Pneumococcus; PneumoniaNCT05698225
Experimental Pneumococcal Carriage in People Living With HIV
A study testing Streptococcus pneumoniae serotype 6B in people with Pneumococcus; Pneumonia and Hiv, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
Trial summary
The goal of this experimental pneumococcal carriage study is to to characterise rates and determinants of experimental pneumococcal carriage in PLHIV. The main questions it aims to answer are: can PLHIV be experimentally inoculated with pneumococcus in a safe manner? what are the immunological determinants of… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcus; Pneumonia, Hiv
- What is being tested?
- Streptococcus pneumoniae serotype 6B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteMalawi
- Study dates
- Jan 2023to Jan 2024
- Phase
- Interventional
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 25 to 45 years old
- Fluent spoken and written Chichewa or English
- Able to give informed written consent
- Access to a functional mobile phone
- Establish on antiretroviral therapy for ≥2 years (if PLHIV)
- Viral load below the lower limit of detection (<LDL) at screening (if PLHIV)
- CD4 count over 350 cells/mm³ at screening (if PLHIV)
Who cannot join
- HIV-associated hospitalisation and/or treatment for major illness in preceding 2 years
- Currently under investigation for HIV-associated weight-loss, chronic diarrhoea, chronic cough, or another unexplained symptom
- Previous illness caused by pneumococcus
- Additional condition or medication impairing immune response or increasing risk of pneumococcal disease
- Living in close contact with an individual vulnerable to pneumococcal disease
- Allergy to penicillin
Show all 13Show fewer
- Acute illness in 7 days preceding inoculation
- Antibiotic course in last 2 weeks (excluding prophylactic co-trimoxazole in PLHIV)
- Pregnant or trying to conceive
- Involved in another clinical study (unless observational or in follow-up)
- Current regular cigarette smoking (5+ cigarettes per week)
- Natural carrier of pneumococcus serotype 6B at screening visit
- Participants without a guardian
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Malawi-Liverpool Wellcome City
Blantyre
Klara Doherty, MBChB, klara.doherty@lstmed.ac.uk
About this study
Official title: Characterising Pneumococcal Carriage and Immunity in People Living With HIV in Blantyre, Malawi, Following Experimental Pneumococcal Inoculation
The goal of this experimental pneumococcal carriage study is to to characterise rates and determinants of experimental pneumococcal carriage in PLHIV.
The main questions it aims to answer are:
Read more
- can PLHIV be experimentally inoculated with pneumococcus in a safe manner?
- what are the immunological determinants of pneumococcal carriage in PLHIV compared to HIV-negative participants?
- how do the pneumococcal carriage dynamics differ between PLHIV and HIV-negative participants?
Participants will be inoculated intranasally with a controlled concentration of pneumococcus after which they will be monitored for 21 days during which nasal and systemic immune dynamics and pneumococcal carriage dynamics will be evaluated. At the end of the study any participants exhibiting carriage will have the pneumococcus cleared with antibiotics.
Read the detailed description
The EHPC has been established at the Malawi-Liverpool Wellcome centre (MLW) and demonstrated acceptability and feasibility in this setting. To date, over 250 participants have been enrolled on the EHPC at MLW without any study complications. Participants will be inoculated in both nostrils with a controlled concentration of penicillin-sensitive Streptococcus pneumoniae. Participants will be followed up for 25 days following inoculation during which sampling will occur at established time-points to establish pneumococcal carriage and immune cell/immunoglobulin dynamics. After 21 days, participants who demonstrate pneumococcal carriage will commence an antibiotic course to clear the bacteria (participants may be advised by the clinical study team to commence antibiotics earlier if they develop any symptoms of pneumococcal disease). Participants will remain under close observation in study accommodation for the first 3 days following inoculation, and will then be monitored daily at home via text message and telephone calls. A final health-check and exit interview will be conducted on day 25 to evaluate participant satisfaction with study participation. The overall objective is to characterise rates and determinants of experimental pneumococcal carriage in PLHIV in Blantyre, Malawi in order to inform vaccine evaluations and vaccine policy.
- Conditions
- Pneumococcus; Pneumonia, Hiv
- Being tested
- Streptococcus pneumoniae serotype 6B
- Medical subject headings
- Pneumonia, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streptococcus pneumoniae serotype 6BOther
A controlled concentration of streptococcus pneumoniae serotype 6B is placed in both nares of participants
| Study group | Role | What they receive |
|---|---|---|
| Inoculation with Streptococcus pneumoniae serotype 6B | Experimental | Participants will be inoculation with a controlled concentration of full sequenced, fully antibiotic sensitive Streptococcus pneumonia serotype 6B Receives: Other: Streptococcus pneumoniae serotype 6B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with pneumococcal carriage in the nasopharynx post-inoculation
Measured by classic culture and PCR-based methods
Measured: From inoculation up to 21 days post-inoculation
Secondary outcomes (7)
Average pneumococcal carriage density in the nasopharynx post-inoculation
Measured by classic culture and PCR-based methods
Measured: From inoculation up to 21 days post-inoculation
Nasal immunoglobulin concentration at baseline
Measured in nasal fluid
Measured: Baseline
Change in nasal immunoglobulin concentration following inoculation
Measured in nasal fluid
Measured: Baseline to 21 days post-inoculation
Density of immune cells in the nasal mucosa at baseline
Immune cell to epithelial cell ratio measured in nasal mucosal cell samples
Measured: Baseline
Change in density of immune cells in the nasal mucosa following inoculation
Immune cell to epithelial cell ratio measured in nasal mucosal cell samples
Measured: Baseline up to 21 days post-inoculation
Immune cell activation activation in the nasal mucosa at baseline
Concentration of markers of immune cell activation measured in nasal fluid and cell samples
Measured: Baseline
Change in immune cell activation in the nasal mucosa following inoculation
Concentration of markers of immune cell activation measured in nasal fluid and cell samples
Measured: Baseline up to 21 days post-inoculation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcus; PneumoniaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Gordon, MA MD, Principal investigator, Malawi-Liverpool Wellcome Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698225
- Sponsor's protocol ID
- EHPC in PLHIV
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising Pneumococcal Carriage and Immunity in People Living With HIV in Blantyre, Malawi, Following Experimental Pneumococcal Inoculation
- ClinicalTrials.gov ID
- NCT05698225
- Acronym / sponsor ID
- EHPC in PLHIV
- Conditions
- Pneumococcus; Pneumonia, Hiv
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 26 Jan 2023 (actual)
- 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.
