PneumoniaPhase 1/2NCT02543892

A Study of a Vaccine for Pneumonia in Adults and Toddlers in Kenya

A Phase 1/2 study testing PATH-wSP in people with Pneumonia, run by PATH at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 year to 40 yearsHealthy volunteers can take part
Conditions the study is for: Pneumonia
What is being tested?: PATH-wSP
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 248 participants
Where: 1 siteKenya
Study dates: 10 Aug 2016to 4 Jan 2018
Phase: Phase 1/2
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 1 year to 40 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy adults who are 18 to 40 years old, or toddlers who are 12 to 19 months old.
Must provide voluntary written/thumb-printed informed consent
Must comply with study requirements and procedures.
Must have an identifiable place of residence to allow home visits, and a consistent means of telephone contact
Must be resident in the study area with no plans to travel outside the study area during the study
Must be willing to not take herbal or other local traditional medications within 28 days of randomization and during the course of the study

Show all 9Show fewer

Adult female subjects must have a negative serum pregnancy test at screening and urine pregnancy test prior to each vaccination
Toddlers must have been born full-term, and have a mid-upper arm circumference > 11.5 cm at the time of enrollment.
Toddlers must have completed their Kenyan infant EPI schedule through 9 months including 1 birth dose of BCG, 3 doses of DTwPHibHep, 3 doses of OPV (birth dose is not required), 3 doses of PCV, and 1 dose of measles vaccine

Who cannot join

Use of any investigational or nonregistered drug within 90 days of enrollment
Use of any potentially hepatotoxic drug
Receipt of any licensed vaccine within 14 days of administration of study vaccine.
Chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or major congenital defects or illness that requires medical therapy, based on medical history or clinical assessment
History of anaphylactic shock
History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines

Show all 24Show fewer

History of immunosuppression or immunodeficiency, inclusive of human immunodeficiency virus (HIV) infection by medical history (including that of an enrolled toddler's mother) or by HIV testing at screening
Evidence of active hepatitis infection (B or C) by serologic testing at screening.
Any screening laboratory test (chemistry or hematology) or vital sign measurement with toxicity grade ≥ 1
Acute illness (moderate or severe) and/or fever (axillary temperature ≥ 37.5°C)
Positive test for malaria (blood film) at screening that remains positive post treatment when retested prior to vaccination
Disorders that require chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within the past 6 months prior to the administration of the study vaccine.
Administration of immunoglobulins and/or any blood products within the 6 months preceding enrollment in the study
Known disturbance of coagulation or other blood disorder (e.g., thalassemia, sickle cell disease, thrombocytopenia, disorders of the lymphocytes, severe anemia at birth) in adult subject or in self/first-degree relative of toddler subject; or receipt of anticoagulants in the past three weeks (aspirin as needed and nonsteroidal anti-inflammatory drugs are acceptable)
History of meningitis, seizures or any neurological disorder (all participants) or major psychiatric disorder (adults)
Any medical or social condition that in the opinion of the investigator will interfere with the study objectives or pose a risk to the study subject
An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel
Female adult subjects who are pregnant or breast-feeding
Adults with a recent history (within the past year) of alcohol or substance abuse.
Toddlers who have already received a pentavalent booster (following the primary series).
Toddlers with a family history of suspected primary immunodeficiency in first-degree relative.
Toddlers who had a sibling die of likely sudden infant death syndrome (SIDS) or die suddenly and without apparent other cause or preceding illness in the first year of life.
Toddlers with evidence of a clinically significant congenital abnormality as judged by the PI.
Toddlers with evidence of fetal alcohol syndrome or maternal history of alcohol abuse during pregnancy

Trial locations and contacts

1 site in 1 country.

Kenya1 site

KEMRI-Wellcome Trust Research Programme; Centre for Geographic Medicine Research - Coast
Kilifi, 80108

Other trials in Kenya

About this study

Official title: Phase 1-2 Safety and Immunogenicity Study of PATH-wSP in Kenyan Adults and Toddlers

This study aimed to determine whether PATH-wSP, a vaccine against a germ that causes pneumonia, is safe and induces immune responses in adults and toddlers. The study vaccine was compared to placebo. First adults received 2 injections of a lower dose of the vaccine or placebo, 28 days apart. Since the lower dose was considered safe, a higher dose was tested. Once the safety was established in adults the lower and higher dose was tested in toddlers, starting with the lower dose and then the higher dose.

