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Not yet recruiting NCT07320716

Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children

Phase II Interventional Diarrhoea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AltSonflex1-2-3, Menveo, Infanrix hexa, TYPHIBEV.
Who it may be relevant to
Registry conditions: Diarrhoea. Basic parameters: 26 months — 55 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Biological AltSonflex1-2-3
    No intervention is administered in this extension study. The selected dose of altSonflex1-2-3 vaccine was administered intramuscularly in the participants' thigh during the H06\_01TP (212149) parent study on Day 1, Day 85, and Day 253; or on Day 1 and Day 169 during the H06\_02TP (219449) study.
  • Biological Menveo
    No intervention is administered in this extension study. The Menveo vaccine was administered intramuscularly in the participants' thigh on Day 1 and Day 85 during the H06\_01TP (212149) parent study.
  • Biological Infanrix hexa
    No intervention is administered in this extension study. The Infanrix hexa vaccine was administered intramuscularly in the participants' thigh on Day 281 during the H06\_01TP (212149) study; or on Day 169 during the H06\_02TP (219449) parent study.
  • Biological TYPHIBEV
    No intervention is administered in this extension study. The TYPHIBEV vaccine was administered intramuscularly in the participants' thigh on Day 1 during the H06\_02TP (219449) parent study.

Primary outcome measures

  • 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)]
  • 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)]
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07320716 · 223136

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