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Respiratory Syncytial Virus (RSV)Phase 1NCT01709019

RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly

A Phase 1 study testing Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28), Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & day 28) and High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28) in people with Respiratory Syncytial Virus (RSV), run by Novavax at 4 sites 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

Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is anticipated that some of the randomized study subjects may not complete the study; subjects who withdraw or are discontinued, will not be replaced. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus (RSV)
What is being tested?
Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28), Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & day 28) and High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
4 sitesUnited States
Study dates
Oct 2012to Mar 2014
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult males and females, ≥ 60 years of age, without symptomatic cardiopulmonary disease. Note that subjects who have any functional limitation or symptoms related to cardiac and/or pulmonary disease (including asthma or other episodic symptoms), or who receive ongoing therapy to control symptoms or functional limitation, are not eligible. The following are examples of subjects who may bear cardio-pulmonary diagnoses but who would remain eligible:
  • Subjects on stable (no change in ≥ 2 months) therapy for findings (e.g., hypertension or hyperlipidemia) that are not associated with current symptoms or disability.
  • Subjects who receive intermittent prophylaxis for risks associated with asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures in a subject with asymptomatic mitral valve prolapse).
  • Other clinically insignificant findings, not deemed to be associated with increased risk due to respiratory viral infections as determined by the Investigator.
  • Free of other illnesses which are believed to increase the risk of influenza or influenza related complications including: diabetes mellitus, congenital or acquired blood dyscrasias, renal or hepatic dysfunction, and morbid obesity.
  • Willing and able to give informed consent prior to study enrollment.
  • Able to comply with study requirements.

Who cannot join

  • Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination and/or planned participation at any time during the study.
  • History of a serious reaction to any prior vaccination or known allergy to constituents of licensed TIV (e.g., egg proteins).
  • History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine.
  • Receipt of any influenza vaccine within the preceding 3 months.
  • Receipt of any vaccine in the 4 weeks preceding the study vaccination and planned receipt of a licensed vaccine any time prior to Day 56.
  • Receipt of an RSV vaccine at any time.
Show all 13Show fewer
  • Any known or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination.
  • Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted provided these are not administered for diagnoses inconsistent with the inclusion criteria. The use of inhaled glucocorticoids, although typically not associated with system absorption, will generally indicate the presence of a diagnosis inconsistent with inclusion criteria 1 or 2.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  • Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration).
  • Known disturbance of coagulation.
  • Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
  • Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Research Across America

    Dallas, Texas, 75234

  • Accelovance

    Melbourne, Florida, 32935

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • Genova Clinical Research

    Tucson, Arizona, 85704

Other trials in United States

About this study

Official title: A Phase I Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum Adjuvant, and Co-administered With a Licensed Inactivated Influenza Vaccine, in Healthy Subjects ≥ 60 Years of Age.

Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is anticipated that some of the randomized study subjects may not complete the study; subjects who withdraw or are discontinued, will not be replaced. Randomization will be stratified by age (60 to <75 years and ≥ 75 years) in order to distribute the proportion of such persons in each age group equally across treatment groups.

Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A rescue dose of the licensed TIV will be provided to subjects in all groups except the placebo group on Day 28, the placebo group will receive saline. For each subject, study follow-up will span approximately one year from the first immunization (on Day 0) for all subjects.

Being tested
Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28), Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & day 28), High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28), High dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28), Placebo (Day 0 & Day 28); Seasonal TIV (Day 0)

What participants receive

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

  • Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)Biological

    0.5mL IM injections

  • Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & day 28)Biological

    0.5mL IM injections

  • High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)Biological

    0.5mL IM injections

  • High dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)Biological

    0.5mL IM injections

  • Placebo (Day 0 & Day 28); Seasonal TIV (Day 0)Biological

    0.5mL IM Injections

Study groups in NCT01709019
Study groupRoleWhat they receive
Group AExperimentalLow dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 \& Day 28)
Receives: Biological: Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)
Group BExperimentalLow dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 \& Day 28)
Receives: Biological: Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & day 28)
Group CExperimentalHigh dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 \& Day 28)
Receives: Biological: High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)
Group DExperimentalHigh dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 \& Day 28)
Receives: Biological: High dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)
Group EPlacebo comparatorPlacebo (Day 0 \& Day 28); Seasonal TIV (Day 28)
Receives: Biological: Placebo (Day 0 & Day 28); Seasonal TIV (Day 0)

What is being measured

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

  1. Assessment of Safety

    Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post injection; all adverse events, solicited and unsolicited over 56 days post-first injection.

    Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year.

    Measured: Day 0 to Day 364

  2. Immunogenicity as assessed by serum IgG antibody titers for the F-Protein antigen

    Immunogenicity will be measured using derived / calculated endpoints based on:

    • Geometric mean titer (GMT)
    • Geometric mean ratio (GMR)
    • Seroconversion rate (SCR)
    • Seroresponse rate (SRR)

    Measured: Day 0 to Day 364

Secondary outcomes (1)

  1. Immunogenicity as assessed by serum HAI titers specific for the influenza antigens contained in the seasonal vaccine.

    Immunogenicity will be measured using derived / calculated endpoints based on:

    • Geometric mean titer (GMT)
    • Geometric mean ratio (GMR)
    • Seroconversion rate (SCR)
    • Seroprotection rate (SPR)

    Measured: Day 0 to Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJul 2013
  4. Study completionMar 2014

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01709019
Sponsor's protocol ID
NVX757.102
Status last verified
Mar 2014
First submitted
15 Oct 2012
Last updated
5 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • Fries L, Shinde V, Stoddard JJ, Thomas DN, Kpamegan E, Lu H, Smith G, Hickman SP, Piedra P, Glenn GM. Immunogenicity and safety of a respiratory syncytial virus fusion protein (RSV F) nanoparticle vaccine in older adults. Immun Ageing. 2017 Apr 12;14:8. doi: 10.1186/s12979-017-0090-7. eCollection 2017.

    PubMed 28413427

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28), Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & day 28) and High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28) in people with Respiratory Syncytial Virus (RSV), run by Novavax at 4 sites 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 7 inclusion and 13 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 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?

Assessment of Safety (time frame: Day 0 to Day 364). The study lists 2 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 NCT01709019, which also lists 1 linked publication.

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 5 Mar 2014.

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