Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04453202
Recruitment Status : Active, not recruiting
First Posted : July 1, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief Summary:
The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).

Condition or disease Intervention/treatment Phase
Healthy Biological: RSV Vaccine Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older
Actual Study Start Date : July 16, 2020
Estimated Primary Completion Date : January 4, 2021
Estimated Study Completion Date : March 15, 2021

Arm Intervention/treatment
Experimental: Cohort 1 Group 1: RSV Vaccine
Participants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1.
Biological: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Experimental: Cohort 1 Group 2: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1.
Biological: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Experimental: Cohort 1 Group 3: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1.
Biological: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Experimental: Cohort 1 Group 4: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1.
Biological: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Placebo Comparator: Cohort 1 Group 5: Placebo
Participants will receive IM injection of placebo on Day 1.
Other: Placebo
Participants will receive a single IM injection of placebo on Day 1.

Experimental: Cohort 2 Group 6: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
Biological: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Experimental: Cohort 2 Group 7: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1.
Biological: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Placebo Comparator: Cohort 2 Group 8: Placebo
Participants will receive IM injection of placebo on Day 1.
Other: Placebo
Participants will receive a single IM injection of placebo on Day 1.

Experimental: Cohort 3 Group 9: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
Biological: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Experimental: Cohort 3 Group 10: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1.
Biological: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Experimental: Cohort 3 Group 11: Placebo
Participants will receive IM injection of placebo on Day 1.
Other: Placebo
Participants will receive a single IM injection of placebo on Day 1.




Primary Outcome Measures :
  1. Cohort 1: RSV Fusion Protein (F Protein) Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: 14 days after vaccination (Day 15) ]
    Antibodies binding to RSV F protein in pre-fusion form will be assessed by ELISA.

  2. Cohorts 2 and 3: Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination [ Time Frame: 7 days after vaccination (Day 1 to Day 8) ]
    An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.

  3. Cohorts 2 and 3: Number of Participants with Solicited Systemic AEs After Vaccination [ Time Frame: 7 days after vaccination (Day 1 to Day 8) ]
    Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.

  4. Cohorts 2 and 3: Number of Participants with Unsolicited AEs After Vaccination [ Time Frame: 28 days after vaccination (Day 1 to Day 29) ]
    Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.


Secondary Outcome Measures :
  1. Cohorts 1, 2 and 3: RSV preF Protein Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Cohort 1: Day 85 and 183; Cohorts 2 and 3: Day 15, 85 and 183 ]
    Antibodies binding to RSV F protein in pre-fusion form will be assessed by ELISA.

  2. Cohorts 1, 2 and 3: RSV A2 Neutralizing Antibody Levels [ Time Frame: Days 15, 85, and 183 ]
    Analysis of neutralizing antibodies to the A2 strain.

  3. Cohorts 1, 2 and 3: Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay [ Time Frame: Days 15, 85, and 183 ]
    RSV F-specific cellular immune responses elicited by the different vaccine regimens.

  4. Cohorts 1, 2 and 3: Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: First vaccination (Day 1) to the end of the study (up to Day 183) ]
    A SAE is any untoward medical occurrence that at any dose: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  5. Cohort 1: Number of Participants with Solicited Local AEs After Vaccination [ Time Frame: 7 days after vaccination (Day 1 to Day 8) ]
    Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.

  6. Cohort 1: Number of Participants with Solicited Systemic AEs After Vaccination [ Time Frame: 7 days after vaccination (Day 1 to Day 8) ]
    Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.

  7. Cohort 1: Number of Participants with Unsolicited AEs After Vaccination [ Time Frame: 28 days after vaccination (Day 1 to Day 29) ]
    Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
  • A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
  • Agree to not donate blood from the time of vaccination until 3 months after vaccination
  • Have a body mass index (BMI) less than (<) 40 kilogram per meter square (kg/m^2)
  • Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study

Exclusion Criteria:

  • Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
  • Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
  • History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
  • Has hepatitis B or C infection, including history of treated hepatitis C infection
  • Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization

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): NCT04453202


Locations
Layout table for location information
United States, California
Optimal Research
San Diego, California, United States, 92108
United States, Florida
Clinical Research of South Florida, an AMR Company
Coral Gables, Florida, United States, 33134
United States, Kansas
Heartland Research Associates, an AMR Company
El Dorado, Kansas, United States, 67042
United States, Maryland
Optimal Research
Rockville, Maryland, United States, 20850
United States, Missouri
The Center for Pharmaceutical Research (CPR)
Kansas City, Missouri, United States, 64114
United States, Nebraska
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States, 68701
Meridian Clinical Research - Omaha
Omaha, Nebraska, United States, 68134
United States, Oklahoma
Tekton Research Inc.
Yukon, Oklahoma, United States, 73099
United States, Tennessee
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
Layout table for investigator information
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
Layout table for additonal information
Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT04453202    
Other Study ID Numbers: CR108835
VAC18193RSV2005 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No