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Respiratory Syncytial Virus InfectionsPhase 2NCT01960686

RSV F Dose-Ranging Study in Women

A Phase 2 study testing Low dose RSV F Antigen, High dose RSV F Antigen and Dose 1 of Aluminum Adjuvant in people with Respiratory Syncytial Virus Infections, run by Novavax at 10 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

The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
Low dose RSV F Antigen, High dose RSV F Antigen and Dose 1 of Aluminum Adjuvant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
720 participants
Where
10 sitesUnited States
Study dates
Oct 2013to Apr 2014
Phase
Phase 2
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 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects must meet the following criteria to be eligible to participate:
  • Healthy adult females, ≥ 18 and ≤ 35 years of age. "Healthy" shall be defined by the absence of any illness, acute or chronic, that requires ongoing systemic therapy for the control of symptoms or prevention of disability.
  • Subjects on stable (no change in ≥ 3 months) therapy for findings (e.g., hypertension or hyperlipidemia) that are not associated with symptoms or disability are eligible, as are users of hormonal contraceptives.
  • Subjects who receive intermittent prophylaxis for risks associated with asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures in a subject with mitral valve prolapse) are eligible.
  • Ongoing therapy will be defined as continuous or, if intermittent, more frequent than once every 3 months (e.g., use of an inhaled bronchodilator for exercise-induced bronchospasm more than once every 3 months). Immunosuppressives are subject to exclusion criterion #5 below.
  • Persons being treated for illnesses or conditions that would become acutely symptomatic or disabling in the absence of treatment are not eligible.
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  • Willing and able to give informed consent prior to study enrollment.
  • Able to comply with study requirements.
  • Women who are not surgically sterile must have a negative urine pregnancy test prior to each vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.

Who cannot join

  • Subjects will be excluded if they fulfill any of the following criteria:
  • Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
  • History of a serious reaction to any prior vaccination.
  • Received any vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time.
  • Any known or suspected immunosuppressive condition, acquired or congenital, as determined by 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 ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
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  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  • Donated blood within 3 weeks of the planned date of first vaccination.
  • 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.
  • Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
  • 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

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Advanced Clinical Research

    Boise, Idaho, 83642

  • Research Across America

    Dallas, Texas, 75234

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219

  • Coastal Carolina Research

    Mt. Pleasant, South Carolina, 29464

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • QPS Bio-Kinetic

    Springfield, Missouri, 65802

  • Clincal Research of Atlanta

    Stockbridge, Georgia, 30281

  • Diablo Clinical Research

    Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Phase II Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Multiple Formulations of an RSV F Particle Vaccine With Aluminum, in Healthy Women of Child-Bearing Age

The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age.

Being tested
Low dose RSV F Antigen, High dose RSV F Antigen, Dose 1 of Aluminum Adjuvant, Dose 2 of Aluminum Adjuvant, Dose 3 of Aluminum Adjuvant
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

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

  • Low dose RSV F AntigenBiological

  • High dose RSV F AntigenBiological

  • Dose 1 of Aluminum AdjuvantBiological

  • Dose 2 of Aluminum AdjuvantBiological

  • Dose 3 of Aluminum AdjuvantBiological

  • Dose 4 of Aluminum AdjuvantBiological

  • PlaceboBiological

Study groups in NCT01960686
Study groupRoleWhat they receive
Low dose RSV F Vaccine with Dose 1 of Aluminum AdjuvantExperimentalDay 0: Low dose RSV F Antigen with Dose 1 of aluminum adjuvant Day 28: Placebo
Receives: Biological: Low dose RSV F Antigen; Biological: Dose 1 of Aluminum Adjuvant; Biological: Placebo
Low dose RSV F Vaccine with Dose 2 of Aluminum AdjuvantExperimentalDay 0: Low dose RSV F Antigen content with Dose 2 of aluminum adjuvant Day 28: Low dose RSV F Antigen content with Dose 2 of aluminum adjuvant
Receives: Biological: Low dose RSV F Antigen; Biological: Dose 2 of Aluminum Adjuvant
Low dose RSV F Vaccine with Dose 3 of Aluminum AdjuvantExperimentalDay 0: Low dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Low dose RSV F Antigen with Dose 3 of aluminum adjuvant
Receives: Biological: Low dose RSV F Antigen; Biological: Dose 3 of Aluminum Adjuvant
Low dose RSV F Vaccine with Dose 4 of Aluminum AdjuvantExperimentalDay 0: Low dose RSV F Antigen with Dose 4 of aluminum adjuvant Day 28: Low dose RSV F Antigen with Dose 4 of aluminum adjuvant
Receives: Biological: Low dose RSV F Antigen; Biological: Dose 4 of Aluminum Adjuvant
High dose RSV F Vaccine with Dose 2 of Aluminum AdjuvantExperimentalDay 0: High dose RSV F Antigen with Dose 2 of aluminum adjuvant Day 28: Placebo
Receives: Biological: High dose RSV F Antigen; Biological: Dose 2 of Aluminum Adjuvant; Biological: Placebo
High dose RSV F Vaccine with Dose 3 of Aluminum AdjuvantExperimentalDay 0: High dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Placebo
Receives: Biological: High dose RSV F Antigen; Biological: Dose 3 of Aluminum Adjuvant; Biological: Placebo
High dose RSV F Vaccine with Dose 4 of Aluminum AdjuvantExperimentalDay 0: High dose RSV F Antigen content with Dose 4 of aluminum adjuvant Day 28: Placebo
Receives: Biological: High dose RSV F Antigen; Biological: Dose 4 of Aluminum Adjuvant; Biological: Placebo
PlaceboPlacebo comparatorDay 0: Placebo Day 28: Placebo
Receives: Biological: Placebo

What is being measured

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

  1. Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups

    Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.

    Derived/calculated endpoints based on these data will include:

    • Geometric mean concentrations as EU (GMEU)
    • Geometric mean ratio (GMR)
    • Geometric mean fold-rise (GMFR)
    • Seroconversion rate (SCR)
    • Seroresponse rate (SRR)

    Measured: Day 0 to Day 56

  2. Assessment of Safety

    Numbers and percentages of subjects with solicited local and systemic adverse events over the seven days post-injection; and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters. In addition, Medically Attended Events, Serious Adverse Events, and Significant New Medical Conditions will be collected for six months.

    Measured: Day 0 to Day 182

Secondary outcomes (3)

  1. Immunogenicity based on neutralizing antibody titer

    Measured: Day 0 to Day 56

  2. Kinetics of serum IgG antibody titers specific for the F-Protein antigen across time

    Measured: Day 0 to Day 91

  3. Immunogenicity based on antibodies sharing specificity with Palivizumab

    Measured: Day 0 to 91

Timeline

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

  1. First posted11 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionApr 2014
  4. Study completionApr 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01960686
Sponsor's protocol ID
NVX757.M202
Status last verified
Apr 2016
First submitted
8 Oct 2013
Last updated
26 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • August A, Glenn GM, Kpamegan E, Hickman SP, Jani D, Lu H, Thomas DN, Wen J, Piedra PA, Fries LF. A Phase 2 randomized, observer-blind, placebo-controlled, dose-ranging trial of aluminum-adjuvanted respiratory syncytial virus F particle vaccine formulations in healthy women of childbearing age. Vaccine. 2017 Jun 27;35(30):3749-3759. doi: 10.1016/j.vaccine.2017.05.045. Epub 2017 Jun 1.

    PubMed 28579233

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low dose RSV F Antigen, High dose RSV F Antigen and Dose 1 of Aluminum Adjuvant in people with Respiratory Syncytial Virus Infections, run by Novavax at 10 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 9 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups (time frame: Day 0 to Day 56). 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 NCT01960686, 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 26 May 2016.

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