ArticleEBioMedicine2019
Preclinical immunogenicity and safety of the cGMP-grade placental malaria vaccine PRIMVAC.
Article in EBioMedicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02658253 (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), which is not on this map. Cited by 19 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
19 citing papers in PubMed.
- High Antibodies to VAR2CSA in Response to Malaria Infection Are Associated With Improved Birthweight in a Longitudinal Study of Pregnant Women.Frontiers in immunology · 2021Trial
- FIKK1, a member of the FIKK kinase family, phosphorylates VAR2CSA and regulates adhesion of Plasmodium falciparum-infected erythrocytes to the placental receptor CSA.PLoS pathogens · 2026Article
- Immunization strategies to prevent malaria in pregnancy - a multistakeholder workshop.Vaccine · 2026Article
- Preclinical immunogenicity and safety evaluation of MDCK cell-derived quadrivalent influenza virus subunit vaccine.Frontiers in immunology · 2026Article
- Prokaryote- and Eukaryote-Based Expression Systems: Advances in Post-Pandemic Viral Antigen Production for Vaccines.International journal of molecular sciences · 2024Review
- Aotus nancymaae model predicts human immune response to the placental malaria vaccine candidate VAR2CSA.Lab animal · 2023Article
- Cryo-EM reveals the conformational epitope of human monoclonal antibody PAM1.4 broadly reacting with polymorphic malarial protein VAR2CSA.PLoS pathogens · 2022Article
- BMFPs, a versatile therapeutic tool for redirecting a preexisting Epstein-Barr virus antibody response toward defined target cells.Science advances · 2022Article
- Comprehensive Overview of Vaccination during Pregnancy in Europe.Journal of personalized medicine · 2021Review
- Future vaccines in pregnancy.Best practice & research. Clinical obstetrics & gynaecology · 2021Review
- Progress and Insights Toward an Effective Placental Malaria Vaccine.Frontiers in immunology · 2021Review
- Generation of a Peptide Vaccine Candidate against Falciparum Placental Malaria Based on a Discontinuous Epitope.Vaccines · 2020Article
- VAR2CSA-Mediated Host Defense Evasion ofFrontiers in immunology · 2020Review
- Placental Malaria.Current tropical medicine reports · 2020Review
- Cerebral Plasmodium falciparum malaria: The role of PfEMP1 in its pathogenesis and immunity, and PfEMP1-based vaccines to prevent it.Immunological reviews · 2020Review
- VAR2CSA binding phenotype has ancient origin and arose before Plasmodium falciparum crossed to humans: implications in placental malaria vaccine design.Scientific reports · 2019Article
- Phosphorylation of the VAR2CSA extracellular region is associated with enhanced adhesive properties to the placental receptor CSA.PLoS biology · 2019Article
- Progress towards vaccines to protect pregnant women from malaria.EBioMedicine · 2019Article
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVAR2CSA is the lead antigen for developing a vaccine that would protect pregnant women against placental malaria. A multi-system feasibility study has identified E. coli as a suitable bacterial expression platform allowing the production of recombinant VAR2CSA-DBL1x-2x (PRIMVAC) to envisage a prompt transition to current Good Manufacturing Practice (cGMP) vaccine production.
methodsExtensive process developments were undertaken to produce cGMP grade PRIMVAC to permit early phase clinical trials. PRIMVAC stability upon storage was assessed over up to 3 years. A broad toxicology investigation was carried out in rats allowing meanwhile the analysis of PRIMVAC immunogenicity.
findingsWe describe the successful cGMP production of 4. 65 g of PRIMVAC. PRIMVAC drug product was stable and potent for up to 3 years upon storage at -20 °C and showed an absence of toxicity in rats. PRIMVAC adjuvanted with Alhydrogel® or GLA-SE was able to generate antibodies able to recognize VAR2CSA expressed at the surface of erythrocytes infected with different strains. These antibodies also inhibit the interaction of the homologous NF54-CSA strain and to a lower extend of heterologous strains to CSA.
interpretationThis work paved the way for the clinical development of an easily scalable low cost effective vaccine that could protect against placental malaria and prevent an estimated 10,000 maternal and 200,000 infant deaths annually. FUND: This work was supported by a grant from the Bundesministerium für Bildung und Forschung (BMBF), Germany through Kreditanstalt für Wiederaufbau (KfW) (Reference No: 202060457) and through funding from Irish Aid, Department of Foreign Affairs and Trade, Ireland.
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