H5 Booster After a Two Dose Schedule

NCT00240968 | Completed Phase 2

• 1 other identifier: 05-0090
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether a third dose of vaccines containing A/Vietnam/1203/04 provides more immunity than two doses. Subjects who participate in this study will have participated in DMID protocol 04-063 involving the A/Vietnam/1203/04. In this study, each subject will be asked to receive a third dose of the H5 vaccine at the same level administered in protocol 04-063. Subjects will be asked to record oral temperature and any experienced side effects for 7 days following the vaccine. Study procedures will include up to 3 blood sample collections. Participants will be involved in study related procedures for up to 6 months.

Conditions

Influenza

Keywords

Avian influenza, vaccine, A/H5N1, sub-study

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus.

  Day 28 following booster immunization.

• Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments).

  Adverse Events will be collected through day 28. Serious Adverse Events will be collected throughout the study through day 180.

Secondary Outcomes (2)

• Proportion of subjects in each group achieving a day 28 post boost titer that is a 4-fold or greater increase compared to the peak titer achieved after the first two doses of vaccine.

  Day 28.

• Geometric mean titer of serum neutralizing and HAI antibodies at 28 and 180 days following booster immunization.

  Day 28 and 180.

Study Arms (4)

3

EXPERIMENTAL

Subjects will receive a single 45 mcg IM dose of the influenza A/H5N1 virus vaccine.

Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)

4

EXPERIMENTAL

Subjects will receive a single 90 mcg IM dose of the influenza A/H5N1 virus vaccine.

Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)

1

EXPERIMENTAL

Subjects will receive a single 7.5 mcg IM dose of the influenza A/H5N1 virus vaccine.

Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)

2

EXPERIMENTAL

Subjects will receive a single 15 mcg IM dose of the influenza A/H5N1 virus vaccine.

Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)

Interventions

Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) BIOLOGICAL

A monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit¿¿dose vials containing either 30-mcg/mL A/H5N1 HA or 90-mcg/mL A/H5N1 HA. Subjects will receive 1 of 4 dose levels of vaccine (7.5, 15, 45, or 90 mcg) administered intramuscularly.

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous recipient of inactivated Influenza A/H5N1 vaccine in study DMID 04-063.
• Male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 65 years, inclusive.
• Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period.
• Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.
• Able to understand and comply with planned study procedures.
• Provides informed consent prior to any study procedures and is available for all study visits.
• Previously achieved a 4-fold or greater increase from baseline in GMT following the second immunization with A/H5N1 approximately 28 days after dose 2 of study DMID 04-063 (approximately Day 56).
• Agrees to the storage of clinical specimens for an indefinite period of time at a central laboratory for use in future research.

You may not qualify if:

• Received placebo in DMID Study 04-063.
• Known allergy to eggs or other components of the vaccine or latex.
• Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
• Is undergoing immunosuppression as a result of an underlying illness or treatment.
• Has or had a neoplastic disease diagnosed or treated within the last 5 years or any lifetime history of hematologic malignancy. Those participants with any history of benign basal cell carcinoma of the skin may participate.
• Is using oral or parenteral steroids, high-dose inhaled steroids (\>800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
• Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
• Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
• Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
• Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
• Has an acute illness, including an isolated oral temperature greater than 100.4 degrees F, within 1 week of vaccination.
• Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study other than DMID 04-063, or expects to receive an experimental agent during the 7-month study period.
• Has a history of alcohol abuse or drug abuse (including chronic pain medication) in the last 5 years.
• Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

UCLA Center For Vaccine Research

Torrance, California, 90502, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases

Rochester, New York, 14642-0001, United States

Location

Related Publications (1)

• Zangwill KM, Treanor JJ, Campbell JD, Noah DL, Ryea J. Evaluation of the safety and immunogenicity of a booster (third) dose of inactivated subvirion H5N1 influenza vaccine in humans. J Infect Dis. 2008 Feb 15;197(4):580-3. doi: 10.1086/526537.

  PMID: 18237269 RESULT

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Bird Diseases; Animal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: August 16, 2013

Record last verified: 2008-07

Locations

US (3)