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

A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health

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ClinicalTrials.gov Identifier: NCT03339713
Recruitment Status : Completed
First Posted : November 13, 2017
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief Summary:
The purpose of this study is to demonstrate the non-inferiority of the concomitant administration of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) and seasonal influenza vaccine versus the administration of seasonal influenza vaccine alone in terms of humoral immune response expressed by the geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, and to assess the safety and tolerability of a single dose of 1*10^11 viral particles (vp) of Ad26.RSV.preF, administered intramuscularly to participants aged greater than or equal to 60 years separately or concomitantly with seasonal influenza vaccine.

Condition or disease Intervention/treatment Phase
Healthy Biological: Ad26.RSV.preF Biological: Fluarix Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and Ad26.RSV.preF, With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health
Actual Study Start Date : December 7, 2017
Actual Primary Completion Date : July 23, 2018
Actual Study Completion Date : July 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Ad26.RSV.preF Plus Fluarix Then Placebo: Group 1
Participants will receive intramuscular injection of 1*10^11 viral particles (vp) of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) on 1 arm administered at the same time as a commercially available seasonal influenza vaccine (Fluarix) on the other arm at Day 1, and intramuscular injection of placebo on Day 29.
Biological: Ad26.RSV.preF
Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp.
Other Name: JNJ-64400141

Biological: Fluarix
Fluarix will be administered as intramuscular injection.

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

Experimental: Placebo Plus Fluarix Then Ad26.RSV.preF: Group 2
Participants will receive intramuscular injection of placebo administered at the same time as a commercially available seasonal influenza vaccine (Fluarix) on Day 1, and 1*10^11 vp of Ad26.RSV.preF on Day 29.
Biological: Ad26.RSV.preF
Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp.
Other Name: JNJ-64400141

Biological: Fluarix
Fluarix will be administered as intramuscular injection.

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




Primary Outcome Measures :
  1. Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains [ Time Frame: Day 28 ]
    Humoral immune responses expressed by the geometric mean titers (GMTs) of HI antibody titers against each of four influenza vaccine strains.

  2. Number of Participants With Solicited Local and Systemic Adverse Events (AEs) After Vaccination [ Time Frame: 7 days after each vaccination (up to Day 36) ]
    Following solicited local AEs (erythema, swelling/induration, and pain/tenderness) 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.

  3. Number of Participants With Unsolicited Adverse Events [ Time Frame: From signing informed consent form until 28 days after each vaccination (up to Day 57) ]
    Unsolicited AEs are all AEs for which participants are specifically not questioned in the participant diary. 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.

  4. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: From signing ICF to throughout the study (up to 6 months) ]
    An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.


Secondary Outcome Measures :
  1. Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers [ Time Frame: Pre-Vaccination on (Days 1 and 28) and at 28 days after the second vaccination (Day 57) ]
    Analysis of RSV A2 neutralizing titers of the vaccine-induced immune response will be assessed.

  2. RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Pre-Vaccination on (Days 1 and 28) and at 28 days after the second vaccination (Day 57) ]
    Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form by ELISA.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
  • Before randomization, a woman must be:

    1. Postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause) and
    2. Not intending to conceive by any methods
  • In the investigator's clinical judgment, participant must be either in good or stable health, and not at risk of serious complications from influenza. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks (or only small, clinically non-significant changes have been made in the judgement of the Principal Investigator) preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed on Day 1
  • From the time of first vaccination through 3 months after the second dose of study vaccine, participant agrees not to donate blood
  • Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Exclusion Criteria:

  • Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree Celsius (ºC) within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
  • Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise 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)
  • Participant has had major surgery (per the investigator's judgment), within 4 weeks before dosing, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 6 months after the final dose of study vaccine
  • Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively

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): NCT03339713


Locations
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United States, South Carolina
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
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.

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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03339713     History of Changes
Other Study ID Numbers: CR108403
VAC18193RSV2003 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs