NCT02658253

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2016

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2019

Completed
Last Updated

December 4, 2025

Status Verified

February 1, 2025

Enrollment Period

2.7 years

First QC Date

January 7, 2016

Last Update Submit

November 26, 2025

Conditions

Malaria

Keywords

Placental malaria vaccinePlasmodiumPRIMALVAC

Outcome Measures

Primary Outcomes (1)

  • Proportion of volunteers with treatment-related adverse events as assessed by FDA scale and the INYVAX EC FP7 Brighton Collaboration Foundation

    Grade 3 or higher clinical or laboratory ARI and persisting at Grade 3 for \> 48 hours between D0 and D35.

    35 days

Secondary Outcomes (7)

  • Proportion of volunteer with at least one Serious Adverse Event Following Immunization (SAEFI) for the entire duration of the study

    14 months

  • Proportion of volunteer with at least one of Adverse Event Following Immunization (AEFI) measured until 1 month post-dose 3

    3 months

  • Proportion of volunteer with at least one Adverse Event Following Immunization (AEFI) measured between M3 and the end of the study (only phase Ia)

    11 months

  • Variation in humoral immune response to the vaccine antigen assessed by ELISA

    14 months

  • Variation in humoral immune response to the vaccine antigen assessed by ELISA

    3 months

  • +2 more secondary outcomes

Other Outcomes (2)

  • Quality of the humoral immune responses

    3 months

  • Quality of the cellular immune response by the Multiplex technology

    63 days

Study Arms (10)

Group A1:Primvac 20 µg +alhydrogel

EXPERIMENTAL

Group A1: 3 European volunteers 0.5 ml intramuscular injection: 20 µg Primvac+ 0.85 mg Alhydrogel® Vaccination schedule: D0, D28 and D56

Biological: PRIMVACBiological: Alhydrogel

Group A2:Primvac 20 µg +GLA-SE

EXPERIMENTAL

Group A2: 3 European volunteers 0.5 ml intramuscular injection:20 µg Primvac+ 2.5 µg GLA-SE Vaccination schedule: D0, D28 and D56

Biological: PRIMVACBiological: GLA-SE

Group B1:Primvac 50 µg +alhydrogel

EXPERIMENTAL

Group B1: 6 European volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 0.85 mg Alhydrogel® Vaccination schedule: D0, D28 and D56

Biological: PRIMVACBiological: Alhydrogel

Group B2:Primvac 50 µg +GLA-SE

EXPERIMENTAL

Group B2: 6 European volunteers 0.5 ml intramuscular injection:50 µg Primvac+ 2.5 µg GLA-SE Vaccination schedule: D0, D28 and D56

Biological: PRIMVACBiological: GLA-SE

Group C1:Primvac 50 µg +alhydrogel

EXPERIMENTAL

Group C1: 10 African volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 0.85 mg Alhydrogel® Vaccination schedule: D0, D28 and D56

Biological: PRIMVACBiological: Alhydrogel

Group C2: Primvac 50 µg +GLA-SE

EXPERIMENTAL

Group C2: 10 African volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 2.5 µg GLA-SE Vaccination schedule: D0, D28 and D56

Biological: PRIMVACBiological: GLA-SE

Group C3: Placebo

PLACEBO COMPARATOR

Group C3: 5 African volunteers 0.5 ml intramuscular injection: NaCl 0.9% (placebo) Vaccination schedule: D0, D28 and D56

Biological: Placebo

Group D1:Primvac 100 µg +alhydrogel

EXPERIMENTAL

Group D1: 10 African volunteers 0.6 ml intramuscular injection: 100µg Primvac+ 0.85 mg Alhydrogel® Vaccination schedule: D0, D28 and D56

Biological: PRIMVACBiological: Alhydrogel

Group D2: Primvac 100 µg +GLA-SE

EXPERIMENTAL

Group D2: 10 African volunteers 0.6 ml intramuscular injection: 100 µg Primvac+ 2.56 µg GLA-SE Vaccination schedule: D0, D28 and D56

Biological: PRIMVACBiological: GLA-SE

Group D3: placebo

PLACEBO COMPARATOR

Group D3: 5 African volunteers 0.6 ml intramuscular injection: NaCl 0.9% (placebo) Vaccination schedule: D0, D28 and D56

Biological: Placebo

Interventions

PRIMVACBIOLOGICAL

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

Group A1:Primvac 20 µg +alhydrogelGroup A2:Primvac 20 µg +GLA-SEGroup B1:Primvac 50 µg +alhydrogelGroup B2:Primvac 50 µg +GLA-SEGroup C1:Primvac 50 µg +alhydrogelGroup C2: Primvac 50 µg +GLA-SEGroup D1:Primvac 100 µg +alhydrogelGroup D2: Primvac 100 µg +GLA-SE
GLA-SEBIOLOGICAL

