HIVPhase 4NCT02724852
MMR Vaccination Among HIV-infected Adults
A Phase 4 study testing 0.5 ml of MMR vaccine in people with HIV, run by Chiang Mai University at 1 site in Thailand.
Trial summary
This is a prevalence study of protective antibodies to measles, mumps, and rubella (MMR) in HIV-infected adults and HIV-uninfected controls. MMR vaccination were provided to both groups who had no protective antibodies to at least one of the three viruses. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- 0.5 ml of MMR vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2011to Mar 2014
- Phase
- Phase 4
- 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 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For HIV-infected participants, inclusions criteria were
- 20-59 years old, ability to provide informed consent
- receiving cART
- CD4 cell count ≥200 cell/mm3 within 6 months before enrollment
- plasma HIV-1 RNA <50 copies/mL, and 5) ability to provide informed consent.
Who cannot join
- For both groups
- pregnancy or lactating
- receiving cancer treatment, organ transplantation, ≥0.5 mg/kg/day of prednisolone or equivalent, or immunomodulating treatment
- impaired renal function (creatinine clearance <30 mL/min)
- impaired liver function as defined by Child-Pugh C.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Muang, Chiang Mai, 50200
About this study
Official title: Seroprevalence of Antibodies to Measles, Mumps, and Rubella, and Serologic Responses After Vaccination Among Human Immunodeficiency Virus (HIV)-1 Infected Adults in Northern Thailand
This is a prevalence study of protective antibodies to measles, mumps, and rubella (MMR) in HIV-infected adults and HIV-uninfected controls. MMR vaccination were provided to both groups who had no protective antibodies to at least one of the three viruses.
Read the detailed description
From July to August 2011, 500 HIV-infected and 132 HIV-uninfected participants those met the eligibility criteria were enrolled and tested for protective antibodies to measles, mumps, and rubella.
All participants who had no protective antibody to at least one of the three viruses were recruited to vaccinate for MMR vaccine. Between June to September 2012, 249 HIV-infected and 46 HIV-uninfected adults were vaccinated. Antibodies to MMR were measured at week 8-12, and week 48 after vaccination, which were completed in August 2013. The results were ready for analysis in March 2014.
- Conditions
- HIV
- Being tested
- 0.5 ml of MMR vaccine
- Keywords
- MMR, vaccination, HIV, Serologic response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 ml of MMR vaccineBiological
Participants in each arm received the same vaccine, a 0.5 ml of MMR vaccine at deltoid region
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected adults | Active comparator | Two-hundreds and forty-nine HIV-infected participants received a single dose of MMR vaccine (GlaxoSmithKline Biologicals) at deltoid region.
Interventions were a single dose of 0.5 ml of MMR vaccine. Each 0.5 ml of vaccine contained at least 1000 TCID50 of Schwarz measles strain, at least 1000 TCID50 of RIT 4385 mumps, and at least 1000 TCID50 of Wistar RA 27/3 rubella strains. Receives: Biological: 0.5 ml of MMR vaccine |
| HIV-uninfected adults | Experimental | Forty-six HIV-uninfected participants received a single dose of MMR vaccine (GlaxoSmithKline Biologic) at deltoid region.
Interventions were a single dose of 0.5 ml of MMR vaccine. Each 0.5 ml of vaccine contained at least 1000 TCID50 of Schwarz measles strain, at least 1000 TCID50 of RIT 4385 mumps, and at least 1000 TCID50 of Wistar RA 27/3 rubella strains. Receives: Biological: 0.5 ml of MMR vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with protective antibodies to measles, mumps, and rubella
Comparison of proportions of participants who had protective antibodies to measles between HIV-infected participants and HIV-uninfected participants
Measured: Baseline
Secondary outcomes (9)
Proportion of participants with protective antibodies to measles, mumps, and rubella
Comparison of proportion of participants who had protective antibodies to measles, mumps, and rubella between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses
Measured: 8-12 weeks after a single dose of MMR vaccination
Proportion of participants with protective antibodies to measles, mumps, and rubella
Comparison of proportion of participants who had protective antibodies to measles, mumps, and rubella between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses
Measured: 48 weeks after a single dose of MMR vaccination
The geometric means of anti-measles IgG level
Comparison of the geometric means of anti-measles IgG level between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses
Measured: 8-12 weeks after a single dose of MMR vaccination
The geometric means of anti-measles IgG level
Comparison of the geometric means of anti-measles IgG level between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses
Measured: 48 weeks after a single dose of MMR vaccination
The geometric means of anti-mumps IgG titers
Comparison of the geometric means of anti-mumps IgG level between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses
Measured: 8-12 weeks after a single dose of MMR vaccination
The geometric means of anti-mumps IgG titers
Comparison of the geometric means of anti-mumps IgG level between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses
Measured: 48 weeks after a single dose of MMR vaccination
The geometric means of anti-rubella IgG level
Comparison of the geometric means of anti-rubella IgG level between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses
Measured: 8-12 weeks after a single dose of MMR vaccination
The geometric means of anti-rubella IgG level
Comparison of the geometric means of anti-rubella IgG level between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses
Measured: 48 weeks after a single dose of MMR vaccination
Proportion of participants who had adverse effects from vaccination
Comparison of proportion of participants who had adverse effects from MMR vaccination between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses
Measured: 72 hours after MMR vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startJul 2011
- Primary completionSep 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 632 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romanee Chaiwarith, Chiang Mai University
- Investigators
- Romanee Chaiwarith, MD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724852
- Sponsor's protocol ID
- Research ID: 268
- Status last verified
- Mar 2016
- First submitted
- 25 Mar 2016
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chaiwarith R, Praparattanapan J, Nuket K, Kotarathitithum W, Supparatpinyo K. Seroprevalence of antibodies to measles, mumps, and rubella, and serologic responses after vaccination among human immunodeficiency virus (HIV)-1 infected adults in Northern Thailand. BMC Infect Dis. 2016 Apr 30;16:190. doi: 10.1186/s12879-016-1499-x.
