Respiratory Syncytial VirusesPhase 1NCT02561871
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
A Phase 1 study testing Ad26.RSV.FA2 and Ad35.RSV.FA2 in people with Respiratory Syncytial Viruses and Respiratory Tract Infections, run by Crucell Holland BV at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Viruses, Respiratory Tract Infections
- What is being tested?
- Ad26.RSV.FA2 and Ad35.RSV.FA2
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Ad26.RSV.FA2, Ad35.RSV.FA2, Placebo
- Keywords
- Ad26.RSV.FA2 (JNJ-61187165-AAA), Ad35.RSV.FA2 (JNJ-61187191-AAA), Healthy participants
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.RSV.FA2Biological
Also called JNJ-61187165-AAA
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.FA2Biological
Also called JNJ-61187191-AAA
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Ad26.RSV.FA2; Biological: 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. Receives: Biological: Ad26.RSV.FA2; Biological: Ad35.RSV.FA2; Drug: Placebo |
| Group 3 | Experimental | Three intramuscular injections of placebo control on Day 1, Day 85 and Day 169. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 days after each vaccination
Number of Participants with Solicited Systemic Adverse Events (AEs)
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day 1 (predose) up to day 337
Immune Responses to the Study Vaccine Regimens Measured by an Enzyme-linked Immunosorbent Assay (ELISA)
Measured: Day 1 (predose) up to day 337
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.
Measured: Day 1 (predose) up to day 337
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial VirusesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Crucell Holland BV Clinical Trial, Study director, Crucell Holland BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561871
- Sponsor's protocol ID
- CR107705
- Other IDs
- VAC18192RSV1003
- Status last verified
- Oct 2016
- First submitted
- 21 Aug 2015
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02561871
- Acronym / sponsor ID
- CR107705
- Keywords
- Ad26.RSV.FA2 (JNJ-61187165-AAA), Ad35.RSV.FA2 (JNJ-61187191-AAA), Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Ad26.RSV.FA2, Biological: Ad35.RSV.FA2Two 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 2 | Experimental | Biological: Ad26.RSV.FA2, Biological: Ad35.RSV.FA2, Drug: PlaceboIntramuscular 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 3 | Experimental | Drug: PlaceboThree intramuscular injections of placebo control on Day 1, Day 85 and Day 169. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad26.RSV.FA2Also: JNJ-61187165-AAAParticipants 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. | Biological | Group 1, Group 2 |
| Ad35.RSV.FA2Also: JNJ-61187191-AAAParticipants 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. | Biological | Group 1, Group 2 |
| PlaceboParticipants 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. | Drug | Group 2, Group 3 |
Primary outcome
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.
Number of Participants with Solicited Systemic Adverse Events (AEs)
Time frame: Up to 8 days after each vaccination
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.
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.
3 secondary outcomes
Immune Responses to the Study Vaccine Regimens as Measured by a Virus Neutralization Assay
Time frame: Day 1 (predose) up to day 337
Immune Responses to the Study Vaccine Regimens Measured by an Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: Day 1 (predose) up to day 337
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
Related trials for Respiratory Syncytial Viruses
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Active, not recruitingPhase 1/2
A Study to Characterize the Safety and Immunogenicity of AZD6489 in Participants 60 Years of Age and Older (ARIES)
RSV Respiratory Syncytial Virus
Active, not recruitingObservational study
SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER
Respiratory Syncytial Virus Infection
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Active, not recruitingPhase 3
RSV Vaccine in Transplant Recipients
Vaccine Response Impaired, Respiratory Syncytial Virus Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crucell Holland BV Clinical Trial study director
Crucell Holland BV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ad26.RSV.FA2 and Ad35.RSV.FA2 in people with Respiratory Syncytial Viruses and Respiratory Tract Infections, run by Crucell Holland BV at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Local Adverse Events (AEs) (time frame: Up to 8 days after each vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.