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

NCT03606512 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: CR1084652017-003859-36VAC18194RSV2002
• Study Type: interventional
• Target: 38
• Locations: 8 countries
• Sites: 25

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.

Conditions

Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (7)

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

  An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.

  Up to Day 8 (7 days after first vaccination on Day 1)

• Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination

  An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.

  Up to Day 36 (7 days after second vaccination on Day 29)

• Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination

  An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.

  Up to Day 64 (7 days after third vaccination on Day 57)

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

  An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.

  Up to Day 29 (28 days after first vaccination on Day 1)

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

  An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.

  Up to Day 57 (28 days after second vaccination on Day 29)

• Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination

  An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.

  Up to Day 85 (28 days after third vaccination on Day 57)

• Number of Participants With Serious Adverse Events (SAEs)

  Number of participants with SAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. 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 suspected transmission of any infectious agent via a medicinal product, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

  Up to 2 year 10 months

Secondary Outcomes (5)

• Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain

  Days 1, 8, 85, and 267 (End of first RSV season)

• Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)

  Days 1, 8, 85, and 267 (End of first RSV season)

• Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA

  Days 1, 8, 85, and 267 (End of first RSV season)

• T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry

  Baseline (Day 1) and Day 85

• Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI)

  Up to 2 year 10 months

Study Arms (2)

Group 1: RSV Seronegative Toddlers (Ad26.RSV.preF)

EXPERIMENTAL

Respiratory syncytial virus (RSV) seronegative toddlers will receive intramuscular (IM) injection of 2.5\*10\^10 viral particles (vp) of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F-protein on Days 1, 29, and 57.

Biological: Ad26.RSV.preF

Group 2: RSV Seronegative Toddlers (Placebo/Nimenrix)

PLACEBO COMPARATOR

RSV seronegative toddlers will receive IM injection of placebo on Days 1, 29 and 57. Placebo can be replaced with Nimenrix on Day 57 in countries where applicable.

Biological: Placebo; Biological: Nimenrix

Interventions

Ad26.RSV.preF BIOLOGICAL

Ad26.RSV.preF will be administered as IM injection at a dose of 2.5\*10\^10 vp.

Also known as: JNJ-64400141

Group 1: RSV Seronegative Toddlers (Ad26.RSV.preF)

Placebo BIOLOGICAL

Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.

Group 2: RSV Seronegative Toddlers (Placebo/Nimenrix)

Nimenrix BIOLOGICAL

Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.

Group 2: RSV Seronegative Toddlers (Placebo/Nimenrix)

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (25)

Barwon Health

Geelong, 3220, Australia

Location

Telethon Kids Institute

Nedlands, 6009, Australia

Location

Murdoch Children's Research Institute

Parkville, 3052, Australia

Location

Complexo Hospital de Clinicas - UFPR

Curitiba, 80030-110, Brazil

Location

Hospital Pequeno Principe

Curitiba, 80250-060, Brazil

Location

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90035-074, Brazil

Location

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, 90610-000, Brazil

Location

Dalhousie University

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

McGill University Health Centre - Vaccine Study Centre

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

CHU de Quebec Universite Laval

Québec, Quebec, G1V 4G2, Canada

Location

Järvenpään rokotetutkimusklinikka

Jarvenpaa, 04400, Finland

Location

Tampereen rokotetutkimusklinikka

Tampere, 33100, Finland

Location

Turun rokotetutkimusklinikka

Turku, 20520, Finland

Location

Jerzy Brzostek Prywatny Gabinet Lekarski

Dębica, 39-200, Poland

Location

Szpital im Swietej Jadwigi Slaskiej Oddzial Pediatryczny z Pododdzialem Niemowlecym

Trzebnica, 55 100, Poland

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Sachsska barn-och ungdomssjukhuset

Stockholm, 11861, Sweden

Location

Norrlands Universitetssjukhus

Umeå, 90185, Sweden

Location

Imperial College London

London, W21PG, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, M13 9WL, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO166YD, United Kingdom

Location

Related Publications (1)

• Langley JM, Nolan TM, Ramet M, Richmond PC, Rosario Filho N, Haazen W, van den Berg SPH, Williams K, Bastian AR, Omoruyi E, Williams Durkin J, Salisch N, Van Geet G, van Duijnhoven W, Heijnen E, Callendret B. A Phase 1/2a Study Evaluating Safety and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers Aged 12-24 Months. Open Forum Infect Dis. 2024 Aug 8;11(9):ofae453. doi: 10.1093/ofid/ofae453. eCollection 2024 Sep.

  PMID: 39220658 DERIVED

Results Point of Contact

• Title: Clinical Franchise Leader
• Organization: Janssen Vaccines & 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 31, 2018
• Study Start: January 21, 2019
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: February 4, 2025
• Results First Posted: November 30, 2022

Record last verified: 2025-01

Locations

GB (3); ES (4); BR (4); PL (2); FI (3); SE (2); CA (4); AU (3)