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Trial record 4 of 6 for:    Ad26.RSV.preF | Phase 2

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

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ClinicalTrials.gov Identifier: NCT03303625
Recruitment Status : Active, not recruiting
First Posted : October 6, 2017
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Viruses Respiratory Tract Infections Biological: Ad26.RSV.preF (1*10^11 vp) Biological: Ad26.RSV.preF (5*10^10 vp) Drug: Placebo Phase 1 Phase 2

Detailed Description:
The study, designed to assess the safety and tolerability of two doses given one month apart of Ad26.RSV.preF, an investigational RSV vaccine candidate based on a Ad26 vector expressing the RSV F protein, will be conducted in a double blinded manner. The study will be divided in two sequential cohorts: cohort 0 (18-50 year-old adults) and cohort 1 (12-24 month-old RSV seropositive toddlers). The vaccine safety will be monitored by reporting solicited and unsolicited adverse events (AEs) and all serious adverse events (SAEs). The data will be reviewed by an independent data monitoring committee (IDMC) to assess safety data and to ensure the continuing safety of the participants enrolled in this study. The safety will be monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-blind, Phase 1/2a Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF in Adults 18 to 50 Years of Age, RSV-seropositive Toddlers 12 to 24 Months of Age
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : April 17, 2020
Estimated Study Completion Date : April 17, 2020

Arm Intervention/treatment
Experimental: Cohort 0: Adults (Ad26.RSV.preF)
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)
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.
Other Name: JNJ-64400141

Placebo Comparator: Cohort 0: Adults (Placebo)
Participants aged >= 18 to <= 50 years will receive placebo via IM route (Group 2) on Day 1 and 29.
Drug: Placebo
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.

Experimental: Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF)
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)
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.
Other Name: JNJ-64400141

Placebo Comparator: Cohort 1: RSV seropositive Toddlers (Placebo)
RSV seropositive participants aged >= 12 to <= 24 months will receive placebo via IM route (Group 4) on Day 1 and 29.
Drug: Placebo
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.




Primary Outcome Measures :
  1. Percentage of Participants With Solicited Local Adverse Events (AEs) [ Time Frame: 7 days after each vaccination (up to Day 36) ]
    Solicited local AEs includes erythema, swelling/induration, and pain/tenderness.

  2. Percentage of Participants With Solicited Systemic AEs [ Time Frame: 7 days after each vaccination (up to Day 36) ]
    Solicited systemic AEs for adult participants includes fever (temperature measurement), fatigue, headache, myalgia, arthralgia, chills, nausea and fever (i.e [that is], body temperature greater than and equal to [>=] 38 °C [degree celsius]) and for pediatric participants includes loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever i.e, body temperature >= 38 °C).

  3. Percentage of Participants With Unsolicited AEs [ Time Frame: 28 days after each vaccination (up to Day 57) ]
    Unsolicited adverse events will include all adverse events for which the participant is not specifically questioned in the participant diary.

  4. Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to end of study (1 year) ]

Secondary Outcome Measures :
  1. Respiratory Syncytial Virus (RSV) A Neutralizing Antibodies Titers [ Time Frame: Days 1, 29, 57, and 211 ]
    Analysis of RSV A neutralizing antibodies.

  2. RSV F-protein Binding Antibody Titer [ Time Frame: Days 1, 29, 57, and 211 ]
    Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion forms by enzyme-linked immunosorbent assay.

  3. CD4 and CD8 T-cell subsets and their Cytokine expression as Measured by Intracellular cytokine Staining (ICS) [ Time Frame: Days 1, 29, 57 (only for adults), and 211 (only for adults) ]
    The frequency of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T-cell subset expressing at least one cytokine amongst interleukin 2 (IL2), tumor necrosis factor alpha (TNFalpha) and interferon gamma (IFNgamma) or interleukin 4 (IL4) will be determined by ICS after stimulation with RSV F peptide pool.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303625


Locations
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United States, Kansas
Heartland Research Associates, LLC
Newton, Kansas, United States, 67114
Finland
Järvenpään rokotetutkimusklinikka
Järvenpää, Finland, 04400
University of Tampere/Vaccine Research Center
Tampere, Finland, 33100
University of Tampere/Vaccine Research Center
Turku, Finland, 20520
United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Oxford Vaccine Group
Oxford, United Kingdom, OX3 7LE
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO166YD
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.

Additional Information:
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03303625     History of Changes
Other Study ID Numbers: CR108371
2017-001345-27 ( EudraCT Number )
VAC18194RSV2001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019

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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
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases