NCT02561871

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 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

First Submitted

Initial submission to the registry

August 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

August 21, 2015

Last Update Submit

October 31, 2016

Conditions

Respiratory Syncytial VirusesRespiratory Tract Infections

Keywords

Ad26.RSV.FA2 (JNJ-61187165-AAA)Ad35.RSV.FA2 (JNJ-61187191-AAA)Healthy participants

Outcome Measures

Primary Outcomes (4)

  • Number of Participants with Solicited Local 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

  • Number of Participants with Solicited Systemic Adverse Events (AEs)

    Up to 8 days after each vaccination

  • Number of Participants with 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

  • Number of Participants with 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.

    From Signing of informed consent up to Day 337

Secondary Outcomes (3)

  • Immune Responses to the Study Vaccine Regimens as Measured by a Virus Neutralization Assay

    Day 1 (predose) up to day 337

  • Immune Responses to the Study Vaccine Regimens Measured by an Enzyme-linked Immunosorbent Assay (ELISA)

    Day 1 (predose) up to day 337

  • Immune responses to the study vaccine regimens as measured by an Enzyme-linked Immunospot Assay (ELISpot)

    Day 1 (predose) up to day 337

Study Arms (3)

Group 1

EXPERIMENTAL

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.FA2Biological: Ad35.RSV.FA2

Group 2

EXPERIMENTAL

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.FA2Biological: Ad35.RSV.FA2Drug: Placebo

Group 3

EXPERIMENTAL

Three intramuscular injections of placebo control on Day 1, Day 85 and Day 169.

Drug: Placebo

Interventions

Ad26.RSV.FA2BIOLOGICAL

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.

Also known as: JNJ-61187165-AAA
Group 1Group 2
Ad35.RSV.FA2BIOLOGICAL

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.

Also known as: JNJ-61187191-AAA
Group 1Group 2
PlaceboDRUG

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.

Group 2Group 3

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 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

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

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Crucell Holland BV Clinical Trial

    Crucell Holland BV

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 21, 2015

First Posted

September 28, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

US(1)