A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants

Summary

The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a. The vaccine was first administered to adults 18 to 50 years of age in Europe. Subsequently, the vaccine was administered to a shigellosis-endemic population in Africa, first to adults 18 to 50 years of age, then to children 24 to 59 months of age, and finally to infants 9 months of age. Infants also received a third vaccination. Three different doses of the vaccine \[low, medium, and high amounts of antigen\] were evaluated using an age de-escalation approach (from the least vulnerable adult population to the most vulnerable paediatric population). The results of this study allowed the selection of the most appropriate dose for further vaccine development in infants 9 months of age, which was the main target age group for this vaccine.

Conditions

• Diarrhoea

Interventions

BIOLOGICAL

AltSonflex1-2-3 High Dose

2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age

BIOLOGICAL

AltSonflex1-2-3 Medium Dose

2 doses in children 24-59 months of age, 3 doses in infants 9 months of age

BIOLOGICAL

AltSonflex1-2-3 Low Dose

3 doses in infants 9 months of age

BIOLOGICAL

Menveo

1 dose in adults 18-50 years of age (stage 2) and children 24-59 months of age and 2 doses in infants 9 months of age

COMBINATION_PRODUCT

Boostrix

1 dose in adults 18-50 years of age (stage 2)

COMBINATION_PRODUCT

INFANRIX HEXA

1 dose in infants 9 months of age

COMBINATION_PRODUCT

Typhim-Vi

1 dose in children 24-59 months of age

BIOLOGICAL

MR-Vac

2 doses in children 24-59 months of age

DRUG

altSonflex Placebo

2 doses in adults 18-50 years of age (stage 1)

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

9 Months

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-06

Primary Completion

2025-06-24

Completion

2025-06-24

Countries

• Belgium
• Kenya

Study Locations