Clinical trial NCT03606512: A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age
Official title: A Randomized, Controlled, Observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers 12 to 24 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Syncytial Virus
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2018-07-31
Enrollment: 38
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5\*10\^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.

Detailed description: RSV is considered the most important cause of serious acute respiratory illness in children under 5 years of age. Ad26.RSV.preF (JNJ-64400141) investigational vaccine is a replication-incompetent serotype 26 adenoviral vector (Ad26) containing a deoxyribonucleic acid (DNA) transgene that encodes for the F protein derived from the respiratory syncytial virus (RSV) A2 strain stabilized in the pre-fusion conformation (Ad26.RSV.preF). The study will evaluate whether Ad26.RSV.preF is safe, well-tolerated, and immunogenic in RSV-seronegative toddlers. The study will have 3 phases: a screening phase (up to 6 weeks before the first dose), a vaccination phase (34 weeks), and a safety follow-up phase through 2 RSV seasons after the first dose. RSV infection will be monitored by active and passive surveillance. The total duration of the study will be approximately 26 months.

Eligibility criteria: Inclusion Criteria:

* Participant who is seronegative for respiratory syncytial virus (RSV) within 42 days prior to dosing
* Participant is the product of a normal term pregnancy greater than or equal to (\>=)37 weeks, with a minimum birth weight of 2.5 kilogram (kg)
* Participant must be in good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening
* Participant has received all routine immunizations appropriate for his or her age according to local guidelines
* Each participant's parent(s)/legal guardian(s) must have access to a consistent means of contact either by telephone contact or email/computer

Exclusion Criteria:

* Participant's weight is below tenth percentile according to World Health Organization (WHO) pediatric growth and weight charts
* Participant has any clinically significant acute or chronic medical condition (for 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 beta 2 agonist, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea, hospitalization for respiratory illness, or mechanical ventilation for respiratory illness) that, in the opinion of the investigator, would preclude participation
* Participant is in receipt of, or planning to receive, live attenuated vaccine (for example, measles, mumps and rubella \[MMR\] or varicella, but excluding rotavirus vaccine) within 28 days of each study vaccination (that is, before and after); other vaccines (for example, influenza, pertussis, polio or rotavirus) should be given at least 14 days before or 14 days after each study vaccination
* Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection
* Participant has a known allergy to vaccines or vaccine components (including any of the constituents of the study vaccine), or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine). Participants with egg allergies can be enrolled

Primary outcomes:
measure: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination
timeFrame: Up to Day 8 (7 days after first vaccination on Day 1)
measure: Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination
timeFrame: Up to Day 36 (7 days after second vaccination on Day 29)
measure: Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination
timeFrame: Up to Day 64 (7 days after third vaccination on Day 57)
measure: Number of Participants With Unsolicited AEs for 28 Days After First Vaccination
timeFrame: Up to Day 29 (28 days after first vaccination on Day 1)
measure: Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination
timeFrame: Up to Day 57 (28 days after second vaccination on Day 29)
measure: Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination
timeFrame: Up to Day 85 (28 days after third vaccination on Day 57)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 2 year 10 months
Secondary outcomes:
measure: Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain
timeFrame: Days 1, 8, 85, and 267 (End of first RSV season)
measure: Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: Days 1, 8, 85, and 267 (End of first RSV season)
measure: Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA
timeFrame: Days 1, 8, 85, and 267 (End of first RSV season)
measure: T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry
timeFrame: Baseline (Day 1) and Day 85
measure: Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI)
timeFrame: Up to 2 year 10 months
Other outcomes:
Locations:
city: Geelong
country: Australia
facility: Barwon Health
city: Nedlands
country: Australia
facility: Telethon Kids Institute
city: Parkville
country: Australia
facility: Murdoch Children's Research Institute
city: Curitiba
country: Brazil
facility: Complexo Hospital de Clinicas - UFPR
city: Curitiba
country: Brazil
facility: Hospital Pequeno Principe
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Pierrefonds
country: Canada
facility: McGill University Health Centre - Vaccine Study Centre
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec Universite Laval
city: Järvenpää
country: Finland
facility: Järvenpään rokotetutkimusklinikka
city: Tampere
country: Finland
facility: Tampereen rokotetutkimusklinikka
city: Turku
country: Finland
facility: Turun rokotetutkimusklinikka
city: Debica
country: Poland
facility: Jerzy Brzostek Prywatny Gabinet Lekarski
city: Trzebnica
country: Poland
facility: Szpital im Swietej Jadwigi Slaskiej Oddzial Pediatryczny z Pododdzialem Niemowlecym
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Stockholm
country: Sweden
facility: Sachsska barn-och ungdomssjukhuset
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
city: London
country: United Kingdom
facility: Imperial College London
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
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: