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A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers

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: NCT02561871
Recruitment Status : Completed
First Posted : September 28, 2015
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Brief Summary:
The purpose of this study is to assess the safety and tolerability of intramuscular prime-boost regimens of Ad26.RSV.FA2 given either once or twice followed by Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) in healthy participants.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Viruses Respiratory Tract Infections Biological: Ad26.RSV.FA2 Biological: Ad35.RSV.FA2 Drug: Placebo Phase 1

Detailed Description:
This is a single-center, randomized (study vaccine assigned to participants by chance), placebo-controlled study (an inactive substance; a pretend treatment [with no vaccine in it] that is compared in a clinical trial with a vaccine to test if the vaccine has a real effect), double-blind (neither the researchers nor the participants know what treatment the participant is receiving) Phase 1 study in healthy participants. The study comprises a 4-week screening period; vaccination for each participant on Days 1, 85, and, 169; a 28-day follow-up period performed after each vaccination and a final visit at Day 337. Approximately 32 Participants will be randomized in parallel in a 3:3:2 ratio to 3 treatment groups (Group 1/2/3) to receive either Ad26.RSV.FA2 or Ad35.RSV.FA2 or placebo. The study duration will be approximately 52 weeks. Blood samples for immunogenicity will be collected. Participant's safety will be evaluated throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Phase 1, First in Human Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
Study Start Date : September 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Group 1
Two subsequent Intramuscular injections of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on Day 1 and Day 85, and one intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on Day 169.
Biological: Ad26.RSV.FA2
Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 and 85 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 in Group 2.
Other Name: JNJ-61187165-AAA

Biological: Ad35.RSV.FA2
Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 169 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 85 in Group 2.
Other Name: JNJ-61187191-AAA

Experimental: Group 2
Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on Day 1, an intramuscular injection of Ad35.RSV.FA2 (1x10^11 vp) on Day 85 and and an intramuscular injection of placebo control consisting of the vaccine formulation buffer on Day 169.
Biological: Ad26.RSV.FA2
Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 and 85 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 in Group 2.
Other Name: JNJ-61187165-AAA

Biological: Ad35.RSV.FA2
Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 169 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 85 in Group 2.
Other Name: JNJ-61187191-AAA

Drug: Placebo
Participants will receive Intramuscular injection of Placebo control on day 169 in Group 2. Intramuscular injection of Placebo control on day 1, 85 and 169 in Group 3.

Experimental: Group 3
Three intramuscular injections of placebo control on Day 1, Day 85 and Day 169.
Drug: Placebo
Participants will receive Intramuscular injection of Placebo control on day 169 in Group 2. Intramuscular injection of Placebo control on day 1, 85 and 169 in Group 3.




Primary Outcome Measures :
  1. Number of Participants with Solicited Local Adverse Events (AEs) [ Time Frame: Up to 8 days after each vaccination ]
    Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the participant diary.

  2. Number of Participants with Solicited Systemic Adverse Events (AEs) [ Time Frame: Up to 8 days after each vaccination ]
  3. Number of Participants with Unsolicited AEs [ Time Frame: From Signing of informed consent up to 28 days after each vaccination ]
    Unsolicited AEs will be reported by the participant from when the informed consent form (ICF) is signed until 28 days after each vaccination, or early discontinuation.

  4. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: From Signing of informed consent up to Day 337 ]
    A serious adverse event (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. Immune Responses to the Study Vaccine Regimens as Measured by a Virus Neutralization Assay [ Time Frame: Day 1 (predose) up to day 337 ]
  2. Immune Responses to the Study Vaccine Regimens Measured by an Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Day 1 (predose) up to day 337 ]
  3. Immune responses to the study vaccine regimens as measured by an Enzyme-linked Immunospot Assay (ELISpot) [ Time Frame: Day 1 (predose) up to day 337 ]
    Enzyme-linked Immunospot Assay (ELISpot) is used to quantify the amount of peripheral blood mononuclear cells (PBMCs) able to produce Interferon-gamma upon RSV antigen stimulation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant must be in good health, without significant medical illness, on the basis of physical examination, medical history, vital signs measurement, and 12-lead electrocardiogram (ECG) performed at screening
  • Participant must meet protocol defined laboratory criteria within 28 days before Day 1
  • Before randomization, a woman must be either; Not of childbearing potential: postmenopausal or surgically sterilized; of childbearing potential and practicing an effective method of birth control before vaccination and through 3 months after the last vaccination. Women, who are not heterosexually active at screening, must agree to utilize highly-effective method of birth control if they become heterosexually active until 3 months after receiving the last dose of study vaccine
  • A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at the screening visit, and a negative urine pregnancy test pre-vaccination on Day 1
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until 3 months after receiving the last dose of study vaccine. A man must agree not to donate sperm until 3 months after receiving the last dose of study vaccine

Exclusion Criteria:

  • Participant has a body mass index (BMI) less than or equal to (<=)19 and greater than or equal to (>=30) kilogram per square meter (kg/m2)
  • Participant has any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation (e.g. history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections)
  • Participant has had major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study
  • Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
  • Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection

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): NCT02561871


Locations
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United States, Florida
Miami, Florida, United States
Sponsors and Collaborators
Crucell Holland BV
Investigators
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Study Director: Crucell Holland BV Clinical Trial Crucell Holland BV
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Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT02561871    
Other Study ID Numbers: CR107705
VAC18192RSV1003 ( Other Identifier: Crucell Holland BV )
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Keywords provided by Crucell Holland BV:
Ad26.RSV.FA2 (JNJ-61187165-AAA)
Ad35.RSV.FA2 (JNJ-61187191-AAA)
Healthy participants
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases