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Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers

Primary Purpose

Influenza

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

colostrum enriched with anti flu antibodies

About this trial

This is an interventional prevention trial for Influenza focused on measuring modulating immune response to flu antigen

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male volunteers ages 18-60
If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication
Men > 18 years.
Ability and willingness of subject to provide informed consent
Screening tests' results within 15% of normal values

Exclusion Criteria:

Female
Continuous use of the following medications for more than 3 days within 30 days of study entry:
Immunosuppressives
Immune modulators
Systemic glucocorticoids
Anti-neoplastic agents
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
Subjects with a clinically significant infectious, immune mediated or malignant disease
Subjects with anemia (Hb <10.5 gm/dl)
Subjects with thrombocytopenia (platelets <100K/µl)
Subjects with lymphopenia (absolute lymphocyte count <0.7)
Subjects who were previously vaccinated against flu.
Subject who received any vaccination within the last 6 months

Sites / Locations

Hadassah Hebrew University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study group

Arm Description

Outcomes

Primary Outcome Measures

alterations in immune response to flu antigen

Secondary Outcome Measures

Full Information

NCT ID

NCT01026350

First Posted

December 3, 2009

Last Updated

December 3, 2009

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT01026350

Brief Title

Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

5. Study Description

Brief Summary

Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

modulating immune response to flu antigen

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

colostrum enriched with anti flu antibodies

Intervention Description

each volunteer will receive six 1.2 g oral tablets (equivalent to 600 mg of bovine colostrum powder each) once a day for two weeks.

Primary Outcome Measure Information:

Title

alterations in immune response to flu antigen

Time Frame

during and after administration of colostrum enriched with anti flu antibodies

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male volunteers ages 18-60 If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication Men > 18 years. Ability and willingness of subject to provide informed consent Screening tests' results within 15% of normal values Exclusion Criteria: Female Continuous use of the following medications for more than 3 days within 30 days of study entry: Immunosuppressives Immune modulators Systemic glucocorticoids Anti-neoplastic agents Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry. Subjects with a clinically significant infectious, immune mediated or malignant disease Subjects with anemia (Hb <10.5 gm/dl) Subjects with thrombocytopenia (platelets <100K/µl) Subjects with lymphopenia (absolute lymphocyte count <0.7) Subjects who were previously vaccinated against flu. Subject who received any vaccination within the last 6 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

tomer adar, MD

Phone

972-2-6778511

tomerad@hadassah.org.il

Facility Information:

Facility Name

Hadassah Hebrew University Medical Center

City

Jerusalem

ZIP/Postal Code

POB 12000

Country

Israel

Facility Contact: