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Respiratory Syncytial Virus InfectionsPhase 1NCT01290419

Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine

A Phase 1 study testing RSV-F Particle Vaccine in people with Respiratory Syncytial Virus Infections, run by Novavax 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

A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age). Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
RSV-F Particle Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteUnited States
Study dates
Dec 2010to Dec 2011
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 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female aged 18 to 49 years inclusive
  • Ability to provide written informed consent to participate
  • Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline
  • Females are required to fulfill one of the following criteria:
  • At least 1 year post-menopausal
  • Surgically sterile
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  • Willing to use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and until 28 days after each vaccination
  • Willing to abstain from sexual intercourse or use another reliable form of contraception approved by the Investigator (eg, intrauterine device, female condom, and diaphragm with spermicide, cervical cap, use of condom by the sexual partner, or a sterile sexual partner) for study duration and until 28 days after vaccination
  • All female subjects must have a negative urine pregnancy test within 48 hours preceding receipt of each vaccination.
  • Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and be contacted by telephone throughout the follow-up period

Who cannot join

  • Presence of significant uncontrolled medical or psychiatric illness (acute or chronic). This includes institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed on Day 1 prior to vaccination
  • Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
  • Pregnant or lactating female
  • Females who plan to become pregnant or plan to discontinue contraceptive precautions within 30 days prior to first vaccination and 28 days after each vaccination
  • Cancer, or treatment for cancer, within 3 years, excluding basal cell carcinoma or squamous cell carcinoma, which is allowed
  • Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus
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  • Receipt (or history of receipt), during the preceding 3-month period, of any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids will be allowed.
  • Receipt or planned administration of a nonstudy vaccine within 30 days prior to vaccination or during the study. If a nonstudy vaccine has been administered, administration of study vaccine injection can be delayed and given as soon as allowable within the 30-day window, provided the nonstudy vaccine is not administered within 2 weeks prior to study enrollment. Immunization with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) vaccine, on an emergency basis, up to 8 days before or at least 8 days after a dose of study vaccine will be allowed.
  • History of illicit drug or alcohol abuse within the previous 1 year or positive drug or alcohol screen
  • History of anaphylactic type reaction to injected vaccines
  • Receipt of any investigational product or nonregistered drug within the 30 days prior to vaccination or current enrollment in any investigational drug study or intent to enroll in such a study within the ensuing study period
  • Receipt or donation of blood or blood products 8 weeks prior to vaccination or planned receipt or donation during the study period
  • Acute disease, defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical examination) with or without fever, or an oral temperature of ≥38ºC, within 72 hours prior to vaccination. Study vaccine can be administered to persons with a minor illness, such as diarrhea or mild upper respiratory tract infection with or without low-grade fever. Vaccination can be delayed until the subject has recovered.
  • Any condition that, in the opinion of the Investigator, would interfere with the primary study objectives

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Healthcare Discoveries d/b/a ICON Development Solutions

    San Antonio, Texas, 78209

Other trials in United States

About this study

Official title: A Phase 1 Randomized, Observer-Blinded,Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Recombinant Respiratory Syncytial Virus F Protein Particle Vaccine in Healthy Adults

A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age).

Study Objectives:

Primary:

  • To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations.

Secondary:

  • To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations
  • To confirm the "dose sparing" and "value added" effects of the aluminum phosphate adjuvant
Read the detailed description

A total of 150 subjects will be allocated to 7 cohorts. Subjects will be randomly assigned to vaccine treatment or saline placebo in a 4:1 ratio, such that each cohort will include 20 subjects who receive active vaccine (Groups A, B, C, D, F and G) and 5 subjects who receive placebo (Group E).

Subjects will be followed for all AEs, including SAEs and non-serious AEs, from the time of each vaccination through 30 days following the second vaccination (Day 60±5). After Day 60, subjects will be contacted via telephone on a monthly basis (approximately Days 90, 120, 150, 180, and 210) and asked about the occurrence of SAEs and SNMCs.

Being tested
RSV-F Particle Vaccine, Placebo
Keywords
RSV
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.

