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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

Primary Purpose

Respiratory Syncytial Viruses, Respiratory Tract Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ad26.RSV.FA2

Ad35.RSV.FA2

Placebo

About this trial

This is an interventional prevention trial for Respiratory Syncytial Viruses focused on measuring Ad26.RSV.FA2 (JNJ-61187165-AAA), Ad35.RSV.FA2 (JNJ-61187191-AAA), Healthy participants

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Number of Participants with Solicited Systemic Adverse Events (AEs)

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.

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.

Secondary Outcome Measures

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

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

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

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.

Full Information

NCT ID

NCT02561871

First Posted

August 21, 2015

Last Updated

October 31, 2016

Sponsor

Crucell Holland BV

1. Study Identification

Unique Protocol Identification Number

NCT02561871

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Crucell Holland BV

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Syncytial Viruses, Respiratory Tract Infections

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Arm Title

Group 3

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Ad26.RSV.FA2

Other Intervention Name(s)

JNJ-61187165-AAA

Intervention Description

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

Intervention Name(s)

Ad35.RSV.FA2

Other Intervention Name(s)

JNJ-61187191-AAA

Intervention Description

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

Drug

Intervention Name(s)

Placebo

Intervention Description

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 Measure Information:

Title

Number of Participants with Solicited Local Adverse Events (AEs)

Description

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

Time Frame

Up to 8 days after each vaccination

Title

Number of Participants with Solicited Systemic Adverse Events (AEs)

Time Frame

Up to 8 days after each vaccination

Title

Number of Participants with Unsolicited AEs

Description

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.

Time Frame

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

Title

Number of Participants with Serious Adverse Events (SAEs)

Description

Time Frame

From Signing of informed consent up to Day 337

Secondary Outcome Measure Information:

Title

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

Time Frame

Day 1 (predose) up to day 337

Title

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

Time Frame

Day 1 (predose) up to day 337

Title

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

Description

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.

Time Frame

Day 1 (predose) up to day 337

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Crucell Holland BV Clinical Trial

Organizational Affiliation

Crucell Holland BV

Official's Role

Study Director

Facility Information:

City

Miami

State/Province

Florida

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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