Clinical trial NCT03795441: A Shedding Study of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) Vaccine in Adults
Official title: Open Label, Single Arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2019-01-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants with Presence of Ad26.RSV.preF (shedding) as Assessed by qPCR
timeFrame: Up to Day 183
Secondary outcomes:
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: First vaccination (Day 1) to the end of the study (Day 183)
measure: Number of Participants with Solicited Local and Systemic Adverse Events (AEs) After Vaccination
timeFrame: 7 days after vaccination (Day 1 up to Day 7)
measure: Number of Participants with Unsolicited AEs as a Measure of Safety
timeFrame: Day 1 Up to Day 28
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: