InfluenzaVAX-002NCT02154061
Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics
A study testing IIV Flu Vaccine, Metronidazole and Neomycin in people with Influenza, run by Emory University at 1 site in United States.
Trial summary
The purpose of the study is to better understand how the use of antibiotics changes micro-organisms in the intestines. The change to micro-organisms in the intestines may change the body's vaccine immune response and alter the effectiveness of the IIV (seasonal flu) vaccine. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- IIV Flu Vaccine, Metronidazole and Neomycin
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 26 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals aged 18-40 years.
- Able to understand and give informed consent.
- Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after TIV vaccination
Who cannot join
- You received blood product within 3 months of enrolling in the study or a live attenuated vaccine within 4 weeks or inactivated vaccines within 2 weeks.
- You received the 2014-2015 flu vaccine or had a confirmed case of influenza during 2014-2015.
- You received any antibiotics 6 months prior to enrolling in the study or expect to take antibiotics one month after vaccination.
- You received probiotics or prebiotics 3 months prior before enrolling in the study or expect to take one month after vaccination.
- You received proton pump inhibitors, H2 blocker receptors, or antacids 3 months regularly before enrolling in the study or one month after
- You had an allergic response or sensitivity to past vaccinations.
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- You have health conditions that weaken your body's ability to fight infections or you are taking drugs like steroids that weaken your body's ability to fight infections.(Some nasal and topical steroids are allowed.).
- You have a chronic medical problem including (but not limited to) insulin dependent diabetes, severe heart disease including arrhythmias, severe lung disease, auto immune diseases and or grade 4 uncontrolled hypertension.
- Chronic neurological conditions such as seizure disorder, Parkinson disease, myasthenia gravis, neuropathy, or histories of encephalopathy, meningitis or ototoxicity.
- Any history of gastrointestinal disease, kidney or liver diseases.
- Alcohol or drug abuse or psychiatric conditions that in the opinion of the investigator would compromise your participation in this trial.
- Pregnant or are breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systems Biology of Inactivated Influenza Vaccine (IIV) in Healthy Adults With or Without Use of Broad Spectrum Antibiotics
The purpose of the study is to better understand how the use of antibiotics changes micro-organisms in the intestines. The change to micro-organisms in the intestines may change the body's vaccine immune response and alter the effectiveness of the IIV (seasonal flu) vaccine.
In particular, the investigators will be looking at certain markers in blood after vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before vaccination.
Read more
There will be two randomized groups. Group A will start taking antibiotic by mouth 3 days prior to vaccination and continue taking antibiotics the day of vaccination and one day after vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu vaccine) and will not take any antibiotics.
The investigators hope to enroll 50 subjects at Emory.
Read the detailed description
We will study using a system biology approach the immune responses to IIV alone vs. IIV with antibiotic administration
- Conditions
- Influenza
- Being tested
- IIV Flu Vaccine, Metronidazole, Neomycin, Vancomycin
- Keywords
- Flu Vaccine, Intestinal Microbiome, Antibiotics
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IIV Flu VaccineDrug
Also called Fluzone
This is an FDA approved and tested Inactivated Flu Vaccine.
MetronidazoleDrug
Also called Flagyl
This is a standard antibiotic
NeomycinDrug
This is a standard antibiotic.
VancomycinDrug
Also called Vancocin
This is a standard antibiotic.
| Study group | Role | What they receive |
|---|---|---|
| IIV Flu Vaccine with Antibiotics | Experimental | This arm will receive antibiotics prior and after IIV administration. Receives: Drug: IIV Flu Vaccine; Drug: Metronidazole; Drug: Neomycin; Drug: Vancomycin |
| IIV Flu Vaccine | Active comparator | This arm will not take antibiotics in conjunction with IIV. Receives: Drug: IIV Flu Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30
Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples
Measured: At day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startApr 2015
- Primary completion26 May 2017
- Study completion26 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Rouphael, Emory University
- Investigators
- Nadine Rouphael, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154061
- Sponsor's protocol ID
- IRB00074239
- Acronym
- VAX-002
- Status last verified
- Jul 2018
- First submitted
- 29 May 2014
- Last updated
- 15 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wimmers F, Donato M, Kuo A, Ashuach T, Gupta S, Li C, Dvorak M, Foecke MH, Chang SE, Hagan T, De Jong SE, Maecker HT, van der Most R, Cheung P, Cortese M, Bosinger SE, Davis M, Rouphael N, Subramaniam S, Yosef N, Utz PJ, Khatri P, Pulendran B. The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination. Cell. 2021 Jul 22;184(15):3915-3935.e21. doi: 10.1016/j.cell.2021.05.039. Epub 2021 Jun 25.
