TerminatedNCT03610581Updated Feb 4, 2025Results posted

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

A Phase 1/2 interventional study of Ad26.HPV16 and Ad26.HPV18 in Human Papillomavirus Infections, sponsored by Janssen Vaccines & Prevention B.V.. Terminated at 12 sites in 2 countries. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Janssen Vaccines & Prevention B.V. · Phase 1/2, Interventional, and Treatment

Why this study was 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

Phase: Phase 1/2
Study type: Interventional
Enrollment: 9
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: Female

Study summary

The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.

Read the detailed description

This study is part of a vaccine program which aims to generate a therapeutic vaccine for women with HPV types 16 or 18 infection, with a focus on early disease interception. The study consists of 3 periods: Screening period of up to 42 days (6 weeks), followed by prime and boost immunizations and follow-up visits up to 12 months after the first vaccination. Evaluation of the safety/reactogenicity of the vaccine regimens will include physical assessment by study-site personnel, participant reports on signs and symptoms and laboratory assessments following vaccinations. Immunogenicity and Virology/Histology assessments will also be performed.

Conditions studied

Human Papillomavirus Infections

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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 9 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Janssen Vaccines & Prevention B.V. is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 32 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Must have an human papillomavirus (HPV) type 16 or 18 infection of the cervix as determined by a qualitative PCR test within 8 weeks prior to screening or at the time of screening. Available history of high-risk (HR)-HPV positivity and HPV16 or HPV18 positivity positivity will be recorded
Must have a recent colposcopy result (with a maximum of 12 months old at screening); in case a colposcopy has not been performed before, it will be done as screening procedure
Contraceptive (birth control) use by participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
Agrees not to donate blood until 3 months after receiving the last dose of study vaccine

Exclusion criteria

Exclusion Criteria:

In case cytology results are available, participant has current or history of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma in situ (AIS) or any high-grade vulvar, vaginal or anal intraepithelial neoplasia
Current or history of cervical intraepithelial neoplasia (CIN)2+ or cervical cancer
Confirmed co-infection with both HPV16 and HPV18
History of an underlying clinically significant acute or chronic medical condition, other than infection with HPV, or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Tests positive for human immunodeficiency virus (HIV) at screening
Chronic active hepatitis B or hepatitis C infection, verified at screening by hepatitis B surface antigen or anti-hepatitis C virus antibody, respectively
Vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators
Exposed to at least 1 dose of an HPV prophylactic vaccine or participant has participated in the past in another preventive or therapeutic HPV vaccine study
Clinically significant gynecological abnormalities that could, in the judgment of the investigator, interfere with study evaluation (for example [e.g.], prolapse, myoma, fibroid, hysterectomy)
Symptomatic vaginal or genital infection (including genital herpes) as confirmed by physician or investigator

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 9 participants (actual)

Study arms

Experimental
Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18
Participants will receive a dose of adenovirus serotype 26 (Ad26)-human papillomavirus (HPV)16 or HPV18 (Ad26.HPV16 or Ad26.HPV18) as prime immunization and a dose of Modified Vaccinia Ankara (MVA)-HPV16/18 (MVA.HPV16/18) as boost immunization.
Biological: Ad26.HPV16 · Biological: Ad26.HPV18 · Biological: MVA.HPV16/18
Experimental
Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18
Participants will receive a double dose of Ad26.HPV16 or Ad26.HPV18 as prime immunization and a dose of MVA.HPV16/18 as boost immunization.
Biological: Ad26.HPV16 · Biological: Ad26.HPV18 · Biological: MVA.HPV16/18
Experimental
Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18
Participants will receive a mix of Ad26.HPV16/Ad26.HPV18 as prime immunization and a dose of MVA.HPV16/18 as boost immunization.
Biological: Ad26.HPV16 · Biological: Ad26.HPV18 · Biological: MVA.HPV16/18
Placebo comparator
Control: Placebo
Participants will receive matched placebo as prime and boost immunizations.
Biological: Placebo

Interventions

BiologicalAd26.HPV16
Participants will receive Ad26.HPV16 as a solution for intramuscular injection.
Also known as: JNJ-63682918
BiologicalAd26.HPV18
Participants will receive Ad26.HPV18 as a solution for intramuscular injection.
Also known as: JNJ-63682931
BiologicalMVA.HPV16/18
Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.
Also known as: JNJ-65195208
BiologicalPlacebo
Participants will receive matched placebo as a solution for intramuscular injection.

What researchers measure

Primary outcomes

Number of Participants With Solicited Local Adverse Events (AEs)
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)
Number of Participants With Solicited Systemic AEs
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)
Number of Participants With Unsolicited AEs
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)
Number of Participants With Serious Adverse Events (SAEs)
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)

Secondary outcomes

Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+
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
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+
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
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+
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
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+
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
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+
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
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+
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

Results

Posted Nov 9, 2021

Limitations and caveats

As the study was terminated prematurely, the Sponsor performed a limited analysis on the available data to meet the requirement for reporting the study.

Participant flow

Participant flow — Overall Study
Milestone	Regimen 1	Placebo
Started	5	4
Vaccinated	4	4
Completed	2	3
Not completed	3	1
Withdrew: Study terminated by sponsor	2	0
Withdrew: Other	0	1
Withdrew: Withdrawal by subject	1	0

Outcome measures

PrimaryNumber of Participants With Solicited Local Adverse Events (AEs)

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)
Reported as:: Count of participants · Participants

Number of Participants With Solicited Local Adverse Events (AEs)
Participants	Regimen 1	Placebo
Post- Dose 1	2	0
Post- Dose 2	1	0

PrimaryNumber of Participants With Solicited Systemic AEs

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)
Reported as:: Count of participants · Participants

Number of Participants With Solicited Systemic AEs
Participants	Regimen 1	Placebo
Post-Dose 1	4	0
Post-Dose 2	1	0

PrimaryNumber of Participants With Unsolicited AEs

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)
Reported as:: Count of participants · Participants

Number of Participants With Unsolicited AEs
Participants	Regimen 1	Placebo
Post-Dose 1	2	1
Post-Dose 2	0	0

PrimaryNumber of Participants With Serious Adverse Events (SAEs)

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)
Reported as:: Count of participants · Participants

Number of Participants With Serious Adverse Events (SAEs)
Participants	Regimen 1	Placebo
Number of Participants With Serious Adverse Events (SAEs)	0	0

SecondaryPercentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+

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
Reported as:: Number · Percentage of participants

Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+
Percentage of participants	Regimen 1	Placebo
Day 57: E2	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E2	33.3 (0.8 to 90.6)	0 (0 to 70.8)
Day 239: E2	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: E2	0 (0 to 84.2)	0 (0 to 70.8)
Day 57: E6/E7	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E6/E7	33.3 (0.8 to 90.6)	0 (0 to 70.8)
Day 239: E6/E7	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: E6/E7	0 (0 to 84.2)	0 (0 to 70.8)
Day 57: Combined Peptide Pools	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: Combined Peptide Pools	33.3 (0.8 to 90.6)	0 (0 to 70.8)
Day 239: Combined Peptide Pools	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: Combined Peptide Pools	0 (0 to 84.2)	0 (0 to 70.8)

SecondaryPercentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+

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
Reported as:: Number · Percentage of participants

Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+
Percentage of participants	Regimen 1	Placebo
Day 57: E2	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E2	0 (0 to 70.8)	0 (0 to 70.8)
Day 239: E2	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: E2	0 (0 to 84.2)	0 (0 to 70.8)
Day 57: E6/E7	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E6/E7	33.3 (0.8 to 90.6)	0 (0 to 70.8)
Day 239: E6/E7	33.3 (0.8 to 90.6)	0 (0 to 70.8)
Day 336: E6/E7	0 (0 to 84.2)	0 (0 to 70.8)
Day 57: Combined Peptide Pools	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: Combined Peptide Pools	33.3 (0.8 to 90.6)	0 (0 to 70.8)
Day 239: Combined Peptide Pools	33.3 (0.8 to 90.6)	0 (0 to 70.8)
Day 366: Combined Peptide Pools	0 (0 to 84.2)	0 (0 to 70.8)

SecondaryPercentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+

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
Reported as:: Number · Percentage of participants

Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+
Percentage of participants	Regimen 1	Placebo
Day 57: E2	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E2	0 (0 to 70.8)	0 (0 to 70.8)
Day 239: E2	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: E2	0 (0 to 84.2)	0 (0 to 70.8)
Day 57: E6/E7	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E6/E7	0 (0 to 70.8)	0 (0 to 70.8)
Day 239: E6/E7	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: E6/E7	0 (0 to 84.2)	0 (0 to 70.8)
Day 57: Combined Peptide Pools	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: Combined Peptide Pools	0 (0 to 70.8)	0 (0 to 70.8)
Day 239: Combined Peptide Pools	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: Combined Peptide Pools	0 (0 to 84.2)	0 (0 to 70.8)

SecondaryPercentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+

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
Reported as:: Number · Percentage of participants

Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+
Percentage of participants	Regimen 1	Placebo
Day 57: E2	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E2	100 (29.2 to 100)	0 (0 to 70.8)
Day 239: E2	66.7 (9.4 to 99.2)	0 (0 to 70.8)
Day 366: E2	50 (1.3 to 98.7)	0 (0 to 70.8)
Day 57: E6/E7	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E6/E7	0 (0 to 70.8)	0 (0 to 70.8)
Day 239: E6/E7	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: E6/E7	0 (0 to 84.2)	0 (0 to 70.8)
Day 57: Combined Peptide Pools	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: Combined Peptide Pools	100 (29.2 to 100)	0 (0 to 70.8)
Day 239: Combined Peptide Pools	66.7 (9.4 to 99.2)	0 (0 to 70.8)
Day 366: Combined Peptide Pools	50 (1.3 to 98.7)	0 (0 to 70.8)

SecondaryPercentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+

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
Reported as:: Number · Percentage of participants

Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+
Percentage of participants	Regimen 1	Placebo
Day 57: E2	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E2	66.7 (9.4 to 99.2)	0 (0 to 70.8)
Day 239: E2	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: E2	50 (1.3 to 98.7)	0 (0 to 70.8)
Day 57: E6/E7	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E6/E7	0 (0 to 70.8)	0 (0 to 70.8)
Day 239: E6/E7	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: E6/E7	0 (0 to 84.2)	0 (0 to 70.8)
Day 57: Combined Peptide Pools	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: Combined Peptide Pools	66.7 (9.4 to 99.2)	0 (0 to 70.8)
Day 239: Combined Peptide Pools	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: Combined Peptide Pools	50 (1.3 to 98.7)	0 (0 to 70.8)

SecondaryPercentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+

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
Reported as:: Number · Percentage of participants

Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+
Percentage of participants	Regimen 1	Placebo
Day 57: E2	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E2	0 (0 to 70.8)	0 (0 to 70.8)
Day 239: E2	33.3 (0.8 to 90.6)	0 (0 to 70.8)
Day 366: E2	0 (0 to 84.2)	0 (0 to 70.8)
Day 57: E6/E7	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: E6/E7	0 (0 to 70.8)	0 (0 to 70.8)
Day 239: E6/E7	0 (0 to 70.8)	0 (0 to 70.8)
Day 366: E6/E7	0 (0 to 84.2)	0 (0 to 70.8)
Day 57: Combined Peptide Pools	0 (0 to 60.2)	0 (0 to 60.2)
Day 78: Combined Peptide Pools	0 (0 to 70.8)	0 (0 to 70.8)
Day 239: Combined Peptide Pools	33.3 (0.8 to 90.6)	0 (0 to 70.8)
Day 366: Combined Peptide Pools	0 (0 to 84.2)	0 (0 to 70.8)

Adverse events

Collected over Up to 12 months after the first vaccination (target visit Day 366). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Regimen 1	0/5 (0%)	0/5 (0%)	2/5 (40%)
Placebo	0/4 (0%)	0/4 (0%)	1/4 (25%)

Most frequent other events

Most frequent other events
Event	Regimen 1	Placebo
Increased Tendency to BruiseBlood and lymphatic system disorders	0/5	1/4
Urinary Tract InfectionInfections and infestations	0/5	1/4
Vulvovaginal Mycotic InfectionInfections and infestations	0/5	1/4
Upper Respiratory Tract InfectionInfections and infestations	1/5	0/4
SyncopeNervous system disorders	1/5	0/4

Baseline characteristics

Full analysis set (FAS) included all participants with at least one vaccination.

Age, Continuous
Age, Continuous(years)	Regimen 1	Placebo	Total
Mean	42 ± 11.85	45.5 ± 5.69	43.6 ± 9.26

Sex: Female, Male
Sex: Female, Male(Participants)	Regimen 1	Placebo	Total
Female	5	4	9
Male	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Regimen 1	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	0	1
White	4	4	8
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Regimen 1	Placebo	Total
UNITED STATES	5	4	9

Study locations

12 sites

Doral Medical Research
Doral, Florida 33166, United States
Clinical Physiology Associates
Fort Myers, Florida 33912, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida 33014, United States
Florida Research Center Inc.
Miami, Florida 33174, United States
University of Iowa Hospital
Iowa City, Iowa 52242, United States
University of Kansas Medical Center
Kansas City, Kansas 66160, United States
Heartland Research Associates, LLC
Newton, Kansas 67114, United States
Medpharmics, LLC
Metairie, Louisiana 70006, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska 68701, United States
Columbia University Medical Center
New York, New York 10032, United States
VGR & NOCCR - Knoxville
Knoxville, Tennessee 37920, United States
UZ Leuven
Leuven, 3000, Belgium

References and documents

Study documents

Study protocol · Aug 20, 2019
Statistical analysis plan · Oct 14, 2020

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03610581
Lead sponsor: Janssen Vaccines & Prevention B.V.
Collaborators: Bavarian Nordic
Responsible party: Sponsor
First posted: Aug 1, 2018
Start date: Sep 27, 2018
Primary completion: Oct 15, 2020
Completion: Oct 15, 2020
Results posted: Nov 9, 2021
Last update: Feb 4, 2025

Study contacts

Janssen Vaccines & Prevention B.V. Clinical Trial

study director · Janssen Vaccines & Prevention B.V.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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