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Trial to Evaluate the Safety and Immunogenicity of a Placental Malaria Vaccine Candidate (PRIMVAC ) in Healthy Adults

NCT02658253 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-12-04

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the safety of 3 different dosages (20µg - 50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and Burkinabe adults.

The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions The safety profile will included local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria

Conditions

Interventions

BIOLOGICAL

PRIMVAC

3 different dosages of VAR2CSA protein (20µg - 50µg and 100µg)

BIOLOGICAL

GLA-SE

2.56 µg of GLA content

BIOLOGICAL

Alhydrogel

0.85 mg og Aluminium content

BIOLOGICAL

Placebo

0.9% Na cl

Sponsors & Collaborators

  • European Vaccine Initiative

    collaborator OTHER

  • Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

    collaborator OTHER

  • Centre national de recherche et de formation sur le paludisme

    collaborator OTHER_GOV

  • EUCLID Clinical Trial Platform

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

  • Odile Launay, Professor · Institut National de la Santé Et de la Recherche Médicale, France

  • Benoit GAMAIN, Dr · Institut National de la Santé Et de la Recherche Médicale, France

  • Sodiomon SIRIMA, Dr · Centre national de recherche et de formation sur le paludisme

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-09-19
Completion
2019-02-21

Countries

  • Burkina Faso
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02658253 on ClinicalTrials.gov