PubMed 34174187
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology of Inactivated Influenza Vaccine (IIV) in Healthy Adults With or Without Use of Broad Spectrum Antibiotics
- ClinicalTrials.gov ID
- NCT02154061
- Acronym / sponsor ID
- VAX-002 / IRB00074239
- Conditions
- Influenza
- Keywords
- Flu Vaccine, Intestinal Microbiome, Antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Posted 27 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to better understand how the use of antibiotics changes micro-organisms in the intestines. The change to micro-organisms in the intestines may change the body's vaccine immune response and alter the effectiveness of the IIV (seasonal flu) vaccine.
In particular, the investigators will be looking at certain markers in blood after vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before vaccination.
There will be two randomized groups. Group A will start taking antibiotic by mouth 3 days prior to vaccination and continue taking antibiotics the day of vaccination and one day after vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu vaccine) and will not take any antibiotics.
The investigators hope to enroll 50 subjects at Emory.
Detailed description
We will study using a system biology approach the immune responses to IIV alone vs. IIV with antibiotic administration
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IIV Flu Vaccine with Antibiotics | Experimental | Drug: IIV Flu Vaccine, Drug: Metronidazole, Drug: Neomycin, Drug: VancomycinThis arm will receive antibiotics prior and after IIV administration. |
| IIV Flu Vaccine | Active comparator | Drug: IIV Flu VaccineThis arm will not take antibiotics in conjunction with IIV. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy individuals aged 18-40 years.
- Able to understand and give informed consent.
- Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after TIV vaccination
Key exclusion criteria (12 listed)
- You received blood product within 3 months of enrolling in the study or a live attenuated vaccine within 4 weeks or inactivated vaccines within 2 weeks.
- You received the 2014-2015 flu vaccine or had a confirmed case of influenza during 2014-2015.
- You received any antibiotics 6 months prior to enrolling in the study or expect to take antibiotics one month after vaccination.
- You received probiotics or prebiotics 3 months prior before enrolling in the study or expect to take one month after vaccination.
- You received proton pump inhibitors, H2 blocker receptors, or antacids 3 months regularly before enrolling in the study or one month after
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 |
|---|---|---|
| IIV Flu VaccineAlso: FluzoneThis is an FDA approved and tested Inactivated Flu Vaccine. | Drug | IIV Flu Vaccine, IIV Flu Vaccine with Antibiotics |
| MetronidazoleAlso: FlagylThis is a standard antibiotic | Drug | IIV Flu Vaccine with Antibiotics |
| NeomycinThis is a standard antibiotic. | Drug | IIV Flu Vaccine with Antibiotics |
| VancomycinAlso: VancocinThis is a standard antibiotic. | Drug | IIV Flu Vaccine with Antibiotics |
Primary outcome
Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30
Time frame: At day 30
Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34174187Wimmers F, Donato M, Kuo A, Ashuach T, Gupta S, Li C, Dvorak M, Foecke MH, Chang SE, Hagan T, De Jong SE, Maecker HT, van der Most R, Cheung P, Cortese M, Bosinger SE, Davis M, Rouphael N, Subramaniam S, Yosef N, Utz PJ, Khatri P, Pulendran B. The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination. Cell. 2021 Jul 22;184(15):3915-3935.e21. doi: 10.1016/j.cell.2021.05.039. Epub 2021 Jun 25.
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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.
Nadine Rouphael, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IIV Flu Vaccine, Metronidazole and Neomycin in people with Influenza, run by Emory University 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 3 inclusion and 12 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 15 Aug 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30 (time frame: At day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02154061, which also lists 1 linked publication.
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 15 Aug 2018.