  • RSV-F Particle VaccineBiological

    Dose 1 + adjuvant / dose; Day 0 and Day 30

  • RSV-F Particle VaccineBiological

    Dose 2 + adjuvant / dose; Day 0 and Day 30

  • RSV-F Particle VaccineBiological

    Dose 3 + adjuvant / dose; Day 0 and Day 30

  • RSV-F Particle VaccineBiological

    Dose 3 / dose; Day 0 and Day 30

  • PlaceboBiological

    Placebo; Day 0 and Day 30

  • RSV-F Particle VaccineBiological

    Dose 4 / dose; Day 0 and Day 30

  • RSV-F Particle VaccineBiological

    Dose 4 + adjuvant / dose; Day 0 and Day 30

Study groups in NCT01290419
Study groupRoleWhat they receive
A: Dose 1 + adjuvantExperimentalNot described
Receives: Biological: RSV-F Particle Vaccine
B: Dose 2 + adjuvantExperimentalNot described
Receives: Biological: RSV-F Particle Vaccine
C: Dose 3 + adjuvantExperimentalNot described
Receives: Biological: RSV-F Particle Vaccine
D: Dose 3 aloneExperimentalNot described
Receives: Biological: RSV-F Particle Vaccine
E: Placebo controlPlacebo comparatorNot described
Receives: Biological: Placebo
F: Dose 4 aloneExperimentalNot described
Receives: Biological: RSV-F Particle Vaccine
G: Dose 4 +adjuvantExperimentalNot described
Receives: Biological: RSV-F Particle Vaccine

What is being measured

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

  1. To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations.

    This primary outcome will be evaluated through an assessment of the following parameters:

    • Immediate AEs
    • Solicited AEs
    • All SAEs and SNMCs
    • Vital signs
    • Laboratory Assessments

    Measured: Day 60 (2 months)

Secondary outcomes (1)

  1. To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations

    This secondary outcome will be assessed in the following manner:

    • Neutralizing antibody against RSV measured in a PRNT assay
    • Total anti-F IgG measured by ELISA by ELISA

    Measured: Day 60 (2 months)

Timeline

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

  1. First posted7 Feb 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2011
  4. Study completionDec 2011

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01290419
Sponsor's protocol ID
NVX 757.101
Status last verified
Mar 2012
First submitted
2 Feb 2011
Last updated
8 Mar 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Calder LJ, Gonzalez-Reyes L, Garcia-Barreno B, Wharton SA, Skehel JJ, Wiley DC, Melero JA. Electron microscopy of the human respiratory syncytial virus fusion protein and complexes that it forms with monoclonal antibodies. Virology. 2000 May 25;271(1):122-31. doi: 10.1006/viro.2000.0279.

    PubMed 10814577

  • Collins PL, Mottet G. Post-translational processing and oligomerization of the fusion glycoprotein of human respiratory syncytial virus. J Gen Virol. 1991 Dec;72 ( Pt 12):3095-101. doi: 10.1099/0022-1317-72-12-3095.

    PubMed 1765771

  • Johnson S, Oliver C, Prince GA, Hemming VG, Pfarr DS, Wang SC, Dormitzer M, O'Grady J, Koenig S, Tamura JK, Woods R, Bansal G, Couchenour D, Tsao E, Hall WC, Young JF. Development of a humanized monoclonal antibody (MEDI-493) with potent in vitro and in vivo activity against respiratory syncytial virus. J Infect Dis. 1997 Nov;176(5):1215-24. doi: 10.1086/514115.

    PubMed 9359721

  • Lopez JA, Bustos R, Orvell C, Berois M, Arbiza J, Garcia-Barreno B, Melero JA. Antigenic structure of human respiratory syncytial virus fusion glycoprotein. J Virol. 1998 Aug;72(8):6922-8. doi: 10.1128/JVI.72.8.6922-6928.1998.

    PubMed 9658147

  • Melero JA, Garcia-Barreno B, Martinez I, Pringle CR, Cane PA. Antigenic structure, evolution and immunobiology of human respiratory syncytial virus attachment (G) protein. J Gen Virol. 1997 Oct;78 ( Pt 10):2411-8. doi: 10.1099/0022-1317-78-10-2411. No abstract available.

    PubMed 9349459

  • Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. doi: 10.1001/jama.289.2.179.

    PubMed 12517228

  • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. September 2007.

  • Glenn GM, Smith G, Fries L, Raghunandan R, Lu H, Zhou B, Thomas DN, Hickman SP, Kpamegan E, Boddapati S, Piedra PA. Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine. Vaccine. 2013 Jan 7;31(3):524-32. doi: 10.1016/j.vaccine.2012.11.009. Epub 2012 Nov 12.

    PubMed 23153449

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RSV-F Particle Vaccine in people with Respiratory Syncytial Virus Infections, run by Novavax 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 10 inclusion and 14 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 8 Mar 2012. 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. 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?

To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations. (time frame: Day 60 (2 months)). 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 NCT01290419, which also lists 8 linked publications.

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 8 Mar 2012.

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