A Phase 2, Open-Label, Single-Center, Long-Term Immunogenicity Follow-Up Study of the GVGH altSonflex1-2-3 Shigella Vaccine 1, 2 and 3 Years After Vaccination in African Children
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- GlaxoSmithKline
- Enrollment
- 528
- Primary Endpoint
- Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA)
Study Overview
Brief Summary
The current study is a follow-up to 2 previous parent studies, a dose-selection study with 3 different dose-levels of the altSonflex1-2-3 vaccine in a schedule of 3 vaccinations (H06_01TP study [NCT05073003, 212149]) and a study with an alternate 2 vaccination schedule H06_02TP study [NCT06663436, 219449]). The current study aims to assess the longevity of the immune response to the selected dose of the altSonflex1-2-3 vaccine 1, 2, and 3 years after the last vaccination in African children. The study involves no new vaccinations but will collect immunogenicity blood samples from participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
This is an open-label study.
Eligibility Criteria
- Ages
- 26 Months to 55 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children who, as infants, previously participated in two completed studies (H06_01TP or H06_02TP) and were vaccinated with 3 or 2 doses of altSonflex1-2-3 or control vaccines, respectively, completed all previous vaccinations and are 12±1 months after the last altSonflex1-2-3 vaccination.
- •Individuals in good health as determined by medical history since last study visit and clinical judgment of the investigator.
Exclusion Criteria
- •Serious and significant progressive, unstable, or uncontrolled clinical condition(s).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition.
- •Clinical condition(s) representing a contraindication to blood draws.
- •Any behavioural or cognitive impairment or psychiatric disease.
- •Acute disease and/or fever at the time of enrollment.
- •Individuals with known or suspected HIV infection or HIV-related disease, with history of an autoimmune disorder or any other known or suspected impairment/alteration of the immune system, or under immunosuppressive therapy.
- •Receipt of immunoglobulins and/or any blood products or plasma derivatives, during the period starting 3 months before each study visit.
Arms & Interventions
H06_01TP Study_Infants_Selected dose
Infants who received 3 doses of the altSonflex1-2-3 vaccine on Day 1, Day 85, and Day 253 in the H06_01TP parent study.
Intervention: AltSonflex1-2-3 (Biological)
H06_01TP Study_ ST2_Infants_Control
Infants who received 2 doses of the Menveo vaccine on Day 1 and Day 85, and 1 dose of the Infanrix hexa vaccine on Day 281 in the H06_01TP parent study.
Intervention: Menveo (Biological)
H06_01TP Study_ ST2_Infants_Control
Infants who received 2 doses of the Menveo vaccine on Day 1 and Day 85, and 1 dose of the Infanrix hexa vaccine on Day 281 in the H06_01TP parent study.
Intervention: Infanrix hexa (Biological)
H06_02TP Study_Infants_Selected dose
Infants who received 2 doses of the altSonflex1-2-3 vaccine on Day 1 and Day 169 in the H06_02TP parent study.
Intervention: AltSonflex1-2-3 (Biological)
H06_02TP Study_ Infants_Control
Infants who received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix hexa vaccine on Day 169 in the H06_02TP parent study.
Intervention: Infanrix hexa (Biological)
H06_02TP Study_ Infants_Control
Infants who received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix hexa vaccine on Day 169 in the H06_02TP parent study.
Intervention: TYPHIBEV (Biological)
Outcomes
Primary Outcomes
Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA)
Time Frame: At Visit 1 of the current study (12 months after last vaccination in the parent studies)
S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.
Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA
Time Frame: At Visit 3 of the current study (36 months after last vaccination in the parent studies)
S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.
Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA
Time Frame: At Visit 2 of the current study (24 months after last vaccination in the parent studies)
S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.
Secondary Outcomes
No secondary outcomes reported