the number of participants analyzed are smaller than 225.

The antibody types that will be measured are HPV types 6, 11, 18, 31, 33, 45, 52, and 58. The milli Merck units (mMU)/mL of measure will be used to determine antibody response.

Outcome measures

Outcome measures
Measure	Gardasil9 n=133 Participants Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. Gardasil9: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Antibody Response to the Other 8 HPV Types 6	2187.2 mMU/mL Interval 1861.3 to 2570.2
Antibody Response to the Other 8 HPV Types 11	1492.1 mMU/mL Interval 1289.1 to 1727.1
Antibody Response to the Other 8 HPV Types 18	1589.8 mMU/mL Interval 1333.6 to 1895.2
Antibody Response to the Other 8 HPV Types 31	1077.5 mMU/mL Interval 924.8 to 1255.4
Antibody Response to the Other 8 HPV Types 33	792.8 mMU/mL Interval 680.0 to 924.4
Antibody Response to the Other 8 HPV Types 45	323.2 mMU/mL Interval 278.9 to 374.6
Antibody Response to the Other 8 HPV Types 52	582.9 mMU/mL Interval 512.2 to 663.3
Antibody Response to the Other 8 HPV Types 58	802.8 mMU/mL Interval 681.9 to 945.1

SECONDARY outcome

Timeframe: After the first dose, up to 7 months

Population: There were some participants seroconverted at the baseline so were excluded from the analysis for each type of HPV.

Calculate the percentage of participants that seroconverted.

Outcome measures

Outcome measures
Measure	Gardasil9 n=134 Participants Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. Gardasil9: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Seropositivity for HPV 16 After 1-dose	118 Participants

SECONDARY outcome

Timeframe: After the second dose, up to 2 months

Population: Participants with anti-HPV 16 titer above the seropositivity threshold were excluded in this analysis. This is analysis among participants who received the second dose.

Calculate the percentage of participants that seroconverted.

Outcome measures

Outcome measures
Measure	Gardasil9 n=128 Participants Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. Gardasil9: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Seropositivity for HPV 16 After 2-doses	128 Participants

SECONDARY outcome

Timeframe: Baseline

Running an assay to measure a participants natural inoculation or prior vaccination before administration of the 1st dose.

Outcome measures

Outcome measures
Measure	Gardasil9 n=225 Participants Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. Gardasil9: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16	91 Participants

SECONDARY outcome

Timeframe: At the end of the study, up to 2 years

Calculate the amount of participants that complete 2-dose vaccination.

Outcome measures

Outcome measures
Measure	Gardasil9 n=225 Participants Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. Gardasil9: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Percentage of Participants Who Complete 2-dose Vaccination	174 Participants

Adverse Events

Gardasil9

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gardasil9 n=225 participants at risk Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. Gardasil9: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Skin and subcutaneous tissue disorders Not serious adverse event due to medication	0.44% 1/225 • 2 years

Additional Information

Dr. Jenell Coleman

Johns Hopkins SOM Department of GYN/OB

Phone: (410)614-9178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place