The goal of this experimental pneumococcal carriage study is to to characterise rates and determinants of experimental pneumococcal carriage in PLHIV.
The main questions it aims to answer are:
- can PLHIV be experimentally inoculated with pneumococcus in a safe manner?
- what are the immunological determinants of pneumococcal carriage in PLHIV compared to HIV-negative participants?
- how do the pneumococcal carriage dynamics differ between PLHIV and HIV-negative participants?
Participants will be inoculated intranasally with a controlled concentration of pneumococcus after which they will be monitored for 21 days during which nasal and systemic immune dynamics and pneumococcal carriage dynamics will be evaluated. At the end of the study any participants exhibiting carriage will have the pneumococcus cleared with antibiotics.
Detailed description
The EHPC has been established at the Malawi-Liverpool Wellcome centre (MLW) and demonstrated acceptability and feasibility in this setting. To date, over 250 participants have been enrolled on the EHPC at MLW without any study complications. Participants will be inoculated in both nostrils with a controlled concentration of penicillin-sensitive Streptococcus pneumoniae. Participants will be followed up for 25 days following inoculation during which sampling will occur at established time-points to establish pneumococcal carriage and immune cell/immunoglobulin dynamics. After 21 days, participants who demonstrate pneumococcal carriage will commence an antibiotic course to clear the bacteria (participants may be advised by the clinical study team to commence antibiotics earlier if they develop any symptoms of pneumococcal disease). Participants will remain under close observation in study accommodation for the first 3 days following inoculation, and will then be monitored daily at home via text message and telephone calls. A final health-check and exit interview will be conducted on day 25 to evaluate participant satisfaction with study participation. The overall objective is to characterise rates and determinants of experimental pneumococcal carriage in PLHIV in Blantyre, Malawi in order to inform vaccine evaluations and vaccine policy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inoculation with Streptococcus pneumoniae serotype 6B | Experimental | Other: Streptococcus pneumoniae serotype 6BParticipants will be inoculation with a controlled concentration of full sequenced, fully antibiotic sensitive Streptococcus pneumonia serotype 6B |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 25 to 45 years old
- Fluent spoken and written Chichewa or English
- Able to give informed written consent
- Access to a functional mobile phone
- Establish on antiretroviral therapy for ≥2 years (if PLHIV)
Key exclusion criteria (13 listed)
- HIV-associated hospitalisation and/or treatment for major illness in preceding 2 years
- Currently under investigation for HIV-associated weight-loss, chronic diarrhoea, chronic cough, or another unexplained symptom
- Previous illness caused by pneumococcus
- Additional condition or medication impairing immune response or increasing risk of pneumococcal disease
- Living in close contact with an individual vulnerable to pneumococcal disease
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 |
|---|---|---|
| Streptococcus pneumoniae serotype 6BA controlled concentration of streptococcus pneumoniae serotype 6B is placed in both nares of participants | Other | Inoculation with Streptococcus pneumoniae serotype 6B |
Primary outcome
Proportion of participants with pneumococcal carriage in the nasopharynx post-inoculation
Time frame: From inoculation up to 21 days post-inoculation
Measured by classic culture and PCR-based methods
7 secondary outcomes
Average pneumococcal carriage density in the nasopharynx post-inoculation
Time frame: From inoculation up to 21 days post-inoculation
Nasal immunoglobulin concentration at baseline
Time frame: Baseline
Change in nasal immunoglobulin concentration following inoculation
Time frame: Baseline to 21 days post-inoculation
Density of immune cells in the nasal mucosa at baseline
Time frame: Baseline
Change in density of immune cells in the nasal mucosa following inoculation
Time frame: Baseline up to 21 days post-inoculation
Immune cell activation activation in the nasal mucosa at baseline
Time frame: Baseline
Change in immune cell activation in the nasal mucosa following inoculation
Time frame: Baseline up to 21 days post-inoculation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- 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.
Stephen Gordon, MA MD principal investigator
Malawi-Liverpool Wellcome Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streptococcus pneumoniae serotype 6B in people with Pneumococcus; Pneumonia and Hiv, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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 Malawi. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klara Doherty, MBChB (+265885908115, klara.doherty@lstmed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with pneumococcal carriage in the nasopharynx post-inoculation (time frame: From inoculation up to 21 days post-inoculation). 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 26 Jan 2023.