An Exploratory, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-Old Adults

Janssen Vaccines & Prevention B.V.1 site in 1 country64 target enrollmentOctober 16, 2017

ConditionsHealthy

InterventionsAd26.RSV.preF Placebo

DrugsAd26.RSV.preF Placebo

Overview

Phase: Phase 2
Intervention: Ad26.RSV.preF
Conditions: Healthy
Sponsor: Janssen Vaccines & Prevention B.V.
Enrollment: 64
Locations: 1
Primary Endpoint: Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess a trend for the prophylactic efficacy of a single dose of 1*10^11 virus particles (vp) of adenovirus serotype 26 respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) administered intramuscularly to adults aged 18-50 years in the respiratory syncytial virus (RSV) challenge model in terms of reduction of nasal wash viral load compared to placebo.

Registry

clinicaltrials.gov

Start Date

October 16, 2017

End Date

November 27, 2018

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Janssen Vaccines & Prevention B.V.

Responsible Party

Sponsor

Eligibility Criteria

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, is willing to be isolated and stay in the clinic for the quarantine phase, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
•Participants must be in good health, without significant medical illness, on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including height and weight), skin examination, medical history, vital signs (systolic and diastolic blood pressure and heart rate, respiratory rate, and body temperature), and the results of clinical laboratory tests performed within 56 days of vaccination. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
•Participants must have a non-clinically significant 12-lead electrocardiogram (ECG) within 56 days of vaccination including: normal sinus rhythm (heart rate between 50 and 100 beats per minute \[bpm\], extremes included); QT interval corrected for heart rate according to Fridericia (QTcF) interval less than or equal to (\<=) 450 millisecond (ms); QT interval corrected for heart rate according to Bazett (QTcB) interval \<= 450 ms; QRS interval less than (\<) 120 ms; PR interval \<= 210 ms
•Participants must be sero-suitable for respiratory syncytial virus (RSV) within 90 days of vaccination (low immunity to the RSV-A Memphis 37b virus using a virus neutralization assay
•Participant must be healthy on the basis of clinical laboratory tests performed within 56 days of vaccination. If the results of the laboratory screening tests are outside the local laboratory normal reference ranges and additionally within the limits of toxicity Grade 1 according to the US Food and Drug Administration (FDA) toxicity tables (that is, 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 (\>=) 37.8 degree Centigrade within 24 hours prior to study vaccination
•Participant has history of malignancy (exceptions are basal cell carcinomas of the skin treated over 5 years prior to vaccination considered cured with minimal risk of recurrence)
•Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
•Viral Challenge Exclusion Criteria:
•Participants having donated or lost more than 1 unit of blood (470 milliliter \[mL\]) within 60 days or more than one unit of plasma within 7 days
•Participants with active acute respiratory infection

Arms & Interventions

Group 1: Ad26.RSV.preF

Participants will receive single intramuscular injection of 1\*10\^11 virus particles (vp) of Ad26.RSV.preF during Day -90 to Day -28. On Day 0, intranasal challenge with respiratory syncytial virus (RSV)-A Memphis 37b virus will occur for all participants.

Intervention: Ad26.RSV.preF

Group 2: Placebo

Participants will receive single intramuscular injection of placebo as sterile 0.9 percent (%) saline for injection during Day -90 to Day -28. On Day 0, intranasal challenge with RSV-A Memphis 37b virus will occur for all participants.

Intervention: Placebo

Outcomes

Primary Outcomes

Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)

Time Frame: From Day 2 to Day 12

VL-AUC for RSV was determined by qRT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.

Secondary Outcomes

Peak Viral Load of RSV-A Memphis 37b(From Day 2 to Day 12)
Percentage of Participants With Serious Adverse Events (SAEs)(Up to 6 months post-vaccination and up to 6 months post-challenge)
Percentage of Participants With Vital Signs Abnormalities(Up to Day 28 post-challenge)
Percentage of Participants With Electrocardiogram (ECG) Abnormalities(Up to Day 12 post challenge)
Viral Load by Quantitative RT-PCR Assay on Day 6 and 7(Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours))
VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7(Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours))
Total Clinical Symptoms Score at Day 6 and 7(Day 6 and 7: morning, afternoon and evening)
Percentage of Participants With Unsolicited Adverse Events (AEs)(Up to 28 days post-vaccination and up to 28 days post-challenge)
Percentage of Participants With Symptomatic RSV Infections(From Day 2 to Day 12)
Weight of Mucus Secretions Over Time(Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
Percentage of Participants With Solicited Local and Systemic AEs(7 days post-vaccination (Day -21))
Number of Tissues Used Over Time(Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
Percentage of Participants With Clinical Laboratory Abnormalities (Graded)(Up to Day 28 post-challenge)