Streptococcus PneumoniaPhase 4Pneumo 2NCT04974294
PREVENTING PNEUMOcoccal Disease Through Vaccination (Study 2)
A Phase 4 study testing PPV23, PCV13 and Saline for injection in people with Streptococcus Pneumonia, run by Liverpool School of Tropical Medicine at 1 site in United Kingdom.
Trial summary
To determine the effect of PCV-13 and PPV-23 vaccination versus control on experimental pneumococcal colonisation of 2 clades of serotypes 3 and 6B at 1 month and 6 months post vaccination respectively, using the EHPC model. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumonia
- What is being tested?
- PPV23, PCV13 and Saline for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 516 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jul 2021to 31 Dec 2023
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-50 years (inclusive)
- Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
- Capacity to provide written informed consent
- Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate birth control measures during the study.
Who cannot join
- Be currently involved in another study unless observational or non-interventional. Exceptions are the EHPC bronchoscopy study and COVID-19 observational and interventional trials. The exceptions will be applied at the discretion of the Chief Investigator to ensure no harm comes to the participants (e.g. excessive blood sampling)
- Be a participant in a previous EHPC trial within the last 3 years (at the discretion of the study team).
- Vaccination (self-reported or confirmed from GP questionnaire [GPQ] or medical summary if deemed necessary at clinician discretion): Have had any previous pneumococcal vaccination (including in a research study).
- Allergy:
- Have allergy to penicillin or amoxicillin.
- Have previous anaphylaxis or severe adverse reaction to any component/excipient of the vaccines or to any vaccine.
Show all 44Show fewer
- Health history (self-reported by the participant or confirmed in GPQ or medical summary if deemed necessary at clinician discretion): Ill health including but not limited to:
- Asplenia or dysfunction of the spleen.
- Chronic respiratory disease (e.g. asthma [on medication], COPD, emphysema, bronchiectasis).
- Chronic heart disease (e.g. angina, ischaemic heart disease, chronic heart failure) [controlled stable hypertension may be included].
- Chronic kidney disease (e.g. nephrotic syndrome, kidney transplant, on dialysis).
- Chronic liver disease (e.g. cirrhosis, biliary atresia, hepatitis).
- Chronic neurological conditions
- Connective tissue disease
- Dementia
- Diabetes mellitus (including diet controlled).
- Immunosuppression or history of receiving immunosuppressive therapy.
- Individuals with cochlear implants.
- Individuals with major cerebrospinal fluid leaks (e.g. following trauma, major skull surgery, or requiring CSF shunt).
- Recurrent otitis media.
- Have any uncontrolled medical/surgical conditions (such as but not restricted to mental health conditions, epilepsy, narcolepsy or chronic pain) at the discretion of the study doctor.
- Major pneumococcal illness requiring hospitalisation within the last 10 years
- Other conditions considered by the clinical team as a concern for participant safety or integrity of the study.
- Taking medication:
- That may affect the immune system e.g. steroids, inflammation altering (e.g. nasal steroids, Roaccutane) or disease-modifying anti-rheumatoid drugs.
- Long-term use of antibiotics (see also section 6.3 Temporary exclusion criteria).
- Nitroglycerin
- That affects blood clotting (any oral/injectable anticoagulants [except aspirin]).
- Female participants who are pregnant, lactating or intending on becoming pregnant during the study.
- Direct caring role or close contact with individuals at higher risk of infection (during the challenge period)
- Children under 5 years age.
- Chronic ill health or immunosuppressed adults.
- People that are part of the extremely vulnerable group as defined by Public Health England (PHE)
- Smoker:
- Current or ex-smoker (regular cigarettes/cigars/e-cigarette/vaping/smoking of recreational drugs) in the last 6 months.
- Previous significant smoking history (more than 20 cigarettes per day for 20 years or the equivalent [>20 pack years]).
- History or current drug or alcohol abuse (frequently drinking alcohol): men and women should not regularly drink >3 units/day and >2 units/day respectively) at discretion of the clinician.
- Significant mental health problems (uncontrolled condition or previous admission in a psychiatric unit, at the discretion of the clinician) that would impair the participant's ability to participate in the study
- Overseas travel planned: Overseas travel during the follow-up period Part A or Part B.
- Participants who meet STOP criteria at the time of screening, as detailed in Table 4.
