A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age

NCT02296463 | Completed Phase 1

• 1 other identifier: RSV-P-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief Summary

This is a randomized, observer-blind, irrelevant comparator-controlled trial in male and female subjects ≥24 months of age and \<72 months of age. Subjects will be without symptomatic chronic cardiopulmonary disease, including recurrent wheezing. Subjects will be screened for seropositivity to RSV in a qualified serum microneutralization (MN) assay and will be excluded if titers for either RSV/A or RSV/B are \<1:16 (4 log2). Treatments will comprise an IM dose of saline placebo or RSV F vaccine on Day 0 and an IM dose of RSV F vaccine or a licensed hepatitis A vaccine on Day 28. Hepatitis A vaccine (and in one group placebo) will be used to maintain the study blind; all subjects will receive a complete course of hepatitis A vaccine as a study benefit.

Conditions

Respiratory Synctial Virus

Outcome Measures

Primary Outcomes (2)

• Numbers and percentages of subjects with solicited local and systemic AEs.

  Solicited local and systemic AEs over the 7 days post injection; and all AES, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 56 days post- first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.

  Up to Day 392

• Immunogenicity as assessed by serum IgG antibody levels specific for the F protein antigen as detected by enzyme-linked immunosorbent assay (ELISA) providing a standardized ELISA Unit (EU) reasout based on a standard reference sample.

  Derived/ calculated endpoints based on these data will include: Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroresponse rate (SRR)

  Up to Day 392

Secondary Outcomes (1)

• Epitope-specific immune responses to the RSV F protein antigen measured by serum titers in a competition ELISA assay using known-efficacious prophylactic antibody preparation, or in vitro neutralization assays using at least one prototype RSV/A and RSV/B

  Up to Day 392

Other Outcomes (1)

• Epitope-specific immune responses to the RSV F protein antigen measured by serum titers in a direct binding ELISA using an immobilized linear peptide representing the conserved RSV F protein neutralizing antigenic site II.

  Up to Day 392

Study Arms (5)

Treatment Group A

EXPERIMENTAL

Day 0: RSV F Vaccine with adjuvant, Day 28: RSV F Vaccine with adjuvant

Biological: RSV F Vaccine with adjuvant (0.5mL injection)

Treatment Group B

EXPERIMENTAL

Day 0: RSV F Vaccine with adjuvant, Day 28: Hepatitis A Vaccine

Biological: RSV F Vaccine with adjuvant (0.5mL injection); Biological: Hepatitis A Vaccine (0.5mL injection)

Treatment Group C

EXPERIMENTAL

Day 0: RSV F Vaccine, Day 28: RSV F Vaccine

Biological: RSV F Vaccine (0.5mL injection)

Treatment Group D

EXPERIMENTAL

Day 0: RSV F Vaccine, Day 28: Hepatitis A Vaccine

Biological: RSV F Vaccine (0.5mL injection); Biological: Hepatitis A Vaccine (0.5mL injection)

Treatment Group E

PLACEBO COMPARATOR

Day 0: Placebo, Day 28: Hepatitis A Vaccine

Biological: Hepatitis A Vaccine (0.5mL injection); Biological: Placebo (0.5mL injection)

Interventions

RSV F Vaccine with adjuvant (0.5mL injection) BIOLOGICAL

Treatment Group A; Treatment Group B

RSV F Vaccine (0.5mL injection) BIOLOGICAL

Treatment Group C; Treatment Group D

Hepatitis A Vaccine (0.5mL injection) BIOLOGICAL

Treatment Group B; Treatment Group D; Treatment Group E

Placebo (0.5mL injection) BIOLOGICAL

Treatment Group E

Eligibility Criteria

• Age: 24 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy males and females, ≥24 months of age and \<72 months of age, without known chronic cardiopulmonary disease including especially persistent or frequently recurrent wheezing.
• Free of other illnesses that are believed to increase the risks associated with influenza or other respiratory viral infections, including: diabetes mellitus, congenital or acquired blood dyscrasias, renal or hepatic dysfunction, and morbid obesity.
• Parent(s)/guardian(s) willing and able to give informed consent prior to study enrollment, and assert ability to comply with study requirements.
• Parent(s)/guardian(s) and/or other designated child care provider must have continuous capacity for telephone communication with the study site.

You may not qualify if:

• Serum MN titers against RSV/A or RSV/B \<1:16 (4 log2).
• Toxicity grade ≥2 for any safety laboratory parameter.
• Participation in research involving an investigational product (drug/biologic/device) within 45 days before planned date of first vaccination and planned participation at any time during the study.
• History of a serious reaction to any prior vaccination, including Guillain-Barré Syndrome within six weeks following a previous influenza vaccination.
• Receipt of any vaccine (other than the influenza vaccine specified in the protocol) in the four weeks preceding the first study vaccination and/or planned receipt of a licensed vaccine (other than the hepatitis A vaccine specified in the protocol) at any time prior to Study Day 56.
• Receipt of an RSV vaccine at any time.
• Any known or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination.
• Administration of immunoglobulins and/or any blood products within the three 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.
• 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 social, neurologic, or psychiatric conditions in the subject or parent(s)/guardian(s) deemed likely to impair the quality of safety reporting).

Sponsors & Collaborators

• Novavax: lead

Study Sites (4)

University of Calgary, Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Dalhousie University, IWK Health Centre- Canadian Center for Vaccinology

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Aggarwal and Associates

Brampton, Ontario, L6T 0G1, Canada

Location

Medicore Research, Inc

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

Related Links

• Related Info

MeSH Terms

Interventions

Adjuvants, Pharmaceutic; Injections; Hepatitis A Vaccines

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Drug Administration Routes; Drug Therapy; Therapeutics; Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• D. Nigel Thomas, Ph.D.

  Novavax

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

CA (4)