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

NCT03303625 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: CR1083712017-001345-27VAC18194RSV2001
• Study Type: interventional
• Target: 48
• Locations: 3 countries
• Sites: 7

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.

Conditions

Respiratory Syncytial Viruses; Respiratory Tract Infections

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination

  An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.

  For 7 days after first vaccination on Day 1 (Up to Day 7)

• Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination

  An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.

  For 7 days after second vaccination on Day 29 (Up to Day 35)

• Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination

  An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature \>=38 degree celsius \[°C\]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature \>=38 °C).

  For 7 days after first vaccination on Day 1 (Up to Day 7)

• Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination

  An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature \>=38 degree celsius \[°C\]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature \>=38 °C).

  For 7 days after second vaccination on Day 29 (Up to Day 35)

• Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination

  An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.

  For 28 days after first vaccination on Day 1 (Up to Day 28)

• Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination

  An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.

  For 28 days after second vaccination on Day 29 (Up to Day 56)

• Number of Participants With Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

  From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months)

Secondary Outcomes (4)

• Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211

  Day 1 (predose), Post-dose on Days 29, 57 and 211

• 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

  Pre-fusion on Days 1, 29, 57 and 211

• Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211

  Post-fusion on Days 1, 29, 57 and 211

• Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57

  Day 1 (predose) and Post-dose on Days, 29, and 57

Study Arms (4)

Cohort 0: Adults (Ad26.RSV.preF)

EXPERIMENTAL

Participants aged greater than or equal to (\>=) 18 to lesser than or equal to (\<=) 50 years will receive vector Ad26.RSV.preF at 1\*10\^11 viral particles (vp) via intramuscular (IM) route (Group 1) on Day 1 and 29.

Biological: Ad26.RSV.preF (1*10^11 vp)

Cohort 0: Adults (Placebo)

PLACEBO COMPARATOR

Participants aged \>= 18 to \<= 50 years will receive placebo via IM route (Group 2) on Day 1 and 29.

Drug: Placebo

Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF)

EXPERIMENTAL

RSV seropositive participants aged \>=12 to \<=24 months will receive Ad26.RSV.preF at 5\*10\^10 vp via IM route (Group 3) on Day 1 and 29.

Biological: Ad26.RSV.preF (5*10^10 vp)

Cohort 1: RSV seropositive Toddlers (Placebo)

PLACEBO COMPARATOR

RSV seropositive participants aged \>= 12 to \<= 24 months will receive placebo via IM route (Group 4) on Day 1 and 29.

Drug: Placebo

Interventions

Ad26.RSV.preF (1*10^11 vp) BIOLOGICAL

Participants will receive two doses of 0.5 milliliter (mL) (1\*10\^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.

Also known as: JNJ-64400141

Cohort 0: Adults (Ad26.RSV.preF)

Ad26.RSV.preF (5*10^10 vp) BIOLOGICAL

RSV seropositive participants will receive two doses of 0.25 mL (5\*10\^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.

Also known as: JNJ-64400141

Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF)

Placebo DRUG

Participants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29.

Cohort 0: Adults (Placebo); Cohort 1: RSV seropositive Toddlers (Placebo)

Eligibility Criteria

• Age: 12 Months - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (7)

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Järvenpään rokotetutkimusklinikka

Jarvenpaa, 04400, Finland

Location

University of Tampere/Vaccine Research Center

Tampere, 33100, Finland

Location

University of Tampere/Vaccine Research Center

Turku, 20520, Finland

Location

Royal Manchester Children's Hospital

Manchester, M13 9WL, United Kingdom

Location

Oxford Vaccine Group

Oxford, OX3 7LE, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO166YD, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Trial Physician
• Organization: Janssen Vaccines and Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 6, 2017
• Study Start: November 29, 2017
• Primary Completion: April 21, 2020
• Study Completion: April 21, 2020
• Last Updated: May 25, 2025
• Results First Posted: June 23, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (3); US (1); FI (3)