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Respiratory Syncytial Virus (RSV)Phase 2NCT01704365

RSV-F Vaccine Dose Ranging Study in Young Women

A Phase 2 study testing Low dose RSV-F Vaccine with Adjuvant, Low dose RSV-F Vaccine without Adjuvant and High dose RSV-F Vaccine with Adjuvant 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

The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential. 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 (RSV)
What is being tested?
Low dose RSV-F Vaccine with Adjuvant, Low dose RSV-F Vaccine without Adjuvant and High dose RSV-F Vaccine with Adjuvant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
330 participants
Where
4 sitesUnited States
Study dates
Oct 2012to May 2013
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

  • 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.
  • 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

  • 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.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
Show all 11Show fewer
  • 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

4 sites in 1 country.

United States4 sites

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • Coastal Carolina Research

    Mt. Pleasant, South Carolina, 29464

  • Accelovance Rockville

    Rockville, Maryland, 20850

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase II Randomized, Observer-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum, in Healthy Women of Child-Bearing Age

The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.

Being tested
Low dose RSV-F Vaccine with Adjuvant, Low dose RSV-F Vaccine without Adjuvant, High dose RSV-F Vaccine with Adjuvant, High dose RSV-F Vaccine without Adjuvant, Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]

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 AdjuvantBiological

    0.5mL IM Injection

  • Low dose RSV-F Vaccine without AdjuvantBiological

    0.5ml IM Injection

  • High dose RSV-F Vaccine with AdjuvantBiological

    0.5mL IM Injection

  • High dose RSV-F Vaccine without AdjuvantBiological

    0.5mL IM Injection

  • Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]Biological

    0.5mL IM Injection

  • PlaceboBiological

    0.5mL IM Injection

Study groups in NCT01704365
Study groupRoleWhat they receive
Group AExperimentalLow dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28)
Receives: Biological: Low dose RSV-F Vaccine with Adjuvant
Group BExperimentalLow dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28)
Receives: Biological: Low dose RSV-F Vaccine with Adjuvant; Biological: Placebo
Group CExperimentalLow dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)
Receives: Biological: Low dose RSV-F Vaccine without Adjuvant
Group DExperimentalLow dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)
Receives: Biological: Low dose RSV-F Vaccine without Adjuvant; Biological: Placebo
Group EExperimentalHigh dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28)
Receives: Biological: High dose RSV-F Vaccine with Adjuvant
Group FExperimentalHigh dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28)
Receives: Biological: High dose RSV-F Vaccine with Adjuvant; Biological: Placebo
Group GExperimentalHigh dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)
Receives: Biological: High dose RSV-F Vaccine without Adjuvant
Group HExperimentalHigh dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)
Receives: Biological: High dose RSV-F Vaccine without Adjuvant; Biological: Placebo
Group JExperimentalLow dose RSV-F Vaccine with Adjuvant [Bedside Mixing] (Day 0 \& Day 28)
Receives: Biological: Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]
Group KPlacebo comparatorPlacebo (Day 0 and Day 28)
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

    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 112

  2. Assessment of the safety

    Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post-injections; 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 six months

    Measured: Day 0 to Day 182

Secondary outcomes (1)

  1. Immunogenicity based on neturalizing antibody titer

    Measured: Day 0 to Day 112

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 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionApr 2013
  4. Study completionMay 2013

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
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01704365
Sponsor's protocol ID
NVX757.201
Status last verified
Feb 2014
First submitted
8 Oct 2012
Last updated
7 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • Glenn GM, Fries LF, Thomas DN, Smith G, Kpamegan E, Lu H, Flyer D, Jani D, Hickman SP, Piedra PA. A Randomized, Blinded, Controlled, Dose-Ranging Study of a Respiratory Syncytial Virus Recombinant Fusion (F) Nanoparticle Vaccine in Healthy Women of Childbearing Age. J Infect Dis. 2016 Feb 1;213(3):411-22. doi: 10.1093/infdis/jiv406. Epub 2015 Aug 10.

    PubMed 26259809

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low dose RSV-F Vaccine with Adjuvant, Low dose RSV-F Vaccine without Adjuvant and High dose RSV-F Vaccine with Adjuvant 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 8 inclusion and 11 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 7 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 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 112). 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 NCT01704365, 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 7 Mar 2014.

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