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Healthy ParticipantsPhase 1NCT02440035

A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad35.RSV.FA2 Regimens Boosted With Ad26.RSV.FA2 in Healthy Adult Participants

A Phase 1 study testing Ad35.RSV.FA2 and Ad26.RSV.FA2 in people with Healthy Participants, run by Crucell Holland BV at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Ad35.RSV.FA2 and Ad26.RSV.FA2
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited States
Study dates
21 Apr 2015to 9 Jun 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 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

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.

United States1 site

  • Study site

    Miami, Florida

Other trials in United States

About this study

Official title: Phase 1, First in Human Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad35.RSV.FA2 Regimens Boosted With Ad26.RSV.FA2 in Healthy Adult Volunteers

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.

Read the detailed description

This is a single-center, randomized (study medication assigned to participants by chance), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), double-blind (neither the researchers nor the participants know what treatment the participant is receiving) and 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 323 or 351. Participants will be randomly assigned to one of the 4 treatment groups (Group 1/2/3/4) to receive either Ad35.RSV.FA2 or Ad26.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
Ad35.RSV.FA2, Ad26.RSV.FA2, Placebo
Keywords
Healthy Participants, Ad35.RSV.FA2, JNJ-61187191

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad35.RSV.FA2Biological

    Also called JNJ-61187191-AAA

    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.

  • Ad26.RSV.FA2Biological

    Also called JNJ-61187165-AAA

    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.

  • 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.

Study groups in NCT02440035
Study groupRoleWhat they receive
Group 1ExperimentalTwo 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.
Receives: Biological: Ad35.RSV.FA2; Biological: Ad26.RSV.FA2
Group 2ExperimentalIntramuscular 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.
Receives: Biological: Ad35.RSV.FA2; Drug: Placebo
Group 3ExperimentalOne 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.
Receives: Biological: Ad35.RSV.FA2; Biological: Ad26.RSV.FA2; Drug: Placebo
Group 4ExperimentalTwo 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.
Receives: Biological: Ad26.RSV.FA2; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 8 days after each vaccination

  2. 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

  3. 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: Up to Day 337

Secondary outcomes (2)

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

    Determine induction and persistence of humoral immune response against RSV F-protein.

    Measured: Day 1 (predose) up to day 337

  2. To Assess RSV-specific Cellular Immune Response

    Assess the quantity and quality of the elicited cellular immune response.

    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.

  1. First posted12 May 2015 (estimated)
  2. Study start21 Apr 2015
  3. Primary completion9 Jun 2016
  4. Study completion9 Jun 2016

Resources

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
Double blind
Who is masked
Participant, Care provider
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02440035
Sponsor's protocol ID
CR107409
Other IDs
VAC18192RSV1001
Status last verified
Aug 2017
First submitted
7 May 2015
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad35.RSV.FA2 and Ad26.RSV.FA2 in people with Healthy Participants, 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 22 Aug 2017. 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?

Solicited Local and Systemic Adverse Events (AEs) (time frame: Up to 8 days after each vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02440035.

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 22 Aug 2017.

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