HIVNCT02357823
Antibodies and Memory Cells Role After Different Pneumococcal Vaccines in HIV Adults
An observational study of HIV and Pneumococcal Infections, run by University of Siena at 2 sites in Italy.
Trial summary
Streptococcus pneumoniae is a cause of high morbidity and mortality in HIV-positive subjects, representing the leading etiological agent of severe bacterial pneumonia. International guidelines recommend that HIV positive patients aged >=19 years, who are 13-valent conjugate vaccine (PCV13) naïve, should receive a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV, Pneumococcal Infections
- What is being tested?
- Evaluation of immunological response and Nasopharyngeal swabs analysis
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2015to Jan 2017
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-positive adults that undergo the International and Italian Ministry of Health indications for administration of pneumococcal vaccines.
Who may be able to join
- age between 18 and 65 years
- acceptance of informed consensus
- HIV positivity
- access to structures in ambulatory or Day Hospital regimen
- CD4+ cell count > or < than 200 cells/ul
- subjects for which Italian Ministry of Health recommend pneumococcal vaccination with PCV13 or PPV23
Who cannot join
- pregnancy
- acute infectious disease ongoing
- antibiotic therapy ongoing in the previous 7 days
- HIV-independent immunodepression
- chronic steroid therapy
- anatomic or functional asplenia
- contraindication to vaccination based on package insert drug facts, such as hypersensitivity to the active ingredient or one of the bulking agents (PPV23, Pneumovax);hypersensitivity to the active ingredient, to one of the bulking agents or to the diphteria toxoid (PCV13, Prevenar 13)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Istituto di Clinica delle Malattie Infettive c/o Policlinico Gemelli, Largo Agostino Gemelli 12
Roma, Rome, 00168
UOC Malattie Infettive Universitarie c/o Policlinico Le Scotte, Viale Mario Bracci 16
Siena, 53100
About this study
Official title: Long Term Serological Response and Memory Cells Role After Different Pneumococcal Vaccine Strategies in HIV Adults
Streptococcus pneumoniae is a cause of high morbidity and mortality in HIV-positive subjects, representing the leading etiological agent of severe bacterial pneumonia. International guidelines recommend that HIV positive patients aged >=19 years, who are 13-valent conjugate vaccine (PCV13) naïve, should receive a single dose of PCV13. Pneumococcal polysaccharide vaccine 23-valent (PPV23) should be given >=8 weeks after indicated dose of PCV13, and a second dose of PPV23 should be given 5 years later. For those who previously received PPV23, PCV13 should be administered >=1 year after the last PPV23 dose. HIV infection affects humoral immunity both through reduced T-cell help and changes in the B-cell compartment. Neither amount of circulating memory B cells nor their functions are restored by antiretroviral therapy: this may affect antibody mediated immunity, even in well-treated HIV patients. In asplenic childrens a single dose of PCV13 seems sufficient to restore the pool of anti-pneumococcal polysaccharides IgG memory B cells. In adults, it has been reported that a single dose of 7-valent pneumococcal conjugate vaccine induces significant increases in serotype-specific memory B-cell populations, conversely, immunization with PPV23 seems to decrease memory B-cell frequency. However, data on immunological response after PCV13 in HIV positive adults are still scanty and the optimal pneumococcal prophylaxis strategy needs further investigation. Number of PCV13 doses is actually demanded to clinical judgment for each patient; also current Italian indications recommend at least one dose, but till 3 doses seem to be suggested for immunocompromised patients. Present study aims to investigate short and long term immunological response after different standard vaccine schedule and to evaluate pneumococcal nasopharyngeal colonization in vaccinated patients.
Read the detailed description
The study will be divided in 3 main aims; in the first, the long term immunological response to PCV13 and PPV23 in HIV+ adults will be evaluated. In a previous clinical trial (PRIN 2009 study, Clinicaltrials: NCT02123433) a cohort of HIV positive adults had been vaccinated either with 2 doses of PCV13 8 weeks apart or 1 dose of PPV23 (last enrollment: December 2012). Immunoglobulins G (IgGs) against 12 common pneumococcal serotypes included in PCV13 and PPV23 were quantified by ELISA at baseline (BL), 8, 24 and 48 weeks: analysis are still ongoing; preliminary data revealed that both vaccines were safe and well tolerated and showed similar immunogenicity. The present study aims to evaluate persistence of long term (>= 3 years) serological and memory B cells response in those previous vaccinated groups. In this phase, population will be screened for inclusion and exclusion criteria to entire study conduction. Once obtained informed consent, patients will be enrolled. Together with the collection of blood samples for routine purposes, an additional blood sample will be taken so to run immunological tests (ELISA, ELISpot). It is important to underline that no invasive procedures are needed for the study, apart from routine clinical practice: blood specimens will be obtained as part of routine investigations, blood will be hence taken for CD4+ cell count, viraemia analysis and anti-HIV drug monitoring; enrolled patients will agree just to donate a blood sample for research purposes. Blood samples will be collected from all previously PCV13 or PPV23 vaccinated HIV+ subjects and serum antibodies and B cells isotypes will be analyzed at baseline (BL), that is >= 3 years after a previous PCV13 or PPV23 vaccination.
The second objective of this study aims to evaluate short and long term immunological response with different combined vaccine strategies in HIV+ adults. Participants will be recruited if they'll have needed to receive antipneumococcal vaccines (primary or booster) according to clinical standard indications.
Elicited immunological response (serum antibodies and B cells isotypes) will be explored at BL, 8, 24, 48 and 96 weeks after additional different received pneumococcal vaccine strategies. At BL, after collecting blood samples as previously described for Aim1, every patient will be assigned to a specific Group on the basis of the received vaccine schedule, prescribed by clinicians according to individual clinical indications. Short- (30 minutes), medium- (<=5 days) and long-term adverse reactions will be reported, by clinical evaluation within 30 minute post-vaccine, phone call at day 5 and anamnestic data collection during follow up 8, 24, 48 and 96 weeks.
Blood samples will be analyzed at 8, 24, 48 and 96 weeks to evaluate serum antibodies and B cells isotypes.
Finally, the third aim of the study will lead an epidemiological and microbiological survey in vaccinated HIV+ adults. At BL, 8, 24, 48 and 96 weeks all clinical-anamnestic data will be updated, together with blood sample analysis to title IgG towards each vaccinal pneumococcal polysaccharides and to evaluate B cells isotypes and nasopharyngeal swab for S. pneumoniae culture, in vitro chemosusceptibility tests, serotyping, clonal analysis by Multilocus Locus Sequence Typing (MLST).
Carriage will be defined as S. pneumoniae isolation from one or more of the nasal swabs, in absence of any clinical signs or symptoms; a 12 months clinical follow up will be performed in colonized patients. All patients developing infections will be followed until resolution.
- Conditions
- HIV, Pneumococcal Infections
- Being tested
- Evaluation of immunological response, Nasopharyngeal swabs analysis
- Keywords
- Pneumococcal vaccine, HIV infection, 13-valent Pneumococcal Conjugate Vaccine, 23-valent Pneumococcal Polysaccharide Vaccine
- Medical subject headings
- Pneumococcal Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of immunological responseOther
Study of short and long term immunological response after different schedule of PCV13 or PPV23
Nasopharyngeal swabs analysisOther
Evaluation of pneumococcal nasopharyngeal colonization
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Immunological and microbiological status of HIV- positive adults with pneumococcal vaccinal status of 2 PCV13 doses received from more than 3 years that have prescription for a single booster dose of PCV13. Receives: Other: Evaluation of immunological response; Other: Nasopharyngeal swabs analysis | |
| Group 2 | Immunological and microbiological status of HIV- positive adults with pneumococcal vaccinal status of 1 PPV23 dose received from more than 3 years that have prescription to receive 2 doses (priming + boost) of PCV13. Receives: Other: Evaluation of immunological response; Other: Nasopharyngeal swabs analysis | |
| Group 3 | HIV- positive adults that have never received a pneumococcal vaccine (naive) and have a CD4+ cell count < 200 cells/ul that have prescription to be primed with a single dose of PCV13 then boosted with a single dose of PPV23. Receives: Other: Evaluation of immunological response; Other: Nasopharyngeal swabs analysis | |
| Group 4 | Immunological and microbiological status of HIV- positive adults that have never received a pneumococcal vaccine (naive) and have a CD4+ cell count > 200 cells/ul that have prescription to be primed with a single dose of PCV13 then boosted with a single dose of PPV23. Receives: Other: Evaluation of immunological response; Other: Nasopharyngeal swabs analysis | |
| Group 5 | Immunological and microbiological status of HIV- positive adults with pneumococcal vaccinal status of 1 PPV23 dose received from more than 3 years and that that have prescription to receive a single dose of PCV13. Receives: Other: Evaluation of immunological response; Other: Nasopharyngeal swabs analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological response evaluation
Dosing of serotype specific antibodies (cut off value: 0.35 mcg/mL for each vaccine polysaccharide antigen) and quantification of number and phenotype of serotype specific B cells
Measured: 24 months
Secondary outcomes (1)
Streptococcus pneumoniae colonization
Presence of S. pneumoniae in nasopharyngeal swabs culture
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Responsible party
- Principal investigator, Francesca Montagnani, University of Siena
- Investigators
- Francesca Montagnani, MD, PhD, Principal investigator, Università degli Studi di Siena - Dipartimento di Biotecnologie Mediche - Dipartimento di Malattie Infettive Universitarie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357823
- Sponsor's protocol ID
- PCV13HIV-BOOST-2013
- Status last verified
- Jan 2017
- First submitted
- 22 Jan 2015
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, Bousvaros A, Dhanireddy S, Sung L, Keyserling H, Kang I; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014 Feb;58(3):309-18. doi: 10.1093/cid/cit816.
PubMed 24421306Clutterbuck EA, Lazarus R, Yu LM, Bowman J, Bateman EA, Diggle L, Angus B, Peto TE, Beverley PC, Mant D, Pollard AJ. Pneumococcal conjugate and plain polysaccharide vaccines have divergent effects on antigen-specific B cells. J Infect Dis. 2012 May 1;205(9):1408-16. doi: 10.1093/infdis/jis212. Epub 2012 Mar 29.
PubMed 22457293Lu CL, Hung CC, Chuang YC, Liu WC, Su CT, Hsiao CF, Tseng YT, Su YC, Chang SF, Chang SY, Chang SC. Comparison of serologic responses to vaccination with one dose or two doses of 7-valent pneumococcal conjugate vaccine in HIV-infected adult patients. Vaccine. 2012 May 21;30(24):3526-33. doi: 10.1016/j.vaccine.2012.03.070. Epub 2012 Apr 4.
PubMed 22484349Klugman KP, Madhi SA, Feldman C. HIV and pneumococcal disease. Curr Opin Infect Dis. 2007 Feb;20(1):11-5. doi: 10.1097/QCO.0b013e328012c5f1.
PubMed 17197876
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Serological Response and Memory Cells Role After Different Pneumococcal Vaccine Strategies in HIV Adults
- ClinicalTrials.gov ID
- NCT02357823
- Acronym / sponsor ID
- PCV13HIV-BOOST-2013
- Conditions
- HIV, Pneumococcal Infections
- Keywords
- Pneumococcal vaccine, HIV infection, 13-valent Pneumococcal Conjugate Vaccine, 23-valent Pneumococcal Polysaccharide Vaccine
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 6 Feb 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.
Streptococcus pneumoniae is a cause of high morbidity and mortality in HIV-positive subjects, representing the leading etiological agent of severe bacterial pneumonia. International guidelines recommend that HIV positive patients aged >=19 years, who are 13-valent conjugate vaccine (PCV13) naïve, should receive a single dose of PCV13. Pneumococcal polysaccharide vaccine 23-valent (PPV23) should be given >=8 weeks after indicated dose of PCV13, and a second dose of PPV23 should be given 5 years later. For those who previously received PPV23, PCV13 should be administered >=1 year after the last PPV23 dose. HIV infection affects humoral immunity both through reduced T-cell help and changes in the B-cell compartment. Neither amount of circulating memory B cells nor their functions are restored by antiretroviral therapy: this may affect antibody mediated immunity, even in well-treated HIV patients. In asplenic childrens a single dose of PCV13 seems sufficient to restore the pool of anti-pneumococcal polysaccharides IgG memory B cells. In adults, it has been reported that a single dose of 7-valent pneumococcal conjugate vaccine induces significant increases in serotype-specific memory B-cell populations, conversely, immunization with PPV23 seems to decrease memory B-cell frequency. However, data on immunological response after PCV13 in HIV positive adults are still scanty and the optimal pneumococcal prophylaxis strategy needs further investigation. Number of PCV13 doses is actually demanded to clinical judgment for each patient; also current Italian indications recommend at least one dose, but till 3 doses seem to be suggested for immunocompromised patients. Present study aims to investigate short and long term immunological response after different standard vaccine schedule and to evaluate pneumococcal nasopharyngeal colonization in vaccinated patients.
