A Study to Investigate the Safety and Immunogenicity of the SF2a-TT15 Synthetic Carbohydrate-based Conjugate Vaccine Against Shigella Flexneri 2a

Summary

A study among adults, children and infants in Kenya to determine if a new type of glycoconjugate vaccine incorporating a synthetic carbohydrate component is safe and induces immunity against Shigella.

Conditions

• Healthy

Interventions

BIOLOGICAL

Injection SF2A-TT15 10 µg Adjuvanted

Intramuscular injection of experimental vaccine (adjuvanted 10 µg)

BIOLOGICAL

Injection SF2A-TT15 10 µg

Intramuscular injection of experimental vaccine (not adjuvanted 10 µg)

BIOLOGICAL

Injection Adjuvanted Placebo

Intramuscular injection of Placebo with alhydrogel

BIOLOGICAL

Injection Placebo

Intramuscular injection of the not adjuvanted Placebo

BIOLOGICAL

Injection SF2A-TT15 2 µg Adjuvanted

Intramuscular injection of experimental vaccine (adjuvanted 2 µg)

BIOLOGICAL

Injection SF2A-TT15 2 µg

Intramuscular injection of experimental vaccine (not adjuvanted 2 µg)

Sponsors & Collaborators

• Wellcome Trust

  collaborator OTHER

• Gates Medical Research Institute

  collaborator OTHER

• Henry M. Jackson Foundation Medical Research International

  collaborator UNKNOWN

• Walter Reed Army Institute of Research (WRAIR)

  collaborator FED

• Parexel

  collaborator INDUSTRY

• ClinWin Research

  collaborator UNKNOWN

• Institut Pasteur

  lead INDUSTRY

Principal Investigators

• Armelle Phalipon, PhD · Institut Pasteur

• Laurence Mulard, PhD · Institut Pasteur

• Christiane Gerke, PhD · Institut Pasteur (Consulting)

• Fredrick Sawe, MBChB MMED · Kenya Medical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

8 Months

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-06

Primary Completion

2023-04-12

Completion

2023-11-15

Countries

• Kenya

Study Locations