HealthyEarly Phase 1NCT03953196
A Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Participants
A Early Phase 1 study testing Imvanex, Shingrix and LPS in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to characterize the immune response in vivo using approved vaccines and antigen challenges, as well as a skin wounding challenge to stimulate the immune system. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Imvanex, Shingrix and LPS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Apr 2019to 26 Dec 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2) (BMI = weight/height^2), inclusive, and a body weight of no less than 50 kilogram (kg)
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (for Cohort 3) performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- All women must have a negative highly sensitive serum (Beta-human chorionic gonadotropin [Beta-hCG]) pregnancy test at screening and a negative urine pregnancy test predose on Day 1
Who cannot join
- History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia. These include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenia and chronic granulomatous disease
- History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, bleeding disorders, rheumatologic, psychiatric, or metabolic disturbances, and atopic dermatitis
- Known allergies, hypersensitivity, or intolerance to any of the interventions in this study or their excipients
- History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
- Contraindications to the use of any of the study interventions per prescribing information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 0 Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Volunteers
The purpose of this study is to characterize the immune response in vivo using approved vaccines and antigen challenges, as well as a skin wounding challenge to stimulate the immune system.
- Conditions
- Healthy
- Being tested
- Imvanex, Shingrix, LPS, Candin, Skin Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImvanexBiological
Also called Imvamune
Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection.
ShingrixBiological
Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection.
LPSBiological
Also called Endotoxin
LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection.
CandinBiological
Also called Candida albicans
Candin 0.1 mL solution for injection will be administered as one intradermal injection.
Skin BiopsyOther
3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1.
Saline ControlOther
Saline control solution for injection will be administered as one intradermal injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Vaccine Challenge Imvanex | Experimental | Participants will receive single dose of Imvanex subcutaneously on Day 1. Participants will also be included in the DREEM EEG substudy. Receives: Biological: Imvanex |
| Cohort 2: Vaccine Challenge Shingrix | Experimental | Participants will receive single dose of Shingrix intramuscularly on Day 1. Participants will also be included in the DREEM EEG substudy. Receives: Biological: Shingrix |
| Cohort 3: Antigen Challenge Lipopolysaccharides (LPS) | Experimental | Participants will receive a single dose of LPS intravenously (IV) on Day 1. Participants will also be included in the DREEM EEG substudy and vital patch physIQ platform substudy. Receives: Biological: LPS |
| Cohort 4: Antigen Challenge Candin | Experimental | Participants will receive one single injection of Candin and one single injection of saline control intradermally on Day 1. Participants will also be included in the DREEM EEG substudy. Receives: Biological: Candin; Other: Saline Control |
| Cohort 5: Skin Wounding Challenge | Experimental | 3 punch biopsies will be performed per standard dermatologic practice guidelines. Lower abdomen tissue biopsy specimens will be collected on Day 1. Receives: Other: Skin Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1 and Cohort 2: Change from Baseline of Immune Cell Populations
Change from baseline in immune cell populations will be measured in peripheral blood samples or tissues of healthy volunteers.
Measured: Baseline up to 90 days
Cohort 3 and Cohort 4: Change from Baseline of Immune Cell Populations
Change from baseline in immune cell populations will be measured in peripheral blood samples or tissues of healthy volunteers.
Measured: Baseline up to 14 days
Cohort 5: Change from Baseline of Immune Cell Populations
Change from baseline in immune cell populations will be measured in tissues of healthy volunteers.
Measured: Baseline up to 10 days
Cohort 1 and Cohort 2: Change from Baseline in Cell Surface Antigen Phenotype
Change from baseline in cell surface antigen phenotype will be measured in peripheral blood samples or tissues of healthy volunteers.
Measured: Baseline up to 90 days
Cohort 3 and Cohort 4: Change from Baseline in Cell Surface Antigen Phenotype
Change from baseline in cell surface antigen phenotype will be measured in peripheral blood samples or tissues of healthy volunteers.
Measured: Baseline up to 14 days
Cohort 5: Change from Baseline in Cell Surface Antigen Phenotype
Change from baseline in cell surface antigen phenotype will be measured in tissues of healthy volunteers.
Measured: Baseline up to 10 days
Cohort 1 and Cohort 2: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines)
Soluble cytokines and chemokines will be measured by immunoassay.
Measured: Baseline up to 90 days
Cohort 3 and Cohort 4: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines)
Soluble cytokines and chemokines will be measured by immunoassay.
Measured: Baseline up to 14 days
Cohort 5: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines)
Soluble cytokines and chemokines will be measured by immunoassay.
Measured: Baseline up to 10 days
Cohort 1 and Cohort 2: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins)
Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry.
Measured: Baseline up to 90 days
Cohort 3 and Cohort 4: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins)
Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry.
Measured: Baseline up to 14 days
Cohort 5: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins)
Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry.
Measured: Baseline up to 10 days
Cohort 1 and Cohort 2: Change from Baseline in Expression of Inflammatory Mediators
Transcriptional changes in gene expression will be measured by established methods such as ribonucleic acid (RNA) microarray, RNAseq, and single cell RNA sequencing, and will be reported in number of gene transcripts per sample or per cell.
