Clincosm LogoSign in Get a demo

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

Sponsor
Janssen Vaccines & Prevention B.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT03606512
Collaborator
(none)
38
Enrollment
25
Locations
2
Arms
33.4
Actual Duration (Months)
1.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Ad26.RSV.preF
  • Biological: Placebo
  • Biological: Nimenrix
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 21, 2019
Actual Primary Completion Date :
Nov 2, 2021
Actual Study Completion Date :
Nov 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Biological: Ad26.RSV.preF
Ad26.RSV.preF will be administered as IM injection at a dose of 2.5*10^10 vp.
Other Names:
  • JNJ-64400141

    		•
    Placebo Comparator: 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.

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Solicited Local and Systemic Adverse Events (AEs) After Vaccination [7 days after each vaccination (up to Day 64)]

      Number of participants with solicited local and systemic AEs will be evaluated. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and solicited systemic AEs (fatigue, headache, myalgia, arthralgia, chills, nausea and fever) will be noted in the participant diary after 7 days of each vaccination. Local and systemic AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).

    2. Number of Participants with Unsolicited AEs [28 days after each vaccination (up to Day 85)]

      Number of participants with unsolicited AEs will be evaluated. 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 clear causal relationship with the relevant investigational product. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).

    3. Number of Participants with Serious Adverse Events (SAEs) [First vaccination to the end of the study (approximately up to 26 months)]

      Number of participants with SAEs will be evaluated. An 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 congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.

    Secondary Outcome Measures

    1. Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A Strain [Days 1, 8, 85, and 267 (End of season [EOS])]

      RSV neutralizing titers of the vaccine-induced immune response will be assessed for detection of neutralizing antibodies to RSV A strain.

    2. RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay (ELISA) [Days 1, 8, 85, and 267 (EOS)]

      Antibodies binding to RSV F-protein in pre-fusion and post-fusion forms will be assessed by enzyme-linked immunosorbent assay (ELISA).

    3. T-Cell Responses Measured by Flow Cytometry (Intracellular cytokine Staining [ICS]) [Days 1 and 85]

      T-cell responses to RSV F-protein peptides for T-helper cells (Th1/Th2) subtyping will be measured by flow cytometry (ICS).

    4. Number of Participants with Severe RSV-Lower Respiratory Tract Infection (LRTI) [Approximately up to 26 months]

      Number of participants with severe RSV-LRTI will be assessed. Severe RSV-LRTI will be defined as the presence of severe LRTI as assessed by the Clinical Endpoint Committee (CEC), and confirmation of RSV infection from a nasal (mid-turbinate or nasopharyngeal) sample using reverse transcriptase polymerase chain reaction (RT-PCR).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 24 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barwon Health Geelong Australia 3220
    2 Telethon Kids Institute Nedlands Australia 6009
    3 Murdoch Children's Research Institute Parkville Australia 3052
    4 Complexo Hospital de Clinicas - UFPR Curitiba Brazil 80030-110
    5 Hospital Pequeno Principe Curitiba Brazil 80250-060
    6 Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre Brazil 90035-074
    7 Hospital São Lucas da PUCRS Porto Alegre Brazil 90610 - 000
    8 Dalhousie University Halifax Nova Scotia Canada B3K 6R8
    9 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    10 McGill University Health Centre - Vaccine Study Centre Pierrefonds Canada H9H 4Y6
    11 CHU de Québec Université Laval Quebec Canada G1V 4G2
    12 Järvenpään rokotetutkimusklinikka Järvenpää Finland 04400
    13 Tampereen rokotetutkimusklinikka Tampere Finland 33100
    14 Turun rokotetutkimusklinikka Turku Finland 20520
    15 Jerzy Brzostek Prywatny Gabinet Lekarski Debica Poland 39-200
    16 Szpital im. Swietej Jadwigi Slaskiej, Oddział Pediatryczny z Pododdziałem Niemowlęcym Trzebnica Poland 55-100
    17 Hosp. Gral. Univ. Gregorio Marañon Madrid Spain 28007
    18 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    19 Hosp. Univ. La Paz Madrid Spain 28046
    20 Hosp. Clinico Univ. de Santiago Santiago de Compostela Spain 15706
    21 Sachsska barn-och ungdomssjukhuset Stockholm Sweden 11861
    22 Norrlands Universitetssjukhus Umeå Sweden 90185
    23 Imperial College London London United Kingdom W21PG
    24 Royal Manchester Children's Hospital Manchester United Kingdom M13 9WL
    25 University Hospital Southampton NHS Foundation Trust Southampton United Kingdom SO166YD

    Sponsors and Collaborators

    • Janssen Vaccines & Prevention B.V.

    Investigators

    • Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Vaccines & Prevention B.V.
    ClinicalTrials.gov Identifier:
    NCT03606512
    Other Study ID Numbers:
    • CR108465
    • 2017-003859-36
    • VAC18194RSV2002
    First Posted:
    Jul 31, 2018
    Last Update Posted:
    Nov 24, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes

    Study Results

    No Results Posted as of Nov 24, 2021