A Shedding Study of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) Vaccine in Adults
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|ClinicalTrials.gov Identifier: NCT03795441|
Recruitment Status : Completed
First Posted : January 7, 2019
Last Update Posted : August 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: Ad26.RSV.preF||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label, Single Arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults|
|Actual Study Start Date :||January 7, 2019|
|Actual Primary Completion Date :||July 28, 2019|
|Actual Study Completion Date :||July 28, 2019|
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.
Ad26.RSV.preF will be administered as intramuscular injection on Day 1.
Other Name: JNJ-64400141
- Percentage of Participants with Presence of Ad26.RSV.preF (shedding) as Assessed by qPCR [ Time Frame: Up to Day 183 ]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.
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: First vaccination (Day 1) to the end of the study (Day 183) ]Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
- Number of Participants with Solicited Local and Systemic Adverse Events (AEs) After Vaccination [ Time Frame: 7 days after vaccination (Day 1 up to Day 7) ]Number of participants with solicited local and systemic AEs will be evaluated. Solicited local AEs (erythema, swelling/induration, and pain/tenderness at the injection site) and solicited systemic AEs (fatigue, headache, myalgia, arthralgia, chills, nausea, and fever) will be noted in the participant diary through the 7 days post-vaccination. Local and systemic AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
- Number of Participants with Unsolicited AEs as a Measure of Safety [ Time Frame: Day 1 Up to Day 28 ]Number of participants with unsolicited AEs will be evaluated. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product, and it does not necessarily have a causal relationship with the intervention, therefore an AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. Unsolicited AEs will include all AEs for which the participant is specifically not questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
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): NCT03795441
|Clinical Pharmacology Unit|
|Merksem, Belgium, 2170|
|Study Director:||Janssen Vaccines & Prevention B.V. Clinical Trial||Janssen Vaccines & Prevention B.V.|