Measured: Baseline up to 90 days
Cohort 3 and Cohort 4: Change from Baseline in Expression of Inflammatory Mediators
Transcriptional changes in gene expression will be measured by established methods such as ribonucleic acid (RNA) microarray, RNAseq, and single cell RNA sequencing, and will be reported in number of gene transcripts per sample or per cell.
Measured: Baseline up to 14 days
Cohort 5: Change from Baseline in Expression of Inflammatory Mediators
Transcriptional changes in gene expression will be measured by established methods such as RNA microarray, RNAseq, and single cell RNA sequencing, and will be reported in number of gene transcripts per sample or per cell.
Measured: Baseline up to 10 days
Secondary outcomes (12)
Change in Standard Deviation from Baseline of Immune Cell Populations Within a Participant
Change in standard deviation from baseline of immune cell populations within a participant will be measured.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline of Immune Cell Populations Between Participants
Change in standard deviation from baseline of immune cell populations between participants will be measured.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Cell Surface Antigen Phenotype Within a Participant
Change in standard deviation from baseline in cell surface antigen phenotype within a participant will be measured.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Cell Surface Antigen Phenotype Between Participants
Change in standard deviation from baseline in cell surface antigen phenotype between participants will be measured.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Activation Status of Inflammatory Mediators Within a Participant
Change in standard deviation from baseline in activation status of inflammatory mediators within a participant will be measured.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Activation Status of Inflammatory Mediators Between Participants
Change in standard deviation from baseline in activation status of inflammatory mediators between participants will be measured.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Expression of Inflammatory Mediators Within a Participant
Change in standard deviation from baseline in expression of inflammatory mediators within a participant will be measured.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Expression of Inflammatory Mediators Between Participants
Change in standard deviation from baseline in expression of inflammatory mediators between participants will be measured.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Correlation of Baseline Immune Cell Populations with Vaccine/Antigen Immune Response Phenotype
Correlation of baseline immune cell populations with vaccine/antigen immune response phenotype will be measured by phenotypic and functional assays.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
Correlation of Genomics with Vaccine/Antigen Immune Response Phenotype
Correlation of genomics with vaccine/antigen immune response phenotype will be measured by phenotypic and functional assays.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
Correlation of Serology with Vaccine/Antigen Immune Response Phenotype
Correlation of serology with vaccine/antigen immune response phenotype will be measured by phenotypic and functional assays.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
Correlation of Soluble Proteins with Vaccine/Antigen Immune Response Phenotype
Correlation of soluble proteins with vaccine/antigen immune response phenotype will be measured by phenotypic and functional assays.
Measured: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start8 Apr 2019
- Primary completion26 Dec 2019
- Study completion26 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953196
- Sponsor's protocol ID
- CR108590
- Other IDs
- NOPRODNAP0016
- Status last verified
- Jan 2025
- First submitted
- 1 Apr 2019
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0 Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03953196
- Acronym / sponsor ID
- CR108590
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the immune response in vivo using approved vaccines and antigen challenges, as well as a skin wounding challenge to stimulate the immune system.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Vaccine Challenge Imvanex | Experimental | Biological: ImvanexParticipants will receive single dose of Imvanex subcutaneously on Day 1. Participants will also be included in the DREEM EEG substudy. |
| Cohort 2: Vaccine Challenge Shingrix | Experimental | Biological: ShingrixParticipants will receive single dose of Shingrix intramuscularly on Day 1. Participants will also be included in the DREEM EEG substudy. |
| Cohort 3: Antigen Challenge Lipopolysaccharides (LPS) | Experimental | Biological: LPSParticipants will receive a single dose of LPS intravenously (IV) on Day 1. Participants will also be included in the DREEM EEG substudy and vital patch physIQ platform substudy. |
| Cohort 4: Antigen Challenge Candin | Experimental | Biological: Candin, Other: Saline ControlParticipants will receive one single injection of Candin and one single injection of saline control intradermally on Day 1. Participants will also be included in the DREEM EEG substudy. |
| Cohort 5: Skin Wounding Challenge | Experimental | Other: Skin Biopsy3 punch biopsies will be performed per standard dermatologic practice guidelines. Lower abdomen tissue biopsy specimens will be collected on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have a body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2) (BMI = weight/height^2), inclusive, and a body weight of no less than 50 kilogram (kg)
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (for Cohort 3) performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- All women must have a negative highly sensitive serum (Beta-human chorionic gonadotropin [Beta-hCG]) pregnancy test at screening and a negative urine pregnancy test predose on Day 1
Key exclusion criteria (5 listed)
- History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia. These include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenia and chronic granulomatous disease
- History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, bleeding disorders, rheumatologic, psychiatric, or metabolic disturbances, and atopic dermatitis
- Known allergies, hypersensitivity, or intolerance to any of the interventions in this study or their excipients
- History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
- Contraindications to the use of any of the study interventions per prescribing information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImvanexAlso: ImvamuneImvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection. | Biological | Cohort 1: Vaccine Challenge Imvanex |
| ShingrixShingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection. | Biological | Cohort 2: Vaccine Challenge Shingrix |
| LPSAlso: EndotoxinLPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection. | Biological | Cohort 3: Antigen Challenge Lipopolysaccharides (LPS) |
| CandinAlso: Candida albicansCandin 0.1 mL solution for injection will be administered as one intradermal injection. | Biological | Cohort 4: Antigen Challenge Candin |
| Skin Biopsy3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1. | Other | Cohort 5: Skin Wounding Challenge |
| Saline ControlSaline control solution for injection will be administered as one intradermal injection. | Other | Cohort 4: Antigen Challenge Candin |
Primary outcome
Cohort 1 and Cohort 2: Change from Baseline of Immune Cell Populations
Time frame: Baseline up to 90 days
Change from baseline in immune cell populations will be measured in peripheral blood samples or tissues of healthy volunteers.
Cohort 3 and Cohort 4: Change from Baseline of Immune Cell Populations
Time frame: Baseline up to 14 days
Change from baseline in immune cell populations will be measured in peripheral blood samples or tissues of healthy volunteers.
Cohort 5: Change from Baseline of Immune Cell Populations
Time frame: Baseline up to 10 days
Change from baseline in immune cell populations will be measured in tissues of healthy volunteers.
Cohort 1 and Cohort 2: Change from Baseline in Cell Surface Antigen Phenotype
Time frame: Baseline up to 90 days
Change from baseline in cell surface antigen phenotype will be measured in peripheral blood samples or tissues of healthy volunteers.
Cohort 3 and Cohort 4: Change from Baseline in Cell Surface Antigen Phenotype
Time frame: Baseline up to 14 days
Change from baseline in cell surface antigen phenotype will be measured in peripheral blood samples or tissues of healthy volunteers.
Cohort 5: Change from Baseline in Cell Surface Antigen Phenotype
Time frame: Baseline up to 10 days
Change from baseline in cell surface antigen phenotype will be measured in tissues of healthy volunteers.
Cohort 1 and Cohort 2: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines)
Time frame: Baseline up to 90 days
Soluble cytokines and chemokines will be measured by immunoassay.
Cohort 3 and Cohort 4: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines)
Time frame: Baseline up to 14 days
Soluble cytokines and chemokines will be measured by immunoassay.
Cohort 5: Change from Baseline in Activation Status of Inflammatory Mediators (Soluble Cytokines and Chemokines)
Time frame: Baseline up to 10 days
Soluble cytokines and chemokines will be measured by immunoassay.
Cohort 1 and Cohort 2: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins)
Time frame: Baseline up to 90 days
Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry.
Cohort 3 and Cohort 4: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins)
Time frame: Baseline up to 14 days
Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry.
Cohort 5: Change from Baseline in Activation Status of Inflammatory Mediators (Cell-bound and Tissue-associated Proteins)
Time frame: Baseline up to 10 days
Cell-bound and tissue-associated proteins will be measured by established methods including flow cytometry and immunohistochemistry.
Cohort 1 and Cohort 2: Change from Baseline in Expression of Inflammatory Mediators
Time frame: Baseline up to 90 days
Transcriptional changes in gene expression will be measured by established methods such as ribonucleic acid (RNA) microarray, RNAseq, and single cell RNA sequencing, and will be reported in number of gene transcripts per sample or per cell.
Cohort 3 and Cohort 4: Change from Baseline in Expression of Inflammatory Mediators
Time frame: Baseline up to 14 days
Transcriptional changes in gene expression will be measured by established methods such as ribonucleic acid (RNA) microarray, RNAseq, and single cell RNA sequencing, and will be reported in number of gene transcripts per sample or per cell.
Cohort 5: Change from Baseline in Expression of Inflammatory Mediators
Time frame: Baseline up to 10 days
Transcriptional changes in gene expression will be measured by established methods such as RNA microarray, RNAseq, and single cell RNA sequencing, and will be reported in number of gene transcripts per sample or per cell.
12 secondary outcomes
Change in Standard Deviation from Baseline of Immune Cell Populations Within a Participant
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline of Immune Cell Populations Between Participants
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Cell Surface Antigen Phenotype Within a Participant
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Cell Surface Antigen Phenotype Between Participants
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Activation Status of Inflammatory Mediators Within a Participant
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Activation Status of Inflammatory Mediators Between Participants
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Expression of Inflammatory Mediators Within a Participant
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Change in Standard Deviation from Baseline in Expression of Inflammatory Mediators Between Participants
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days; Cohort 5: Baseline up to 10 days
Correlation of Baseline Immune Cell Populations with Vaccine/Antigen Immune Response Phenotype
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
Correlation of Genomics with Vaccine/Antigen Immune Response Phenotype
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
Correlation of Serology with Vaccine/Antigen Immune Response Phenotype
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
Correlation of Soluble Proteins with Vaccine/Antigen Immune Response Phenotype
Time frame: Cohort 1 and Cohort 2: Baseline up to 90 days; Cohort 3 and Cohort 4: Baseline up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Imvanex, Shingrix and LPS in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1 and Cohort 2: Change from Baseline of Immune Cell Populations (time frame: Baseline up to 90 days). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.