Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine.

NCT00192309 | Completed Phase 2

• 1 other identifier: D153 P004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study was to perform a variety of assays on blood, serum, nasal wash and cell samples obtained from healthy adult subjects for the purposes of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A \& B, live, cold-adapted (liquid formulation CAIV-T; Wyeth, Marietta, PA).

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Kinetics of the hemagglutination inhibition antibody response to each vaccine strain

  The geometric mean titers for each strain between Day 0 and 28 were examined.

  Day 0-28

Secondary Outcomes (6)

• Expression of IgA in nasal wash and saliva swab samples

  Days 0-28

• Expression of B-cells in peripheral blood

  Days 0-28

• Number of CD3+ peripheral blood mononuclear cells secreting interferon gamma

  Days 0-28

• Number of subjects with local reactions

  Days 0-7

• Number of subjects with systemic reactions

  Days 0-7

Study Arms (3)

Cold-adapted influenza vaccine (CAIVT)

EXPERIMENTAL

A single intranasal dose of 10\^7 fluorescent focus units.

Biological: CAIV-T

Trivalent inactivated vaccine (TIV)

ACTIVE COMPARATOR

A single dose of commercially available Flushield was administered intramuscularly.

Biological: TIV

Placebo

PLACEBO COMPARATOR

The 0.2 mL administered intranasally.

Biological: Placebo

Interventions

CAIV-T BIOLOGICAL

Liquid CAIV-T vaccine for this study consisted of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2) and B/Yamanashi/166/98 influenza virus strains. The reassortant vaccine strains were grown in specific pathogen-free (SPF) eggs and the allantoic fluid, which contained virus, was harvested, concentrated and purified. Each dose of CAIV-T used in this study was formulated to contain approximately 107 FFU of each of the 6:2 influenza reassortant vaccine strains.

Also known as: FluMist

Cold-adapted influenza vaccine (CAIVT)

TIV BIOLOGICAL

TIV in this study consisted of Flushield™, manufactured by Wyeth Vaccines, Marietta, PA, USA. Each 0.5 mL dose contained no less than 15 ug of the hemagglutinin antigens from each of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Yamanashi/166/98 strains, making TIV in this study antigenically matched to the influenza strains contained in CAIV-T.

Also known as: Flushield

Trivalent inactivated vaccine (TIV)

Placebo BIOLOGICAL

Placebo in this study consisted of physiological saline. The total volume of 0.2 mL was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects had to have been at least 18 years of age and less than 65 years of age at the time informed consent was obtained;
• Women of child-bearing potential had to use reliable methods of hormonal and/or nonhormonal contraception (which includes cervical cap, diaphragm, condoms with spermicide or IUD) during sexual intercourse throughout the entire study period; a negative urine pregnancy test (with detection limit of less than or equal to 25mIU/mL) no more than 24 hours prior to vaccine administration; and agreed to avoid pregnancy during participation in the study. A urine pregnancy test was also conducted at the completion of study participation. Females who were surgically sterile at time of enrollment were not required to undergo pregnancy testing.
• who were determined by medical history, physical examination and clinical judgement to be eligible for the study.
• who provided written informed consent after the nature of the study has been explained;
• who were available for one month duration of the trial (from enrollment to study completion);
• who could be reached by study staff for the post-vaccination contact \[telephone, clinic or home visit\].

You may not qualify if:

• who were perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
• with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids and intranasal steroids; or cytotoxic agents;
• who had an immunosuppressed or an immunocompromised individual living in the same household;
• who had a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
• who received any commercially-available or investigational injected influenza vaccine in the 6 months prior to enrollment, or a non-study influenza vaccine since enrollment;
• who previously received an intranasally administered influenza vaccine;
• who had any medical conditions that, in the opinion of the investigator, might interfere with interpretation of the study results;

Sponsors & Collaborators

• MedImmune LLC: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

David M. Radin, MD

Stamford, Connecticut, 06905, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist; Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Robert Walker, MD

  MedImmune LLC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: September 1, 2001
• Primary Completion: December 1, 2001
• Study Completion: December 1, 2001
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

US (1)