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

NCT03795441 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1085542018-003261-34VAC18193RSV1005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Presence of Ad26.RSV.preF (shedding) as Assessed by qPCR

  Percentage of Participants with presence of Ad26.RSV.preF in the adhesive bandage covering the injection site, the injection site area, nares (mid-turbinate), throat, rectum, urine, semen and blood, will be assessed by Quantitative Polymerase Chain Reaction (qPCR). Percentage of participants with presence of Ad26.RSV.preF (shedding) will be assessed.

  Up to Day 183

Secondary Outcomes (3)

• Number of Participants with Serious Adverse Events (SAEs)

  First vaccination (Day 1) to the end of the study (Day 183)

• Number of Participants with Solicited Local and Systemic Adverse Events (AEs) After Vaccination

  7 days after vaccination (Day 1 up to Day 7)

• Number of Participants with Unsolicited AEs as a Measure of Safety

  Day 1 Up to Day 28

Study Arms (1)

Ad26.RSV.preF

EXPERIMENTAL

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.

Biological: Ad26.RSV.preF

Interventions

Ad26.RSV.preF BIOLOGICAL

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

Also known as: JNJ-64400141

Ad26.RSV.preF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 7, 2019
• Study Start: January 7, 2019
• Primary Completion: July 28, 2019
• Study Completion: July 28, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)