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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03610581
Recruitment Status : Terminated (Low enrolment and increasing COVID restrictions, following an earlier enrolment pause in April made it clear that completion of the study would not be feasible)
First Posted : August 1, 2018
Results First Posted : November 9, 2021
Last Update Posted : November 24, 2021
Sponsor:
Collaborator:
Bavarian Nordic
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Human Papillomavirus Infections
Interventions Biological: Ad26.HPV16
Biological: Ad26.HPV18
Biological: MVA.HPV16/18
Biological: Placebo
Enrollment 9
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description 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. Participants received matching placebo on Day 1 and Day 57.
Period Title: Overall Study
Started 5 4
Vaccinated 4 4
Completed 2 3
Not Completed 3 1
Reason Not Completed
Study terminated by sponsor             2             0
Other             0             1
Withdrawal by Subject             1             0
Arm/Group Title Regimen 1 Placebo Total
Hide Arm/Group Description 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. Participants received matching placebo on Day 1 and Day 57. Total of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants with at least one vaccination.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 9 participants
42  (11.85) 45.5  (5.69) 43.6  (9.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
5
 100.0%
4
 100.0%
9
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  20.0%
0
   0.0%
1
  11.1%
White
4
  80.0%
4
 100.0%
8
  88.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
UNITED STATES Number Analyzed 5 participants 4 participants 9 participants
5
 100.0%
4
 100.0%
9
 100.0%
1.Primary Outcome
Title Number of Participants With Solicited Local Adverse Events (AEs)
Hide Description Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling.
Time Frame Up to 7 days after each vaccination (Up to Day 64)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants with at least one vaccination. Here, "n (number analyzed)" is defined as participants analyzed for specified category.
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description:
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.
Participants received matching placebo on Day 1 and Day 57.
Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Post- Dose 1 Number Analyzed 5 participants 4 participants
2
  40.0%
0
   0.0%
Post- Dose 2 Number Analyzed 4 participants 4 participants
1
  25.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Solicited Systemic AEs
Hide Description Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, chills, and fever.
Time Frame Up to 7 days after each vaccination (Up to Day 64)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants with at least one vaccination. Here, "n (number analyzed)" is defined as participants analyzed for specified category.
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description:
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.
Participants received matching placebo on Day 1 and Day 57.
Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Post-Dose 1 Number Analyzed 5 participants 4 participants
4
  80.0%
0
   0.0%
Post-Dose 2 Number Analyzed 4 participants 4 participants
1
  25.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants With Unsolicited AEs
Hide Description 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.
Time Frame 28 days after each vaccination (Up to Day 85)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants with at least one vaccination. Here, "n (number analyzed)" is defined as participants analyzed for specified category.
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description:
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.
Participants received matching placebo on Day 1 and Day 57.
Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Post-Dose 1 Number Analyzed 5 participants 4 participants
2
  40.0%
1
  25.0%
Post-Dose 2 Number Analyzed 4 participants 4 participants
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Up to 12 months after the first vaccination (target visit Day 366)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants with at least one vaccination.
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description:
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.
Participants received matching placebo on Day 1 and Day 57.
Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+
Hide Description 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).
Time Frame Day 57, Day 78, Day 239, and Day 366
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description:
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.
Participants received matching placebo on Day 1 and Day 57.
Overall Number of Participants Analyzed 4 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 57: E2 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E2 Number Analyzed 3 participants 3 participants
33.3
(0.8 to 90.6)
0
(0 to 70.8)
Day 239: E2 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: E2 Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
Day 57: E6/E7 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E6/E7 Number Analyzed 3 participants 3 participants
33.3
(0.8 to 90.6)
0
(0 to 70.8)
Day 239: E6/E7 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: E6/E7 Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
Day 57: Combined Peptide Pools Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: Combined Peptide Pools Number Analyzed 3 participants 3 participants
33.3
(0.8 to 90.6)
0
(0 to 70.8)
Day 239: Combined Peptide Pools Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: Combined Peptide Pools Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
6.Secondary Outcome
Title Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+
Hide Description 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).
Time Frame Day 57, Day 78, Day 239, and Day 366
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description:
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.
Participants received matching placebo on Day 1 and Day 57.
Overall Number of Participants Analyzed 4 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 57: E2 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E2 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 239: E2 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: E2 Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
Day 57: E6/E7 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E6/E7 Number Analyzed 3 participants 3 participants
33.3
(0.8 to 90.6)
0
(0 to 70.8)
Day 239: E6/E7 Number Analyzed 3 participants 3 participants
33.3
(0.8 to 90.6)
0
(0 to 70.8)
Day 336: E6/E7 Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
Day 57: Combined Peptide Pools Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: Combined Peptide Pools Number Analyzed 3 participants 3 participants
33.3
(0.8 to 90.6)
0
(0 to 70.8)
Day 239: Combined Peptide Pools Number Analyzed 3 participants 3 participants
33.3
(0.8 to 90.6)
0
(0 to 70.8)
Day 366: Combined Peptide Pools Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
7.Secondary Outcome
Title Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+
Hide Description 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).
Time Frame Day 57, Day 78, Day 239, and Day 366
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description:
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.
Participants received matching placebo on Day 1 and Day 57.
