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
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: Ad26.RSV.preF Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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.
Placebo will be administered as sterile 0.9% saline for injection.
- 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.
- 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.
- 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.
- 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.
- Total Weight of Mucus [ Time Frame: From Day 1 to Day 12 ]Total weight of mucus produced will be measured.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
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
|hVIVO Services Limited|
|London, United Kingdom, E1 2AX|
|Study Director:||Janssen Vaccines & Prevention B.V. Clinical Trial||Janssen Vaccines & Prevention B.V.|