MalariaPhase 1PRIMALVACNCT02658253

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

A Phase 1 study testing PRIMVAC, GLA-SE and Alhydrogel in people with Malaria, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Malaria
What is being tested?: PRIMVAC, GLA-SE and Alhydrogel
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 2 sitesin 2 countries
Study dates: Jan 2016to 21 Feb 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Show all 13Show fewer

Individuals affiliated to a social security regimen
Volunteer registered in the French Health ministry computerized file and authorized to participate in a clinical trial
Written informed consent (must be obtained prior initiation of any study related intervention)
Nulligest 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)

Who cannot join

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).

Show all 44Show fewer

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.
Administration of immunoglobulins and/or any blood products within the three months preceding the inclusion.
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)
Seropositive for hepatitis B virus surface antigen (HBsAg)
Seropositive for hepatitis C virus (antibodies to HCV)
Seropositive for human immunodeficiency virus (antibodies to HIV 1-2)
Any other serious chronic illness requiring hospital specialist supervision.
Any clinically significant abnormal finding on screening biochemistry or hematology blood tests or urinalysis
Symptoms, physical signs or laboratory values suggestive of systemic disorders, including infectious renal, hepatic, cardiovascular, pulmonary, cutaneous, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the volunteers.
Volunteer under guardianship or legal incapacitation.
Pregnancy ongoing as determined by a positive urinary test
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 trial data, based on investigator's judgment.
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.
Administration of immunoglobulins and/or any blood products within the three months preceding the inclusion.
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).
Seropositive for hepatitis B virus surface antigen (HBsAg).
Seropositive for hepatitis C virus (antibodies to HCV).
Seropositive for human immunodeficiency virus (antibodies to HIV 1-2).
Any other serious chronic illness requiring hospital specialist supervision.
Any clinically significant abnormal finding on screening biochemistry or hematology blood tests or urinalysis
Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, cutaneous, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the volunteers.
Volunteer under guardianship or legal incapacitation.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Burkina Faso1 site

CNRFP
Ouagadougou, BP 2208

Other trials in Burkina Faso

France1 site

CIC 1417
Paris, 75679

Other trials in France

About this study

Official title: Phase Ia/Ib, Randomized, Double Blinded, Dose Escalation Trial to Evaluate the Safety and Immunogenicity in Healthy European and Burkinabe Adults of a Placental Malaria Vaccine Candidate (PRIMVAC) Formulated With Alhydrogel ® or GLA-SE

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

Read the detailed description

The project aims are:

Primary objective is to evaluate the safety of 3 different dosages (20µg - 50µg and 100µg) of the PRIMVAC vaccine adjuvanted either with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and Burkinabe adults.
Secondary objectives are to assess:
the humoral immune response to the PRIMVAC vaccine antigen (VAR2CSA) by measuring the variation in the level of total IgG and the level of the isotypic subtypes capable of recognizing the native antigen.
the cellular immune response by measuring:
the number of T cell secreting IL5 and IFNg following an ex-vivo stimulation with the vaccine antigen
the B lymphocyte phenotypes isolated from PBMC
Exploratory objectives are:
To explore the quality of the humoral immune response by the measure of the capability of the antibodies specific to the vaccine antigen to:
Cross-react with different VAR2CSA variants expressed on the surface of erythrocytes infected by various strains of Plasmodium falciparum,
Inhibit interactions between parasitized erythrocytes expressing different VAR2CSA variants and Chondroitin Sulfate A (receptor involved in placental sequestration),
Promote opsonic phagocytosis of parasitized erythrocytes with various strains of Plasmodium falciparum expressing different VAR2CSA variants
To explore the quality of the cellular immune response induced by the vaccine antigen by the quantitation of a large panel of cytokines in the ELISpot supernatants.

Conditions: Malaria
Being tested: PRIMVAC, GLA-SE, Alhydrogel, Placebo
Keywords: Placental malaria vaccine, Plasmodium, PRIMALVAC
Medical subject headings: Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRIMVACBiological
3 different dosages of VAR2CSA protein (20µg - 50µg and 100µg)
GLA-SEBiological
2.56 µg of GLA content
AlhydrogelBiological
0.85 mg og Aluminium content
PlaceboBiological
0.9% Na cl