Read the detailed description

pneumoniae whole cell vaccine (SPWCV) is a vaccine candidate made from whole unencapsulated pneumococcal cells and adsorbed to aluminum hydroxide adjuvant (Alum). After adsorption of the Alum to SPWCV, the vaccine is referred to as PATH-wSP. PATH-wSP has been previously tested in Phase 1/2 studies in healthy US adults (VAC-002), and in healthy Kenyan adults and toddlers (VAC-010) and showed a favorable safety, tolerability, and immunogenicity profile. The SPWCV and Alum used in previous Phase 1/2 trials were supplied separately in a two-vial configuration; the SPWCV was manufactured at Walter Reed Army Institute of Research and the Alum at Instituto Butantan. A single-vial formulation of PATH wSP, an adsorbed suspension of SPWCV and Alum, has now been manufactured by PT Bio Farma, Indonesia. The purpose of this study was to assess the safety and tolerability of this new formulation.

Conditions: Pneumonia
Being tested: PATH-wSP, Placebo
Keywords: Vaccine
Medical subject headings: Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PATH-wSPBiological
Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide
PlaceboBiological
Normal Saline

Study groups in NCT02543892
Study group	Role	What they receive
Adult 0.6mg PATH-wSP	Experimental	Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses Receives: Biological: PATH-wSP
Adult Placebo Low Dose	Placebo comparator	Two injections of normal saline with a 28 day interval between injections Receives: Biological: Placebo
Adult 1.0 mg PATH-wSP	Experimental	Two 1 mg doses of PATH-wSP with a 28 day interval between doses Receives: Biological: PATH-wSP
Adult Placebo High Dose	Placebo comparator	Two injections of normal saline with a 28 day interval between injections Receives: Biological: Placebo
Toddler 0.6mg PATH-wSP	Experimental	Two 0.6 mg doses of PATH-wSP with a 28 day interval between doses Receives: Biological: PATH-wSP
Toddler Placebo Low Dose	Placebo comparator	Two injections of normal saline with a 28 day interval between injections Receives: Biological: Placebo
Toddler 1.0 mg PATH-wSP	Experimental	Two 1 mg doses of PATH-wSP with a 28 day interval between doses Receives: Biological: PATH-wSP
Toddler Placebo High Dose	Placebo comparator	Two injections of normal saline with a 28 day interval between injections Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.
Measured: 7 days after the first dose (Day 7)
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity.
Measured: 7 days after the second dose (Day 35)
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.
Measured: 7 days after the first dose (Day 7)
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.
Measured: 7 days after the second dose (Day 35)
Number of Adverse Events (AE), by Relation to Vaccine and Seriousness
Only treatment-emergent adverse events (TEAEs) were included in the analysis; adverse events (AEs) that were not TEAEs were to have been listed.
Measured: 112 days

Secondary outcomes (3)

Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins
Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay. Units were arbitrary.
Measured: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins
Between baseline and 28 days after vaccination 2. Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay.
Measured: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)
Number of Subjects With Immunoglobulin G (IgG) Seroresponse
Between baseline and 28 days after vaccination 2. Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay.
Measured: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 20164 Jan 2018

First posted7 Sep 2015 (estimated)
Study start10 Aug 2016
Primary completion4 Jan 2018
Study completion4 Jan 2018