Detailed description
The study will be divided in 3 main aims; in the first, the long term immunological response to PCV13 and PPV23 in HIV+ adults will be evaluated. In a previous clinical trial (PRIN 2009 study, Clinicaltrials: NCT02123433) a cohort of HIV positive adults had been vaccinated either with 2 doses of PCV13 8 weeks apart or 1 dose of PPV23 (last enrollment: December 2012). Immunoglobulins G (IgGs) against 12 common pneumococcal serotypes included in PCV13 and PPV23 were quantified by ELISA at baseline (BL), 8, 24 and 48 weeks: analysis are still ongoing; preliminary data revealed that both vaccines were safe and well tolerated and showed similar immunogenicity. The present study aims to evaluate persistence of long term (>= 3 years) serological and memory B cells response in those previous vaccinated groups. In this phase, population will be screened for inclusion and exclusion criteria to entire study conduction. Once obtained informed consent, patients will be enrolled. Together with the collection of blood samples for routine purposes, an additional blood sample will be taken so to run immunological tests (ELISA, ELISpot). It is important to underline that no invasive procedures are needed for the study, apart from routine clinical practice: blood specimens will be obtained as part of routine investigations, blood will be hence taken for CD4+ cell count, viraemia analysis and anti-HIV drug monitoring; enrolled patients will agree just to donate a blood sample for research purposes. Blood samples will be collected from all previously PCV13 or PPV23 vaccinated HIV+ subjects and serum antibodies and B cells isotypes will be analyzed at baseline (BL), that is >= 3 years after a previous PCV13 or PPV23 vaccination.
The second objective of this study aims to evaluate short and long term immunological response with different combined vaccine strategies in HIV+ adults. Participants will be recruited if they'll have needed to receive antipneumococcal vaccines (primary or booster) according to clinical standard indications.
Elicited immunological response (serum antibodies and B cells isotypes) will be explored at BL, 8, 24, 48 and 96 weeks after additional different received pneumococcal vaccine strategies. At BL, after collecting blood samples as previously described for Aim1, every patient will be assigned to a specific Group on the basis of the received vaccine schedule, prescribed by clinicians according to individual clinical indications. Short- (30 minutes), medium- (<=5 days) and long-term adverse reactions will be reported, by clinical evaluation within 30 minute post-vaccine, phone call at day 5 and anamnestic data collection during follow up 8, 24, 48 and 96 weeks.
Blood samples will be analyzed at 8, 24, 48 and 96 weeks to evaluate serum antibodies and B cells isotypes.
Finally, the third aim of the study will lead an epidemiological and microbiological survey in vaccinated HIV+ adults. At BL, 8, 24, 48 and 96 weeks all clinical-anamnestic data will be updated, together with blood sample analysis to title IgG towards each vaccinal pneumococcal polysaccharides and to evaluate B cells isotypes and nasopharyngeal swab for S. pneumoniae culture, in vitro chemosusceptibility tests, serotyping, clonal analysis by Multilocus Locus Sequence Typing (MLST).