- Any other issue which, in the opinion of the study staff, may
- Put the participant or their contacts at risk because of participation in the study,
- Adversely affect the interpretation of the study results, or
- Impair the participant's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool School of Tropical Medicine
Liverpool
angela hyder wright
About this study
Official title: A Phase IV Double Blind Randomised Controlled Trial (DBRCT) to Investigate the Effect of PCV-13 and PPV-23 on Pneumococcal Colonisation Using the Experimental Human Pneumococcal Challenge (EHPC) Model in Healthy Adults
To determine the effect of PCV-13 and PPV-23 vaccination versus control on experimental pneumococcal colonisation of 2 clades of serotypes 3 and 6B at 1 month and 6 months post vaccination respectively, using the EHPC model.
Read the detailed description
Streptococcus pneumoniae (SPN) is the leading cause of morbidity and mortality worldwide, causing community acquired pneumonia (CAP), bacterial meningitis and bacteremia. Pneumococcal infections cause over 1 million pneumonia deaths per year in children in the developing world and is a major burden of otitis media globally.
The LSTM Experimental Human Pneumococcal Challenge (EHPC) model is a unique method of measuring pneumococcal colonization of bacteria, understanding the effect of pneumococcal colonization on acquired immunity, and allows vaccines to be tested in adults to understand their effect on colonization in a manner which is cost-effective and uses much smaller numbers of participants compared to large phase III clinical trials.
Participants: Healthy adults aged 18-50 years of age (inclusive) will be recruited. A recruitment target of up to 516 participants with an approximate screen failure/dropout rate of 20% will ensure 410 participants complete Part A and 246 complete Part A \& B of the trial.
Methods: Double blind randomized controlled trial (DBRCT) to investigate the effect of PCV-13 and PPV-23 vaccination on pneumococcal colonisation using the EHPC model in healthy adults. Participants will be randomised to 5 arms for Part A of the study that:
- to receive PCV-13 vaccine IM and inoculation a month later with SPN3 clade 1a;
- to receive PCV-13 vaccine IM and inoculation a month later with SPN3 clade 2;
- to receive PPV-23 vaccine IM and inoculation a month later with SPN3 clade 1a;
- to receive 0.9% saline for injection IM and inoculation a month later with SPN3 clade 1a or
- to receive 0.9% saline for injection IM and inoculation a month later with SPN3 clade 2.
The last two 0.9% saline of injection groups represent the placebo control groups. The SPN3 (2 clades) is amoxicillin-susceptible. After challenge (inoculation) they will be followed up for 23 days where nasal, blood and urine samples will be taken. Part B of the trial will run 6 months post vaccination. Participants will be re-screened for safety prior to Part B to ensure they remain eligible. The 3 groups of participants detailed below from the Part A population will proceed to Part B of the trial:
- Up to 104 of the participants that received PCV-13 in Part A (split across clades 1a and 2)
- Up to 104 of the participants that received PPV-23 in Part A
- Up to 104 of the participants that received 0.9% saline for injection in Part A (split across clades 1a and 2) The total number to proceed to Part B will be up to 312 to allow for 20% dropout / screen failure to ensure 246 complete part A \& B. All Part B Participants will receive a second inoculation of amoxicillin-susceptible SPN6B at 6 months post-vaccine and will be followed up for 23 days in total where further samples will be taken (Trial Flow Chart and Table 2). All participants will take a 5-day course of amoxicillin three times a day (TDS) at the end of Part A to ensure experimental colonization clearance prior to Part B inoculation. Participants that are experimentally colonized at any point following the SPN6B challenge at 6 months (Part B) will take a 3-day course of amoxicillin TDS.
Randomization \& Blinding: Participants will be randomized to receive PCV-13 vaccine and clade 1a (group 1), PCV-13 and clade 2 (group 2), PPV-23 vaccine and clade 1a (group 3), 0.9% saline for injection and clade 1a (group 4) or 0.9% saline for injection and clade 2 (group 5) vaccine in a ratio of 1:1:1:1:1 with up to 104 participants in each arm. Randomization will be computer-generated.
Randomization will occur in two cohorts:
- Cohort I: 312 subjects for five groups 1:1:2:1:1 in block sizes of 6
- Cohort II: 204 participants for four groups 1:1:0:1:1 in block sizes of 4 This will ensure that overall the randomization ratio is 1:1:1:1:1, but it will allow 312 participants from Cohort I, split equally across participants that have received PCV-13, PPV-23 and placebo to proceed to part B of the trial.
- Conditions
- Streptococcus Pneumonia
- Being tested
- PPV23, PCV13, Saline for injection
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPV23Biological
Also called pneumovax
random allocation 1:1:1 IM injection
PCV13Biological
Also called prevenar
random allocation 1:1:1 IM injection
Saline for injectionOther
random allocation 1:1:1 IM injection
| Study group | Role | What they receive |
|---|---|---|
| PPV23 | Active comparator | Not described Receives: Biological: PPV23 |
| PCV13 | Active comparator | Not described Receives: Biological: PCV13 |
| Saline placebo | Placebo comparator | Not described Receives: Other: Saline for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of experimental pneumococcal colonisation with SPN3 determined by the presence of pneumococcus in nasal wash (NW) by classical culture or molecular methods
The rate of experimental pneumococcal colonisation with SPN3 determined by the presence of pneumococcus in nasal wash (NW) by classical culture or molecular methods at any time point during 23 days following experimental human pneumococcal challenge (EHPC) 1 month after vaccination in the PCV-13, PPV-23 and control groups.
Measured: any time point during 23 days following experimental human pneumococcal challenge (EHPC) 1 month after vaccination in the PCV-13, PPV-23 and control groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start28 Jul 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Streptococcus 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double blind RCT
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974294
- Sponsor's protocol ID
- 19-104
- Acronym
- Pneumo 2
- Status last verified
- Jan 2023
- First submitted
- 21 Jul 2021
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Dias P, Goncalves A, Reine J, Elterish F, Liatsikos K, Kerruish L, Hamilton J, Wright J, Fowler J, Campos IB, Mitsi E, Solorzano C, Clutterbuck EA, Hyder-Wright A, El Safadi D, Farrar M, Howard A, Robinson RE, Mulvihill KM, Guo H, Goldblatt D, Pollard AJ, Collins AM, Anderson A, Lahuerta M, Theilacker C, Catusse J, Begier E, Tan Y, Kanevsky I, Gessner BD, Urban BC, Ferreira DM. Evaluation of the effect of serotype on pneumococcal conjugate vaccine-induced immunity: an exploratory analysis of the PREVENTING PNEUMO 2 trial. Lancet Microbe. 2026 Sep 15:101496. doi: 10.1016/j.lanmic.2026.101496. Online ahead of print.
PubMed 42743942Liatsikos K, Hyder-Wright A, Davies K, El Safadi D, Farrar M, Goncalves A, Gonzalez-Dias P, Gordon SB, Howard A, Lesosky M, Liu X, Mitsi E, Myerscough C, Nyazika TK, Pollard AJ, Reine J, Robinson RE, Solorzano C, Urban BC, Zhang Y, Lahuerta M, Theilacker C, Catusse J, Begier E, Tan Y, Jodar L, Gessner BD, Collins A, Ferreira DM; PNEUMO 2 study group. The effect of pneumococcal conjugate vaccine and pneumococcal polysaccharide vaccine on nasopharyngeal colonisation following human infection challenge with serotype 3 and serotype 6B (PREVENTING PNEUMO 2): a double-masked, randomised, controlled, phase 4 trial. Lancet Microbe. 2026 Mar;7(3):101267. doi: 10.1016/j.lanmic.2025.101267. Epub 2026 Feb 13.
PubMed 41698388Liatsikos K, Hyder-Wright A, Pojar S, Chen T, Wang D, Davies K, Myerscough C, Reine J, Robinson RE, Urban B, Mitsi E, Solorzano C, Gordon SB, Quinn A, Pan K, Anderson AS, Theilacker C, Begier E, Gessner BD, Collins A, Ferreira DM; PNEUMO 2 study group. Protocol for a phase IV double-blind randomised controlled trial to investigate the effect of the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine on pneumococcal colonisation using the experimental human pneumococcal challenge model in healthy adults (PREVENTING PNEUMO 2). BMJ Open. 2022 Jul 7;12(7):e062109. doi: 10.1136/bmjopen-2022-062109.
PubMed 35798520
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Double Blind Randomised Controlled Trial (DBRCT) to Investigate the Effect of PCV-13 and PPV-23 on Pneumococcal Colonisation Using the Experimental Human Pneumococcal Challenge (EHPC) Model in Healthy Adults
- ClinicalTrials.gov ID
- NCT04974294
- Acronym / sponsor ID
- Pneumo 2 / 19-104
- Conditions
- Streptococcus Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 516 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Jul 2021 (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.
To determine the effect of PCV-13 and PPV-23 vaccination versus control on experimental pneumococcal colonisation of 2 clades of serotypes 3 and 6B at 1 month and 6 months post vaccination respectively, using the EHPC model.
