Trial Outcomes & Findings for Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix (NCT NCT03610581)

NCT ID: NCT03610581

Last Updated: 2025-02-04

Results Overview

Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: Up to 7 days after each vaccination (Up to Day 64)
• Results posted on: 2025-02-04

Participant Flow

Due to premature study termination, participants were only randomized and treated for Regimen 1 and Placebo. Hence, all results are reported below for Regimen 1 and Placebo only and not for Regimen 2 and 3.

Participant milestones

Measure	Regimen 1 Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo Participants received matching placebo on Day 1 and Day 57.
Overall Study STARTED	5	4
Overall Study Vaccinated	4	4
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Regimen 1 Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo Participants received matching placebo on Day 1 and Day 57.
Overall Study Study terminated by sponsor	2	0
Overall Study Other	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix

Baseline characteristics by cohort

Measure	Regimen 1 n=5 Participants Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 Participants Participants received matching placebo on Day 1 and Day 57.	Total n=9 Participants Total of all reporting groups
Age, Continuous	42 years STANDARD_DEVIATION 11.85 • n=5 Participants	45.5 years STANDARD_DEVIATION 5.69 • n=7 Participants	43.6 years STANDARD_DEVIATION 9.26 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment UNITED STATES	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 days after each vaccination (Up to Day 64)

Population: Full analysis set (FAS) included all participants with at least one vaccination. Here, "n (number analyzed)" is defined as participants analyzed for specified category.

Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling.

Outcome measures

Measure	Regimen 1 n=5 Participants Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 Participants Participants received matching placebo on Day 1 and Day 57.
Number of Participants With Solicited Local Adverse Events (AEs) Post- Dose 2	1 Participants	0 Participants
Number of Participants With Solicited Local Adverse Events (AEs) Post- Dose 1	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 days after each vaccination (Up to Day 64)

Population: FAS included all participants with at least one vaccination. Here, "n (number analyzed)" is defined as participants analyzed for specified category.

Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, chills, and fever.

Outcome measures

Measure	Regimen 1 n=5 Participants Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 Participants Participants received matching placebo on Day 1 and Day 57.
Number of Participants With Solicited Systemic AEs Post-Dose 1	4 Participants	0 Participants
Number of Participants With Solicited Systemic AEs Post-Dose 2	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 28 days after each vaccination (Up to Day 85)

Population: FAS included all participants with at least one vaccination. Here, "n (number analyzed)" is defined as participants analyzed for specified category.

Number of participants with unsolicited AEs were reported. Unsolicited AEs included all AEs for which the participant was not specifically questioned in the participant diary.

Outcome measures

Measure	Regimen 1 n=5 Participants Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 Participants Participants received matching placebo on Day 1 and Day 57.
Number of Participants With Unsolicited AEs Post-Dose 1	2 Participants	1 Participants
Number of Participants With Unsolicited AEs Post-Dose 2	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 12 months after the first vaccination (target visit Day 366)

Population: FAS included all participants with at least one vaccination.

Number of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Measure	Regimen 1 n=5 Participants Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 Participants Participants received matching placebo on Day 1 and Day 57.
Number of Participants With Serious Adverse Events (SAEs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 57, Day 78, Day 239, and Day 366

Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category.

Percentage of participants with HPV-Specific CD4+ T-cell responses for IFNg+ to peptide pools were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Outcome measures

Measure	Regimen 1 n=4 Participants Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 Participants Participants received matching placebo on Day 1 and Day 57.
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 57: E2	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 239: E6/E7	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 366: E6/E7	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 78: Combined Peptide Pools	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 239: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 78: E2	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 239: E2	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 366: E2	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 57: E6/E7	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 78: E6/E7	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 57: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ Day 366: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: Day 57, Day 78, Day 239, and Day 366

Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category.

Percentage of participants with HPV-Specific CD4+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Outcome measures

Measure	Regimen 1 n=4 Participants Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 Participants Participants received matching placebo on Day 1 and Day 57.
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 78: E6/E7	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 366: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 57: E2	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 78: E2	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 239: E2	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 366: E2	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 57: E6/E7	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 239: E6/E7	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 336: E6/E7	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 57: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 78: Combined Peptide Pools	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ Day 239: Combined Peptide Pools	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: Day 57, Day 78, Day 239, and Day 366

Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category.

Percentage of participants with HPV-Specific CD4+ T-cell responses for TNF a+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Outcome measures

Measure	Regimen 1 n=4 Participants Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 Participants Participants received matching placebo on Day 1 and Day 57.
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 57: E2	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 78: E2	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 239: E2	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 366: E2	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 57: E6/E7	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 78: E6/E7	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 239: E6/E7	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 366: E6/E7	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 57: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 78: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 239: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ Day 366: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: Day 57, Day 78, Day 239, and Day 366

Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category.

Percentage of participants with HPV-Specific CD8+ T-cell responses for IFNg+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Outcome measures

Measure	Regimen 1 n=4 Participants Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 Participants Participants received matching placebo on Day 1 and Day 57.
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 239: E6/E7	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 366: E6/E7	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 57: E2	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 78: E2	100 Percentage of participants Interval 29.2 to 100.0	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 239: E2	66.7 Percentage of participants Interval 9.4 to 99.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 366: E2	50 Percentage of participants Interval 1.3 to 98.7	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 57: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 78: Combined Peptide Pools	100 Percentage of participants Interval 29.2 to 100.0	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 239: Combined Peptide Pools	66.7 Percentage of participants Interval 9.4 to 99.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 366: Combined Peptide Pools	50 Percentage of participants Interval 1.3 to 98.7	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 57: E6/E7	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ Day 78: E6/E7	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: Day 57, Day 78, Day 239, and Day 366

Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category.

Percentage of participants with HPV-Specific CD8+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Outcome measures

Measure	Regimen 1 n=4 Participants Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 Participants Participants received matching placebo on Day 1 and Day 57.
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 57: E2	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 366: E2	50 Percentage of participants Interval 1.3 to 98.7	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 57: E6/E7	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 78: E6/E7	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 239: E6/E7	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 78: E2	66.7 Percentage of participants Interval 9.4 to 99.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 239: E2	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 366: E6/E7	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 57: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 78: Combined Peptide Pools	66.7 Percentage of participants Interval 9.4 to 99.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 239: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ Day 366: Combined Peptide Pools	50 Percentage of participants Interval 1.3 to 98.7	0 Percentage of participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: Day 57, Day 78, Day 239, and Day 366

Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category.

Percentage of participants with HPV-Specific CD8+ T-cell responses for TNFa+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).

Outcome measures

Measure	Regimen 1 n=4 Participants Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 Participants Participants received matching placebo on Day 1 and Day 57.
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 366: E2	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 366: E6/E7	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 57: E2	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 78: E2	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 239: E2	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 57: E6/E7	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 78: E6/E7	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 239: E6/E7	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 57: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 60.2
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 78: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 239: Combined Peptide Pools	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 70.8
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ Day 366: Combined Peptide Pools	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 70.8

Adverse Events

Regimen 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Regimen 1 n=5 participants at risk Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57.	Placebo n=4 participants at risk Participants received matching placebo on Day 1 and Day 57.
Blood and lymphatic system disorders Increased Tendency to Bruise	0.00% 0/5 • Up to 12 months after the first vaccination (target visit Day 366) Full analysis set (FAS) included all participants with at least one vaccination.	25.0% 1/4 • Up to 12 months after the first vaccination (target visit Day 366) Full analysis set (FAS) included all participants with at least one vaccination.
Infections and infestations Upper Respiratory Tract Infection	20.0% 1/5 • Up to 12 months after the first vaccination (target visit Day 366) Full analysis set (FAS) included all participants with at least one vaccination.	0.00% 0/4 • Up to 12 months after the first vaccination (target visit Day 366) Full analysis set (FAS) included all participants with at least one vaccination.
Infections and infestations Urinary Tract Infection	0.00% 0/5 • Up to 12 months after the first vaccination (target visit Day 366) Full analysis set (FAS) included all participants with at least one vaccination.	25.0% 1/4 • Up to 12 months after the first vaccination (target visit Day 366) Full analysis set (FAS) included all participants with at least one vaccination.
Infections and infestations Vulvovaginal Mycotic Infection	0.00% 0/5 • Up to 12 months after the first vaccination (target visit Day 366) Full analysis set (FAS) included all participants with at least one vaccination.	25.0% 1/4 • Up to 12 months after the first vaccination (target visit Day 366) Full analysis set (FAS) included all participants with at least one vaccination.
Nervous system disorders Syncope	20.0% 1/5 • Up to 12 months after the first vaccination (target visit Day 366) Full analysis set (FAS) included all participants with at least one vaccination.	0.00% 0/4 • Up to 12 months after the first vaccination (target visit Day 366) Full analysis set (FAS) included all participants with at least one vaccination.

Additional Information

Clinical Franchise Leader

Janssen Vaccines & Prevention B.V

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER