Pneumonia, PneumococcalPhase 1/2NCT02097472
Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Adsorbed to Alum (PATH-wSP) in Healthy Kenyan Adults and Toddlers
A Phase 1/2 study testing PATH-wSP, Synflorix and Pentavac in people with Pneumonia, Pneumococcal, run by PATH at 1 site in Kenya.
Trial summary
The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV). Read more about this study
- Who is it for?
- Ages 12 months to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal
- What is being tested?
- PATH-wSP, Synflorix and Pentavac
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteKenya
- Study dates
- Apr 2014to Dec 2015
- 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 12 months to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy young Kenyan adults between 18 to 45 years of age
- Willing to provide written informed consent, able to understand comply with study requirements/procedures.
- Adult female subjects surgically sterilized or with a negative serum pregnancy test on enrollment and prior to each vaccination. Adult females must be willing to avoid becoming pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study.
- Subjects willing to avoid consumption of herbal medication (including herbal medication taken by a mother, which may transmit to a toddler through breast milk) that could have effects on liver function or bleeding indices during the course of the study.
- Healthy toddlers between 12 to 15 months of age who have completed their primary EPI vaccines.
- Toddler's parent willing to provide written informed consent for subject, able to understand and comply with study requirements and procedures.
- Not premature, had a birth weight of >2.5 kg, and a weight-to-height Z score of ≥ -2 at the time of enrollment.
Who cannot join
- Use of any investigational or nonregistered drug within 90 days prior and during the course of study participation.
- History of administration of any vaccine within 30 days prior to administration of study vaccine or planned vaccination during the course of study.
- History of anaphylactic shock.
- Positive test for malaria (blood film) at time of screening and when retested at Visit 1.
- Immunosuppression or immunodeficiency, inclusive of human immunodeficiency virus, by medical history or by testing at screening.
- Chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or major congenital defects or illness that requires medical therapy, as deemed by medical history or clinical assessment.
Show all 21Show fewer
- Evidence of active hepatitis infection (B or C) by immunologic testing at screening.
- 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 or may prevent the subject from completing the study follow-up.
- An employee (or first degree relative of employee) of the Sponsor, the Clinical Research Organization, or any investigator or site personnel.
- Any screening laboratory test result or vital sign measurement outside normal parameters and deemed by the clinician to be clinically significant, including a positive test for malaria.
- Acute illness (moderate or severe) and/or fever (tympanic temperature >38°C for adults and >37.5°C for toddlers), or any acute and limited illness requiring medical treatment, including the use of antibiotics and treatment for parasites.
- History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.
- Disorders that require chronic administration of 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; or anticipation of such administration during the study period.
- Known disturbance of coagulation or other blood disorder in adult subject or in self/first degree relative of toddler subject; or receipt of anticoagulants in the past 3 weeks.
- History of meningitis or seizures or any neurological disorder or major psychiatric disorder (adult).
- Female subjects who are pregnant or breast-feeding.
- Suspicion or recent history of alcohol or substance abuse.
- Toddlers with evidence of congenital abnormality or developmental delay.
- Toddlers with evidence of fetal alcohol syndrome or history of alcohol abuse in mother during pregnancy.
- Toddlers exposed to HIV, born of an HIV infected mother, or who are HIV positive by either antibody or polymerase chain reaction testing.
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Kenya Medical Research Institute/Walter Reed Project
Kisumu, Nyanza, PO Box 54-40100
About this study
Official title: A Dose-Finding Study to Assess the Safety, Tolerability, and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (PATH-wSP) in Healthy Kenyan Young Adults and PCV-Primed Toddlers
The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV).
Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.
Read the detailed description
- pneumoniae whole cell vaccine (SPWCV) is a vaccine candidate made from whole, unencapsulated pneumococcal cells. S. pneumoniae whole cell antigen bulk was manufactured at Walter Reed Army Institute of Research from strain RM200 RX1E PdT ΔlytA and is inactivated with beta-propiolactone. Pneumolysin, a proven virulence factor, was genetically knocked out in SPWCV and replaced with pneumolysoid, a derivative carrying the toxin gene with 3 point mutations known to abolish both cytolytic activity and complement activation. When adsorbed to aluminum hydroxide (alum), SPWCV is utilized as the vaccine candidate Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide adjuvant (PATH-wSP) for clinical investigation. PATH-wSP has been previously tested in adults in a Phase 1 trial in the US, in which doses of 100 to 600 μg were given to healthy young adults in a 3-vaccination series and showed a favorable safety, tolerability, and immunogenicity profile.
This study was a dose escalation and age de-escalation study, and sequential cohorts of subjects were identified to allow safety evaluations of dosing and ages to occur progressively during the study. The following PATH-wSP cohorts were defined for adult and toddler subjects:
- Adult Cohort 1: 600 μg PATH-wSP or saline
- Adult Cohort 2: 1000 μg PATH-wSP or saline
- Toddler Cohort 1: 300 μg PATH-wSP and/or active control vaccines
- Toddler Cohort 2: 600 μg PATH-wSP and/or active control vaccines.