Study groups in NCT02658253
Study group	Role	What they receive
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 Receives: Biological: PRIMVAC; Biological: 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 Receives: Biological: PRIMVAC; Biological: 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 Receives: Biological: PRIMVAC; Biological: 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 Receives: Biological: PRIMVAC; Biological: 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 Receives: Biological: PRIMVAC; Biological: 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 Receives: Biological: PRIMVAC; Biological: 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 Receives: 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 Receives: Biological: PRIMVAC; Biological: 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 Receives: Biological: PRIMVAC; Biological: 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 Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
clinical and biological SAEFI and SARI (Serious Adverse Reaction following Immunization (SARI) measured at any time during the volunteer follow-up
Measured: 14 months
Proportion of volunteer with at least one of Adverse Event Following Immunization (AEFI) measured until 1 month post-dose 3
Immediate AEFI (within 1h following vaccination) as well as unrelated, Related or possibly related solicited and unsolicited AEFI
Measured: 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)
Immediate AEFI (within 1h following vaccination) as well as unrelated, Related or possibly related solicited and unsolicited AEFI
Measured: 11 months
Variation in humoral immune response to the vaccine antigen assessed by ELISA
The level of total IgG (g/l): between D0 and the post-vaccination time points M1, M1+7D, M2, M2+7D, M3, M6 and M14
Measured: 14 months
Variation in humoral immune response to the vaccine antigen assessed by ELISA
The level (g/l) of the isotypic subtypes (IgG1, IgG2, IgG3, IgG4) between D0 and the post-vaccination time point M3
Measured: 3 months
Cellular immune responses to the vaccine antigen by Elispot
The median number of spots by ELISpot assay, allowing the counting of IL5 and IFNg secreting cells following an ex-vivo stimulation of PBMC with the vaccine antigen at V0, and 7 days post-dose 1 and 3 (D0- D7 and M2+7D)
Measured: 63 days
Cellular immune responses to the vaccine antigen by FACS
CD19, IgD, CD27, CD38, CD24 and CD43 B lymphocytes subpopulations will be isolated from PBMC at D0 and M2+7D. The data will be expressed for each phenotype as the median percentage of subpopulations among total CD19 B lymphocytes
Measured: 63 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201621 Feb 2019

First posted18 Jan 2016 (estimated)
Study startJan 2016
Primary completion19 Sep 2018
Study completion21 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for MalariaStudies of the same condition, open and under way.
More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02658253
Sponsor's protocol ID: C14-60
Other IDs: 2015-002246-31, 2015
Acronym: PRIMALVAC
Status last verified: Feb 2025
First submitted: 7 Jan 2016
Last updated: 4 Dec 2025
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 30885725
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.
PubMed 33717176
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.
PubMed 32032566

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase Ia/Ib, Randomized, Double Blinded, Dose Escalation Trial to Evaluate the Safety and Immunogenicity in Healthy European and Burkinabe Adults of a Placental Malaria Vaccine Candidate (PRIMVAC) Formulated With Alhydrogel ® or GLA-SE
ClinicalTrials.gov ID: NCT02658253
Acronym / sponsor ID: PRIMALVAC / C14-60
Conditions: Malaria
Keywords: Placental malaria vaccine, Plasmodium, PRIMALVAC
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, FranceOther government
Collaborators: European Vaccine Initiative, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne, Centre national de recherche et de formation sur le paludisme, EUCLID Clinical Trial Platform
Study start: Jan 2016
Primary completion: 19 Sep 2018 (actual)
Study completion: 21 Feb 2019 (actual)
First posted: 18 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The project aims are:

