A phase 3, double-blind, randomized, controlled trial to assess the safety of a novel type 2 oral polio vaccine (nOPV2) in infants and young children and lot-to-lot consistency of the immune response to nOPV2 in infants in The Gambia
- Conditions
- Polio
- Registration Number
- PACTR202010705577776
- Lead Sponsor
- PATH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 2945
1.Age:
•Infants: =18 and <52 weeks at the time of first study vaccination (126 days through the day before their first birthday, inclusive, with the day after birth considered 1-day old)
•Young children: =1 to <5 years old at the time of the first study vaccination (from the first birthday up to the day prior to the fifth birthday)
2.The subject’s parent must be judged to be willing and able to provide informed consent based on the content of the informed consent document and signed/thumb-printed informed consent must be provided .
3.Intention of the subjects’ parents to remain in the study area with the infant/young child during the study period
4.The subject must have a readily identifiable place of residence in the study area
5.Infants: prior receipt of full primary series of bOPV and a single dose of IPV prior to randomization, with IPV dose at least 4 weeks prior to randomization
6.Young children: prior receipt of at least one dose of type 2-containing vaccine (IPV, tOPV or mOPV2), with the last dose of type 2-containing vaccine at least 4 weeks prior to the day of first study vaccination
[Young children who have not received type 2 containing vaccine may receive IPV and become eligible to be randomized to receive study vaccine 4 weeks after receipt of IPV.]
7.Parent ability and willingness to comply with the required study procedures, including the home visits, clinic visits, assessment and sampling procedures, as judged by the investigator
8.Parent willingness to contact the study team in the event of an acute illness
9.Willingness not to use herbal and other traditional medications for the duration of the study
10.Infant Welfare Card (IWC) is available
11.Baseline peripheral blood sample obtained from the infant/young child that is sufficient to allow the primary trial immunogenicity endpoints to be evaluated
1.Moderate or severe (grade = 2) acute illness at the time of enrollment/first study vaccination – temporary exclusion (see Appendix 2: Severity Grading Tables)
oSubject with mild (grade 1) acute illnesses may be enrolled at the discretion of the investigator
2.Presence of fever on the day of enrollment/first study vaccination (axillary temperature =37.5oC) – temporary exclusion
3.Presence of abnormal vital signs (respiratory rate and/or heart rate) for age on the day of enrollment/first study vaccination – temporary exclusion
4.Receipt of any investigational medicinal product within six months of study enrollment or intended receipt of any investigational medicinal product at any time during study participation
5.Concurrent participation or intent to participate in another clinical trial or other study throughout the entire timeframe for this study.
6.Presence of severe malnutrition [weight-for- length/height z-score <-3SD median (per WHO published child growth standards)] – temporary exclusion if marginal and subsequently gains weight.
7.Presence of any clinically significant systemic disorder (cardiovascular, respiratory, hepatic, renal, gastrointestinal, hematological, endocrine, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination that could compromise the subject’s health, is likely to result in nonconformance to the protocol or is likely to interfere with the evaluation of safety or immunogenicity endpoints.
8.History or examination findings suggestive of a primary or secondary immunodeficiency or known maternal HIV infection
9.Household member (living under the same roof/in the same building rather than in the same compound) with a history indicating or suggestive of a primary or secondary immunodeficiency
10.Evidence of a clinically significant congenital or genetic defect as judged by the investigator
11.Known sensitivity or allergy to any components
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety:<br>•Frequency of serious adverse events (SAEs) throughout the 3 months after the last dose of study vaccine<br>•Frequency of solicited adverse events (AEs) during the 7 days post-vaccination (in young children and a subset of infants receiving 2 doses)<br>•Frequency of unsolicited AEs through 28 days after the last dose of study vaccine<br>Immunogenicity:<br>•Proportion of infants with anti-polio Nab seroconversion 28 days following a single dose of nOPV2. Seroconversion is defined by minimum 4-fold increase in titer between baseline and 28 days post-vaccination among those initially seropositive, or seropositivity [anti-polio Nab titer =1:8] at 28 days among those initially seronegative. <br>
- Secondary Outcome Measures
Name Time Method Immunogenicity<br>•To further evaluate the immune response across three lots of a single dose of nOPV2 in healthy infants in The Gambia (in terms of median and geometric mean Nab titers and seroprotection rate [SPR])<br>•To assess the combined immunogenicity of three lots of nOPV2 in healthy infants in The Gambia (in terms of SCR, SPR, and median and geometric mean of anti-type 2 polio Nab)<br>•To evaluate the immune response following a second dose of nOPV2 in healthy infants in The Gambia (in terms of SCR, SPR, median and geometric mean Nab titers)<br>•To evaluate the immune response following a first and second dose of nOPV2 in healthy young children in The Gambia (in terms of SCR, SPR, and median and geometric mean Nab titers)<br>Viral Shedding<br>•To evaluate the rate and duration of viral shedding following a single dose of nOPV2<br>Exploratory Objective:<br>•To assess the magnitude of shed virus (among those identified as shedding post-vaccination)<br>