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A Study to Assess the Safety and Immunogenicity of M-001 Influenza Vaccine as a Primer to TIV in Elderly Volunteers

NCT01419925 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-05-13

No results posted yet for this study

Summary

"Multimeric-001" (M-001) has been recently developed, containing conserved, common linear influenza epitopes that activate both cellular and humoral arms of the immune system against a wide variety of influenza A and B strains. Apart from its direct action, M-001 is an attractive candidate for priming immune responses to seasonal influenza vaccine in the elderly population. The current clinical study was designed to assess M-001's standalone and priming action in subjects over 65 years old.

This is a second Phase II study comprising 120 participants. Eligible subjects were randomized to receive to receive either two sequential non-adjuvanted or a single non-adjuvanted or a single adjuvanted intramuscular injection of 500 mcg M-001 (treatment), or one placebo (saline) injection, before receiving the TIV.

Conditions

Interventions

BIOLOGICAL

Two Multimeric-001 administrations followed by TIV

Two administrations of non adjuvanted M-001, 500 mcg followed by TIV at intervals of 19-23 days

BIOLOGICAL

One administration of Multimeric-001 followed by TIV

One administration of non adjuvanted Multimeric-001, 500 mcg, followed by TIV at intervals of 19-23 days

BIOLOGICAL

One administration of adjuvanted M-001 followed by TIV

One administration of adjuvanted (Aluminum phosphate) Multimeric-001, 500 mcg, followed by TIV at intervals of 19-23 days

BIOLOGICAL

One administration of placebo followed by TIV

One administration of saline (Placebo)followed by TIV at intervals of 19-23 days (serving as an active comparator)

Sponsors & Collaborators

  • BiondVax Pharmaceuticals ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Jacob Atzmon, MD · Tel Aviv Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01419925 on ClinicalTrials.gov