ObesityROVENCT02471014
Effect of Obesity on Immune Response to Pneumovax 23
An observational study of Obesity, run by University of Florida at 1 site in United States.
Trial summary
Pneumococcal infections are a leading cause of adult and childhood hospitalization and death. It has been shown that obese individuals are at higher risk for this bacterial infection. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Pneumovax 23, Blood tests and Questionnaires
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 16 May 2019
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Area County Adults residents with a diagnosis of Obesity who are otherwise healthy.
Who may be able to join
- Control group
- aged 18-35
- BMIs between 22-25kg/m2, Obese group
- Aged 18 - 35
- BMIs greater than 30kg/m2, and
- waist to hip ratio of at least 0.9 in males and at least 0.85 in females
Who cannot join
- Pregnancy: Pregnant, Planning to become pregnant, or Breastfeeding
- Diabetes mellitus (A1C> 6.5%): Diagnosed with diabetes
- Abnormal CMP and CBC values as determined by the Principal Investigator.
- Inability to fast for 8 hours prior to the initial blood draw
- Immunization: Immunized with Pneumovax 23, or Immunized with Prevnar
- Medications:Currently taking any of the following medications or within the 4 weeks of study:
Show all 37Show fewer
- Immunosuppressive drugs or chemotherapeutic agents such as azathioprine, mycophenolate mofetil, TNF inhibitors, cyclosporine, methotrexate, leflunomide, cyclophosphamide, sulfasalazine, antimalarial drugs, chlorambucil, nitrogen mustard
- Steroids such as prednisone, cortisone, hydrocortisone
- Antidiabetic drugs such as metformin, insulin, glipizide, meglitinide, sulfonylurea, glimepiride, repaglinide, nateglinide
- History of clinical illness (exclusion during clinic)
- Pneumonia or Previously had Pneumonia
- Low blood pressure or Experienced dizzy spells
- Significant cardiovascular disease:Recently hospitalizations deemed significant at the discretion of the Principal Investigator, or History of heart attack, or History of stroke
- Spleen, Splenectomy, or Damage to spleen
- Lung Disease or History of lung disease
- Kidney disease, Blood in urine, or Protein in urine
- Liver disease, Previous or current liver diseases such as hepatitis A, B, or C, liver cirrhosis, or autoimmune hepatitis, or Elevated AST/ALT lab test
- Leukopenias
- Hemoglobinopathies, History of sickle cell disease, or thalassemia
- HIV/AIDS, or a history of HIV infection
- Recreational IV drug use, or Intravenous drug injection predisposes users to infections, such as human immunodeficiency virus, that may alter the immune system and therefore affect the immunoglobulin response to Pneumovax23.
- History of IV-drug use, or IV drug use is a risk factor for HIV infection, which may change the immune response to Pneumovax 23.
- History of idiopathic thrombocytopenic purpura
- History of chronic inflammatory diseases such as rheumatoid arthritis or chronic granulomatous disease
- Autoimmune disease
- Immunodeficiencies: neutropenia, common variable immune deficiency, Bruton's X-linked agammaglobulinemia; SCID; Selective IgA deficiency; Wiskott-Aldrich Syndrome; Ataxia Telangiectasia; DiGeorge Syndrome; Chronic Granulomatous Disease; Hyper IgE Syndrome; Complement deficiencies
- Weight
- Planning on losing weight within the time frame of the study
- Have experienced excessive weight loss or gain within two months prior to the study
- Planning to undergo liposuction, gastric bypass, stomach stapling, whipple procedure, or reconstructive surgery involving transplantation of adipose tissue within the study period
- Bodybuilder or someone who takes part in excessive weight training
- Allergy
- Any severe side effects from vaccines
- Allergic reaction to phenol
- Medications/Supplementations
- Taking any antioxidant supplements (EmergenC)
- Unable to refrain from antioxidant supplements throughout the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Obesity on Immune Responses to Pneumococcal Polysaccharide Vaccine, ROVE Study
Pneumococcal infections are a leading cause of adult and childhood hospitalization and death. It has been shown that obese individuals are at higher risk for this bacterial infection. As a result, investigators will vaccinate obese individuals to see if they are offered the same level of protection from the vaccine as normal-weight individuals. The vaccine used for this particular bacterial infection is called Pneumovax 23.
The purpose of this study is to compare how body mass index affects protection that the vaccine provides against these bacteria.
Primary Hypothesis: Levels of protection from the vaccine are no different in pre- and post- vaccination in healthy BMI individuals and obese individuals.
Read the detailed description
Study Participants: For this study, the investigators will recruit 56 participants separated into two groups. Group 1 will enroll 23 individuals with a BMI between 22 and 25. Group 2 will enroll 23 obese individuals. Study participants will be between the ages of 18-35 and in good health.
Pre-Screening: Basic eligibility will first be determined by phone or through a questionnaire. The investigators will acquire weight and height information to calculate BMI, as well as ask about any chronic health problems. At the end of the pre-screening, an email address will be requested in order to email a copy of the consent form for the participant to review before the first visit, during which the consent form will be reviewed with the participant and any questions addressed. A cell phone number will also be requested to text participant reminders the night before their appointments (visit 1 and visit 2). If the participant declines a reminder text, a reminder phone call will be set-up.
Screening: During the in-person screening, the investigators will ask several questions. Participants with chronic health problems (significant vascular disease, hepatitis, renal disease, diabetes, immunodeficiency) will be excluded. Individuals already immunized with Pneumovax23 or Prevnar (another vaccine that protects against pneumococcal infection) will also be excluded. A pregnancy test will be given to females to exclude pregnant individuals. An HbA1C (finger prick to get a drop of blood) will also be performed to exclude participants with high blood sugar levels. Physical exams will be performed and vitals will be taken on participants who pass the initial screening to help assess health.
Questionnaires will also be given at the first visit to assess stress, which has been shown to affect the ability to protect against infection.
Study Visits: All participants will receive a Pneumovax 23 vaccine, questionnaires, physical exams, and undergo 2 blood draws.
Part of the blood will be sent to a research laboratory for gene analysis. This will help us determine if certain genetic markers explain individual differences in Pneumovax 23 efficacy.
- Conditions
- Obesity
- Being tested
- Pneumovax 23, Blood tests, Questionnaires
- Keywords
- Pneumovax23, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumovax 23Drug
Also called pneumococcal polysaccharide vaccine
All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Blood testsOther
All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.
QuestionnairesOther
All participants will answer the following questionnaires:
UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.
Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.
Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups.
| Study group | Role | What they receive |
|---|---|---|
| Obese Individuals | Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later. Receives: Drug: Pneumovax 23; Other: Blood tests; Other: Questionnaires | |
| Normal Individuals | Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later. Receives: Drug: Pneumovax 23; Other: Blood tests; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-pneumococcal Antibodies Between the Groups
IgG antibody titers specific for each serotype in Pneumovax 23 (i.e. 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F) will be analyzed.
Measured: Changes in baseline and up to 6 weeks
Secondary outcomes (5)
UCLA Loneliness Scale Questionnaire Will be Used to Measure a Difference Between the Groups.
The UCLA loneliness scale is a 20-item questionnaire, on a scale of 0-3 for each question. This questionnaire measures subjective feelings of loneliness and social isolation. Final score of 0 reflects no loneliness and 60 reflects the maximum amount of loneliness.
Measured: Baseline
Perceived Stress Scale-10 Questionnaire Will be Used to Measure a Difference Between the Groups.
The Perceived Stress Scale-10 is a 10-item questionnaire assessing how stressful participants perceive their lives to be. Each question is assessed on a scale of 0 to 4. Final score of 0 reflects no stress and 40 indicates maximum amount of stress.
Measured: Baseline
Interpersonal Support Evaluation List-12 Will be Used to Measure a Difference Between the Groups
The Interpersonal Support Evaluation List-12, a 12-item questionnaire that measures perceived social support along 3 dimensions: appraisal support (availability of someone to talk to), belonging support (availability of people to do things with), and tangible support (e.g. material aid). This is measured on a scale of 0 to 36. The greater the number the greater perceived support.
Measured: Baseline
Life Orientation Test-Revised Will be Used to Measure a Difference Between the Groups.
The Life Orientation Test-Revised, a 10-item scale measuring optimism versus pessimism along a continuous scale; a higher score indicates more optimism. The lowest score is 0 and the highest is 24.
Measured: Baseline
Genetic Analysis
A small amount of blood will be sent to a research laboratory for an analysis of genetic markers Specifically, we will be analyzing the the stimulator of interferon genes (STING). This will help us determine if this gene, which has been previously thought to contribute to Pneumovax efficacy, helps explain individual differences in immune response.
Measured: Test to be performed in a research laboratory after Visits are completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startDec 2016
- Primary completionMar 2019
- Study completion16 May 2019
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 ObesityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Brantly, MD, Principal investigator, Professor of Medicine & Chief, Division of Pulmonary, Critical Care & Sleep Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471014
- Sponsor's protocol ID
- IRB201401069
- Acronym
- ROVE
- Status last verified
- Nov 2020
- First submitted
- 10 Jun 2015
- Last updated
- 1 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sebastian M, Hsiao CJ, Futch HS, Eisinger RS, Dumeny L, Patel S, Gobena M, Katikaneni DS, Cohen J, Carpenter AM, Spiryda L, Heldermon CD, Jin L, Brantly ML. Obesity and STING1 genotype associate with 23-valent pneumococcal vaccination efficacy. JCI Insight. 2020 May 7;5(9):e136141. doi: 10.1172/jci.insight.136141.
PubMed 32376795
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Obesity on Immune Responses to Pneumococcal Polysaccharide Vaccine, ROVE Study
- ClinicalTrials.gov ID
- NCT02471014
- Acronym / sponsor ID
- ROVE / IRB201401069
- Conditions
- Obesity
- Keywords
- Pneumovax23, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Posted 1 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pneumococcal infections are a leading cause of adult and childhood hospitalization and death. It has been shown that obese individuals are at higher risk for this bacterial infection. As a result, investigators will vaccinate obese individuals to see if they are offered the same level of protection from the vaccine as normal-weight individuals. The vaccine used for this particular bacterial infection is called Pneumovax 23.
