Clinical trial NCT03303625: A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age
Official title: A Randomized, Double-blind, Phase 1/2a Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF in Adults 18 to 50 Years of Age, RSV-seropositive Toddlers 12 to 24 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Syncytial Viruses
Respiratory Tract Infections
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2017-10-06
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1\*10\^11 viral particles \[vp\]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein \[pre-F\] \[Ad26.RSV.preF\]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.

Detailed description: The study, designed to assess the safety and tolerability of two doses given one month apart of Ad26.RSV.preF, an investigational RSV vaccine candidate based on a Ad26 vector expressing the RSV F protein, will be conducted in a double blinded manner. The study will be divided in two sequential cohorts: cohort 0 (18-50 year-old adults) and cohort 1 (12-24 month-old RSV seropositive toddlers). The vaccine safety will be monitored by reporting solicited and unsolicited adverse events (AEs) and all serious adverse events (SAEs). The data will be reviewed by an independent data monitoring committee (IDMC) to assess safety data and to ensure the continuing safety of the participants enrolled in this study. The safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

Adults Participants:

* Participant must be in good health, without significant medical illness, on the basis of physical examination, medical history, and vital signs measurement
* Participant must be healthy on the basis of clinical laboratory tests performed at screening. 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 United stated (US) Food and Drug Administration (FDA) toxicity tables, 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
* 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 each study vaccine administration

Pediatric Participants:

* Participant is the product of a normal term pregnancy greater than and equal to (\>=) 37 weeks, with a minimum birth weight of 2.5 kilogram (kg)
* Participants must be in good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening

Exclusion Criteria:

Adults Participants:

* Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature \>=38.0 ºC (degree celsius)/100.4 °F (fahrenheit) within 24 hours prior to the first dose of study vaccine
* Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)

Pediatric Participants:

* Participant's weight is below 10th percentile according to World Health Organization (WHO) pediatric growth and weight charts
* Participant has any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation: example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, systemic infections, congenital heart disease, history of any pulmonary condition requiring medication, atopy, reactive airway disease, medically-confirmed wheezing, bronchoconstriction or treatment with a beta2 agonist, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea, hospitalization for respiratory illness, or mechanical ventilation for respiratory illness

Primary outcomes:
measure: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination
timeFrame: For 7 days after first vaccination on Day 1 (Up to Day 7)
measure: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination
timeFrame: For 7 days after second vaccination on Day 29 (Up to Day 35)
measure: Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination
timeFrame: For 7 days after first vaccination on Day 1 (Up to Day 7)
measure: Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination
timeFrame: For 7 days after second vaccination on Day 29 (Up to Day 35)
measure: Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination
timeFrame: For 28 days after first vaccination on Day 1 (Up to Day 28)
measure: Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination
timeFrame: For 28 days after second vaccination on Day 29 (Up to Day 56)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months)
Secondary outcomes:
measure: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211
timeFrame: Day 1 (predose), Post-dose on Days 29, 57 and 211
measure: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211
timeFrame: Pre-fusion on Days 1, 29, 57 and 211
measure: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211
timeFrame: Post-fusion on Days 1, 29, 57 and 211
measure: Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57
timeFrame: Day 1 (predose) and Post-dose on Days, 29, and 57
Other outcomes:
Locations:
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Järvenpää
country: Finland
facility: Järvenpään rokotetutkimusklinikka
city: Tampere
country: Finland
facility: University of Tampere/Vaccine Research Center
city: Turku
country: Finland
facility: University of Tampere/Vaccine Research Center
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Oxford
country: United Kingdom
facility: Oxford Vaccine Group
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: