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A Shedding Study of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) Vaccine in Adults

NCT ID: NCT03795441

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2019-07-28

Brief Summary

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The purpose of this study is to assess the shedding and kinetics of the Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) vaccine after one intramuscular injection of Ad26.RSV.preF in adults.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ad26.RSV.preF

Participants will receive one intramuscular injection of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) on Day 1.

Group Type EXPERIMENTAL

Ad26.RSV.preF

Intervention Type BIOLOGICAL

Ad26.RSV.preF will be administered as intramuscular injection on Day 1.

Interventions

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Ad26.RSV.preF

Ad26.RSV.preF will be administered as intramuscular injection on Day 1.

Intervention Type BIOLOGICAL

Other Intervention Names

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JNJ-64400141

Eligibility Criteria

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Inclusion Criteria

* In the investigator's clinical judgment, participant must be in good or stable health. Participants may have underlying illnesses such as hypertension, Type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and 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 measurement and 12-lead electrocardiogram (ECG; for participants greater than \[\>\] 65 years of age only) performed at screening
* Contraceptive use by women should be consistent with local regulations regarding the use of contraceptive methods for participants in clinical studies
* All women of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine beta-hCG pregnancy test immediately prior to study vaccine administration
* From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
* Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Exclusion Criteria

* 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 (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Per medical history, participant has chronic active hepatitis B or hepatitis C infection
* Participant has received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study
* Participant has received treatment with immunoglobulin in the 2 months, or blood products in the 4 months before the planned administration of study vaccine or has any plans to receive such treatment during the study
* Participant has received any RSV vaccine in any previous RSV vaccine study at any time prior to randomization
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Vaccines & Prevention B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

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Clinical Pharmacology Unit

Merksem, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2018-003261-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAC18193RSV1005

Identifier Type: OTHER

Identifier Source: secondary_id

CR108554

Identifier Type: -

Identifier Source: org_study_id