Detailed description
Streptococcus pneumoniae (SPN) is the leading cause of morbidity and mortality worldwide, causing community acquired pneumonia (CAP), bacterial meningitis and bacteremia. Pneumococcal infections cause over 1 million pneumonia deaths per year in children in the developing world and is a major burden of otitis media globally.
The LSTM Experimental Human Pneumococcal Challenge (EHPC) model is a unique method of measuring pneumococcal colonization of bacteria, understanding the effect of pneumococcal colonization on acquired immunity, and allows vaccines to be tested in adults to understand their effect on colonization in a manner which is cost-effective and uses much smaller numbers of participants compared to large phase III clinical trials.
Participants: Healthy adults aged 18-50 years of age (inclusive) will be recruited. A recruitment target of up to 516 participants with an approximate screen failure/dropout rate of 20% will ensure 410 participants complete Part A and 246 complete Part A \& B of the trial.
Methods: Double blind randomized controlled trial (DBRCT) to investigate the effect of PCV-13 and PPV-23 vaccination on pneumococcal colonisation using the EHPC model in healthy adults. Participants will be randomised to 5 arms for Part A of the study that:
- to receive PCV-13 vaccine IM and inoculation a month later with SPN3 clade 1a;
- to receive PCV-13 vaccine IM and inoculation a month later with SPN3 clade 2;
- to receive PPV-23 vaccine IM and inoculation a month later with SPN3 clade 1a;
- to receive 0.9% saline for injection IM and inoculation a month later with SPN3 clade 1a or
- to receive 0.9% saline for injection IM and inoculation a month later with SPN3 clade 2.
The last two 0.9% saline of injection groups represent the placebo control groups. The SPN3 (2 clades) is amoxicillin-susceptible. After challenge (inoculation) they will be followed up for 23 days where nasal, blood and urine samples will be taken. Part B of the trial will run 6 months post vaccination. Participants will be re-screened for safety prior to Part B to ensure they remain eligible. The 3 groups of participants detailed below from the Part A population will proceed to Part B of the trial:
- Up to 104 of the participants that received PCV-13 in Part A (split across clades 1a and 2)
- Up to 104 of the participants that received PPV-23 in Part A
- Up to 104 of the participants that received 0.9% saline for injection in Part A (split across clades 1a and 2) The total number to proceed to Part B will be up to 312 to allow for 20% dropout / screen failure to ensure 246 complete part A \& B. All Part B Participants will receive a second inoculation of amoxicillin-susceptible SPN6B at 6 months post-vaccine and will be followed up for 23 days in total where further samples will be taken (Trial Flow Chart and Table 2). All participants will take a 5-day course of amoxicillin three times a day (TDS) at the end of Part A to ensure experimental colonization clearance prior to Part B inoculation. Participants that are experimentally colonized at any point following the SPN6B challenge at 6 months (Part B) will take a 3-day course of amoxicillin TDS.
Randomization \& Blinding: Participants will be randomized to receive PCV-13 vaccine and clade 1a (group 1), PCV-13 and clade 2 (group 2), PPV-23 vaccine and clade 1a (group 3), 0.9% saline for injection and clade 1a (group 4) or 0.9% saline for injection and clade 2 (group 5) vaccine in a ratio of 1:1:1:1:1 with up to 104 participants in each arm. Randomization will be computer-generated.
Randomization will occur in two cohorts:
- Cohort I: 312 subjects for five groups 1:1:2:1:1 in block sizes of 6
- Cohort II: 204 participants for four groups 1:1:0:1:1 in block sizes of 4 This will ensure that overall the randomization ratio is 1:1:1:1:1, but it will allow 312 participants from Cohort I, split equally across participants that have received PCV-13, PPV-23 and placebo to proceed to part B of the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- double blind RCT
| Arm | Type | Receives |
|---|---|---|
| PPV23 | Active comparator | Biological: PPV23 |
| PCV13 | Active comparator | Biological: PCV13 |
| Saline placebo | Placebo comparator | Other: Saline for injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults aged 18-50 years (inclusive)
- Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
- Capacity to provide written informed consent
- Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate birth control measures during the study.
Key exclusion criteria (44 listed)
- Be currently involved in another study unless observational or non-interventional. Exceptions are the EHPC bronchoscopy study and COVID-19 observational and interventional trials. The exceptions will be applied at the discretion of the Chief Investigator to ensure no harm comes to the participants (e.g. excessive blood sampling)
- Be a participant in a previous EHPC trial within the last 3 years (at the discretion of the study team).