Overall Number of Participants Analyzed 4 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 57: E2 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E2 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 239: E2 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: E2 Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
Day 57: E6/E7 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E6/E7 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 239: E6/E7 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: E6/E7 Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
Day 57: Combined Peptide Pools Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: Combined Peptide Pools Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 239: Combined Peptide Pools Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: Combined Peptide Pools Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
8.Secondary Outcome
Title Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+
Hide Description 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).
Time Frame Day 57, Day 78, Day 239, and Day 366
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description:
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.
Participants received matching placebo on Day 1 and Day 57.
Overall Number of Participants Analyzed 4 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 57: E2 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E2 Number Analyzed 3 participants 3 participants
100
(29.2 to 100)
0
(0 to 70.8)
Day 239: E2 Number Analyzed 3 participants 3 participants
66.7
(9.4 to 99.2)
0
(0 to 70.8)
Day 366: E2 Number Analyzed 2 participants 3 participants
50
(1.3 to 98.7)
0
(0 to 70.8)
Day 57: E6/E7 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E6/E7 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 239: E6/E7 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: E6/E7 Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
Day 57: Combined Peptide Pools Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: Combined Peptide Pools Number Analyzed 3 participants 3 participants
100
(29.2 to 100)
0
(0 to 70.8)
Day 239: Combined Peptide Pools Number Analyzed 3 participants 3 participants
66.7
(9.4 to 99.2)
0
(0 to 70.8)
Day 366: Combined Peptide Pools Number Analyzed 2 participants 3 participants
50
(1.3 to 98.7)
0
(0 to 70.8)
9.Secondary Outcome
Title Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+
Hide Description 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).
Time Frame Day 57, Day 78, Day 239, and Day 366
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description:
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.
Participants received matching placebo on Day 1 and Day 57.
Overall Number of Participants Analyzed 4 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 57: E2 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E2 Number Analyzed 3 participants 3 participants
66.7
(9.4 to 99.2)
0
(0 to 70.8)
Day 239: E2 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: E2 Number Analyzed 2 participants 3 participants
50
(1.3 to 98.7)
0
(0 to 70.8)
Day 57: E6/E7 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E6/E7 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 239: E6/E7 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: E6/E7 Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
Day 57: Combined Peptide Pools Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: Combined Peptide Pools Number Analyzed 3 participants 3 participants
66.7
(9.4 to 99.2)
0
(0 to 70.8)
Day 239: Combined Peptide Pools Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: Combined Peptide Pools Number Analyzed 2 participants 3 participants
50
(1.3 to 98.7)
0
(0 to 70.8)
10.Secondary Outcome
Title Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+
Hide Description 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).
Time Frame Day 57, Day 78, Day 239, and Day 366
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description:
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.
Participants received matching placebo on Day 1 and Day 57.
Overall Number of Participants Analyzed 4 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 57: E2 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E2 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 239: E2 Number Analyzed 3 participants 3 participants
33.3
(0.8 to 90.6)
0
(0 to 70.8)
Day 366: E2 Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
Day 57: E6/E7 Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: E6/E7 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 239: E6/E7 Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 366: E6/E7 Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
Day 57: Combined Peptide Pools Number Analyzed 4 participants 4 participants
0
(0 to 60.2)
0
(0 to 60.2)
Day 78: Combined Peptide Pools Number Analyzed 3 participants 3 participants
0
(0 to 70.8)
0
(0 to 70.8)
Day 239: Combined Peptide Pools Number Analyzed 3 participants 3 participants
33.3
(0.8 to 90.6)
0
(0 to 70.8)
Day 366: Combined Peptide Pools Number Analyzed 2 participants 3 participants
0
(0 to 84.2)
0
(0 to 70.8)
Time Frame Up to 12 months after the first vaccination (target visit Day 366)
Adverse Event Reporting Description Full analysis set (FAS) included all participants with at least one vaccination.
 
Arm/Group Title Regimen 1 Placebo
Hide Arm/Group Description 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. Participants received matching placebo on Day 1 and Day 57.
All-Cause Mortality
Regimen 1 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Regimen 1 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Regimen 1 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/5 (40.00%)   1/4 (25.00%) 
Blood and lymphatic system disorders     
Increased Tendency to Bruise * 1  0/5 (0.00%)  1/4 (25.00%) 
Infections and infestations     
Upper Respiratory Tract Infection * 1  1/5 (20.00%)  0/4 (0.00%) 
Urinary Tract Infection * 1  0/5 (0.00%)  1/4 (25.00%) 
Vulvovaginal Mycotic Infection * 1  0/5 (0.00%)  1/4 (25.00%) 
Nervous system disorders     
Syncope * 1  1/5 (20.00%)  0/4 (0.00%) 
1
Term from vocabulary, MedDRA Version 23.0
*
Indicates events were collected by non-systematic assessment
As the study was terminated prematurely, the Sponsor performed a limited analysis on the available data to meet the requirement for reporting the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Franchise Leader
Organization: Janssen Vaccines & Prevention B.V
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03610581    
Other Study ID Numbers: CR108458
2018-000200-41 ( EudraCT Number )
VAC81623HPV1002 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Submitted: July 26, 2018
First Posted: August 1, 2018
Results First Submitted: October 11, 2021
Results First Posted: November 9, 2021
Last Update Posted: November 24, 2021