Carriage will be defined as S. pneumoniae isolation from one or more of the nasal swabs, in absence of any clinical signs or symptoms; a 12 months clinical follow up will be performed in colonized patients. All patients developing infections will be followed until resolution.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Evaluation of immunological response, Other: Nasopharyngeal swabs analysisImmunological and microbiological status of HIV- positive adults with pneumococcal vaccinal status of 2 PCV13 doses received from more than 3 years that have prescription for a single booster dose of PCV13. |
| Group 2 | – | Other: Evaluation of immunological response, Other: Nasopharyngeal swabs analysisImmunological and microbiological status of HIV- positive adults with pneumococcal vaccinal status of 1 PPV23 dose received from more than 3 years that have prescription to receive 2 doses (priming + boost) of PCV13. |
| Group 3 | – | Other: Evaluation of immunological response, Other: Nasopharyngeal swabs analysisHIV- positive adults that have never received a pneumococcal vaccine (naive) and have a CD4+ cell count < 200 cells/ul that have prescription to be primed with a single dose of PCV13 then boosted with a single dose of PPV23. |
| Group 4 | – | Other: Evaluation of immunological response, Other: Nasopharyngeal swabs analysisImmunological and microbiological status of HIV- positive adults that have never received a pneumococcal vaccine (naive) and have a CD4+ cell count > 200 cells/ul that have prescription to be primed with a single dose of PCV13 then boosted with a single dose of PPV23. |
| Group 5 | – | Other: Evaluation of immunological response, Other: Nasopharyngeal swabs analysisImmunological and microbiological status of HIV- positive adults with pneumococcal vaccinal status of 1 PPV23 dose received from more than 3 years and that that have prescription to receive a single dose of PCV13. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-positive adults that undergo the International and Italian Ministry of Health indications for administration of pneumococcal vaccines.
Key inclusion criteria (6 listed)
- age between 18 and 65 years
- acceptance of informed consensus
- HIV positivity
- access to structures in ambulatory or Day Hospital regimen
- CD4+ cell count > or < than 200 cells/ul
Key exclusion criteria (7 listed)
- pregnancy
- acute infectious disease ongoing
- antibiotic therapy ongoing in the previous 7 days
- HIV-independent immunodepression
- chronic steroid 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 |
|---|---|---|
| Evaluation of immunological responseStudy of short and long term immunological response after different schedule of PCV13 or PPV23 | Other | Group 1, Group 2, Group 3, Group 4, Group 5 |
| Nasopharyngeal swabs analysisEvaluation of pneumococcal nasopharyngeal colonization | Other | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
Immunological response evaluation
Time frame: 24 months
Dosing of serotype specific antibodies (cut off value: 0.35 mcg/mL for each vaccine polysaccharide antigen) and quantification of number and phenotype of serotype specific B cells
1 secondary outcome
Streptococcus pneumoniae colonization
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Results publication: PubMed 24421306Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, Bousvaros A, Dhanireddy S, Sung L, Keyserling H, Kang I; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014 Feb;58(3):309-18. doi: 10.1093/cid/cit816.
- Results publication: PubMed 22457293Clutterbuck EA, Lazarus R, Yu LM, Bowman J, Bateman EA, Diggle L, Angus B, Peto TE, Beverley PC, Mant D, Pollard AJ. Pneumococcal conjugate and plain polysaccharide vaccines have divergent effects on antigen-specific B cells. J Infect Dis. 2012 May 1;205(9):1408-16. doi: 10.1093/infdis/jis212. Epub 2012 Mar 29.
- Results publication: PubMed 22484349Lu CL, Hung CC, Chuang YC, Liu WC, Su CT, Hsiao CF, Tseng YT, Su YC, Chang SF, Chang SY, Chang SC. Comparison of serologic responses to vaccination with one dose or two doses of 7-valent pneumococcal conjugate vaccine in HIV-infected adult patients. Vaccine. 2012 May 21;30(24):3526-33. doi: 10.1016/j.vaccine.2012.03.070. Epub 2012 Apr 4.
- Results publication: PubMed 17197876Klugman KP, Madhi SA, Feldman C. HIV and pneumococcal disease. Curr Opin Infect Dis. 2007 Feb;20(1):11-5. doi: 10.1097/QCO.0b013e328012c5f1.
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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.
Francesca Montagnani, MD, PhD principal investigator
Università degli Studi di Siena - Dipartimento di Biotecnologie Mediche - Dipartimento di Malattie Infettive Universitarie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Pneumococcal Infections, run by University of Siena at 2 sites in Italy.
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 7 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: withdrawn, as of the sponsor's last update on 10 Jan 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 Italy. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Immunological response evaluation (time frame: 24 months). 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 NCT02357823, which also lists 4 linked publications.
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 10 Jan 2017.