NCT02440035

Brief Summary

The purpose of this study is to assess the safety and tolerability of intramuscular homologous and heterologous prime-boost regimens of Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) and Ad26.RSV.FA2 in healthy participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

May 7, 2015

Last Update Submit

August 18, 2017

Conditions

Healthy Participants

Keywords

Healthy ParticipantsAd35.RSV.FA2JNJ-61187191

Outcome Measures

Primary Outcomes (3)

  • Solicited Local and Systemic Adverse Events (AEs)

    Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the participant diary.

    Up to 8 days after each vaccination

  • Unsolicited AEs

    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.

    From Signing of informed consent up to 28 days after each vaccination

  • Serious Adverse Events (SAEs)

    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

    Up to Day 337

Secondary Outcomes (2)

  • Determination of Respiratory Syncytial Virus (RSV)-Specific Humoral Immune Response

    Day 1 (predose) up to day 337

  • To Assess RSV-specific Cellular Immune Response

    Day 1 (predose) up to day 337

Study Arms (4)

Group 1

EXPERIMENTAL

Two subsequent Intramuscular injections of Ad35.RSV.FA2 (1x10\^11 virus particles \[vp\]) on Day 1, Day 85 and an intramuscular injection of Ad26.RSV.FA2 (5x10\^10 vp) on Day 169.

Biological: Ad35.RSV.FA2Biological: Ad26.RSV.FA2

Group 2

EXPERIMENTAL

Intramuscular injection of Ad35.RSV.FA2 (1x10\^11 vp) on Day 1, an intramuscular injection of placebo control on Day 85 and an injection of Ad35.RSV.FA2 (1x10\^11 vp) on Day 169.

Biological: Ad35.RSV.FA2Drug: Placebo

Group 3

EXPERIMENTAL

One intramuscular injection of Ad35.RSV.FA2 (1x10\^11 vp) on Day 1 and an intramuscular injection of placebo control on Day 85 and an intramuscular injection of Ad26.RSV.FA2 (5x10\^10 vp) on Day 169.

Biological: Ad35.RSV.FA2Biological: Ad26.RSV.FA2Drug: Placebo

Group 4

EXPERIMENTAL

Two subsequent intramuscular injections of placebo control on Day 1, Day 85 and an intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on Day 169.

Biological: Ad26.RSV.FA2Drug: Placebo

Interventions

Ad35.RSV.FA2BIOLOGICAL

Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10\^11) virus particles on Day 1 and 85 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10\^11) virus particles on Day 1 and 169 in Group 2. Intramuscular injection of Ad35.RSV.FA2 (1x10\^11) virus particles on Day 1 in Group 3.

Also known as: JNJ-61187191-AAA
Group 1Group 2Group 3
Ad26.RSV.FA2BIOLOGICAL

Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on Day 169 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10\^10) virus particles on Day 169 in Group 3. Intramuscular injection of Ad26.RSV.FA2 (5x10\^10) virus particles on Day 169 in Group 4.

Also known as: JNJ-61187165-AAA
Group 1Group 3Group 4
PlaceboDRUG

Participants will receive intramuscular injection of placebo (sterile formulation buffer) on Day 85 in Group 2. One intramuscular injections of placebo on Day 85 in Group 3. Two intramuscular injections of placebo on Day 1, and Day 85 in Group 4.

Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 methods 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Miami, Florida, United States

Location

Study Officials

  • Crucell Holland BV Clinical Trial

    Crucell Holland BV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 12, 2015

Study Start

April 21, 2015

Primary Completion

June 9, 2016

Study Completion

June 9, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

US(1)