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.
Other trials for 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02543892
Sponsor's protocol ID: VAC-040
Status last verified: Nov 2018
First submitted: 1 Sep 2015
Last updated: 28 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1-2 Safety and Immunogenicity Study of PATH-wSP in Kenyan Adults and Toddlers
ClinicalTrials.gov ID: NCT02543892
Acronym / sponsor ID: VAC-040
Conditions: Pneumonia
Keywords: Vaccine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 248 participants (actual)
Lead sponsor: PATHUniversity, hospital or other
Study start: 10 Aug 2016 (actual)
Primary completion: 4 Jan 2018 (actual)
Study completion: 4 Jan 2018 (actual)
First posted: 7 Sep 2015 (estimated)
Results: Posted 28 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

pneumoniae whole cell vaccine (SPWCV) is a vaccine candidate made from whole unencapsulated pneumococcal cells and adsorbed to aluminum hydroxide adjuvant (Alum). After adsorption of the Alum to SPWCV, the vaccine is referred to as PATH-wSP. PATH-wSP has been previously tested in Phase 1/2 studies in healthy US adults (VAC-002), and in healthy Kenyan adults and toddlers (VAC-010) and showed a favorable safety, tolerability, and immunogenicity profile. The SPWCV and Alum used in previous Phase 1/2 trials were supplied separately in a two-vial configuration; the SPWCV was manufactured at Walter Reed Army Institute of Research and the Alum at Instituto Butantan. A single-vial formulation of PATH wSP, an adsorbed suspension of SPWCV and Alum, has now been manufactured by PT Bio Farma, Indonesia. The purpose of this study was to assess the safety and tolerability of this new formulation.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Adult 0.6mg PATH-wSP	Experimental	Biological: PATH-wSPTwo 0.6 mg doses of PATH-wSP with a 28 day interval between doses
Adult Placebo Low Dose	Placebo comparator	Biological: PlaceboTwo injections of normal saline with a 28 day interval between injections
Adult 1.0 mg PATH-wSP	Experimental	Biological: PATH-wSPTwo 1 mg doses of PATH-wSP with a 28 day interval between doses
Adult Placebo High Dose	Placebo comparator	Biological: PlaceboTwo injections of normal saline with a 28 day interval between injections
Toddler 0.6mg PATH-wSP	Experimental	Biological: PATH-wSPTwo 0.6 mg doses of PATH-wSP with a 28 day interval between doses
Toddler Placebo Low Dose	Placebo comparator	Biological: PlaceboTwo injections of normal saline with a 28 day interval between injections
Toddler 1.0 mg PATH-wSP	Experimental	Biological: PATH-wSPTwo 1 mg doses of PATH-wSP with a 28 day interval between doses
Toddler Placebo High Dose	Placebo comparator	Biological: PlaceboTwo injections of normal saline with a 28 day interval between injections

Who may qualify

Ages: 1 year to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

Healthy adults who are 18 to 40 years old, or toddlers who are 12 to 19 months old.
Must provide voluntary written/thumb-printed informed consent
Must comply with study requirements and procedures.
Must have an identifiable place of residence to allow home visits, and a consistent means of telephone contact
Must be resident in the study area with no plans to travel outside the study area during the study

Key exclusion criteria (24 listed)

Use of any investigational or nonregistered drug within 90 days of enrollment
Use of any potentially hepatotoxic drug
Receipt of any licensed vaccine within 14 days of administration of study vaccine.
Chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or major congenital defects or illness that requires medical therapy, based on medical history or clinical assessment
History of anaphylactic shock

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
PATH-wSPStreptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide	Biological	Adult 0.6mg PATH-wSP, Adult 1.0 mg PATH-wSP, Toddler 0.6mg PATH-wSP, Toddler 1.0 mg PATH-wSP
PlaceboNormal Saline	Biological	Adult Placebo High Dose, Adult Placebo Low Dose, Toddler Placebo High Dose, Toddler Placebo Low Dose

Primary outcome

Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1
Time frame: 7 days after the first dose (Day 7)
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.
Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2
Time frame: 7 days after the second dose (Day 35)
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity.
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1
Time frame: 7 days after the first dose (Day 7)
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.
Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2
Time frame: 7 days after the second dose (Day 35)
Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.
Number of Adverse Events (AE), by Relation to Vaccine and Seriousness
Time frame: 112 days
Only treatment-emergent adverse events (TEAEs) were included in the analysis; adverse events (AEs) that were not TEAEs were to have been listed.

