InfluenzaPhase 2NCT00192309
Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine.
A Phase 2 study testing CAIV-T and TIV in people with Influenza, run by MedImmune LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- CAIV-T and TIV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Dec 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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].
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Placebo-Controlled Trial to Investigate the Kinetics of the Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent,Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Adults Aged 18 to <65 Years.
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).
Read the detailed description
This was a randomized, open-label, placebo-controlled, outpatient study carried out in healthy adults 18 to < 65 years of age. The study was designed to evaluate the kinetics of the immune responses generated by each of the study products in order to determine the best sampling time for future studies. Subjects were randomized in a 1:1:1 ratio to receive a single dose of either CAIV-T, inactivated influenza virus vaccine (TIV), or placebo.
- Conditions
- Influenza
- Being tested
- CAIV-T, TIV, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAIV-TBiological
Also called FluMist
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.
TIVBiological
Also called Flushield
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.
PlaceboBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Cold-adapted influenza vaccine (CAIVT) | Experimental | A single intranasal dose of 10^7 fluorescent focus units. Receives: Biological: CAIV-T |
| Trivalent inactivated vaccine (TIV) | Active comparator | A single dose of commercially available Flushield was administered intramuscularly. Receives: Biological: TIV |
| Placebo | Placebo comparator | The 0.2 mL administered intranasally. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0-28
Secondary outcomes (6)
Expression of IgA in nasal wash and saliva swab samples
Nasal wash and saliva swab IgA antibody titers were expressed as the ratio of specific to total IgA.
Measured: Days 0-28
Expression of B-cells in peripheral blood
The B-cell ELISPOT assays are designed to detect B-cells in the peripheral blood that are actively secreting influenza strain-specific IgG or IgA antibody.
Measured: Days 0-28
Number of CD3+ peripheral blood mononuclear cells secreting interferon gamma
The number of CD3+ peripheral blood mononuclear cells (PBMCs), i.e., T-cells, secreting IFN-γ prior to and after vaccination following in vitro stimulation of these cells using the IFN-γ ELISPOT assay.
Measured: Days 0-28
Number of subjects with local reactions
Local injection site reactions were collected from subjects in the TIV treatment group only.
Measured: Days 0-7
Number of subjects with systemic reactions
Each study subject collected prompted reactogenicity events on a diary card worksheet for 7 days (study days 0 - 6) following vaccination.
Measured: Days 0-7
Number of subjects with adverse events
An Adverse Event (or Adverse Experience, AE) was any untoward, undesired or unexpected clinical event in the form of signs, symptoms, disease or laboratory or physiological observations occurring (in a human being) in a temporal relationship to the use of a WLV product, regardless of causal relationship.
Measured: Days 0-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2001
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Robert Walker, MD, Principal investigator, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192309
- Sponsor's protocol ID
- D153 P004
- Status last verified
- Feb 2012
- First submitted
- 12 Sep 2005
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Placebo-Controlled Trial to Investigate the Kinetics of the Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent,Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Adults Aged 18 to <65 Years.
- ClinicalTrials.gov ID
- NCT00192309
- Acronym / sponsor ID
- D153 P004
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Sep 2001
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This was a randomized, open-label, placebo-controlled, outpatient study carried out in healthy adults 18 to < 65 years of age. The study was designed to evaluate the kinetics of the immune responses generated by each of the study products in order to determine the best sampling time for future studies. Subjects were randomized in a 1:1:1 ratio to receive a single dose of either CAIV-T, inactivated influenza virus vaccine (TIV), or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cold-adapted influenza vaccine (CAIVT) | Experimental | Biological: CAIV-TA single intranasal dose of 10^7 fluorescent focus units. |
| Trivalent inactivated vaccine (TIV) | Active comparator | Biological: TIVA single dose of commercially available Flushield was administered intramuscularly. |
| Placebo | Placebo comparator | Biological: PlaceboThe 0.2 mL administered intranasally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAIV-TAlso: FluMistLiquid 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. | Biological | Cold-adapted influenza vaccine (CAIVT) |
| TIVAlso: FlushieldTIV 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. | Biological | Trivalent inactivated vaccine (TIV) |
| PlaceboPlacebo 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). | Biological | Placebo |
Primary outcome
Kinetics of the hemagglutination inhibition antibody response to each vaccine strain
Time frame: Day 0-28
The geometric mean titers for each strain between Day 0 and 28 were examined.
6 secondary outcomes
Expression of IgA in nasal wash and saliva swab samples
Time frame: Days 0-28
Expression of B-cells in peripheral blood
Time frame: Days 0-28
Number of CD3+ peripheral blood mononuclear cells secreting interferon gamma
Time frame: Days 0-28
Number of subjects with local reactions
Time frame: Days 0-7
Number of subjects with systemic reactions
Time frame: Days 0-7
Number of subjects with adverse events
Time frame: Days 0-7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Walker, MD principal investigator
MedImmune LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAIV-T and TIV in people with Influenza, run by MedImmune LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetics of the hemagglutination inhibition antibody response to each vaccine strain (time frame: Day 0-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.