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

ConditionDiarrhoea
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age26-55
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AltSonflex1-2-3

    Biological/Vaccine

    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.

  • Menveo

    Biological/Vaccine

    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.

  • Infanrix hexa

    Biological/Vaccine

    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.

  • TYPHIBEV

    Biological/Vaccine

    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.

Treatment groups

528 Participants
are divided into 4 treatment groups
Group A: H06_01TP Study_Infants_Selected doseExperimental treatment 1 intervention
Group B: H06_01TP Study_ ST2_Infants_ControlActive comparator 2 interventions
Group C: H06_02TP Study_Infants_Selected doseExperimental treatment 1 intervention
Group D: H06_02TP Study_ Infants_ControlActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA)

S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.

Time frame
At Visit 1 of the current study (12 months after last vaccination in the parent studies)
2

Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA

S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.

Time frame
At Visit 2 of the current study (24 months after last vaccination in the parent studies)
3

Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA

S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.

Time frame
At Visit 3 of the current study (36 months after last vaccination in the parent studies)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov

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