- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02926430
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
February 18, 2019 updated by: Janssen Vaccines & Prevention B.V.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami, Florida, United States
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ad26.RSV.preF 5*10^10 vp (Day 1 and Day 365): Group 1
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).
|
Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
Other Names:
|
Experimental: Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2
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).
|
Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
Other Names:
Participants will receive placebo as formulation buffer.
|
Experimental: Ad26.RSV.preF 1*10^11 vp (Day 1 and Day 365): Group 3
Participants 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 will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
Other Names:
|
Experimental: Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4
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).
|
Participants will receive placebo as formulation buffer.
Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
Other Names:
|
Experimental: Placebo (Day 1 and Day 365): Group 5
Participants will receive placebo at Day 1 and Day 365 (10 to 13 months after first vaccination).
|
Participants will receive placebo as formulation buffer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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7 days after each vaccination (Day 1)
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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)
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7 days after each vaccination (Day 365)
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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)
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7 days after each vaccination (Day 1)
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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)
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7 days after each vaccination (Day 365)
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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)
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28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
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Number of Participants With Serious Adverse Events (SAEs) Throughout Study
Time Frame: Up to 730 days
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Up to 730 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory Syncytial Virus (RSV) Neutralization A2
Time Frame: Days 1, 29, 183, 365, 393, 547, 730
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Analysis of RSV A2 neutralizing titers of the vaccine-induced immune response will be assessed.
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Days 1, 29, 183, 365, 393, 547, 730
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RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay
Time Frame: Days 1, 29, 183, 365, 393, 547, 730
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Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form.
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Days 1, 29, 183, 365, 393, 547, 730
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Intracellular Cytokine Staining
Time Frame: Day 1, 29, 183, 365, 393, 547, 730
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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).
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Day 1, 29, 183, 365, 393, 547, 730
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2016
Primary Completion (Actual)
March 14, 2018
Study Completion (Actual)
January 29, 2019
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
October 5, 2016
First Posted (Estimate)
October 6, 2016
Study Record Updates
Last Update Posted (Actual)
February 19, 2019
Last Update Submitted That Met QC Criteria
February 18, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- CR108214
- VAC18193RSV1003 (Other Identifier: Janssen Vaccines & Prevention B.V.)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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