3 secondary outcomes

Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins
Time frame: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)
Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins
Time frame: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)
Number of Subjects With Immunoglobulin G (IgG) Seroresponse
Time frame: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)

Results and safety

Results posted to the registry on 28 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adult 0.6mg PATH-wSP	12	12
Adult 1.0 mg PATH-wSP	12	12
Adult Placebo Low Dose	12	12
Adult Placebo High Dose	12	12
Toddler 0.6mg PATH-wSP	50	50
Toddler 1.0 mg PATH-wSP	50	50
Toddler Placebo Low Dose	50	50
Toddler Placebo High Dose	50	50

Primary outcome: Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1

Time frame: 7 days after the first dose (Day 7). Count of participants. Unit: Participants

Measure	Adult 0.6mg PATH-wSP n = 12	Adult 1.0 mg PATH-wSP n = 12	Adult Placebo n = 24
Cutaneous Rash: Grade 0	11	12	22
Cutaneous Rash: Grade 1	1	0	1
Cutaneous Rash: Grade 2	0	0	1
Cutaneous Rash: Grade 3	0	0	0
Headache: Grade 0	11	8	19
Headache: Grade 1	1	3	5
Headache: Grade 2	0	1	0
Headache: Grade 3	0	0	0

Primary outcome: Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2

Time frame: 7 days after the second dose (Day 35). Count of participants. Unit: Participants

Measure	Adult 0.6mg PATH-wSP n = 11	Adult 1.0 mg PATH-wSP n = 11	Adult Placebo n = 24
Cutaneous Rash: Grade 0	11	11	22
Cutaneous Rash: Grade 1	0	0	2
Cutaneous Rash: Grade 2	0	0	0
Cutaneous Rash: Grade 3	0	0	0
Headache: Grade 0	10	10	19
Headache: Grade 1	1	1	5
Headache: Grade 2	0	0	0
Headache: Grade 3	0	0	0

Primary outcome: Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1

Time frame: 7 days after the first dose (Day 7). Count of participants. Unit: Participants

Measure	Toddler 0.6mg PATH-wSP n = 50	Toddler 1.0 mg PATH-wSP n = 50	Toddler Placebo n = 100
Temperature: Grade 0	43	47	93
Temperature: Grade 1	5	2	6
Temperature: Grade 2	2	1	0
Temperature: Grade 3	0	0	1
Cutaneous Rash: Grade 0	46	44	91
Cutaneous Rash: Grade 1	0	4	7
Cutaneous Rash: Grade 2	4	2	2
Cutaneous Rash: Grade 3	0	0	0

Primary outcome: Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2

Time frame: 7 days after the second dose (Day 35). Count of participants. Unit: Participants

Measure	Toddler 0.6mg PATH-wSP n = 50	Toddler 1.0 mg PATH-wSP n = 50	Toddler Placebo n = 100
Temperature: Grade 0	42	41	80
Temperature: Grade 1	5	6	11
Temperature: Grade 2	3	2	8
Temperature: Grade 3	0	1	1
Cutaneous Rash: Grade 0	45	46	93
Cutaneous Rash: Grade 1	4	4	6
Cutaneous Rash: Grade 2	1	0	1
Cutaneous Rash: Grade 3	0	0	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 112 days from receipt of first vaccination. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adult 0.6mg PATH-wSP	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Adult 1.0 mg PATH-wSP	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Adult Placebo	0 of 24 (0%)	20 of 24 (83.3%)	0 of 24
Toddler 0.6mg PATH-wSP	2 of 50 (4%)	45 of 50 (90%)	0 of 50
Toddler 1.0 mg PATH-wSP	1 of 50 (2%)	44 of 50 (88%)	0 of 50
Toddler Placebo	5 of 100 (5%)	87 of 100 (87%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Anthony Scott, MD study chair

London School of Hygiene and Tropical Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PATH-wSP in people with Pneumonia, run by PATH at 1 site in Kenya.

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 9 inclusion and 24 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 28 Nov 2018. 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 Kenya. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2018). 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?

Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 (time frame: 7 days after the first dose (Day 7)). The study lists 5 primary outcomes in all. 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 NCT02543892.

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 28 Nov 2018.