2.56 µg of GLA content

Group A2:Primvac 20 µg +GLA-SEGroup B2:Primvac 50 µg +GLA-SEGroup C2: Primvac 50 µg +GLA-SEGroup D2: Primvac 100 µg +GLA-SE
AlhydrogelBIOLOGICAL

0.85 mg og Aluminium content

Group A1:Primvac 20 µg +alhydrogelGroup B1:Primvac 50 µg +alhydrogelGroup C1:Primvac 50 µg +alhydrogelGroup D1:Primvac 100 µg +alhydrogel
PlaceboBIOLOGICAL

0.9% Na cl

Group C3: PlaceboGroup D3: placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent (must be obtained prior initiation of any study related intervention)
  • Female of age ≥18 years to ≤35 years
  • Healthy as a result of review of medical history and/or clinical examination at the time of screening and clinical judgment of the investigator
  • Available for the duration of the trial (15 months)
  • Willingness to use reliable contraceptive methods such as: birth control pills or birth control patches or vaginal ring, diaphragm, IUD (intrauterine device), condom, progestin implant or injection, or surgical sterilization (hysterectomy, bilateral oophorectomy, tubal ligation) prior to enrollment at V0 and up to 4 weeks after last vaccination (V6)
  • Volunteer reachable by phone during the entire study duration
  • Individuals affiliated to a social security regimen
  • Volunteer registered in the French Health ministry computerized file and authorized to participate in a clinical trial

You may not qualify if:

  • Pregnancy ongoing as determined by a positive blood test or breastfeeding or lactation.
  • Intention to become pregnant during the trial
  • Volunteers who are not able to understand and to follow all required study procedures for the whole period of the study in the opinion of the investigator.
  • Volunteers with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
  • Volunteers participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
  • History of psychiatric condition that may affect participation in the study (i.e. depression, anti-depressant treatment).
  • Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the study data based on investigator's judgment.
  • Any history of malaria infection.
  • Travel to a malaria endemic region during the study period or within the six months preceding enrolment in the study.
  • Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • History of a serious adverse reaction to any vaccine, including Guillain-Barre Syndrome.
  • Administration or planned administration of a vaccine or gammaglobulin not foreseen by the clinical trial protocol within 30 days prior to the first immunization and up to 4 weeks after the last immunization.
  • Volunteers with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  • Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 3 months (inhaled and topical steroids are allowed)
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CNRFP

Ouagadougou, BP 2208, Burkina Faso

Location

CIC 1417

Paris, 75679, France

Location

Related Publications (3)

  • Chene A, Gangnard S, Guadall A, Ginisty H, Leroy O, Havelange N, Viebig NK, Gamain B. Preclinical immunogenicity and safety of the cGMP-grade placental malaria vaccine PRIMVAC. EBioMedicine. 2019 Apr;42:145-156. doi: 10.1016/j.ebiom.2019.03.010. Epub 2019 Mar 15.

    PMID: 30885725RESULT

  • Gamain B, Chene A, Viebig NK, Tuikue Ndam N, Nielsen MA. Progress and Insights Toward an Effective Placental Malaria Vaccine. Front Immunol. 2021 Feb 25;12:634508. doi: 10.3389/fimmu.2021.634508. eCollection 2021.

    PMID: 33717176RESULT

  • Sirima SB, Richert L, Chene A, Konate AT, Campion C, Dechavanne S, Semblat JP, Benhamouda N, Bahuaud M, Loulergue P, Ouedraogo A, Nebie I, Kabore M, Kargougou D, Barry A, Ouattara SM, Boilet V, Allais F, Roguet G, Havelange N, Lopez-Perez E, Kuppers A, Konate E, Roussillon C, Kante M, Belarbi L, Diarra A, Henry N, Soulama I, Ouedraogo A, Esperou H, Leroy O, Batteux F, Tartour E, Viebig NK, Thiebaut R, Launay O, Gamain B. PRIMVAC vaccine adjuvanted with Alhydrogel or GLA-SE to prevent placental malaria: a first-in-human, randomised, double-blind, placebo-controlled study. Lancet Infect Dis. 2020 May;20(5):585-597. doi: 10.1016/S1473-3099(19)30739-X. Epub 2020 Feb 4.

    PMID: 32032566RESULT

MeSH Terms

Conditions

Malaria

Interventions

glucopyranosyl lipid-AAluminum Hydroxide

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAluminum CompoundsAnionsIonsElectrolytes

Study Officials

  • Odile Launay, Professor

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

    STUDY CHAIR

  • Benoit GAMAIN, Dr

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

    STUDY DIRECTOR

  • Sodiomon SIRIMA, Dr

    Centre national de recherche et de formation sur le paludisme

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 18, 2016

Study Start

January 1, 2016

Primary Completion

September 19, 2018

Study Completion

February 21, 2019

Last Updated

December 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)FR(1)