Safety and Immunogenicity of the Placental Malaria Vaccine Candidate PAMVAC Variously Adjuvanted

Summary

Despite having developed robust acquired immunity against complications of malaria, women can return to a susceptible state during their first pregnancies and contribute significantly to the burden of severe malaria in highly endemic areas. Naturally acquired protection against placental malaria correlates with the presence of high concentration of immunoglobulin G molecules (IgGs) against VAR2CSA, a parasite protein of the var gene family that is essential for the binding of infected erythrocytes to CSA in the placenta.

To induce high concentrations of specific IgGs, subjects will receive escalating doses of PAMVAC vaccine antigen adjuvanted with Alhydrogel, Glucopyranosyl Lipid Adjuvant-Stable Emulsion (GLA-SE) or Glucopyranosyl Lipid Adjuvant-Liposome-QS-21 Formulation (GLA-LSQ). Three injections with the same dosage and adjuvant will be done, each 28 days apart (Day 0, 28 and 56). Control subjects will receive physiological saline instead of the vaccine and dose escalation will be staggered to ensure safety during the trial.

Conditions

• Malaria, Antepartum

Interventions

BIOLOGICAL

PAMVAC

BIOLOGICAL

Alhydrogel

BIOLOGICAL

GLA-SE

BIOLOGICAL

GLA-LSQ

OTHER

Placebo

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Université d'Abomey-Calavi

  collaborator OTHER

• European Vaccine Initiative

  collaborator OTHER

• Institut de Recherche pour le Developpement

  collaborator OTHER_GOV

• ExpreS2ion Biotechnologies

  collaborator INDUSTRY

• University Hospital Tuebingen

  lead OTHER

Principal Investigators

• Benjamin G Mordmüller, MD · University Hospital Tübingen

• Saadou Issifou, MD · Université d'Abomey-Calavi

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2017-11-10

Completion

2017-11-10

Countries

• Benin

Study Locations