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

NCT ID: NCT03606512

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-21
• Study Completion Date: 2021-11-02

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.

Conditions

Respiratory Syncytial Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Ad26.RSV.preF

Intervention Type: BIOLOGICAL

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

Group 2: RSV Seronegative Toddlers (Placebo/Nimenrix)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Nimenrix

Intervention Type: BIOLOGICAL

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

Interventions

Ad26.RSV.preF

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

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: BIOLOGICAL

Nimenrix

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

Intervention Type: BIOLOGICAL

Other Intervention Names

JNJ-64400141

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Vaccines & Prevention B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

Barwon Health

Geelong, , Australia

Telethon Kids Institute

Nedlands, , Australia

Murdoch Children's Research Institute

Parkville, , Australia

Complexo Hospital de Clinicas - UFPR

Curitiba, , Brazil

Hospital Pequeno Principe

Curitiba, , Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

Dalhousie University

Halifax, Nova Scotia, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

McGill University Health Centre - Vaccine Study Centre

Pierrefonds, Quebec, Canada

CHU de Quebec Universite Laval

Québec, Quebec, Canada

Järvenpään rokotetutkimusklinikka

Järvenpää, , Finland

Tampereen rokotetutkimusklinikka

Tampere, , Finland

Turun rokotetutkimusklinikka

Turku, , Finland

Jerzy Brzostek Prywatny Gabinet Lekarski

Dębica, , Poland

Szpital im Swietej Jadwigi Slaskiej Oddzial Pediatryczny z Pododdzialem Niemowlecym

Trzebnica, , Poland

Hosp. Gral. Univ. Gregorio Maranon

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. La Paz

Madrid, , Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Sachsska barn-och ungdomssjukhuset

Stockholm, , Sweden

Norrlands Universitetssjukhus

Umeå, , Sweden

Imperial College London

London, , United Kingdom

Royal Manchester Children's Hospital

Manchester, , United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Countries

Australia; Brazil; Canada; Finland; Poland; Spain; Sweden; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39220658 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-003859-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAC18194RSV2002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108465

Identifier Type: -

Identifier Source: org_study_id