- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02561871
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
October 31, 2016 updated by: Crucell Holland BV
Phase 1, First in Human Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
The purpose of this study is to assess the safety and tolerability of intramuscular prime-boost regimens of Ad26.RSV.FA2 given either once or twice followed by Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) in healthy participants.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This is a single-center, randomized (study vaccine assigned to participants by chance), placebo-controlled study (an inactive substance; a pretend treatment [with no vaccine in it] that is compared in a clinical trial with a vaccine to test if the vaccine has a real effect), double-blind (neither the researchers nor the participants know what treatment the participant is receiving) Phase 1 study in healthy participants.
The study comprises a 4-week screening period; vaccination for each participant on Days 1, 85, and, 169; a 28-day follow-up period performed after each vaccination and a final visit at Day 337.
Approximately 32 Participants will be randomized in parallel in a 3:3:2 ratio to 3 treatment groups (Group 1/2/3) to receive either Ad26.RSV.FA2 or Ad35.RSV.FA2 or placebo.
The study duration will be approximately 52 weeks.
Blood samples for immunogenicity will be collected.
Participant's safety will be evaluated throughout the study.
Study Type
Interventional
Enrollment (Actual)
34
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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant must be in good health, without significant medical illness, on the basis of physical examination, medical history, vital signs measurement, and 12-lead electrocardiogram (ECG) performed at screening
- Participant must meet protocol defined laboratory criteria within 28 days before Day 1
- Before randomization, a woman must be either; Not of childbearing potential: postmenopausal or surgically sterilized; of childbearing potential and practicing an effective method of birth control before vaccination and through 3 months after the last vaccination. Women, who are not heterosexually active at screening, must agree to utilize highly-effective method of birth control if they become heterosexually active until 3 months after receiving the last dose of study vaccine
- A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at the screening visit, and a negative urine pregnancy test pre-vaccination on Day 1
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until 3 months after receiving the last dose of study vaccine. A man must agree not to donate sperm until 3 months after receiving the last dose of study vaccine
Exclusion Criteria:
- Participant has a body mass index (BMI) less than or equal to (<=)19 and greater than or equal to (>=30) kilogram per square meter (kg/m2)
- Participant has any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation (e.g. history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections)
- 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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Two subsequent Intramuscular injections of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on Day 1 and Day 85, and one intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on Day 169.
|
Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 and 85 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 in Group 2.
Other Names:
Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 169 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 85 in Group 2.
Other Names:
|
Experimental: Group 2
Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on Day 1, an intramuscular injection of Ad35.RSV.FA2 (1x10^11 vp) on Day 85 and and an intramuscular injection of placebo control consisting of the vaccine formulation buffer on Day 169.
|
Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 and 85 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 in Group 2.
Other Names:
Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 169 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 85 in Group 2.
Other Names:
Participants will receive Intramuscular injection of Placebo control on day 169 in Group 2. Intramuscular injection of Placebo control on day 1, 85 and 169 in Group 3.
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Experimental: Group 3
Three intramuscular injections of placebo control on Day 1, Day 85 and Day 169.
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Participants will receive Intramuscular injection of Placebo control on day 169 in Group 2. Intramuscular injection of Placebo control on day 1, 85 and 169 in Group 3.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Solicited Local Adverse Events (AEs)
Time Frame: Up to 8 days after each vaccination
|
Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the participant diary.
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Up to 8 days after each vaccination
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Number of Participants with Solicited Systemic Adverse Events (AEs)
Time Frame: Up to 8 days after each vaccination
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Up to 8 days after each vaccination
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Number of Participants with Unsolicited AEs
Time Frame: From Signing of informed consent up to 28 days after each vaccination
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Unsolicited AEs will be reported by the participant from when the informed consent form (ICF) is signed until 28 days after each vaccination, or early discontinuation.
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From Signing of informed consent up to 28 days after each vaccination
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Number of Participants with Serious Adverse Events (SAEs)
Time Frame: From Signing of informed consent up to Day 337
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A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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From Signing of informed consent up to Day 337
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune Responses to the Study Vaccine Regimens as Measured by a Virus Neutralization Assay
Time Frame: Day 1 (predose) up to day 337
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Day 1 (predose) up to day 337
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Immune Responses to the Study Vaccine Regimens Measured by an Enzyme-linked Immunosorbent Assay (ELISA)
Time Frame: Day 1 (predose) up to day 337
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Day 1 (predose) up to day 337
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Immune responses to the study vaccine regimens as measured by an Enzyme-linked Immunospot Assay (ELISpot)
Time Frame: Day 1 (predose) up to day 337
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Enzyme-linked Immunospot Assay (ELISpot) is used to quantify the amount of peripheral blood mononuclear cells (PBMCs) able to produce Interferon-gamma upon RSV antigen stimulation.
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Day 1 (predose) up to day 337
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
August 21, 2015
First Submitted That Met QC Criteria
September 25, 2015
First Posted (Estimate)
September 28, 2015
Study Record Updates
Last Update Posted (Estimate)
November 1, 2016
Last Update Submitted That Met QC Criteria
October 31, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR107705
- VAC18192RSV1003 (Other Identifier: Crucell Holland BV)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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