The purpose of this study is to compare how body mass index affects protection that the vaccine provides against these bacteria.
Primary Hypothesis: Levels of protection from the vaccine are no different in pre- and post- vaccination in healthy BMI individuals and obese individuals.
Detailed description
Study Participants: For this study, the investigators will recruit 56 participants separated into two groups. Group 1 will enroll 23 individuals with a BMI between 22 and 25. Group 2 will enroll 23 obese individuals. Study participants will be between the ages of 18-35 and in good health.
Pre-Screening: Basic eligibility will first be determined by phone or through a questionnaire. The investigators will acquire weight and height information to calculate BMI, as well as ask about any chronic health problems. At the end of the pre-screening, an email address will be requested in order to email a copy of the consent form for the participant to review before the first visit, during which the consent form will be reviewed with the participant and any questions addressed. A cell phone number will also be requested to text participant reminders the night before their appointments (visit 1 and visit 2). If the participant declines a reminder text, a reminder phone call will be set-up.
Screening: During the in-person screening, the investigators will ask several questions. Participants with chronic health problems (significant vascular disease, hepatitis, renal disease, diabetes, immunodeficiency) will be excluded. Individuals already immunized with Pneumovax23 or Prevnar (another vaccine that protects against pneumococcal infection) will also be excluded. A pregnancy test will be given to females to exclude pregnant individuals. An HbA1C (finger prick to get a drop of blood) will also be performed to exclude participants with high blood sugar levels. Physical exams will be performed and vitals will be taken on participants who pass the initial screening to help assess health.
Questionnaires will also be given at the first visit to assess stress, which has been shown to affect the ability to protect against infection.
Study Visits: All participants will receive a Pneumovax 23 vaccine, questionnaires, physical exams, and undergo 2 blood draws.
Part of the blood will be sent to a research laboratory for gene analysis. This will help us determine if certain genetic markers explain individual differences in Pneumovax 23 efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese Individuals | – | Drug: Pneumovax 23, Other: Blood tests, Other: QuestionnairesParticipants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later. |
| Normal Individuals | – | Drug: Pneumovax 23, Other: Blood tests, Other: QuestionnairesParticipants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Area County Adults residents with a diagnosis of Obesity who are otherwise healthy.
Key inclusion criteria (6 listed)
- Control group
- aged 18-35
- BMIs between 22-25kg/m2, Obese group
- Aged 18 - 35
- BMIs greater than 30kg/m2, and
Key exclusion criteria (37 listed)
- Pregnancy: Pregnant, Planning to become pregnant, or Breastfeeding
- Diabetes mellitus (A1C> 6.5%): Diagnosed with diabetes
- Abnormal CMP and CBC values as determined by the Principal Investigator.
- Inability to fast for 8 hours prior to the initial blood draw
- Immunization: Immunized with Pneumovax 23, or Immunized with Prevnar
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 |
|---|---|---|
| Pneumovax 23Also: pneumococcal polysaccharide vaccineAll participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline. | Drug | Normal Individuals, Obese Individuals |
| Blood testsAll participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later. | Other | Normal Individuals, Obese Individuals |
| QuestionnairesAll participants will answer the following questionnaires: UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups. Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups. Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups. | Other | Normal Individuals, Obese Individuals |
Primary outcome
Anti-pneumococcal Antibodies Between the Groups
Time frame: Changes in baseline and up to 6 weeks
IgG antibody titers specific for each serotype in Pneumovax 23 (i.e. 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F) will be analyzed.
5 secondary outcomes
UCLA Loneliness Scale Questionnaire Will be Used to Measure a Difference Between the Groups.
Time frame: Baseline
Perceived Stress Scale-10 Questionnaire Will be Used to Measure a Difference Between the Groups.
Time frame: Baseline
Interpersonal Support Evaluation List-12 Will be Used to Measure a Difference Between the Groups
Time frame: Baseline
Life Orientation Test-Revised Will be Used to Measure a Difference Between the Groups.
Time frame: Baseline
Genetic Analysis
Time frame: Test to be performed in a research laboratory after Visits are completed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32376795Sebastian M, Hsiao CJ, Futch HS, Eisinger RS, Dumeny L, Patel S, Gobena M, Katikaneni DS, Cohen J, Carpenter AM, Spiryda L, Heldermon CD, Jin L, Brantly ML. Obesity and STING1 genotype associate with 23-valent pneumococcal vaccination efficacy. JCI Insight. 2020 May 7;5(9):e136141. doi: 10.1172/jci.insight.136141.
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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.
Mark Brantly, MD principal investigator
Professor of Medicine & Chief, Division of Pulmonary, Critical Care & Sleep Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Florida 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 37 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 Dec 2020. 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 1 Dec 2020). 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?
Anti-pneumococcal Antibodies Between the Groups (time frame: Changes in baseline and up to 6 weeks). 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 NCT02471014, 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 Dec 2020.