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An Exploratory 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

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ClinicalTrials.gov Identifier: NCT03334695
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

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.

Condition or disease Intervention/treatment Phase
Healthy Biological: Ad26.RSV.preF Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 16, 2017
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : November 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Biological: Ad26.RSV.preF
Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp in single-use vials.
Other Name: JNJ-64400141

Placebo Comparator: 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.
Drug: Placebo
Placebo will be administered as sterile 0.9% saline for injection.




Primary Outcome Measures :
  1. Area Under the Viral Load-time Curve (VL-AUC) of RSV-A Memphis 37b [ Time Frame: From Day 2 onwards up to Day 11 (post viral challenge) ]
    VL-AUC for respiratory syncytial virus (RSV)-A Memphis 37b will be determined by quantitative reverse transcriptase -polymerase chain reaction (qRT-PCR) assay of nasal wash samples. The VL-AUC is calculated based on the viral load values measured twice daily, starting with the baseline value, and ending with the last available value before discharge.


Secondary Outcome Measures :
  1. Peak Viral Load of RSV-A Memphis 37b [ Time Frame: From Day 2 onwards up to Day 11 (post viral challenge) ]
    Peak viral load of RSV-A Memphis 37b is defined as the maximum viral load as determined by quantitative RT-PCR assay of nasal wash samples.

  2. Percentage of Participants With Symptomatic RSV Infection [ Time Frame: From Day 2 to Day 12 ]
    Symptomatic RSV infection is defined as two quantifiable RT-PCR measurements at different timepoints plus symptoms of any grade from two different categories from the subject symptom card (SSC) or two quantifiable RT-PCR measurements plus any Grade 2 symptom from any category. The three SSC categories are: Upper Respiratory symptoms: runny nose, stuffy nose, sneezing, sore throat, earache; Lower Respiratory symptoms: cough, shortness of breath, chest tightness, wheeze; Systemic symptoms: malaise, headache, muscle and/or joint ache, chilliness/ feverishness.

  3. Percentage of Participants With RSV Infection Defined as two Quantifiable RT-PCR Measurements Plus any Clinical Symptom of any Severity [ Time Frame: Day 2 up to Day 11 (Post-viral challenge) and Day 12 (Discharge) ]
    RSV infection is defined as having two or more quantifiable RT-PCR measurements or serology confirmation of RSV, and any clinical symptom of any severity.

  4. Total Weight of Mucus [ Time Frame: From Day 1 to Day 12 ]
    Total weight of mucus produced will be measured.

  5. Total Number of Tissues Used by Participants [ Time Frame: From Day 1 to Day 12 ]
    Number of tissues (handkerchiefs) used during the study will be counted.

  6. Number of Participants With Unsolicited Adverse Events (AEs) [ Time Frame: From signing Informed Consent Form (ICF) until 28 days after vaccination and from the entry into the Unit until 28 days after challenge (Up to Day 28) ]
    Unsolicited AEs are all AEs for which participants are specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  7. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 6 months after vaccination (up to Day 155) ]
    An 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.

  8. Number of Participants With Solicited Local and Systemic AEs [ Time Frame: 7 days post vaccination (Day -21) ]
    Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever.

  9. Viral Load-AUC (VL-AUC) on Day 6 and Day 7 [ Time Frame: Day 6 and Day 7 ]
    The effect of vaccination on viral load will be assessed which is measured by the area under the curve (AUC) over time by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR).

  10. Number of Participants With Clinical Symptom on Day 6 and Day 7 [ Time Frame: Day 6 and Day 7 ]
    The effect of vaccination on clinical symptoms on Day 6 and Day 7 will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334695


Locations
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United Kingdom
hVIVO Services Limited
London, United Kingdom, E1 2AX
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
Additional Information:
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03334695    
Other Study ID Numbers: CR108398
2017-003194-33 ( EudraCT Number )
VAC18193RSV2002 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections