Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine

NCT01072799 | Completed Phase 2 DMC

• 1 other identifier: NVX 754 H1N1-MEX
• Study Type: interventional
• Target: 4,560
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (5µg, 15µg and 45µg HA) of the novel A (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults (18 to 64 years of age).

Conditions

Seasonal Influenza

Keywords

A (H1N1)

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of two injections of A (H1N1) 2009 influenza VLP vaccine

  35 days

Secondary Outcomes (2)

• Evaluation of immunogenicity of two injections of A (H1N1) 2009 influenza VLP vaccine by Hemagglutination Inhibition

  35 days

• Long-term Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMCs)

  6 months post second dose

Study Arms (4)

Low dose H1N1

EXPERIMENTAL

Biological: A/H1N1 2009 Influenza VLP Vaccine

Mid dose H1N1

EXPERIMENTAL

Biological: A/H1N1 2009 Influenza VLP Vaccine

High dose H1N1

EXPERIMENTAL

Biological: A/H1N1 2009 Influenza VLP Vaccine

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Placebo BIOLOGICAL

Two doses (Day 1 and Day 22); 0.5mL

Placebo

A/H1N1 2009 Influenza VLP Vaccine BIOLOGICAL

Two doses (Day 1 \& Day 22); 0.5mL

High dose H1N1; Low dose H1N1; Mid dose H1N1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female 18-64 years of age at the time of the vaccination.
• Informed consent must be obtained from the subject prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.
• Available by telephone.
• Free of obvious health problems or chronic illnesses (e.g., recent exacerbation or acute episode of chronic illness in the last 3 months) as established by medical history, review of systems, and clinical examination before entering the study. This includes any mental condition that would interfere with subject self-assessment. Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable. Stable disease is defined as no new onset of exacerbation of pre-existing chronic disease 3 months prior to study vaccine injection.
• Female of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination. Subject must also have a negative pregnancy test at study entry then at Day 22 and must agree to continue to use adequate contraceptive precautions for three months after vaccination.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
• Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 201 follow-up call - 180 days after the second vaccination).
• Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. The use of topical, inhaled and nasal steroids will be permitted.
• Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
• 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 on the day of vaccination (baseline/dose 1 or dose 2). Acute disease is defined as the presence of a moderate or severe illness with or without fever \> 38 C.
• Acute clinically-significant pulmonary (including asthma), cardiovascular, hepatic or renal functional abnormality as determined by physical examination or laboratory screening tests.
• Major congenital defects that may increase the risk for complications from influenza.
• History of any neurological disorders or seizures (with the exception of febrile seizures during childhood) related to an underlying immune disease or disorder, such as but not limited to multiple sclerosis, lupus, and Guillain-Barre syndrome. Individuals with other neurological disorders that are clinically mild and stable with medication, such as mild Parkinson's disease, will not be excluded.
• Pregnant or lactating female.
• Females planning to become pregnant or planning to discontinue contraceptive precautions within 60 days of enrollment in this study.
• Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results.
• Participation in a novel A (H1N1) 2009 influenza vaccine study or a known history of novel A (H1N1) 2009 influenza infection.

Sponsors & Collaborators

• Novavax: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

Specialities Hospital, National Medical Centre "Siglo XXI" Mexican Institute for Social Security (IMSS)

Mexico City, C.P 06720, Mexico

Location

Study Officials

• Constantino R Lopez Macias, M.D.

  Specialities Hospital, National Medical Centre "Siglo XXI" Mexican Institute for Social Security (IMSS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: October 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

ME (1)