PubMed 27138005
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Antibodies to Measles, Mumps, and Rubella, and Serologic Responses After Vaccination Among Human Immunodeficiency Virus (HIV)-1 Infected Adults in Northern Thailand
- ClinicalTrials.gov ID
- NCT02724852
- Acronym / sponsor ID
- Research ID: 268
- Conditions
- HIV
- Keywords
- MMR, vaccination, HIV, Serologic response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 31 Mar 2016 (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 prevalence study of protective antibodies to measles, mumps, and rubella (MMR) in HIV-infected adults and HIV-uninfected controls. MMR vaccination were provided to both groups who had no protective antibodies to at least one of the three viruses.
Detailed description
From July to August 2011, 500 HIV-infected and 132 HIV-uninfected participants those met the eligibility criteria were enrolled and tested for protective antibodies to measles, mumps, and rubella.
All participants who had no protective antibody to at least one of the three viruses were recruited to vaccinate for MMR vaccine. Between June to September 2012, 249 HIV-infected and 46 HIV-uninfected adults were vaccinated. Antibodies to MMR were measured at week 8-12, and week 48 after vaccination, which were completed in August 2013. The results were ready for analysis in March 2014.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-infected adults | Active comparator | Biological: 0.5 ml of MMR vaccineTwo-hundreds and forty-nine HIV-infected participants received a single dose of MMR vaccine (GlaxoSmithKline Biologicals) at deltoid region. Interventions were a single dose of 0.5 ml of MMR vaccine. Each 0.5 ml of vaccine contained at least 1000 TCID50 of Schwarz measles strain, at least 1000 TCID50 of RIT 4385 mumps, and at least 1000 TCID50 of Wistar RA 27/3 rubella strains. |
| HIV-uninfected adults | Experimental | Biological: 0.5 ml of MMR vaccineForty-six HIV-uninfected participants received a single dose of MMR vaccine (GlaxoSmithKline Biologic) at deltoid region. Interventions were a single dose of 0.5 ml of MMR vaccine. Each 0.5 ml of vaccine contained at least 1000 TCID50 of Schwarz measles strain, at least 1000 TCID50 of RIT 4385 mumps, and at least 1000 TCID50 of Wistar RA 27/3 rubella strains. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- For HIV-infected participants, inclusions criteria were
- 20-59 years old, ability to provide informed consent
- receiving cART
- CD4 cell count ≥200 cell/mm3 within 6 months before enrollment
- plasma HIV-1 RNA <50 copies/mL, and 5) ability to provide informed consent.
Key exclusion criteria (5 listed)
- For both groups
- pregnancy or lactating
- receiving cancer treatment, organ transplantation, ≥0.5 mg/kg/day of prednisolone or equivalent, or immunomodulating treatment
- impaired renal function (creatinine clearance <30 mL/min)
- impaired liver function as defined by Child-Pugh C.
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 |
|---|---|---|
| 0.5 ml of MMR vaccineParticipants in each arm received the same vaccine, a 0.5 ml of MMR vaccine at deltoid region | Biological | HIV-infected adults, HIV-uninfected adults |
Primary outcome
Proportion of participants with protective antibodies to measles, mumps, and rubella
Time frame: Baseline
Comparison of proportions of participants who had protective antibodies to measles between HIV-infected participants and HIV-uninfected participants
9 secondary outcomes
Proportion of participants with protective antibodies to measles, mumps, and rubella
Time frame: 8-12 weeks after a single dose of MMR vaccination
Proportion of participants with protective antibodies to measles, mumps, and rubella
Time frame: 48 weeks after a single dose of MMR vaccination
The geometric means of anti-measles IgG level
Time frame: 8-12 weeks after a single dose of MMR vaccination
The geometric means of anti-measles IgG level
Time frame: 48 weeks after a single dose of MMR vaccination
The geometric means of anti-mumps IgG titers
Time frame: 8-12 weeks after a single dose of MMR vaccination
The geometric means of anti-mumps IgG titers
Time frame: 48 weeks after a single dose of MMR vaccination
The geometric means of anti-rubella IgG level
Time frame: 8-12 weeks after a single dose of MMR vaccination
The geometric means of anti-rubella IgG level
Time frame: 48 weeks after a single dose of MMR vaccination
Proportion of participants who had adverse effects from vaccination
Time frame: 72 hours after MMR vaccination
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 1 Apr 2016.
- Derived from this study: PubMed 27138005Chaiwarith R, Praparattanapan J, Nuket K, Kotarathitithum W, Supparatpinyo K. Seroprevalence of antibodies to measles, mumps, and rubella, and serologic responses after vaccination among human immunodeficiency virus (HIV)-1 infected adults in Northern Thailand. BMC Infect Dis. 2016 Apr 30;16:190. doi: 10.1186/s12879-016-1499-x.
- Individual participant dataSharing planned: No
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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.
Romanee Chaiwarith, MD principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.5 ml of MMR vaccine in people with HIV, run by Chiang Mai University at 1 site in Thailand.
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 5 inclusion and 5 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 1 Apr 2016. 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 Thailand. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of participants with protective antibodies to measles, mumps, and rubella (time frame: Baseline). 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 NCT02724852, 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 1 Apr 2016.