HealthyPhase 1NCT02926430
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
A Phase 1 study testing Ad26.RSV.preF 5*10^10 vp and Ad26.RSV.preF 1*10^11 vp in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF, administered intramuscularly to elderly adults given approximately 12 months apart. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ad26.RSV.preF 5*10^10 vp and Ad26.RSV.preF 1*10^11 vp
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2016to 29 Jan 2019
- Phase
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
- Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; and not intending to conceive by any methods
- From the time of first vaccination until 3 months after the first dose of study vaccine, and from the second vaccination through 3 months after, a man who has not had a vasectomy (or if a vasectomy was performed less than 1 year ago and the absence of sperm cannot be verified)
- In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grades 1 or 2 according to the US Food and Drug Administration (FDA) toxicity tables (for tests in the FDA table ), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Who cannot join
- Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree celsius within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
- Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has had major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study
- Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF, administered intramuscularly to elderly adults given approximately 12 months apart.
- Conditions
- Healthy
- Being tested
- Ad26.RSV.preF 5*10^10 vp, Ad26.RSV.preF 1*10^11 vp, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.RSV.preF 5*10^10 vpBiological
Also called JNJ-64400141
Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
Ad26.RSV.preF 1*10^11 vpBiological
Also called JNJ-64400141
Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
PlaceboDrug
Participants will receive placebo as formulation buffer.
| Study group | Role | What they receive |
|---|---|---|
| Ad26.RSV.preF 5*10^10 vp (Day 1 and Day 365): Group 1 | Experimental | Participants will receive 5*10^10 viral particles (vp) Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination). Receives: Biological: Ad26.RSV.preF 5*10^10 vp |
| Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2 | Experimental | Participants will receive 5*10^10 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination). Receives: Biological: Ad26.RSV.preF 5*10^10 vp; Drug: Placebo |
| Ad26.RSV.preF 1*10^11 vp (Day 1 and Day 365): Group 3 | Experimental | Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination). Receives: Biological: Ad26.RSV.preF 1*10^11 vp |
| Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4 | Experimental | Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination). Receives: Biological: Ad26.RSV.preF 1*10^11 vp; Drug: Placebo |
| Placebo (Day 1 and Day 365): Group 5 | Experimental | Participants will receive placebo at Day 1 and Day 365 (10 to 13 months after first vaccination). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
Measured: 7 days after each vaccination (Day 1)
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
Measured: 7 days after each vaccination (Day 365)
Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
Measured: 7 days after each vaccination (Day 1)
Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
Measured: 7 days after each vaccination (Day 365)
Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
Measured: 28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
Number of Participants With Serious Adverse Events (SAEs) Throughout Study
Measured: Up to 730 days
Secondary outcomes (3)
Respiratory Syncytial Virus (RSV) Neutralization A2
Analysis of RSV A2 neutralizing titers of the vaccine-induced immune response will be assessed.
Measured: Days 1, 29, 183, 365, 393, 547, 730
RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay
Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form.
Measured: Days 1, 29, 183, 365, 393, 547, 730
Intracellular Cytokine Staining
The activation of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T-cell subsets and their cytokine expression patterns will be determined by flow cytometry after RSV protein peptide stimulation (including, but not limited to CD4/CD8, interleukin [IL-2], interferon gamma [IFN gamma], tumor necrosis factor alpha [TNF-alpha] and/or activation markers, memory, T-helper [cells] Th1/Th2 subtyping).
Measured: Day 1, 29, 183, 365, 393, 547, 730
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start8 Nov 2016
- Primary completion14 Mar 2018
- Study completion29 Jan 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.
- 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
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926430
- Sponsor's protocol ID
- CR108214
- Other IDs
- VAC18193RSV1003
- Status last verified
- Feb 2019
- First submitted
- 22 Sep 2016
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
- ClinicalTrials.gov ID
- NCT02926430
- Acronym / sponsor ID
- CR108214
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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 assess the safety and tolerability of 2 single doses of either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF, administered intramuscularly to elderly adults given approximately 12 months apart.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ad26.RSV.preF 5*10^10 vp (Day 1 and Day 365): Group 1 | Experimental | Biological: Ad26.RSV.preF 5*10^10 vpParticipants will receive 5*10^10 viral particles (vp) Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination). |
| Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2 | Experimental | Biological: Ad26.RSV.preF 5*10^10 vp, Drug: PlaceboParticipants will receive 5*10^10 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination). |
| Ad26.RSV.preF 1*10^11 vp (Day 1 and Day 365): Group 3 | Experimental | Biological: Ad26.RSV.preF 1*10^11 vpParticipants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination). |
| Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4 | Experimental | Biological: Ad26.RSV.preF 1*10^11 vp, Drug: PlaceboParticipants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination). |
| Placebo (Day 1 and Day 365): Group 5 | Experimental | Drug: PlaceboParticipants will receive placebo at Day 1 and Day 365 (10 to 13 months after first vaccination). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
- Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; and not intending to conceive by any methods
- From the time of first vaccination until 3 months after the first dose of study vaccine, and from the second vaccination through 3 months after, a man who has not had a vasectomy (or if a vasectomy was performed less than 1 year ago and the absence of sperm cannot be verified)
- In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grades 1 or 2 according to the US Food and Drug Administration (FDA) toxicity tables (for tests in the FDA table ), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Key exclusion criteria (5 listed)
- Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree celsius within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
- Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has had major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study
- Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
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 |
|---|---|---|
| Ad26.RSV.preF 5*10^10 vpAlso: JNJ-64400141Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL). | Biological | Ad26.RSV.preF 5*10^10 vp (Day 1 and Day 365): Group 1, Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2 |
| Ad26.RSV.preF 1*10^11 vpAlso: JNJ-64400141Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL). | Biological | Ad26.RSV.preF 1*10^11 vp (Day 1 and Day 365): Group 3, Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4 |
| PlaceboParticipants will receive placebo as formulation buffer. | Drug | Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4, Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2, Placebo (Day 1 and Day 365): Group 5 |
Primary outcome
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
Time frame: 7 days after each vaccination (Day 1)
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
Time frame: 7 days after each vaccination (Day 365)
Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
Time frame: 7 days after each vaccination (Day 1)
Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
Time frame: 7 days after each vaccination (Day 365)
Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
Time frame: 28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
Number of Participants With Serious Adverse Events (SAEs) Throughout Study
Time frame: Up to 730 days
3 secondary outcomes
Respiratory Syncytial Virus (RSV) Neutralization A2
Time frame: Days 1, 29, 183, 365, 393, 547, 730
RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay
Time frame: Days 1, 29, 183, 365, 393, 547, 730
Intracellular Cytokine Staining
Time frame: Day 1, 29, 183, 365, 393, 547, 730
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 19 Feb 2019.
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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 Vaccines & Prevention B.V. Clinical Trial study director
Janssen Vaccines & Prevention B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ad26.RSV.preF 5*10^10 vp and Ad26.RSV.preF 1*10^11 vp in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 1 site in United States.
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 19 Feb 2019. 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 United States. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1) (time frame: 7 days after each vaccination (Day 1)). The study lists 6 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 19 Feb 2019.