Overview

This trial is active, not recruiting.

Condition pneumococcal disease
Treatments siilpcv10, pneumovax 23, prevenar 13
Phase phase 1/phase 2
Sponsor PATH
Start date January 2015
End date October 2016
Trial size 346 participants
Trial identifier NCT02308540, VAC-017

Summary

Phase 1/2, Prospective, Single Center, Randomized, ActiveControlled, Double-Blind, Age De-escalation Study to assess the safety and tolerability of SIILPCV10 administered as a single-dose regimen to healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve young adults and PCV-primed toddlers through 4 weeks post vaccination.

Each adult and toddler subject will undergo a total of 4 clinic visits. Each infant subject will undergo a total of 9 scheduled visits. Blood will be collected from all subjects during the screening visit for safety and potential immunological assessments, and 28 days after completion of the vaccination schedule for immunological assessments. For adults, the vaccine will be given IM into the mid-deltoid muscle of nondominant arm using a 24-gauge needle. For toddlers and infants, the vaccine will be given IM into the anterolateral aspect of the left thigh. Blood will be collected from adults and toddlers for safety labs at the Day 7 post-vaccination visit.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Single dose of SIILPCV10 on day 0
siilpcv10
10-valent Pneumococcal Conjugate Vaccine (SIILPCV10) at a dosage of 2 µg for each serotype polysaccharide, except 4 µg for 6B serotype, conjugated to a carrier protein (CRM197), with adjuvant (aluminum phosphate [alum]) and preservative (thiomersal).
(Active Comparator)
Single dose of Pneumovax 23 on day 0
pneumovax 23 23-valent Pneumococcal Polysaccharide Vaccine
23-valent Pneumococcal Polysaccharide Vaccine (Pneumovax 23; MSD Pharmaceuticals) for the adult cohort.
(Experimental)
Single dose of SIILPCV10 on day 0
siilpcv10
10-valent Pneumococcal Conjugate Vaccine (SIILPCV10) at a dosage of 2 µg for each serotype polysaccharide, except 4 µg for 6B serotype, conjugated to a carrier protein (CRM197), with adjuvant (aluminum phosphate [alum]) and preservative (thiomersal).
(Active Comparator)
Single dose of Prevenar 13 on day 0
prevenar 13 13-valent Pneumococcal Conjugate Vaccine
13-valent Pneumococcal Conjugate Vaccine (Prevenar 13; Pfizer-Wyeth) for the toddler and infant cohorts
(Experimental)
A three-dose series of SIILPCV10 on day 0, day 28, and day 56
siilpcv10
10-valent Pneumococcal Conjugate Vaccine (SIILPCV10) at a dosage of 2 µg for each serotype polysaccharide, except 4 µg for 6B serotype, conjugated to a carrier protein (CRM197), with adjuvant (aluminum phosphate [alum]) and preservative (thiomersal).
(Active Comparator)
A three-dose series of Prevenar 13 on day 0, day 28, and day 56
prevenar 13 13-valent Pneumococcal Conjugate Vaccine
13-valent Pneumococcal Conjugate Vaccine (Prevenar 13; Pfizer-Wyeth) for the toddler and infant cohorts

Primary Outcomes

Measure
reactogenicity assessed by occurrence, severity of solicited local and systemic reactions
time frame: Day 7 post vaccination
adverse events in adults and toddlers
time frame: Day 28 post last vaccination
incidence of subjects with abnormal laboratory values
time frame: 7 days after vaccination
adverse events in infants
time frame: 12 weeks post last vaccination

Secondary Outcomes

Measure
IgG immune response
time frame: baseline and 4 weeks after last vaccination

Eligibility Criteria

Male or female participants up to 40 years old.

Inclusion Criteria: - • Healthy adults (18-40 yrs), toddlers (12-15 mo), full term infants (6-8 wks) and ≥ 3.5 kg - Able to provide informed consent (for themselves or child) - Willing to comply with study requirements and procedures. - Toddlers have completed their Gambian infant EPI schedule - Infants who have received the birth doses of BCG, HepB and OPV but who have not received any additional vaccines. - Infants and toddlers with a weight-to-height Z score of ≥ -2. - Subjects resident in the study area with no plans to travel outside the study area during the period of study participation. Exclusion Criteria: - Use of any investigational medicinal product within 90 days prior to randomization and throughout the study. - Ingestion of herbal or other traditional local medication within 14 days of randomization. - Adults and infants who have previously been vaccinated against S. pneumoniae. - History of S. pneumoniae infection confirmed by culture from a normally sterile site. - History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines. - History of anaphylactic shock. - Screening laboratory test or vital signs outside the normal range. - HIV-positive or HbsAg- positive based on testing during screening. - Acute illness (moderate or severe) and/or fever (axillary temperature of ≥ 38.0°C for adults or ≥ 37.5°C for toddlers and infants). - Use of antibiotics within 5 days of randomization (excluding treatment for malaria). - A positive test for malaria at time of screening, which remains positive post treatment when retested at time of randomization (Day 0). - Administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned vaccination during the course of study participation. - Chronic administration of immunosuppressant or other immune modifying drugs prior to the administration of the study. The use of topical and inhaled glucocorticoids will be permitted. - Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine or during the study period. - History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding. - Employee of, or direct descendant of any person employed by the Sponsor, the CRO, the PI, study site personnel, or site. Adults only - Recent history or signs of alcohol or substance abuse. - History of major psychiatric disorder. - Female adult subjects who are pregnant or breast-feeding. Infants/Toddlers only - Family history of suspected primary immunodeficiency in first-degree relative. - Had a sibling die suddenly and without apparent other cause or preceding illness in the first year of life. - Evidence of a clinically significant congenital abnormality as judged by the PI. - Evidence of fetal alcohol syndrome or maternal history of alcohol abuse during pregnancy. - History of meningitis, seizures or any neurological disorder. - Evidence of exposure to an HIV-positive individual through maternal fetal transmission, breast milk, or other bloodborne mechanisms

Additional Information

Official title A Phase 1/2, Prospective, Randomized, Double-Blind, Age De-escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 10-Valent Pneumococcal Conjugate Vaccine in Healthy Young Adults, Toddlers, and Infants
Principal investigator Ed Clarke, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by PATH.