- Conditions
- Pneumonia, Pneumococcal
- Being tested
- PATH-wSP, Synflorix, Pentavac, Saline
- Medical subject headings
- Pneumonia, Pneumococcal
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 adsorbed to Alum
SynflorixBiological
Also called 10-valent Pneumococcal Conjugate Vaccine (PCV10)
1 dose (0.5 mL) contains:
1 μg of each of the following pneumococcal polysaccharide serotypes:
1, 5, 6B, 7F, 9V, 14, and 23 F
And 3 μg of the following pneumococcal polysaccharide serotypes:
4, 18C and 19F.
The serotypes are conjugated to either:
protein D (derived from Non-Typeable Haemophilus influenzae) carrier protein, tetanus toxoid carrier protein or diphtheria toxoid carrier protein
PentavacBiological
Also called Diptheria Pertussis Tetanus Hep B Haemophilus b Conjugate
Each PFS contains 0.5 ml (single dose):
Diphtheria Toxoid 20 Lf to 30 Lf Tetanus Toxoid 2.5 Lf to 10 Lf B. Pertussis 4 IU HBsAg (rDNA) 10 mcg Purified capsular HIB Polysaccharide (PRP) Conjugated to Tetanus Toxoid (carrier protein) 10 mcg Adsorbed on Aluminium Phosphate, AL+++ 1.25 mg Preservative: Thiomersal 0.005 % Dose: O.5ml by intramuscular injection.
SalineOther
0.9% Sodium Chloride Injection, USP
| Study group | Role | What they receive |
|---|---|---|
| Adult Cohort 1, PATH-wSP, 600 mcg | Experimental | A single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm. Receives: Biological: PATH-wSP |
| Adult Cohort 1, Saline | Placebo comparator | A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm. Receives: Other: Saline |
| Adult Cohort 2, PATH-wSP, 1000 mcg | Experimental | A single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm. Receives: Biological: PATH-wSP |
| Adult Cohort 2, Saline | Placebo comparator | A single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm. Receives: Other: Saline |
| Toddler Cohort 1 PATH-wSP 300 mcg+Active control | Experimental | A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later. Receives: Biological: PATH-wSP; Biological: Synflorix; Biological: Pentavac |
| Toddler Cohort 1 PATH-wSP 300 mcg+Saline | Experimental | A single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later. Receives: Biological: PATH-wSP; Other: Saline |
| Toddler Cohort 1: Active Control Only | Active comparator | A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later. Receives: Biological: Synflorix; Biological: Pentavac; Other: Saline |
| Toddler Cohort 2 PATH-wSP 600 mcg+Active control | Experimental | A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later. Receives: Biological: PATH-wSP; Biological: Synflorix; Biological: Pentavac |
| Toddler Cohort 2 PATH-wSP 600 mcg+saline | Experimental | A single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later. Receives: Biological: PATH-wSP; Other: Saline |
| Toddler Cohort 2: Active Control Only | Active comparator | A single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later. Receives: Biological: Synflorix; Biological: Pentavac; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Adult Subjects Experiencing Headache Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Grade 2 includes repeated use of non-narcotic pain reliever for more than 24 hours.
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Grade 2 includes use of non-narcotic pain reliever for more than 24 hours.
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Grade 1: does not interfere with activity Grade 2: interferes with activity
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Grade 2: includes diffuse macular/maculopapular/morbilliform rash
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
Measured: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Secondary outcomes (35)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay
Measured with enzyme-linked immunosorbent assay (ELISA).
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay
Measured with enzyme-linked immunosorbent assay (ELISA).
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein
Measured using meso scale discovery (MSD).
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein
Measured using Meso Scale Discovery (MSD) Assay
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein
MSD Assay
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein
MSD Assay
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein
MSD Assay
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA
Measured using ELISA
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA
Measured using ELISA
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD
Measured using MSD
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD
Measured using ELISA
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein
Measured using MSD
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein
Measured using MSD
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein
Measured using MSD
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein
Measured using MSD
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein
Measured using MSD
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein
Measured using MSD
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein
Measured using MSD
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA)
Measured using ELISA
Measured: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PspA-Fam1 (ELISA)
Measured using ELISA
Measured: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to L460D Pneumococcal Protein (MSD)
Measured using MSD
Measured: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD)
Measured using MSD
Measured: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PhtD Pneumococcal Protein
Measured using MSD
Measured: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to BCH0785 Pneumococcal Protein
Measured using MSD
Measured: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to StkP Pneumococcal Protein
Measured using MSD
Measured: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PcpA Pneumococcal Protein
Measured using MSD
Measured: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to SPWCA Pneumococcal Protein
Measured using MSD
Measured: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PiuA Pneumococcal Protein
Measured using MSD
Measured: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PiaA Pneumococcal Protein
Measured using MSD
Measured: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin
Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin
Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).
Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
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 Pneumonia, PneumococcalStudies 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
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nekoye Otsyula, MD, Principal investigator, Kenya Medical Research Institute/Walter Reed Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097472
- Sponsor's protocol ID
- VAC-010
- Status last verified
- Oct 2019
- First submitted
- 17 Mar 2014
- Last updated
- 10 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Finding Study to Assess the Safety, Tolerability, and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (PATH-wSP) in Healthy Kenyan Young Adults and PCV-Primed Toddlers
- ClinicalTrials.gov ID
- NCT02097472
- Acronym / sponsor ID
- VAC-010
- Conditions
- Pneumonia, Pneumococcal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Posted 12 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV).
Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.
Detailed description
- pneumoniae whole cell vaccine (SPWCV) is a vaccine candidate made from whole, unencapsulated pneumococcal cells. S. pneumoniae whole cell antigen bulk was manufactured at Walter Reed Army Institute of Research from strain RM200 RX1E PdT ΔlytA and is inactivated with beta-propiolactone. Pneumolysin, a proven virulence factor, was genetically knocked out in SPWCV and replaced with pneumolysoid, a derivative carrying the toxin gene with 3 point mutations known to abolish both cytolytic activity and complement activation. When adsorbed to aluminum hydroxide (alum), SPWCV is utilized as the vaccine candidate Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide adjuvant (PATH-wSP) for clinical investigation. PATH-wSP has been previously tested in adults in a Phase 1 trial in the US, in which doses of 100 to 600 μg were given to healthy young adults in a 3-vaccination series and showed a favorable safety, tolerability, and immunogenicity profile.
This study was a dose escalation and age de-escalation study, and sequential cohorts of subjects were identified to allow safety evaluations of dosing and ages to occur progressively during the study. The following PATH-wSP cohorts were defined for adult and toddler subjects:
- Adult Cohort 1: 600 μg PATH-wSP or saline
- Adult Cohort 2: 1000 μg PATH-wSP or saline
- Toddler Cohort 1: 300 μg PATH-wSP and/or active control vaccines
- Toddler Cohort 2: 600 μg PATH-wSP and/or active control vaccines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Adult Cohort 1, PATH-wSP, 600 mcg | Experimental | Biological: PATH-wSPA single injection of 600 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 600 mcg PATH-wSP in the alternate arm. |
| Adult Cohort 1, Saline | Placebo comparator | Other: SalineA single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm. |
| Adult Cohort 2, PATH-wSP, 1000 mcg | Experimental | Biological: PATH-wSPA single injection of 1000 mcg PATH-wSP in one arm, followed 4 weeks later by a single injection of 1000 mcg PATH-wSP in the alternate arm. |
| Adult Cohort 2, Saline | Placebo comparator | Other: SalineA single injection of saline in one arm, followed 4 weeks later by a single injection of saline in the alternate arm. |
| Toddler Cohort 1 PATH-wSP 300 mcg+Active control | Experimental | Biological: PATH-wSP, Biological: Synflorix, Biological: PentavacA single injection of PATH-wSP 300 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later. |
| Toddler Cohort 1 PATH-wSP 300 mcg+Saline | Experimental | Biological: PATH-wSP, Other: SalineA single injection of PATH-wSP 300 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 300 mcg in the left thigh 8 weeks later. |
| Toddler Cohort 1: Active Control Only | Active comparator | Biological: Synflorix, Biological: Pentavac, Other: SalineA single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later. |
| Toddler Cohort 2 PATH-wSP 600 mcg+Active control | Experimental | Biological: PATH-wSP, Biological: Synflorix, Biological: PentavacA single injection of PATH-wSP 600 mcg in the left thigh and a single injection of each of the two active comparator vaccines (Synflorix and Pentavac) in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later. |
| Toddler Cohort 2 PATH-wSP 600 mcg+saline | Experimental | Biological: PATH-wSP, Other: SalineA single injection of PATH-wSP 600 mcg in the left thigh and a single injection of saline in the right thigh along with a separate single injection of saline in the right thigh. These 3 injections are followed by a single injection of PATH-wSP 600 mcg in the left thigh 8 weeks later. |
| Toddler Cohort 2: Active Control Only | Active comparator | Biological: Synflorix, Biological: Pentavac, Other: SalineA single injection of saline in the left thigh and a single injection of each of the two active comparator vaccines in the right thigh. These 3 injections are followed by a single injection of saline in the left thigh 8 weeks later. |
Who may qualify
- Ages
- 12 months to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Healthy young Kenyan adults between 18 to 45 years of age
- Willing to provide written informed consent, able to understand comply with study requirements/procedures.
