Yellow Fever
Conditions
Interventions
BIBP Yellow fever vaccine
WHO prequalified YFV
Sponsors
Beijing Institute of Biological Products Co Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy young adolescents, young children and 9 month-old infants as established by medical history and clinical examination before entering the study 2. Age: a. Young adolescents: =12 to =15 years old at time of enrollment b. Young children: =2 to 9 to <11 months old at the time of enrollment 3. Parental ability and willingness to provide written informed consent (signed by either a parent/guardian or, if unable to sign, a witness). For young adolescents, ability and willingness to provide assent. 4. Demonstrate comprehension of the protocol by successfully passing the Test of Understanding (TOU) with a score of 80% or more on ten questions after three attempts 5. Intention for the participant and parent to remain in the area during the study period 6. If female and of childbearing potential, be not breastfeeding and not pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test at the study injection visit, prior to injection), planning to avoid pregnancy for at least 4 weeks after study injection, and willing to use an adequate method of contraception consistently for at least one month after the study injection.
Exclusion criteria
Exclusion criteria: 1. Presence of fever on the day of enrollment (axillary or oral temperature >37.6oC) 2. Acute disease at the time of enrollment 3. Concurrent participation in another clinical trial during the timeframe of this study 4. Presence of severe malnutrition (weight-for height/length z-score =-3 standard deviations [SD]) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination that would compromise the participant’s health or is likely to result in nonconformance to the protocol 5. History of neurological disorder, including history of seizures 6. Known or suspected impairment of immunological function based on medical history and physical examination 7. Prior receipt of any flavivirus vaccine (i.e., yellow fever, dengue, Japanese encephalitis vaccine) 8. For infants only: prior receipt of MR vaccine 9. Previous diagnosis of yellow fever infection 10. Receipt of other vaccines during the prior 4 weeks 11. A known sensitivity or allergy to any components of the study vaccine 12. History of anaphylactic reaction 13. Major congenital or genetic defect 14. Receipt of any immunoglobulin therapy and/or blood products in the last 6 months or planned administration during the study period 15. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids, in the last 6 months (those on inhaled or topical steroids may be permitted to participate in the study) 16. Any condition in the participant or parents that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant’s (or parents’) ability to give informed consent 17. HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: •Frequency of serious adverse events (SAEs) throughout the study •Frequency of local and systemic solicited adverse events (AEs) during the 7 days post-vaccination •Frequency of unsolicited AEs through 28 days post-vaccination Immunogenicity: •Yellow fever neutralizing antibody GMTs in infants 28 days following a single dose of =4.2 log10 PFU/dose BIBP YFV for the assessment of consistency of response across three lots of vaccine •Proportion of infants with yellow fever neutralizing antibody seroconversion 28 days following a single dose of either BIBP YFV (both dose levels) or a WHO PQ YFV | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity: • Yellow fever neutralizing antibody GMTs in adolescents and young children 28 days following a single dose of =4.2 log10 PFU/dose BIBP YFV or a WHO PQ YFV • Yellow fever neutralizing antibody GMTs in infants 28 days following a single dose of =3.0 log10 IU/dose BIBP YFV • YF neutralizing antibody GMT fold-rise between baseline and 28 days following a single dose of >4.2 log10 PFU/dose (adolescents, young children, and infants) or =3.0 log10 IU/dose (infants only) BIBP YFV or a WHO PQ YFV (adolescents, young children, and infants) • Proportion of adolescents and young children with yellow fever neutralizing antibody seroconversion 28 days following a single dose of either =4.2 log10 PFU/dose BIBP YFV or a WHO PQ YFV Seroconversion is defined as a reciprocal 50% plaque reduction neutralization titer (PRNT50) of =10 28 days after vaccination among those participants negative (PRNT50< 10) at baseline; among those initially seropositive (PRNT50 =10) at baseline, seroconversion will be defined as a minimum 4-fold rise in PRNT50 • Proportion of infants with measles immunoglobulin G (IgG) seroconversion 28 days following receipt of MR co-administered with BIBP YFV (both dose levels) or a WHO PQ YFV, co-administered with a measles-rubella vaccine. Measles seroconversion in initially seronegative infants will be defined as concentrations =200 mIU/mL • Proportion of infants with rubella IgG seroconversion 28 days following receipt of MR co-administered with BIBP YFV (both dose levels) or a WHO PQ YFV, co-administered with a measles-rubella vaccine. Rubella seroconversion in initially seronegative infants will be defined as concentrations =10 IU/mL • Measles IgG GMC 28 days following receipt of MR co-administered with either BIBP YFV (both dose levels) or a WHO PQ YFV, co-administered with a measles-rubella vaccine • Rubella IgG GMC 28 days following receipt of MR co-administered with either BIBP YFV (both dose levels) or a WHO PQ YFV, co-administered | — |
Countries
Kenya
Contacts
Public ContactCharles Kilel
Community Liason Officer
Outcome results
None listed