Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
- 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.
- Acronym
- H06_04TP
- Short title
- Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
- Official title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2028-10-31
- First posted
- 2026-01-06
- Registry last updated
- 2026-01-06
- Primary completion date
- 2028-10-31
- Start date
- 2026-01-02
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- GlaxoSmithKline
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07320716
- ClinicalTrials.gov ID
- NCT07320716
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- No masking
- Masking description
- This is an open-label study.
Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA)
Timeframe: 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
Timeframe: 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.
Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA
Timeframe: 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.
- Sex
- All
- Age groups
- Children
- Minimum age
- 26 Months
- Maximum age
- 55 Months
- Healthy volunteers
- Yes
- 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.
- 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.
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Diarrheal disease Primary condition