Primary objective is to evaluate the safety of 3 different dosages (20µg - 50µg and 100µg) of the PRIMVAC vaccine adjuvanted either with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and Burkinabe adults.
Secondary objectives are to assess:
the humoral immune response to the PRIMVAC vaccine antigen (VAR2CSA) by measuring the variation in the level of total IgG and the level of the isotypic subtypes capable of recognizing the native antigen.
the cellular immune response by measuring:
the number of T cell secreting IL5 and IFNg following an ex-vivo stimulation with the vaccine antigen
the B lymphocyte phenotypes isolated from PBMC
Exploratory objectives are:
To explore the quality of the humoral immune response by the measure of the capability of the antibodies specific to the vaccine antigen to:
Cross-react with different VAR2CSA variants expressed on the surface of erythrocytes infected by various strains of Plasmodium falciparum,
Inhibit interactions between parasitized erythrocytes expressing different VAR2CSA variants and Chondroitin Sulfate A (receptor involved in placental sequestration),
Promote opsonic phagocytosis of parasitized erythrocytes with various strains of Plasmodium falciparum expressing different VAR2CSA variants
To explore the quality of the cellular immune response induced by the vaccine antigen by the quantitation of a large panel of cytokines in the ELISpot supernatants.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
Group A1:Primvac 20 µg +alhydrogel	Experimental	Biological: PRIMVAC, Biological: AlhydrogelGroup A1: 3 European volunteers 0.5 ml intramuscular injection: 20 µg Primvac+ 0.85 mg Alhydrogel® Vaccination schedule: D0, D28 and D56
Group A2:Primvac 20 µg +GLA-SE	Experimental	Biological: PRIMVAC, Biological: GLA-SEGroup A2: 3 European volunteers 0.5 ml intramuscular injection:20 µg Primvac+ 2.5 µg GLA-SE Vaccination schedule: D0, D28 and D56
Group B1:Primvac 50 µg +alhydrogel	Experimental	Biological: PRIMVAC, Biological: AlhydrogelGroup B1: 6 European volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 0.85 mg Alhydrogel® Vaccination schedule: D0, D28 and D56
Group B2:Primvac 50 µg +GLA-SE	Experimental	Biological: PRIMVAC, Biological: GLA-SEGroup B2: 6 European volunteers 0.5 ml intramuscular injection:50 µg Primvac+ 2.5 µg GLA-SE Vaccination schedule: D0, D28 and D56
Group C1:Primvac 50 µg +alhydrogel	Experimental	Biological: PRIMVAC, Biological: AlhydrogelGroup C1: 10 African volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 0.85 mg Alhydrogel® Vaccination schedule: D0, D28 and D56
Group C2: Primvac 50 µg +GLA-SE	Experimental	Biological: PRIMVAC, Biological: GLA-SEGroup C2: 10 African volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 2.5 µg GLA-SE Vaccination schedule: D0, D28 and D56
Group C3: Placebo	Placebo comparator	Biological: PlaceboGroup C3: 5 African volunteers 0.5 ml intramuscular injection: NaCl 0.9% (placebo) Vaccination schedule: D0, D28 and D56
Group D1:Primvac 100 µg +alhydrogel	Experimental	Biological: PRIMVAC, Biological: AlhydrogelGroup D1: 10 African volunteers 0.6 ml intramuscular injection: 100µg Primvac+ 0.85 mg Alhydrogel® Vaccination schedule: D0, D28 and D56
Group D2: Primvac 100 µg +GLA-SE	Experimental	Biological: PRIMVAC, Biological: GLA-SEGroup D2: 10 African volunteers 0.6 ml intramuscular injection: 100 µg Primvac+ 2.56 µg GLA-SE Vaccination schedule: D0, D28 and D56
Group D3: placebo	Placebo comparator	Biological: PlaceboGroup D3: 5 African volunteers 0.6 ml intramuscular injection: NaCl 0.9% (placebo) Vaccination schedule: D0, D28 and D56

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

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)

Key exclusion criteria (44 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PRIMVAC3 different dosages of VAR2CSA protein (20µg - 50µg and 100µg)	Biological	Group A1:Primvac 20 µg +alhydrogel, Group A2:Primvac 20 µg +GLA-SE, Group B1:Primvac 50 µg +alhydrogel, Group B2:Primvac 50 µg +GLA-SE, Group C1:Primvac 50 µg +alhydrogel, Group C2: Primvac 50 µg +GLA-SE, Group D1:Primvac 100 µg +alhydrogel, Group D2: Primvac 100 µg +GLA-SE
GLA-SE2.56 µg of GLA content	Biological	Group A2:Primvac 20 µg +GLA-SE, Group B2:Primvac 50 µg +GLA-SE, Group C2: Primvac 50 µg +GLA-SE, Group D2: Primvac 100 µg +GLA-SE
Alhydrogel0.85 mg og Aluminium content	Biological	Group A1:Primvac 20 µg +alhydrogel, Group B1:Primvac 50 µg +alhydrogel, Group C1:Primvac 50 µg +alhydrogel, Group D1:Primvac 100 µg +alhydrogel
Placebo0.9% Na cl	Biological	Group C3: Placebo, Group D3: placebo

Primary outcome

Proportion of volunteers with treatment-related adverse events as assessed by FDA scale and the INYVAX EC FP7 Brighton Collaboration Foundation
Time frame: 35 days
Grade 3 or higher clinical or laboratory ARI and persisting at Grade 3 for > 48 hours between D0 and D35.

7 secondary outcomes

Proportion of volunteer with at least one Serious Adverse Event Following Immunization (SAEFI) for the entire duration of the study
Time frame: 14 months
Proportion of volunteer with at least one of Adverse Event Following Immunization (AEFI) measured until 1 month post-dose 3
Time frame: 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)
Time frame: 11 months
Variation in humoral immune response to the vaccine antigen assessed by ELISA
Time frame: 14 months
Variation in humoral immune response to the vaccine antigen assessed by ELISA
Time frame: 3 months
Cellular immune responses to the vaccine antigen by Elispot
Time frame: 63 days
Cellular immune responses to the vaccine antigen by FACS
Time frame: 63 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
Results publication: PubMed 30885725Chene 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.
Results publication: PubMed 33717176Gamain 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.
Results publication: PubMed 32032566Sirima 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Odile Launay, Professor study chair

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

Benoit GAMAIN, Dr study director

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

Sodiomon SIRIMA, Dr study chair

Centre national de recherche et de formation sur le paludisme

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRIMVAC, GLA-SE and Alhydrogel in people with Malaria, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Burkina Faso, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of volunteers with treatment-related adverse events as assessed by FDA scale and the INYVAX EC FP7 Brighton Collaboration Foundation (time frame: 35 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02658253, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.