High Risk for HIVPhase 1/2SiVETNCT02589678
Zambia SiVET MMR Tdap-IPV
A Phase 1/2 study testing Tdap - IPV Vaccine and MMR Vaccine in people with High Risk for HIV, run by Emory University at 2 sites in Zambia.
Trial summary
Participants will receive vaccination for measles, mumps, and rubella (MMR) and tetanus, diphtheria, pertussis, and inactivated polio (Tdap-IPV). The study schedule design is to simulate a vaccine efficacy trial to see if single women can participate in studies that mimic actual HIV vaccine studies. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Risk for HIV
- What is being tested?
- Tdap - IPV Vaccine and MMR Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesZambia
- Study dates
- Aug 2015to 16 May 2017
- Phase
- Phase 1/2
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At high risk of HIV, defined by occupation (female sex workers) or recent delivery (single mothers)
- Planning to stay in Lusaka or Ndola for at least 12 months
- Willing to undergo HIV testing, counseling and receive HIV test results Able and willing to provide adequate locator information for tracking purposes, and willing to be contacted by the study staff
- Willing and able to provide adequate locator information and willing to be contacted by phone if available or home visit by study staff.
- Willing to answer questions on HIV risk factors, and if infected, questions related to the route and timing of exposure
- Willing and able to return for follow-up visits
- Willing and able to provide informed consent
- Willing to undergo pregnancy testing and use an injectable, implant or intrauterine device (IUD) from screening until four months after the last vaccination during the study
Who cannot join
- HIV-1/2 infection
- Pregnant or intending to become pregnant during the study
- History of severe allergic reaction to any substance including eggs, gelatin, and neomycin
- Any clinically significant acute illness or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study
- Immunosuppressive therapy
- Women who opt out of HIV counseling and testing services provided by the clinic
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- Women who have any condition that in the opinion of the Investigator or designee, would preclude provision of informed consent, or otherwise interfere with achieving the study objectives
- Participation in another clinical trial unless approved by the Principal Investigator and the International AIDS Vaccine Initiative (IAVI)
- Recent receipt of an investigational blood product or vaccine
- Failure of assessment of understanding
Trial locations and contacts
2 sites in 1 country.
Zambia2 sites
Zambia Emory HIV Research Project
Lusaka
Zambia Emory HIV Research Project
Ndola
About this study
Official title: A Simulated Vaccine Efficacy Trial Using MMR and Tdap-IPV Vaccines in Healthy, HIV Negative Women at High Risk of HIV Infection in Lusaka and Ndola, Zambia.
Participants will receive vaccination for measles, mumps, and rubella (MMR) and tetanus, diphtheria, pertussis, and inactivated polio (Tdap-IPV). The study schedule design is to simulate a vaccine efficacy trial to see if single women can participate in studies that mimic actual HIV vaccine studies.
Read the detailed description
This study will evaluate if women at high risk for HIV infection residing in Lusaka, Zambia and Ndola, Zambia are willing to participate and can be retained in future HIV vaccine trials. 150 women will be enrolled that are either sex workers or single women that were identified at infant vaccination clinics (at risk due to a recent pregnancy indicating unprotected sexual contact outside of marriage or cohabitation). Two licensed vaccines will be administered as proxies for HIV vaccine administration. The clinic and laboratory procedures will simulate HIV vaccine trial procedures and will therefore inform recruitment and retention strategies and HIV incidence among high risk women in future HIV vaccine trials.
- Conditions
- High Risk for HIV
- Being tested
- Tdap - IPV Vaccine, MMR Vaccine
- Keywords
- AIDS, Immunology, Public Health, Female sex workers, Single mothers
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tdap - IPV VaccineBiological
Also called Adacel Quadra
Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, combined with inactivated poliomyelitis vaccine (0.5 ml) will be administered intramuscularly.
MMR VaccineBiological
Also called TRIMOVAX
A live attenuated virus vaccine against measles, mumps and rubella (0.5 ml) will be administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| MMR/Tdap-IPV | Other | Participants receiving MMR vaccine (Measles, mumps, and rubella) at 0 months/at enrollment, followed by Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 3 months. Receives: Biological: Tdap - IPV Vaccine; Biological: MMR Vaccine |
| Tdap-IPV/MMR | Other | Participants receiving Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 0 months/at enrollment, followed by MMR vaccine (Measles, mumps, and rubella) at 3 months. Receives: Biological: Tdap - IPV Vaccine; Biological: MMR Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants retained
The number of participants who complete the study versus the number of participants enrolled will be calculated at the end of the study.
Measured: 12 Months from Baseline
Number of participants who receive 1 Vaccine
The number of participants who receive at least 1 of the vaccines at the end of the study will be recorded by the study staff.
Measured: 12 Months from Baseline
Number of participants who receive both vaccines
The number of participants who receive both vaccines at the end of the study will be recorded by the study staff.
Measured: 12 Months from Baseline
Ratio of Female Sex Workers vs Single Mothers who adhere to study procedures
The number of female sex workers and single mothers who adhere to all study procedures will be recorded and the ratio calculated.
Measured: 12 Months from Baseline
Number of protocol violations
The number of protocol violations that occur in the course of the study will be recorded.
Measured: 12 Months from Baseline
Number of Corrective Action Plans
The total number of Corrective and Preventative Action Plans implemented in the course of the study to address protocol deviations will be recorded.
