InfluenzaPhase 1NCT00851266
A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy Adults
A Phase 1 study testing V512 in people with Influenza, run by Merck Sharp & Dohme LLC.
Trial summary
This is a first in man study evaluating the tolerability and immunogenicity of BIPCV/IMX (V512) at increasing concentrations of influenza viral peptides A/M2+B/HA0 peptides and IMX, a saponin-based adjuvant. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- V512
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Jan 2009
- Phase
- Phase 1
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is in good physical health
- Subject is not in the category of individuals recommended by the CDC to receive influenza vaccine for the upcoming 2 influenza seasons
- Subject agrees not to seek vaccination with licensed influenza vaccines during the study
- Female subjects agree to use acceptable birth control for 6 weeks prior to first dose of vaccine until 1 month post Dose 3
Who cannot join
- Subject has a history of allergic reaction to the vaccine components
- Subject has has a fever within 3 days of screening
- Subject had a vaccination with an inactive virus within 14 days of Dose 1
- Subject had a vaccination with a live virus within 30 days of Dose 1
About this study
Official title: A Dose-Escalation, Dose-Ranging Study of the Safety, Tolerability, and Immunogenicity of a Bivalent Influenza Peptide Conjugate Vaccine Formulated With Aluminum- and ISCOMATRIX(TM) Containing Adjuvants (BIPCV/IMX) Evaluated in Healthy Adults 18 to 35 Years of Age
This is a first in man study evaluating the tolerability and immunogenicity of BIPCV/IMX (V512) at increasing concentrations of influenza viral peptides A/M2+B/HA0 peptides and IMX, a saponin-based adjuvant.
- Conditions
- Influenza
- Being tested
- V512, Comparator: Placebo to V512
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V512Biological
Subjects received 1 of 8 formulations of the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6:
- 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 2) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 3) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 4) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 5) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX; 6) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 7) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 8) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX;
Comparator: Placebo to V512Biological
Subjects received placebo to the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | V512 Receives: Biological: V512 |
| 2 | Placebo comparator | Placebo to V512 Receives: Biological: Comparator: Placebo to V512 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Safety and tolerability of BIPCV/IMX as assessed by vaccine-related SAEs; Immunogenicity: 1) A/M2 specific immunogenicity; 2) B/HA0 specific immunogenicity
Measured: Safety: 7 months; Immunogenicity: 1) 7 months; 2) 7 months
Secondary outcomes (1)
Persistence of A/M2 and B/HA0 immunogenicity
Measured: Months 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startOct 2006
- Primary completionAug 2007
- Study completionJan 2009
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.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851266
- Sponsor's protocol ID
- V512-002
- Other IDs
- 2009_550
- Status last verified
- Feb 2015
- First submitted
- 23 Feb 2009
- Last updated
- 12 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation, Dose-Ranging Study of the Safety, Tolerability, and Immunogenicity of a Bivalent Influenza Peptide Conjugate Vaccine Formulated With Aluminum- and ISCOMATRIX(TM) Containing Adjuvants (BIPCV/IMX) Evaluated in Healthy Adults 18 to 35 Years of Age
- ClinicalTrials.gov ID
- NCT00851266
- Acronym / sponsor ID
- V512-002
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 Feb 2009 (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.
This is a first in man study evaluating the tolerability and immunogenicity of BIPCV/IMX (V512) at increasing concentrations of influenza viral peptides A/M2+B/HA0 peptides and IMX, a saponin-based adjuvant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: V512V512 |
| 2 | Placebo comparator | Biological: Comparator: Placebo to V512Placebo to V512 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is in good physical health
- Subject is not in the category of individuals recommended by the CDC to receive influenza vaccine for the upcoming 2 influenza seasons
- Subject agrees not to seek vaccination with licensed influenza vaccines during the study
- Female subjects agree to use acceptable birth control for 6 weeks prior to first dose of vaccine until 1 month post Dose 3
Key exclusion criteria (4 listed)
- Subject has a history of allergic reaction to the vaccine components
- Subject has has a fever within 3 days of screening
- Subject had a vaccination with an inactive virus within 14 days of Dose 1
- Subject had a vaccination with a live virus within 30 days of Dose 1
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 |
|---|---|---|
| V512Subjects received 1 of 8 formulations of the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6: 1) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 2) 0.5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 3) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 4) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 5) 5 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX; 6) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 20 mcg IMX; 7) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 60 mcg IMX; 8) 20 mcg each of A/M2 and B/HA0 peptides with 225 mcg MAA and 100 mcg IMX; | Biological | 1 |
| Comparator: Placebo to V512Subjects received placebo to the BIPCV/IMX vaccine (V512) in a 3-dose regimen of 0.5 mL injections at Day 1, Month 2, and Month 6. | Biological | 2 |
Primary outcome
Safety: Safety and tolerability of BIPCV/IMX as assessed by vaccine-related SAEs; Immunogenicity: 1) A/M2 specific immunogenicity; 2) B/HA0 specific immunogenicity
Time frame: Safety: 7 months; Immunogenicity: 1) 7 months; 2) 7 months
1 secondary outcome
Persistence of A/M2 and B/HA0 immunogenicity
Time frame: Months 12, 18, and 24
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 12 Feb 2015.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V512 in people with Influenza, run by Merck Sharp & Dohme LLC.
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 4 inclusion and 4 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 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety: Safety and tolerability of BIPCV/IMX as assessed by vaccine-related SAEs; Immunogenicity: 1) A/M2 specific immunogenicity; 2) B/HA0 specific immunogenicity (time frame: Safety: 7 months; Immunogenicity: 1) 7 months; 2) 7 months). 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 12 Feb 2015.