- Have allergy to penicillin or amoxicillin.
- Have previous anaphylaxis or severe adverse reaction to any component/excipient of the vaccines or to any vaccine.
- Asplenia or dysfunction of the spleen.
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 |
|---|---|---|
| PPV23Also: pneumovaxrandom allocation 1:1:1 IM injection | Biological | PPV23 |
| PCV13Also: prevenarrandom allocation 1:1:1 IM injection | Biological | PCV13 |
| Saline for injectionrandom allocation 1:1:1 IM injection | Other | Saline placebo |
Primary outcome
The rate of experimental pneumococcal colonisation with SPN3 determined by the presence of pneumococcus in nasal wash (NW) by classical culture or molecular methods
Time frame: any time point during 23 days following experimental human pneumococcal challenge (EHPC) 1 month after vaccination in the PCV-13, PPV-23 and control groups.
The rate of experimental pneumococcal colonisation with SPN3 determined by the presence of pneumococcus in nasal wash (NW) by classical culture or molecular methods at any time point during 23 days following experimental human pneumococcal challenge (EHPC) 1 month after vaccination in the PCV-13, PPV-23 and control groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Derived from this study: PubMed 42743942Gonzalez-Dias P, Goncalves A, Reine J, Elterish F, Liatsikos K, Kerruish L, Hamilton J, Wright J, Fowler J, Campos IB, Mitsi E, Solorzano C, Clutterbuck EA, Hyder-Wright A, El Safadi D, Farrar M, Howard A, Robinson RE, Mulvihill KM, Guo H, Goldblatt D, Pollard AJ, Collins AM, Anderson A, Lahuerta M, Theilacker C, Catusse J, Begier E, Tan Y, Kanevsky I, Gessner BD, Urban BC, Ferreira DM. Evaluation of the effect of serotype on pneumococcal conjugate vaccine-induced immunity: an exploratory analysis of the PREVENTING PNEUMO 2 trial. Lancet Microbe. 2026 Sep 15:101496. doi: 10.1016/j.lanmic.2026.101496. Online ahead of print.
- Derived from this study: PubMed 41698388Liatsikos K, Hyder-Wright A, Davies K, El Safadi D, Farrar M, Goncalves A, Gonzalez-Dias P, Gordon SB, Howard A, Lesosky M, Liu X, Mitsi E, Myerscough C, Nyazika TK, Pollard AJ, Reine J, Robinson RE, Solorzano C, Urban BC, Zhang Y, Lahuerta M, Theilacker C, Catusse J, Begier E, Tan Y, Jodar L, Gessner BD, Collins A, Ferreira DM; PNEUMO 2 study group. The effect of pneumococcal conjugate vaccine and pneumococcal polysaccharide vaccine on nasopharyngeal colonisation following human infection challenge with serotype 3 and serotype 6B (PREVENTING PNEUMO 2): a double-masked, randomised, controlled, phase 4 trial. Lancet Microbe. 2026 Mar;7(3):101267. doi: 10.1016/j.lanmic.2025.101267. Epub 2026 Feb 13.
- Derived from this study: PubMed 35798520Liatsikos K, Hyder-Wright A, Pojar S, Chen T, Wang D, Davies K, Myerscough C, Reine J, Robinson RE, Urban B, Mitsi E, Solorzano C, Gordon SB, Quinn A, Pan K, Anderson AS, Theilacker C, Begier E, Gessner BD, Collins A, Ferreira DM; PNEUMO 2 study group. Protocol for a phase IV double-blind randomised controlled trial to investigate the effect of the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine on pneumococcal colonisation using the experimental human pneumococcal challenge model in healthy adults (PREVENTING PNEUMO 2). BMJ Open. 2022 Jul 7;12(7):e062109. doi: 10.1136/bmjopen-2022-062109.
- 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.
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 PPV23, PCV13 and Saline for injection in people with Streptococcus Pneumonia, run by Liverpool School of Tropical Medicine at 1 site in United Kingdom.
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 4 inclusion and 44 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 5 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Davies (+44 151 702 9391, kelly.davies@lstmed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of experimental pneumococcal colonisation with SPN3 determined by the presence of pneumococcus in nasal wash (NW) by classical culture or molecular methods (time frame: any time point during 23 days following experimental human pneumococcal challenge (EHPC) 1 month after vaccination in the PCV-13, PPV-23 and control groups.). 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 NCT04974294, which also lists 3 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 5 Jan 2023; AzTrials last refreshed its copy on 27 Oct 2026.