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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

NCT ID: NCT02561871

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Respiratory Syncytial Viruses Respiratory Tract Infections

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Ad26.RSV.FA2

Intervention Type BIOLOGICAL

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.

Ad35.RSV.FA2

Intervention Type BIOLOGICAL

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.

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.

Group Type EXPERIMENTAL

Ad26.RSV.FA2

Intervention Type BIOLOGICAL

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.

Ad35.RSV.FA2

Intervention Type BIOLOGICAL

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.

Placebo

Intervention Type DRUG

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 3

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

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.

Intervention Type DRUG

Other Intervention Names

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JNJ-61187165-AAA JNJ-61187191-AAA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Crucell Holland BV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Crucell Holland BV Clinical Trial

Role: STUDY_DIRECTOR

Crucell Holland BV

Locations

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Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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VAC18192RSV1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR107705

Identifier Type: -

Identifier Source: org_study_id