Measured: 12 Months from Baseline
Time to Achieve Target Enrollment
The total time from the enrollment of first participant until enrollment of last participant will be recorded.
Measured: 12 Months from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startAug 2015
- Primary completion16 May 2017
- Study completion16 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk for HIVStudies 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 1/2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- International AIDS Vaccine Initiative, Zambia-Emory HIV Research Project
- Responsible party
- Principal investigator, Susan Allen, Emory University
- Investigators
- Susan Allen, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589678
- Sponsor's protocol ID
- IRB00080202
- Acronym
- SiVET
- Status last verified
- Nov 2017
- First submitted
- 27 Oct 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simulated Vaccine Efficacy Trial Using MMR and Tdap-IPV Vaccines in Healthy, HIV Negative Women at High Risk of HIV Infection in Lusaka and Ndola, Zambia.
- ClinicalTrials.gov ID
- NCT02589678
- Acronym / sponsor ID
- SiVET / IRB00080202
- Conditions
- High Risk for HIV
- Keywords
- AIDS, Immunology, Public Health, Female sex workers, Single mothers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- International AIDS Vaccine Initiative, Zambia-Emory HIV Research Project
- Study start
- Aug 2015
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 28 Oct 2015 (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.
Participants will receive vaccination for measles, mumps, and rubella (MMR) and tetanus, diphtheria, pertussis, and inactivated polio (Tdap-IPV). The study schedule design is to simulate a vaccine efficacy trial to see if single women can participate in studies that mimic actual HIV vaccine studies.
Detailed description
This study will evaluate if women at high risk for HIV infection residing in Lusaka, Zambia and Ndola, Zambia are willing to participate and can be retained in future HIV vaccine trials. 150 women will be enrolled that are either sex workers or single women that were identified at infant vaccination clinics (at risk due to a recent pregnancy indicating unprotected sexual contact outside of marriage or cohabitation). Two licensed vaccines will be administered as proxies for HIV vaccine administration. The clinic and laboratory procedures will simulate HIV vaccine trial procedures and will therefore inform recruitment and retention strategies and HIV incidence among high risk women in future HIV vaccine trials.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMR/Tdap-IPV | Other | Biological: Tdap - IPV Vaccine, Biological: MMR VaccineParticipants receiving MMR vaccine (Measles, mumps, and rubella) at 0 months/at enrollment, followed by Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 3 months. |
| Tdap-IPV/MMR | Other | Biological: Tdap - IPV Vaccine, Biological: MMR VaccineParticipants receiving Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 0 months/at enrollment, followed by MMR vaccine (Measles, mumps, and rubella) at 3 months. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- At high risk of HIV, defined by occupation (female sex workers) or recent delivery (single mothers)
- Planning to stay in Lusaka or Ndola for at least 12 months
- Willing to undergo HIV testing, counseling and receive HIV test results Able and willing to provide adequate locator information for tracking purposes, and willing to be contacted by the study staff
- Willing and able to provide adequate locator information and willing to be contacted by phone if available or home visit by study staff.
- Willing to answer questions on HIV risk factors, and if infected, questions related to the route and timing of exposure
Key exclusion criteria (10 listed)
- HIV-1/2 infection
- Pregnant or intending to become pregnant during the study
- History of severe allergic reaction to any substance including eggs, gelatin, and neomycin
- Any clinically significant acute illness or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study
- Immunosuppressive therapy
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 |
|---|---|---|
| Tdap - IPV VaccineAlso: Adacel QuadraTetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, combined with inactivated poliomyelitis vaccine (0.5 ml) will be administered intramuscularly. | Biological | MMR/Tdap-IPV, Tdap-IPV/MMR |
| MMR VaccineAlso: TRIMOVAXA live attenuated virus vaccine against measles, mumps and rubella (0.5 ml) will be administered intramuscularly. | Biological | MMR/Tdap-IPV, Tdap-IPV/MMR |
Primary outcome
Number of participants retained
Time frame: 12 Months from Baseline
The number of participants who complete the study versus the number of participants enrolled will be calculated at the end of the study.
Number of participants who receive 1 Vaccine
Time frame: 12 Months from Baseline
The number of participants who receive at least 1 of the vaccines at the end of the study will be recorded by the study staff.
Number of participants who receive both vaccines
Time frame: 12 Months from Baseline
The number of participants who receive both vaccines at the end of the study will be recorded by the study staff.
Ratio of Female Sex Workers vs Single Mothers who adhere to study procedures
Time frame: 12 Months from Baseline
The number of female sex workers and single mothers who adhere to all study procedures will be recorded and the ratio calculated.
Number of protocol violations
Time frame: 12 Months from Baseline
The number of protocol violations that occur in the course of the study will be recorded.
Number of Corrective Action Plans
Time frame: 12 Months from Baseline
The total number of Corrective and Preventative Action Plans implemented in the course of the study to address protocol deviations will be recorded.
Time to Achieve Target Enrollment
Time frame: 12 Months from Baseline
The total time from the enrollment of first participant until enrollment of last participant will be recorded.
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 6 Nov 2017.
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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.
Susan Allen, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tdap - IPV Vaccine and MMR Vaccine in people with High Risk for HIV, run by Emory University at 2 sites in Zambia.
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 8 inclusion and 10 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zambia. 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.
What does this combined 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.
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?
Number of participants retained (time frame: 12 Months from Baseline). The study lists 7 primary outcomes in all. 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 6 Nov 2017.