- Adult female subjects surgically sterilized or with a negative serum pregnancy test on enrollment and prior to each vaccination. Adult females must be willing to avoid becoming pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study.
- Subjects willing to avoid consumption of herbal medication (including herbal medication taken by a mother, which may transmit to a toddler through breast milk) that could have effects on liver function or bleeding indices during the course of the study.
- Healthy toddlers between 12 to 15 months of age who have completed their primary EPI vaccines.
Key exclusion criteria (21 listed)
- Use of any investigational or nonregistered drug within 90 days prior and during the course of study participation.
- History of administration of any vaccine within 30 days prior to administration of study vaccine or planned vaccination during the course of study.
- History of anaphylactic shock.
- Positive test for malaria (blood film) at time of screening and when retested at Visit 1.
- Immunosuppression or immunodeficiency, inclusive of human immunodeficiency virus, by medical history or by testing at screening.
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 adsorbed to Alum | Biological | Adult Cohort 1, PATH-wSP, 600 mcg, Adult Cohort 2, PATH-wSP, 1000 mcg, Toddler Cohort 1 PATH-wSP 300 mcg+Active control, Toddler Cohort 1 PATH-wSP 300 mcg+Saline, Toddler Cohort 2 PATH-wSP 600 mcg+Active control, Toddler Cohort 2 PATH-wSP 600 mcg+saline |
| SynflorixAlso: 10-valent Pneumococcal Conjugate Vaccine (PCV10)1 dose (0.5 mL) contains: 1 μg of each of the following pneumococcal polysaccharide serotypes: 1, 5, 6B, 7F, 9V, 14, and 23 F And 3 μg of the following pneumococcal polysaccharide serotypes: 4, 18C and 19F. The serotypes are conjugated to either: protein D (derived from Non-Typeable Haemophilus influenzae) carrier protein, tetanus toxoid carrier protein or diphtheria toxoid carrier protein | Biological | Toddler Cohort 1 PATH-wSP 300 mcg+Active control, Toddler Cohort 1: Active Control Only, Toddler Cohort 2 PATH-wSP 600 mcg+Active control, Toddler Cohort 2: Active Control Only |
| PentavacAlso: Diptheria Pertussis Tetanus Hep B Haemophilus b ConjugateEach PFS contains 0.5 ml (single dose): Diphtheria Toxoid 20 Lf to 30 Lf Tetanus Toxoid 2.5 Lf to 10 Lf B. Pertussis 4 IU HBsAg (rDNA) 10 mcg Purified capsular HIB Polysaccharide (PRP) Conjugated to Tetanus Toxoid (carrier protein) 10 mcg Adsorbed on Aluminium Phosphate, AL+++ 1.25 mg Preservative: Thiomersal 0.005 % Dose: O.5ml by intramuscular injection. | Biological | Toddler Cohort 1 PATH-wSP 300 mcg+Active control, Toddler Cohort 1: Active Control Only, Toddler Cohort 2 PATH-wSP 600 mcg+Active control, Toddler Cohort 2: Active Control Only |
| Saline0.9% Sodium Chloride Injection, USP | Other | Adult Cohort 1, Saline, Adult Cohort 2, Saline, Toddler Cohort 1 PATH-wSP 300 mcg+Saline, Toddler Cohort 1: Active Control Only, Toddler Cohort 2 PATH-wSP 600 mcg+saline, Toddler Cohort 2: Active Control Only |
Primary outcome
Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Number/Percent of Adult Subjects Experiencing Headache Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2 includes repeated use of non-narcotic pain reliever for more than 24 hours.
Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2 includes use of non-narcotic pain reliever for more than 24 hours.
Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 1: does not interfere with activity Grade 2: interferes with activity
Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2: includes diffuse macular/maculopapular/morbilliform rash
Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.
Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination
Time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)
Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).
35 secondary outcomes
Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA)
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PspA-Fam1 (ELISA)
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to L460D Pneumococcal Protein (MSD)
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD)
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PhtD Pneumococcal Protein
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to BCH0785 Pneumococcal Protein
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to StkP Pneumococcal Protein
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PcpA Pneumococcal Protein
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to SPWCA Pneumococcal Protein
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PiuA Pneumococcal Protein
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Fold Change in IgG Response to PiaA Pneumococcal Protein
Time frame: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)
Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin
Time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pneumonia, Pneumococcal
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
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.
Nekoye Otsyula, MD principal investigator
Kenya Medical Research Institute/Walter Reed Project
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, Synflorix and Pentavac in people with Pneumonia, Pneumococcal, 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 7 inclusion and 21 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 10 Oct 2019. 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 12 Jun 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?
Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination (time frame: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)). The study lists 14 primary outcomes in all. 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 10 Oct 2019.